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Guide on Patentability Issues arising during

Search & Examination

Guide on Patentability Issues


arising during Search &
Examination

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Guide on Patentability Issues arising during
Search & Examination
What is in this Guide?

This Guide explains IPOS’ Search and Examination (SE) practice on patentability
issues in Singapore.

Purpose of this Guide

This Guide serves as a source of reference for our Examiners appointed pursuant to rule
2(3) of the Patent Rules and this will assist them in the course of performing SE on
Singapore patent applications as well as patents in re-examination or post grant SE.

The Registry of Patents, IPOS will continue to update this Guide from time to time, so
as to keep it relevant as far as possible.

Statements made in this Guide are not in themselves an authority and should not be
used as a set of legal requirements. Reference to legal requirements includes reference
to the Singapore Patents Act (Cap. 221), the Singapore Patents Rules and the Singapore
legal decisions.

Feedback if any

This Guide is prepared by the Patent Quality Management Unit (Search &
Examination). If you have any suggestions or feedback in relation to this Guide, please
drop us an e-mail (ipos_enquiry@ipos.gov.sg) and attention it to this Unit.

Patent Quality Management Unit (Search & Examination)


Registry of Patents
Intellectual Property Office of Singapore
51 Bras Basah Road #04-01
Plaza By The Park Singapore 189554
Tel: (65) 63398616
Fax (General): (65) 63390252
Fax (Patents): (65) 63399230
http://www.ipos.gov.sg; ipos_enquiry@ipos.gov.sg (attention: Patent Quality
Management Unit (Search & Examination))

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CONTENTS
Chapter Paragraphs Description

1 Introduction
1.1 to 1.5 A. Background
1.6 B. Singapore patents case law

2 Patentable Inventions
2.1 A. Statutory Requirements
2.2 to 2.4 B. Legislative History
2.5 to 2.6 C. Effect of the 1996 amendments – Open floodgates?
2.7 to 2.13 D. Patentable subject matter
i. Approach taken in Europe
ii. Approach taken in UK
iii. Approach taken in US
iv. Approach taken in Singapore
2.14 to 2.16 E. Invention
2.17 to 2.18 F. Patentable Invention
2.19 G. Patentability Assessment: In a Nutshell

3 Novelty
3.1 A. Statutory Requirements
3.2 to 3.6 B. State of the art
3.7 to 3.9 C. Grace Period
3.10 to 3.15 D. Priority Date
3.16 to 3.20 E. Novelty Test
i. Signpost is not enough
ii. Publicly made available
iii. Combining prior art
iv. Enabling Disclosure
3.21 to 3.23 F. Minimum Documentation
3.24 to 3.25 G. Internet Disclosures
3.26 to 3.27 H. Prior Art Consideration: Standard of proof

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CONTENTS
Chapter Paragraphs Description

3.28 to 3.31 I. Medical Use Claims


3.32 J. Novelty assessment: In a nutshell

4 Inventive Step
4.1 to 4.2 A. Statutory Requirements
4.3 to 4.6 B. Inventive Step Test
4.7 to 4.9 C. The Inventive Concept
4.10 to 4.14 D. The skilled addressee
4.15 to 4.17 E. Common General Knowledge
4.18 to 4.22 F. Third and fourth steps mentioned in the Windsurfing case
4.23 G. Combining prior art
4.24 H. No rule of thumb
4.25 I. Inventive Step assessment: In a nutshell

5 Industrial Application
5.1 to 5.2 A. Statutory Requirements
5.3 to 5.4 B. Industry
5.5 to 5.6 C. Capable of industrial application: Insufficient if vague and
speculative
5.7 to 5.8 D. “Methods of treatment & diagnosis” Exception
5.9 E. Industrial Applicability assessment: In a nutshell

6 Offensive, immoral or anti-social behaviour


6.1 A. Statutory Requirements
6. 2 to 6.7 B. Legislative History
6.8 to 6.12 C. What is offensive, immoral or anti-social behaviour
i. Examiner’s personal beliefs should not colour their
judgment
ii. Abhorrent
iii. Offensive and non-offensive use

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CONTENTS
Chapter Paragraphs Description

6.13 to 6.18 D. Section 13(3)


6.19 to 6.22 E. Patentability (Sections 13(2)) of inventions relating to genes
6.23 to 6.24 F. Patentability (Sections 13(2)) of inventions relating to
Chimeric animals
6.25 to 6.27 G. Patentability (Sections 13(2)) of inventions relating to
transgenic animals
6.28 to 6.30 H. Patentability (Sections 13(2)) of inventions relating to the
use of human embryonic stem cells
6.31 I. Section 13(2) assessment: In a nutshell

Annex List of Patent Decisions in Singapore

Table 1: 2.10 Comparison of patentability provisions


Table 2: 2.19 Overall Steps Involved in section 13 assessment
Table 3: 3.30 Comparison of Medical Use provisions (Novelty)
Table 4: 3.32 Steps Involved in assessing novelty under section 14
Table 5: 4.25 Steps Involved in assessing inventive step under section 15
Table 6: 5.2 Comparison of Industrial Application & Method of Treatment &
Diagnosis provisions
Table 7: 5.9 Steps Involved in assessing industrial application under section 16
Table 8: 6.3 Comparison of Morality provisions
Table 9: 6.31 Steps Involved in assessing the subject matter under section 13(2)

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1 INTRODUCTION
A Background

1.1 The patent system in Singapore has features which are similar to other patent regimes
around the world. In a nutshell, it allows for patent applications for inventions to be
filed with the Registry of Patents (Registry) at the Intellectual Property of Singapore
(IPOS), searched and examined on formal and substantive (includes patentability)
requirements, published soon after 18 months and granted patents if the grant
requirements are met. Further, as Singapore is a member of the Patent Co-operation
Treaty (PCT), in addition to allowing PCT applications to be filed with the Registry
as a PCT receiving Office, PCT applications designating Singapore can enter national
phase with the Registry.

S29 1.2 What is special in the Singapore patent system is the availability of several search
r36-50 and substantive examination (SE) options for applicants to choose from. They are
namely:

• the LOCAL SE route where applicants file search and/or examination


requests with the Registry,

• the FOREIGN SE route where applicants rely on the SE results of


corresponding or international/PCT patent applications and

• the MIXED SE route where applicants rely on the search results of


corresponding or international/PCT patent applications and file examination
requests with the Registry.

S 2(1) 1.3 This Guide focuses on the LOCAL & MIXED SE route where Search, Examination
or combined Search and Examination requests are filed with the Registry and then
subsequently sent to the Examiner. Section 2(1) of the Patents Act defines an
Examiner to mean “such person, organisation or foreign or international patent office
or organisation as may be prescribed to whom the Registrar may refer questions
relating to patents, including search and examination of applications for patents”.

r2(3) 1.4 Rule 2(3) of the Patent Rules explains that the Examiners prescribed for the purposes
of section 2 shall be the Australian Patent Office, the Austrian Patent Office, the
Danish Patent and Trademark Office and the Hungarian Patent Office.

1.5 The law that the Examiners apply when conducting Search, Examination or
combined Search and Examination on Singapore patent applications is Singapore

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patents law and this includes the Patents Act, the Patents Rules and local case law in
Singapore. Foreign case law and practice may be referred to, especially when it is
grounded on similarly worded legislative text. However, where there is a conflict
between local and foreign case law and practice, the local case law and practice
prevail and take precedence. We would add that the jurisprudence in Singapore is
relatively young in this area and there are provisions in the Patents Act which have
yet to be judicially decided on. Hence, in the absence of local case law on these
provisions, we would refer to relevant foreign law and practice for guidance. In any
event, we are not bound by these foreign law and practice but there could be relevant
principles to which we can draw from enabling us to provide an interface during this
period until local jurisprudence is available. This Guide is that interface.

B Singapore patents case law

1.6 Even though the patent system in Singapore started as early as in 1937, local case law
only started to grow in the last two decades. And grow we did, as to date, there are
patent decisions made by the Registry of Patents, IPOS, the High Court as well as the
Court of Appeal (which is the highest court of appeal in Singapore). These decisions
are important in the patent history of Singapore as they lay down the foundation on
how our patent legislation should be applied and we have annexed to this Guide
(Annex) a list of these patent decisions for one’s ease of reference. Copies of these
patent decisions are also provided to the Examiners and in addition, they can also ask
for them from our Patent Quality Management Unit (Search & Examination).

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2 PATENTABLE INVENTION
A Statutory requirements
S 13 2.1 Patentable inventions

Section 13.—(1) Subject to subsection (2), a patentable invention is one that satisfies
the following conditions:
(a) the invention is new;
(b) it involves an inventive step; and
(c) it is capable of industrial application

(2) An invention the publication or exploitation of which would be generally


expected to encourage offensive, immoral or anti-social behaviour is not a patentable
invention.

(3) For the purposes of subsection (2), behaviour shall not be regarded as offensive,
immoral or antisocial only because it is prohibited by any law in force in Singapore.

B Legislative History

2.2 Section 13 of the Patents Act shares its roots with section 1 of the United Kingdom
Patents Act 1977.

2.3 This section was amended by The Patents (Amendment) Act 1995 and the
amendments came into force on 1 Jan 96 via The Patents Act (Commencement)
Notification 1995. Section 13 as it was then (see extract below) was amended by
deleting subsections (2) and (5).

2.4 Section 13 as it was then (prior to the amendment in 1996).

Patentable inventions

13. —(1) Subject to subsections (2) and (3), a patentable invention is one that
satisfies the following conditions:
(a) the invention is new;
(b) it involves an inventive step; and
(c) it is capable of industrial application.

(2) It is hereby declared that the following (among other things) are not

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inventions for the purposes of this Act, that is to say, anything which consists
of —

(a) a discovery, scientific theory or mathematical method;

(b) a literary, dramatic, musical or artistic work or any other


aesthetic creation whatsoever;

(c) a scheme, rule or method for performing a mental act, playing a


game or doing business, or a program for a computer; or

(d) the presentation of information,

but the foregoing provisions shall prevent anything from being treated as an
invention for the purposes of this Act only to the extent that a patent or an
application for a patent relates to that thing as such.

(3) An invention the publication or exploitation of which would be generally


expected to encourage offensive, immoral or anti-social behaviour is not a
patentable invention.

(4) For the purposes of subsection (3), behaviour shall not be regarded as
offensive, immoral or anti-social only because it is prohibited by any law in
force in Singapore.

(5) The Minister may, by order published in the Gazette, vary the provisions
of subsection (2) for the purposes of maintaining them in conformity with
developments in science and technology.

NB. The sub-sections in italics were deleted in the 1996 amendments.

C Effect of the 1996 amendments – Open floodgates?

2.5 Arising from the 1996 amendments where Section 13 as it was then was amended by
deleting subsections (2) and (5), some questioned whether they resulted in the
opening of floodgates and that anything now can be an invention. Guidance in
Singapore can be derived from the Parliamentary Speech of Assoc. Prof. Ho Peng
Kee (then Parliamentary Secretary to the Minister for Law) when he introduced the
amendments to the Patents Act in 1995 and explained during the Second Reading in
Parliament:

Sir, other amendments in the Bill include the deletion of section 13(2) of the
Act. Section 13(2) is a short and non- exhaustive listing of subjects which are

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considered non-patentable, eg, a discovery or mathematical model.

He went further to explain:

Sir, this deletion will not limit our flexibility in rejecting any subject matter
which is non-patentable under section 13(1). The existing provisions are
sufficient to enable Singapore to keep up with advances and changes in
science and technology.

2.6 Section 13(2) as it was then, provides a non exhaustive list of subject matter which
were not inventions under Section 13 and with the removal of this subsection, the
impact as to what inventions fall under Section 13 remains unchanged. The repeal of
this non exhaustive list should not be read to mean that subject matter which was
formerly excluded as “invention” is now considered as “patentable invention”. The
subject matter still has to meet the requirements of it being an invention and that it
meets the test in section 13.

D Patentable subject matter


i. Approach taken in Europe

2.7 Articles 52(2) and 52(3) of the European Patent Convention (EPC) contains a non
exclusive list of subject matter as such that are not to be regarded as inventions and
article 53 identifies the types of inventions that are excluded from patentability. In
UK, similar provisions are found in sections 1, 4A and Schedule A2 of the UK
Patents Act. Even though the UK and EPC requirements are similar, the steps
leading up to an assessment of whether an invention meets these requirements is not
the same.

2.8 In brief, the European Patent Office (EPO) determines whether the claimed subject
matter in the patent application as a whole is excluded from being considered an
invention and assesses whether the claimed subject matter has a technical character.
In the process, features of the claimed subject matter having technical character are
identified and assessed for inventive step. An invention is non patentable if it has no
technical character. Therefore if the claimed subject matter does not have technical
character the claims will not be examined. More information on the patent practice
before the EPO can be found in http://www.epo.org/.

ii. Approach taken in UK

2.9 The UK patent office’s practice on the other hand applies the “four step approach”
referred to by Jacob LJ in Aerotel Ltd v Telco Holdings Ltd & Ors Rev 1 [2007] RPC
7 (Aerotel/Macrossan). This test is reproduced as follows:

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40. The approach is in 4 steps:

“(1) properly construe the claim

(2) identify the actual contribution;

(3) ask whether it falls solely within the excluded


subject matter;

(4) check whether the actual or alleged contribution is


actually technical in nature”.

2.10 A quick comparison of articles 52(2), 52(3) and 53 of the European Patent
Convention (EPC) with sections 1, 4A and Schedule A2 of the UK Patents Act and
sections 13, 14, 16 of the Singapore Patents Act can be found in the table below. For
the most part, one can say that our laws are similar. However, what is noticeably
absent in the Singapore provisions is an elaboration of what is not considered to be
an invention. Neither is there any mention about excluding plant or animal varieties
or essentially biological processes for the production of plants or animals from
patentability.

Table 1: Comparison of patentability provisions


SG Current UK Current EPC
Not inventions No Equivalent “(2) It is hereby “(2) The following in
statutory provision declared that the particular shall not be
following (among regarded
other things) are not as inventions…:
inventions for the …discoveries,
purposes of scientific theories and
this Act, …- mathematical
… a discovery, methods… as such.”
scientific theory or Re: EPC Art 52(2)
mathematical
method… as such.”
Re: UK Section 1(2)

Not inventions No Equivalent “(2) It is hereby “(2) The following in


statutory provision declared that the particular shall not be
following (among regarded as
other things) are not inventions…:
inventions for the … aesthetic
purposes of creations… as such.”
this Act, …- Re: EPC Art 52(2)
… a literary, dramatic,
musical or artistic work

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Table 1: Comparison of patentability provisions
SG Current UK Current EPC
or any other aesthetic
creation whatsoever…
as such.”
Re: UK Section 1(2)
Not inventions No Equivalent “(2) It is hereby “(2) The following in
statutory provision declared that the particular shall not be
following (among regarded as
other things) are not inventions…:
inventions for the … schemes, rules and
purposes of methods for
this Act, …- performing mental
… a scheme, rule or acts, playing games or
method for performing doing business, and
a mental act, playing a programs for
game or doing computers… as such.”
business, or a program Re: EPC Art 52(2)
for a computer… as
such.”
Re: UK Section 1(2)
Not inventions No Equivalent “(2) It is hereby “… presentations of
statutory provision declared that the information… as
following (among such.”
other things) are not Re: EPC Art 52(2)
inventions for the
purposes of
this Act, …-
… the presentation of
information;… as
such.”
Re: UK Section 1(2)

Not patentable / “An invention the “A patent shall not be European patents shall
patent not to be publication or granted for an not be granted in
granted exploitation of which invention the respect of:
would be generally commercial “(a) inventions the
expected to encourage exploitation of which commercial
offensive, immoral or would be contrary exploitation of which
anti-social behaviour is to public policy or would be contrary to
not a patentable morality” "ordre public" or
invention.” Re: UK Section 1(3) morality…”
Re: SG Section 13(2) Re: EPC Article 53a

Unpatentable / patent No Equivalent “An invention shall not European patents shall
not to be granted statutory provision be considered not be granted in
unpatentable solely on respect of:
the ground that it “(b) plant or animal
varieties or essentially

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Table 1: Comparison of patentability provisions
SG Current UK Current EPC
concerns - biological processes
(a) a product consisting for the production of
of or containing plants or animals; this
biological material; or provision shall not
(b) a process by which apply to
biological material is microbiological
produced, processed or processes or the
used.” products thereof”
Re: UK Paragraph 1 Re: EPC Article 53b
Schedule A2
Not capable of “An invention of a “A patent shall not be European patents shall
industrial application method of treatment of granted for the not be granted in
/ patent not to be the human or animal invention of- respect of
granted body by surgery or (a) a method of
therapy or of diagnosis treatment of the human
or animal body by “(c) methods for
practised on the human treatment of the human
or animal body shall surgery or therapy, or
(b) a method of or animal body by
not be taken to be surgery or therapy and
capable of industrial diagnosis practised on
the human or animal diagnostic methods
application.” practised on the human
Re: SG Section 16(2) body.”
or animal body; this
Re: UK Section provision shall not
4A(1) apply to products, in
particular substances or
compositions, for use
in any of these
methods.
Re: EPC Article 53c

Not patentable / No Equivalent “The following are not (1) The human body, at
patent not to be statutory provision patentable inventions – the various stages of its
granted formation and
(a) the human body, at development, and the
the various stages of simple discovery of
its formation and one of its elements,
development, and the including the sequence
simple discovery of or partial sequence of a
one of its elements, gene, cannot constitute
including the sequence patentable inventions.
or partial sequence
of a gene;
Re: EPC Rule 28
(b) processes for
cloning human beings;
Under Article 53(a),
(c) processes for European patents shall
modifying the germ not be granted in

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Table 1: Comparison of patentability provisions
SG Current UK Current EPC
line genetic identity of respect of
human beings; biotechnological
inventions which, in
(d) uses of human particular, concern the
embryos for industrial following:
or commercial
purposes; (a) processes for
cloning human beings;
(e) processes for
modifying the genetic
identity of animals (b) processes for
which are likely to modifying the germ
cause them suffering line genetic identity of
without any substantial human beings;
medical benefit to man
or animal, and also (c) uses of human
animals resulting from embryos for industrial
such processes; or commercial
purposes;
(f) any variety of
animal or plant or any
essentially biological (d) processes for
process for the modifying the genetic
production of animals identity of animals
or plants, not being a which are likely to
micro-biological or cause them suffering
other technical process without any substantial
or the product of such a medical benefit to man
process.” or animal, and also
animals resulting from
such processes.
Re: UK Paragraph 3
Schedule A2
Re: EPC Rule 28

See also European


Directive 98/44/EC on
the legal protection of
biotechnological
inventions

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iii. Approach taken in US

2.11 In the US 35 Patents Code, section 100 defines the term “invention” to mean an
invention or discovery and section 101 states that whoever invents or discovers any
new and useful process, machine, manufacture, or composition of matter, or any new
and useful improvement thereof, may obtain a patent therefor, subject to the
conditions and requirements of this title. Its Supreme Court in Diamond v.
Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), held that microorganisms
produced by genetic engineering are not excluded from patent protection by
35 U.S.C. 101. It also read the term 'manufacture' in section 101 in accordance with
its dictionary definition to mean 'the production of articles for use from raw materials
prepared by giving to these materials new forms, qualities, properties, or
combinations whether by hand labor or by machinery.'". More information on the
patent practice before the USPTO can be found in http://www.uspto.gov/

Recently, the case of In re Bilski, 545 F.3d 943, 88 U.S.P.Q.2d 1385 (Fed. Cir. 2008),
revived discussions on this subject when the US Court of Appeals for the Federal
Circuit did not apply the "useful, concrete, and tangible" test for patent-eligibility
previously set out in State Street Bank & Trust Co. v. Signature Financial Group,
Inc., 149 F.3d 1368 (Fed. Cir. 1998). In place, the court applied the machine-or
transformation test as the applicable test for patent-eligible subject matter. This is
now pending before the US Supreme Court.

This prompted the USPTO to issue interim examination instructions (See extracts
below) for evaluating subject matter eligibility under 35 USC § 101 pending the
Supreme Court’s decision on the appeal.

“There are two criteria for determining subject matter eligibility and both
must be satisfied. The claimed invention (1) must be directed to one of the
four statutory categories, and (2) must not be wholly directed to subject
matter encompassing a judicially recognized exception, as defined below.

Step 1: Is the claim directed to one of the four patent-eligible subject


matter categories: process, machine, manufacture, or composition of
matter? …

Step 2: Does the claim wholly embrace a judicially recognized


exception, which includes abstract ideas, mental processes or
substantially all practical uses (pre-emption) of a law of nature or a
natural phenomenon, or is it a particular practical application of a
judicial exception?”.

More information on the interim examination instructions can be found in


http://www.uspto.gov/web/offices/pac/dapp/opla/2009-08-

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25_interim_101_instructions.pdf

iv. Approach taken in Singapore

2.12 The approaches taken in Europe, UK and even in the US, however different their
patent laws may be, reveal a similar constant challenge faced when assessing whether
a particular subject matter is deserving of patent protection. Judicial bodies continue
to struggle to identify workable tests that could successfully sieve out cases not
eligible for patent protection. Tests such as “technical character”, “technical
contribution”, “technical effect”, "useful, concrete, and tangible" and “machine or
transformation” have sprung out through the years and we need to approach the use
of such tests with the relevant background (e.g. different statutory provisions) in
mind.

2.13 In Singapore, our Examiners should approach section 13 as it is and begin to assess
whether a claimed subject matter in a patent application is an invention. Unlike in
some other jurisdictions, our Examiners need not be embroiled in the debate on
whether a particular claimed subject matter falls within a statutory list of exclusions
and whether the subject matter has “technical character”, “technical contribution” or
“technical effect”. Instead, our Examiners should focus on the quest in ascertaining
whether a claimed subject matter is an invention to begin with.

E. Invention
2.14 What then is an invention? In the Singapore Court of Appeal’s decision of Merck &
Co Inc v Pharmaforte Singapore Pte Ltd [2000] SGCA 39, Chao Hick Tin JA said
said:

“In this regard, we must also point out that the fact that a discovery is made
does not mean there is an invention. The latter does not necessarily follow
from the former“.

His Honour cited Lindley LJ’s statement in the United Kingdom’s case of Lane Fox v
Kensington and Knightsbridge Electric Lighting Co [1892] 3 Ch 424 at p 429 where
he said:
“An invention is not the same thing as a discovery. When Volta discovered
the effect of an electric current from his battery on a frog’s leg he made a
great discovery, but no patentable invention. Again, a man who discovers that
a known machine can produce effects which no one before him knew could
be produced by it, may make a great and useful discovery; but, if he does no
more, his discovery is not a patentable invention: … He has added nothing
but knowledge to what previously existed. A patentee must do something

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more; he must make some addition, not only to knowledge, but to previously
known inventions, and must so use his knowledge and ingenuity as to
produce either a new and useful thing or result, or a new and useful method of
producing an old thing or result.”

2.15 Our Examiners should thus look out for that “something more” for the subject matter
in question to rise above the status of a “discovery” to the status of an “invention”.
Subject matter e.g. a scheme, rule or method for performing a mental act, playing a
game or doing business, or a program for a computer will thus have to pass the first
hurdle of it being an invention.

2.16 However, even if the Examiner were to form a preliminary view that the subject
matter in question is not an invention, he should proceed to consider if the other
limbs in section 13(1) are met. This subsequent step could assist the Examiner in re-
assessing his earlier preliminary view that the subject matter in question is not an
invention.

F Patentable invention
2.17 In Singapore, section 13(1) states that a patentable invention is one that satisfies the
following conditions:
(a) the invention is new;
(b) it involves an inventive step; and
(c) it is capable of industrial application.

Section 13(2) also goes on to say that “An invention the publication or exploitation of
which would be generally expected to encourage offensive, immoral or anti-social
behaviour is not a patentable invention.”

2.18 Hence, even after determining that the subject matter in question is an invention, is
new, involves an inventive step and is capable of industrial application, the invention
can still fail to qualify as a patentable invention if the publication or exploitation of
the invention would be generally expected to encourage offensive, immoral or anti-
social behaviour.

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G Patentability assessment: In a nutshell


2.19 In sum, the Examiner will assess the subject matter in question as follows and he
should include his assessment on all steps in the Written Opinion or Examination
Report, as the case may be. The following table summarises the steps to be taken by
the Examiner.

Table 2: Overall Steps Involved in section 13 assessment


Step 1 Is the subject matter in question is an invention? If yes or no, proceed to
Step 2.

Step 2 Is the subject matter in question, new? If yes or no, proceed to Step 3.

Step 3 Does the subject matter in question, involve an inventive step? If yes or
no, proceed to Step 4.

Step 4 Is the subject matter in question, capable of industrial application? If yes


or no, proceed to Step 5

Step 5 Is the subject matter in question, the publication or exploitation of the


invention would be generally expected to encourage offensive, immoral
or anti-social behaviour?

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3 NOVELTY
A Statutory requirements
S 14 3.1 Novelty

Section 14.—(1) An invention shall be taken to be new if it does not form part of the
state of the art.

(2) The state of the art in the case of an invention shall be taken to comprise all
matter (whether a product, a process, information about either, or anything else)
which has at any time before the priority date of that invention been made available
to the public (whether in Singapore or elsewhere) by written or oral description, by
use or in any other way.

(3) The state of the art in the case of an invention to which an application for a patent
or a patent relates shall be taken also to comprise matter contained in an application
for another patent which was published on or after the priority date of that invention,
if the following conditions are satisfied:

(a) that matter was contained in the application for that other patent both as
filed and as published; and

(b) the priority date of that matter is earlier than that of the invention.

(4) For the purposes of this section, the disclosure of matter constituting an invention
shall be disregarded in the case of a patent or an application for a patent if occurring
later than the beginning of the period of 12 months immediately preceding the date of
filing the application for the patent and either

(a) the disclosure was due to, or made in consequence of, the matter having
been obtained unlawfully or in breach of confidence by any person —

(i) from the inventor or from any other person to whom the matter was
made available in confidence by the inventor or who obtained it from
the inventor because he or the inventor believed that he was entitled to
obtain it; or

(ii) from any other person to whom the matter was made available in
confidence by any person mentioned in sub-paragraph (i) or in this
sub-paragraph or who obtained it from any person so mentioned
because he or the person from whom he obtained it believed that he

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was entitled to obtain it;

(b) the disclosure was made in breach of confidence by any person who
obtained the matter in confidence from the inventor or from any other person
to whom it was made available, or who obtained it, from the inventor;

(c) the disclosure was due to, or made in consequence of, the inventor
displaying the invention at an international exhibition and the applicant states,
on filing the application, that the invention has been so displayed and also,
within the prescribed period, files written evidence in support of the statement
complying with any prescribed condition; or

(d) the disclosure was due to, or made in consequence of, the inventor
describing the invention in a paper read by him or another person with his
consent or on his behalf before any learned society or published with his
consent in the transactions of any learned society.

(5) In subsection (4) (d), “learned society” includes any club or association
constituted in Singapore or elsewhere whose main object is the promotion of any
branch of learning or science.

(6) In this section, references to the inventor include references to any proprietor of
the invention for the time being.

(7) In the case of an invention consisting of a substance or composition for use in a


method of treatment of the human or animal body by surgery or therapy or of
diagnosis practised on the human or animal body, the fact that the substance or
composition forms part of the state of the art shall not prevent the invention from
being taken to be new if the use of the substance or composition in any such method
does not form part of the state of the art.

B State of the Art


S 14(1) 3.2 Section 14(1) sets out the requirements on novelty. It says that an invention shall be
S 14(2) taken to be new if it does not form part of the state of the art. Section 14(2) explains
S17
that the state of the art in the case of an invention shall be taken to comprise:

• all matter (whether a product, a process, information about either, or anything


else)
• which has at any time before the priority date of that invention been made
available to the public (whether in Singapore or elsewhere)
• by written or oral description, by use or in any other way.

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R42(3) 3.3 Where a Request for Examination Report relies on Foreign Search Results and the
Examiner requires any non-English documents cited in these results to be translated
into English, such translations may be sought from the IPOS Officer in the Patents
Search and Examination Unit who had previously forwarded the Request for
Examination Report to the Examiner. The applicants will then be informed of this
need and they will be required to respond within a specified time frame e.g. 2
months.

In the light of high translation costs to be borne by the applicants, translations of the
whole or part of the Non-English cited document should be sought only after the
Examiner exhausts the following alternatives:
(a) Rely on his or her knowledge of the e.g. French and German language where
applicable
(b) Refer to any English family members
(c) Refer to any available English Abstracts
(d) Apply Machine Translation Tools (freely available from the web) or request
the applicants to furnish a Machine Translation over the Non-English cited
document.

If, from the above, the Examiner is still of the opinion that a translation of part or the
whole Non-English cited document is necessary, he/she may proceed to request for it.

S2(1) 3.4 Section 14(2) defines a cut off date when making a state of the art consideration to
S 14(2) include all matter made publicly available at any time before the priority date.
S 14(3)
S17
However, Section 14(3) carves out an exception as it explains that the state of the art
in the case of an invention to which an application for a patent or a patent relates
includes matter
• contained in an application for another patent* which was published on or
after the priority date of that invention, if
o that matter was contained in the application for that other patent
both as filed and as published; and
o the priority date of that matter is earlier than that of the invention.

* Section 2(1) defines "patent" to mean a patent under the Patents Act and includes a
patent in force by virtue of Section 117 (3).

S 14(3) 3.5 In sum, Section 14(3) allows under limited circumstances, matter published after the
priority date of the invention to be considered as part of the state of the art. Only
applications for a patent, that is, either an application which is made under the Act or
one which is treated as such, are considered. See Figure below which illustrates a
patent application filed in Singapore and was accorded a number 123. This
application 123 claims priority of an earlier filed patent application in US. Hence, the
assessment of novelty will cover all relevant disclosures made before the US filing
date, this being the priority date of Singapore patent application 123. Meanwhile,

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there is a Singapore patent application 234 that was filed before the US filing but was
published after Singapore patent application 123. Singapore patent application 234
can fall under the ambit of Section 14(3).

S 15 3.6 It must also be noted that the Section 14(3) consideration is also limited to the
assessment of novelty and is not used for assessing inventive step.

C Grace Period
S 14(4) 3.7 On the issue of matter that had been made available to the public, Section 14(4)
S 14(5) provides for certain matter to be disregarded under Section 14(1) notwithstanding
that the matter falls under Section 14(2), if the disclosure was made under certain
circumstances, and within what is seen as a 12 month “grace period”. These
circumstances briefly include disclosures made as a result of a breach of confidence
or where the inventor revealed the invention at an International Exhibition or before a
learned society and Section 14(5) explains that a “learned society” includes any club
or association constituted in Singapore or elsewhere whose main object is the
promotion of any branch of learning or science.

r8 3.8 In the case of a disclosure at an International Exhibition, rule 8 of the Patent Rules
details the requirements that applicants are required to comply with.

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International exhibitions

8.—(1) An applicant for a patent who wishes the disclosure of matter


constituting an invention to be disregarded in accordance with section 14 (4)
(c) shall, within the same day of filing the application for the patent, inform the
Registrar in writing that the invention has been displayed at an international
exhibition.

(2) The applicant shall, within 4 months from the day of filing the application,
file a certificate, issued by the authority responsible for the exhibition, stating
that the invention was in fact exhibited there.

(3) The certificate shall also state the opening date of the exhibition and, where
the first disclosure of the invention did not take place on the opening date, the
date of the first disclosure.

(4) The certificate shall be accompanied by an identification of the invention,


duly authenticated by the authority.

(5) For the purposes of section 2 (2), a statement may be published in the
journal that an exhibition described in the statement falls within the definition
of international exhibition in section 2 (1).

(6) In the case of an international application for a patent (Singapore), the


application of this rule shall be subject to rule 86 (4).

3.9 Examiners will be informed of whether such a disclosure has been made in the
Patents Form 1 filed by the applicant. The patent request form (See extract of Patents
Form 1 below) of the patent application contains a section which facilitates the
applicant in making such a disclosure. Patents Form 1 is also enclosed together with
the Request for Search and/or Examination, when the Request is forwarded to the
Examiner.

For PCT national-phase (SG) entry applications, where applicants file a request for
Examination with IPOS, the Examiner will note that such a disclosure is made at the
International phase and this fact is revealed in the International Search Report (Rule
33.1 of the PCT Regulations).

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D Priority Date
S 14(2) 3.10 It is recalled that Section 14(1) says that an invention shall be taken to be new if it
does not form part of the state of the art while Section 14(2) explains that the state of
the art in the case of an invention shall be taken to comprise all matter which has at
any time before the priority date of that invention been made available to the public.

S17 3.11 Subsections (1) & (2) of Section 17 of the Patents Act are reproduced below and they
explain what the priority date refers to. In a nutshell, the priority date of an invention
by default is the date of filing of a patent application unless there is an earlier
relevant application filed in a convention country.

Priority date

17.—(1) For the purposes of this Act, the priority date of an invention to which
an application for a patent relates and also of any matter (whether or not the
same as the invention) contained in the application is, except as provided by
the provisions of this Act, the date of filing the application.

(2) Where in or in connection with an application for a patent (referred to in


this section as the application in suit) a declaration is made, whether by the
applicant or any predecessor in title of his, complying with the relevant
requirements of the rules and specifying one or more earlier relevant
applications for the purposes of this section made by the applicant or a
predecessor in title of his, and the application in suit has a date of filing, within
the period referred to in subsection (2A) (a) or (b), then

(a) if an invention to which the application in suit relates is supported
by matter disclosed in the earlier relevant application or applications,
the priority date of that invention shall, instead of being the date of
filing the application in suit, be the date of filing the relevant
application in which that matter was disclosed or, if it was disclosed in
more than one relevant application, the earliest of them; and

(b) the priority date of any matter contained in the application in suit
which was also disclosed in the earlier relevant application or
applications shall be the date of filing the relevant application in
which that matter was disclosed or, if it was disclosed in more than
one relevant application, the earliest of them.

S17 3.12 The other subsections of section 17 and the corresponding provisions in the rules
r9 specify requirements that include when the subsequent patent application has to be
r9A
r9B
filed in order to claim priority over the earlier relevant application, when the

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r9C declaration of priority has to be made and when documents supporting the priority
claim are required to be furnished.

r9B(4) 3.13 During the search process, the Examiners shall identify as far as possible, all relevant
r33 prior art immediately before the date of filing of a patent application, regardless of
whether there is a priority declaration made in the patent application.

r9B(4) 3.14 During the examination process, the Examiner shall generally not investigate the
validity of the priority claim. However, the Examiner shall do so when there is a
potential prior art that is published on or after the priority date but before the date of
filing of the patent application that is being examined. Hence, in Singapore, priority
documents are not furnished by the applicants as a matter of course in all cases. They
are to be furnished by the applicants when the Examiner informs the Registrar of the
need.

3.15 Likewise, in the case of non English priority documents, rule 9C states that
r9C translations need to be furnished only when required (the Examiner informs the
IPOS Officer in the Patents Search and Examination Unit who had previously
forwarded the Request for Search and/or Examination Report to the Examiner, of the
need) and where the validity of the claim to priority is relevant to determining
whether the invention concerned is patentable.

E Novelty Test
3.16 Tay Yong Kwang J in the decision of Mühlbauer AG v Manufacturing Integration
Technology Ltd [2009] SGHC 45 where he applied the guiding principles set out by
Lai Kew Chai J in Trek Technology (Singapore) Pte Ltd v FE Global Electronics
Pte Ltd (No. 2) [2005] 3 SLR 389 at [16] and they are reproduced as follows:

(a) the issue is determined by asking whether an invention forms part of the
state of the art;

(b) the prior art must, in order to invalidate the patent, be such that a person of
ordinary skill and knowledge of the subject would at once perceive and
understand and be able to practically apply the discovery without the
necessity of making further experiments;

(c) the prior art documents must be construed as at the date of publication and
it is not permissible to perform an ex post facto analysis;

(d) each prior art document has to be considered separately and not combined
into a mosaic to arrive at the invention;

(e) the person skilled in the art is an unimaginative person of competent but

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average technical skill;

(f) the prior art document must contain clear directions to do what the patent
claims to have invented.

i. Signpost is not enough

3.17 Further guidance can be found in Merck & Co Inc v Pharmaforte Singapore Pte
Ltd, [1999] SGHC 323, where the plaintiffs argued that any prior art that is relied on
to destroy novelty must unequivocally point to the invention and must not merely be
a signpost on the path to discovering the invention. Lai Kew Chai J in delivering the
judgment of the High Court agreed and he said that “they correctly stated that
anticipation only arises if it discloses to a notional instructed reader essential integers
to the invention as claimed: General Tire and Rubber Co v Firestone Tyre and
Rubber Co [1972] RPC 457 at 485.”.

ii. Publicly made available

3.18 Tay Yong Kwang J in Insitutut Pasteur v Genelabs Diagnostics Pte Ltd [2000]
SGHC 53 at paragraph 188 also explained:

188 The law concerning anticipation is strict to the patentee and to the
challenger of the patent. A claim is invalid if it covers any item of the prior
art which has been disclosed to anyone (except in confidence), by any means
(written or oral or by use), anywhere in the world, at any time in history
(before the priority date). Even availability to a single member of the public
will suffice. Similarly, availability to the public is satisfied if the document
can be found on the shelves of a public library. It is irrelevant whether anyone
knew it was available or had inspected it. [Vitoria, Encyclopedia of United
Kingdom and European Patent Law] Anticipation can therefore encompass a
disclosure which the inventor was totally ignorant of.

iii. Combining prior art

3.19 As for the combination of prior art in the assessment of novelty, Tay Yong Kwang J
in Insitutut Pasteur v Genelabs Diagnostics Pte Ltd [2000] SGHC 53 at paragraph
190 said:

Anticipation must be found within the document alleged to have anticipated the
invention. It is not permissible to combine the teachings of two or more
documents except where one of these directs the reader to study the other. One
cannot create a "mosaic of extracts" from documents spread over a number of
years [Von Heydon v Neustadt (1880) 50 LJ Ch. 126]. Similarly, "it is not open to
you to take a packet of prior documents and by putting a puzzle together produce

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what you say is a disclosure in the nature of a combination of the various
elements which have been contained in the prior documents. … it is necessary to
point to a clear and specific disclosure of something which is said to be like the
patentee’s invention" [Lowndes’ Patent (1928) 45 RPC 48].

iv. Enabling Disclosure

3.20 Another novelty requirement is that the disclosure must be ‘enabling’, i.e. sufficient
so as to enable the skilled addressee to put the invention into practice. The Court of
Appeal in Genelabs Diagnostics Pte Ltd v Institut Pasteur [2000] SGCA 60
observed that Merck & Co Inc v Pharmaforte Singapore Pte Ltd [2000] SGCA 39
had concluded that for a prior publication to anticipate the patent it must be
established that following the teachings in the prior publication would inevitably lead
to the invention covered by the patent. The prior disclosure must not only identify the
subject matter of the claim in the later patent, it must do so in a way that enables the
skilled man to make or obtain it, a kind of enabling disclosure.

F Minimum Documentation
r40 3.21 The primary aim of the search process conducted by the Examiner is to identify as
much relevant prior art as possible. Hence, even though Section 14(2) defines the
state of the art to comprise all matter (whether a product, a process, information
about either, or anything else) which has at any time before the priority date of that
invention been made available to the public (whether in Singapore or elsewhere) by
written or oral description, by use or in any other way, rule 40 of the Patent Rules
prescribes the minimum set of documentation that should be referred to in the course
of search.

Minimum documentation for search

40.—(1) The documentation prescribed for the purposes of section 29 (3) and
(6) (“minimum documentation”) shall consist of —
(a) the patents issued by or registered in Singapore;
(b) the patent applications published in Singapore;
(c) the “national patent documents” as specified in paragraph (2); and
(d) the published international (Patent Co-operation Treaty)
applications.

(1A) The documentation prescribed for the purposes of section 38A (7)
(“minimum documentation”) shall consist of —
(a) the patents issued by or registered in Singapore;
(b) the patent applications published in Singapore;
(c) the “national patent documents” as specified in paragraph (2); and
(d) the published international (Patent Co-operation Treaty)

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applications.

(2) Subject to paragraphs (3) and (4), the “national patent documents” shall be
the following:

(a) the patents issued by Australia, France, the former


Reichspatentamt of Germany, Japan, Switzerland (in French and
German languages only), the United Kingdom and the United States
of America;
(b) the patents issued by the Federal Republic of Germany; and
(c) the patent applications, if any, published in the countries referred
to in sub-paragraphs (a) and (b).

(3) The patent documents of Japan, for which no abstracts in the English
language are generally available, need not form part of the “minimum
documentation” referred to in paragraph (1) or (1A).

(4) Only those patents issued and those patent applications published, after a
date not more than 50 years before the declared priority date or, where there is
no declared priority date, the date of filing of the application being subjected
to a search, need form part of the “minimum documentation” referred to in
paragraph (1) or (1A).

S38A 3.22 Hence, rule 40 only specifies the minimum extent that Examiners should consider but
S80 it does not cover the extent mentioned in Section 14. Examiners may refer to other
documents if they have access to them. Disclosures (e.g. oral) not captured by the
Examiner can be raised after a patent is granted, by anyone who wishes to challenge
the validity of the patent under Section 80 of the Patents Act. Anyone can also file a
search and examination request after grant under Section 38A of the Patents Act if
they wish to have an assessment of that disclosure which was previously not
considered.

3.23 The Registry has also made available an on-line access to published patent
applications and patents in Singapore through this portal
http://www.epatents.gov.sg/PE/. This enables anyone, anywhere in the world with
internet access to conduct such searches. Our Examiners should use this site when
conducting search. In the event where the Examiners encounter any potential prior art
from this Singapore patent database, they can pull out the published patent
specification from it as well as the relevant extract from the patent register. The
documents are available free of charge.

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G Internet disclosures
3.24 Internet Disclosures can be relevant and may fall within the ambit of Section 14.
There are however challenges arising when considering such disclosures.

3.25 The PCT International Search and Preliminary Examination Guidelines provide some
guidance on this subject. (http://www.wipo.int/pct/en/texts/pdf/ispe.pdf)

• Disclosure on the Internet


11.13 Prior art disclosure on the Internet or on an on-line database is
considered in the same manner as other forms of written disclosure.
Information disclosed on the Internet or on-line database are considered to be
publicly available as of the date the disclosure was publicly posted. When
citing an Internet disclosure (a web page), problems may arise in establishing
the date of publication and whether or not the disclosure has been modified
over time. When establishing the publication date of a web page, it is
important to distinguish between two types of Internet disclosure, viz.: those
made on the web sites of trusted publishers and those made on web sites of
unknown reliability.

• Disclosure Made on the Web Sites of Trusted Publishers


11.14 Examples of these are on-line scientific journals (which make available
the contents of a paper journal on-line, or may be uniquely on-line
publications). The web sites of newspapers, periodicals, television and radio
stations will usually fall into this category as well. This type of Internet
disclosure gives the publication date of the disclosure which, in the absence
of evidence to the contrary, should be taken at face value. The examiner
should cite the Internet disclosure in the International search report and use it
in the written opinion of the International Searching Authority and in
preliminary examination accordingly. The onus is on the applicant to prove
otherwise.

11.15 It may happen that the publication date is not sufficiently identified to
know if it is published in time to be considered to be state of the art according
to Rule 64.1(b) (that is, it is not clear if the disclosure occurred before or after
the valid priority date). This may happen, for example, where only the month
or year of publication is given and this is the same as the month or year of the
valid priority of the international application. In these cases, the Authority
may need to make enquiries with the owner of the web site in order to
establish the publication date to a sufficient degree of accuracy to know if it is
relevant state of the art in accordance with Rule 64.1(b) in the same way as it
would act in order to establish a more accurate publication date for a paper
published document.

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• Disclosures Made on Web Sites of Unknown Reliability
11.16 Examples of such web sites include those belonging to private
individuals, private organizations (for example, clubs), commercial web sites
(for example, advertising) etc. Where such an Internet disclosure is retrieved
during the international search and it does not give any explicit indication of
the publication date in the text of the disclosure, the Authority may consider
using those technical means available to it to attempt to reveal the publication
date.

11.17 Such technical means include:

(a) information relating to the publication date embedded in the


Internet disclosure itself (date information is sometimes hidden in the
programming used to create the web site, but is not visible in the web
page as it appears in the browser),

(b) indexing dates given to the web page by search engines (these are
usually later than the actual publication date of the disclosure since the
search engines usually take some time to index a new web site) and

(c) information available relating to the web site on commercial


Internet archiving databases (for example, the “Internet Archive
Wayback Machine”).

11.18 Where the examiner obtains an electronic document which establishes


the publication date for the Internet disclosure, he should make a print-out of
this document, which must mention both the URL of the relevant Internet
disclosure and the date of publication of that relevant Internet disclosure. The
examiner must then cite this print-out in the international search report as an
“L” document and cite the relevant Internet disclosure according to the
relevance of its content (“X”, “Y”, “A”) and according to the date as
established (“X”, “Y”, “A”, “P,X”, “P,Y”, “P,A”, “E”1 etc). Where the
examiner is unable to establish the publication date of the relevant Internet
disclosure and it is relevant to the inventive step and/or novelty of the claimed
invention, he should cite it in the international search report with the category
“L” for those claims which it would have affected if it were published in time
and giving it the date it was printed out as the publication date (see paragraph
16.69(b)).

11.19 Where this type of Internet disclosure does explicitly mention a

1
The category "E" document refers to an earlier patent application and it may have been mistakenly referenced in this
paragraph of the PCT International Search and Preliminary Examination Guidelines. PCT has been informed and they
agree that category “E” should not have been so referenced and they will make the changes accordingly.

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publication date and this publication date:

(i) is not contradicted by the information sources mentioned above (in


this regard it should be noted that the indexing date given by a search
engine is usually later than the actual publication date and so where
the examiner uncovers an indexing date for an Internet disclosure
which is later than the publication date given in the Internet disclosure
itself; this does not necessarily mean that the Internet disclosure was
made available later than it claimed, it simply means that it was
indexed by that search engine after it was made available); and

(ii) is accurate enough to establish if the document was published


early enough to be considered relevant according to Rule 33.1(a) and
Rule 64.1(b), then the examiner should trust the date given and give
this as the publication date in the search report and use this publication
date in preliminary examination. The onus is on the applicant to prove
otherwise.

11.20 In the absence of evidence to the contrary, the examiner should assume
that the content of the Internet disclosure has not changed over time.

H Prior Art Consideration: Standard of proof


3.26 Paragraph 2.29.1 of the UK Manual of Patent Practice (Jul 2010) specifies the level
of assessment required when considering evidence relating to prior use in general.

2.29.1 In cases of alleged prior use, the required standard of proof is the
balance of probabilities. Within this standard, the Patents County Court in
Kavanagh Balloons Pty Ltd v Cameron Balloons Ltd [2004] RPC 5 held that
a flexible degree of probability should be applied to evidence relating to prior
use. The cogency of the evidence had to match the occasion and be
proportionate to the subject matter. Because of the nature of the monopoly
itself and question of public interest, no stricter standard should be applied. It
was held that it was not necessary for an opponent to prove his case “up to the
hilt” as had been required by the EPO Technical Board of Appeal in
Sekisui/shrinkable sheet [1998] OJEPO 161 (T 472/92). The hearing officer
in Colley's Application [1999] RPC 97 also distinguished from Sekisui by not
requiring proof “up to the hilt”, but followed this decision and Demmeler
Maschinenbau GmbH & Co KG (T 908/95) in holding that mere assertion of
prior use was insufficient: place, time and detail were essential.

3.27 In Singapore, we would apply the PCT approach taken on internet disclosures as well
as the standard of proof i.e. “balance of probabilities” adopted in the UK for prior art
consideration This should guide the Examiner in his consideration on whether a

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certain disclosure falls within the ambit of section 14(2).

I Medical Use Claims


S14(7) 3.28 Section 14(7) corresponds with section 2(6) of the UK Patents Act (prior to the 2004
amendments) and is similar to section 4A of the UK Patents Act (after the 2004
amendments) and Article 54 of the European Patent Convention. In brief, it provides
an exception to the general understanding of novelty as it says that the fact that a
substance or composition for use in a method of treatment of the human or animal
body by surgery or therapy or of diagnosis practised on the human or animal body is
not new, this fact shall not prevent the invention from being taken to be new if the
use of the substance or composition in any such method is new.

3.29 Paragraphs 4A.16, 4A.26 and 4A.27 of the UK Manual of Patent Practice (Jul 2010)
explains how the current UK provisions are interpreted.

4A.16 Section 4A(3) has the effect that a known substance or composition
may be patented for use in a method of treatment by surgery or therapy or of
diagnosis provided that its use in any such method is new ("first medical
use"). That is to say, if a known substance or composition not previously used
in surgery, therapy or diagnosis is found to be useful in treating, say a human
disease, or to obtain a specific "therapeutic" effect (eg analgesic or antibiotic),
a patent for the substance or composition for use in therapy (unspecified) may
be obtained, i.e. the claim need not be limited to the specific therapeutic
effect; additional claims directed towards more than one specific therapeutic
effect may be allowed in the same patent application, provided of course that
they are supported by the description. The terms surgery, therapy and
diagnosis are discussed in more detail in paragraphs 4A.02-4A.14.

4A.26 Before implementation in 2007 of the medical provisions of the 2000


revision of the EPC (EPC 2000 – introduced into UK law by the Patents Act
2004), a second or subsequent medical use could only be protected by a claim
in the “Swiss type” format of “the use of substance X for the manufacture of a
medicament to treat disease Y”. Section 4A(4) now enables patent protection
to be obtained for a second, or subsequent, different use of a substance or
composition in a method of treatment or diagnosis by a direct claim in the
form “substance X for use in the treatment of disease Y”. A claim of this type
for a known substance or composition for use in a specific method of
treatment or diagnosis is treated as new if that specific use was previously
unknown. This does not extend the availability of patent protection in respect
of an invention consisting of a substance or a composition for use in a method
of treatment or diagnosis; it simplifies and clarifies the manner in which
patent protection may be obtained for such inventions.

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4A.27 Following implementation of the EPC 2000, the practice in both this
Office and the EPO was to allow inventions relating to second medical uses
to be claimed using either the direct second medical use claim format under
Section 4A(4), or the Swiss-type format, or both, pending guidance from the
UK courts and/or the EPO Boards of Appeal. In February 2010, the EPO
Enlarged Board of Appeal issued its decision on G 02/08 ABBOTT
RESPIRATORY/Dosage regime. This decided that applicants may no longer
claim second medical use inventions in the Swiss format. The Enlarged Board
held that Swiss-type claims were previously accepted (in G 05/83
EISAI/Second medical indication [1985] 3 OJEPO 64) as the only possible
means of protecting inventions relating to second medical uses in order to fill
a loophole in the provisions of the EPC 1973. The new Article 54(5)
(equivalent to Section 4A(4)) fills this loophole by explicitly allowing claims
to the further specific use of a known drug, and so the reason for this special,
“judge-made” law no longer exists.

3.30 A table of comparison between the various provisions from Singapore, UK and the
EPC is reproduced below to highlight the similarities and differences.

Table 3: Comparison of Medical Use provisions (Novelty)


Current SINGAPORE UK (Pre 2004 Current UK Current EPC
amendments)
Section 16(2) Section 4(2) Section 4A Article 53 (c)

(2) An invention of a (2) An invention of a 4A.-(1) A patent shall not European patents shall
method of treatment of method of treatment of be granted for the not be granted in respect
the human or animal the human or animal invention of- of:
body by surgery or body by surgery or
therapy or of diagnosis therapy or of diagnosis (a) a method of (c) methods for treatment
practised on the human practised on the human treatment of the of the human or animal
or animal body shall not or animal body shall not human or animal body by surgery or
be taken to be capable of be taken to be capable of body by surgery or therapy and diagnostic
industrial application. industrial application. therapy, or methods practised on the
human or animal body;
(b) a method of this provision shall not
Section 14(7) Section 2(6) diagnosis practised apply to products, in
on the human or particular substances or
animal body. compositions, for use in
(7) In the case of an (6) In the case of an any of these methods.
invention consisting of a invention consisting of a
substance or composition substance or composition
for use in a method of for use in a method of Article 54(4)
(2) Subsection (1) above
treatment of the human treatment of the human does not apply to an
or animal body by or animal body by invention consisting of a (4) Paragraphs 2 and 3
surgery or therapy or of surgery or therapy or of

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Table 3: Comparison of Medical Use provisions (Novelty)
Current SINGAPORE UK (Pre 2004 Current UK Current EPC
amendments)
diagnosis practised on diagnosis practised on substance or composition shall not exclude the
the human or animal the human or animal for use in any such patentability of any
body, the fact that the body, the fact that the method. substance or
substance or composition substance or composition composition, comprised
forms part of the state of forms part of the state of (3) In the case of an in the state of the art, for
the art shall not prevent the art shall not prevent invention consisting of a use in a method referred
the invention from being the invention from being substance or composition to in Article 53(c),
taken to be new if the use taken to be new if the use for use in any such provided that its use for
of the substance or of the substance or method, the fact that the any such method is not
composition in any such composition in any such substance or composition comprised in the state of
method does not form method does not form forms part of the state of the art.
part of the state of the part of the state of the the art shall not prevent
art. art. the invention from being
taken to be new if the use
of the substance or
composition in any such
method does not form
part of the state of the
art.
Article 54(5)
(4) In the case of an
invention consisting of a (5) Paragraphs 2 and 3
substance or composition shall also not exclude the
for a specific use in any patentability of any
such method, the fact that substance or composition
the substance or referred to in paragraph 4
composition forms part for any specific use in a
of the state of the art shall method referred to in
not prevent the invention Article 53(c), provided
from being taken to be that such use is not
new if that specific use comprised in the state of
does not form part of the the art.
state of the art.

3.31 Section 14(7) of the Singapore Patents Act corresponds to Section 2(6) of the UK
Patents Act prior to the amendments made in 2004. Paragraph 76 of the
"Examination Guidelines for Patent Applications relating to Medical Inventions in
the UKIPO" updated as of August 2008, explains that the “case law relating to first
medical use under the repealed Section 2(6) (or the equivalent Article 54(5) of the
EPC 1973) will continue to govern our practice under Section 4A(3). The exception
to this is the case law relating to the novelty of claims of the form “substance X, for
use in treating disease Y”, which is now governed by Section 4A(4)…”.

Singapore currently does not have a provision in the Singapore Patents Act which

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corresponds to Section 4A(4) of the UK Patents Act. Instead, our laws in this regard
continue to correspond with the UK patent provisions (prior to the 2004
amendments). Hence, our Examiners shall continue to examine the Swiss type claim
format in Singapore patent applications. Second or subsequent medical use claim in
the “Swiss type” format of “the use of substance X for the manufacture of a
medicament to treat disease Y” is acceptable. On the other hand, claims drafted in a
manner that corresponds to Section 4A(4) of the UK Patents Act would not be novel
under Section 14 of the SG Patents Act if substance X had been used in ANY
medical method in the prior art.

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J NOVELTY ASSESSMENT: IN A NUTSHELL


3.32 The following table summarises the steps to be taken by the Examiner.

Table 4: Steps Involved in assessing novelty under section 14


Step 1 Identify the Date of Filing of the invention in question for novelty
assessment, regardless of whether there is a priority declaration made in
the patent application. Then proceed to Step 2.

Step 2 Ensure that Examiner has access to the Minimum Documentation which
includes Singapore published patent applications. Then proceed to Step
3.

Step 3 Apply the Novelty Test mentioned in this Chapter on the subject matter
in question.

Step 3A Examiners shall continue to examine the Swiss type claim format in
Singapore patent applications. Claims drafted in a manner that
corresponds to Section 4A(4) of the UK Patents Act would not be novel
under Section 14 of the SG Patents Act if substance X had been used in
ANY medical method in the prior art.

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4 INVENTIVE STEP
A Statutory requirements
S15 4.1 Inventive step

Section 15. An invention shall be taken to involve an inventive step if it is not


obvious to a person skilled in the art, having regard to any matter which forms part of
the state of the art by virtue only of Section 14 (2) and without having regard to
Section 14 (3).

4.2 Consideration of inventive step occurs during the substantive examination phase of a
patent application. This occurs after the completion of the search process.

B Inventive Step Test


4.3 The test that our Examiners should use when assessing inventive step is as follows.

Tay Yong Kwang J in Mühlbauer AG v Manufacturing Integration Technology


Ltd [supra] at paragraph 34, relied on the approach taken by our Court of Appeal in
First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd [2007] SGCA
50 where the court adopted the oft-cited four-step test laid down by the English Court
of Appeal in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd
[1985] RPC 59 at 73-74 (see [41] and [44] of our Court of Appeal’s judgment)
(hereinafter referred to as “Windsurfing”) which said:

There are, we think, four steps which require to be taken in answering the
jury question. The first is to identify the inventive concept embodied in the
patent in suit. Thereafter, the court has to assume the mantle of the normally
skilled but unimaginative addressee in the art at the priority date and to
impute to him what was, at that date, common general knowledge in the art in
question. The third step is to identify what, if any, differences exist between
the matter cited as being “known or used” and the alleged invention. Finally,
the court has to ask itself whether, viewed without any knowledge of the
alleged invention, those differences constitute steps which would have been
obvious to the skilled man or whether they require any degree of invention.

4.4 This test was slightly modified by Lord Justice Jacob in the UK Court of Appeal’s
decision of Pozzoli SPA vs. BDMO SA et anor. [2007] EWCA Civ 588 (“Pozzoli”)
where he explained in [15] and [16], that the Windsurfing [supra] test:

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15 …requires some restatement and elaboration. First one must actually


conduct the first two operations in the opposite order – mantle first, then
concept. For it is only through the eyes of the skilled man that one properly
understand what such a man would understand the patentee to have meant
and thereby set about identifying the concept.

16 Next, that first step actually involves two steps, identification of the
attributes of the notional “person skilled in the art” (the statutory term) and
second identification of the common general knowledge of such a person.

4.5 Whichever test is applied to assist in deciding on the inventive step issue, V K Rajah
JA (delivering the judgment of the court) in First Currency Choice Pte Ltd v Main-
Line Corporate Holdings Ltd and Another Appeal [supra] reminds us at [42]-[45]
of his judgment as follows:

42 An appraisal of the relevant English and Singapore decisions dealing with


the issue of obviousness suggests that the courts often refer to the first three
questions in the Windsurfing test (see [41] above) in a matter-of-fact way
before proceeding almost immediately to deal with the fourth and final
question: Is the alleged invention obvious? Some critics have gone further to
say that the courts are often merely paying lip service to the Windsurfing test.

43 In this respect, the Windsurfing test ([41] above) has been criticised for
over- elaborating the statutory definition of “inventive step” without reducing
the confusion and uncertainty that has long been associated with it. David I
Bainbridge in Intellectual Property (Pearson, 6th Ed, 2007) at p 400
contends that the first three steps of the Windsurfing test are, in reality,
redundant. He notes that s 3 of the Patents Act 1977 (c 37) (UK) (“the 1977
English Act”) (which is equivalent to s 15 of the Act) seems straightforward
and requires a one-step test only, namely, whether the alleged invention is
“not obvious to a person skilled in the art”. The Windsurfing test, in
Bainbridge’s view, does not provide any intrinsic guidance on the statutory
provision itself, but “merely affords a structured method of assessing whether
the requirement of inventive step has been satisfied” (see Intellectual
Property at p 400). Bainbridge further cautions that in breaking down the test
in s 3 of the 1977 English Act, there is a latent danger that artificiality will be
introduced, which might distort the test. He persuasively suggests (ibid) that a
simpler formulation is to ask:

[W]hether, from the point of view of a person who had total


knowledge of the state of the art, the invention was obvious at the
priority date. It goes without saying that the person concerned cannot
be endowed with inventive faculties...

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It is also pertinent to note that the European Patent Office does not appear to
have adopted a structured approach along the lines of the Windsurfing test in
determining whether an invention involves an inventive step.

44 Nonetheless, the Windsurfing test ([41] above) appears to be here to stay.


It was astutely observed by the English Court of Appeal in Wheatley v
Drillsafe Ltd [2001] RPC 7 at [45] that the failure to follow the structured
Windsurfing approach led the trial judge in that case to apply ex post facto
reasoning erroneously, resulting in a failure to distinguish what was actually
known from what was common general knowledge. When all is said and done,
the Windsurfing approach has its advantages. The first three steps of this test
lay the ground work for the final question – which is ultimately the only
critical question – namely: Is the alleged invention obvious? (See Terrell
([22] supra) at para 7-53.) As aptly pointed out by Neuberger J in DSM NV’s
Patent [2001] RPC 35 at [58]:

By adopting the structured approach, one ensures that there is a


measure of discipline, reasoning and method in one’s approach.
Indeed, it helps to ensure that there is consistency of approach in
different cases involving the issue of obviousness.

45 Be that as it may, simplicity is certainly to be appreciated, and, in


assessing the obviousness of an alleged invention, it may sometimes suffice in
straightforward cases to refer to the test formulated by Lord Herschell in
Vickers, Sons And Co, Limited v Siddell (1890) 7 RPC 292, where he stated
(at 304) that an invention lacked an inventive step if what was claimed was
“so obvious that it would at once occur to anyone acquainted with the
subject, and desirous of accomplishing the end”. Quite often, it is difficult, in
practice, to break down the Windsurfing test ([41] above) into its component
parts. Thus, while the Windsurfing test remains a useful guide, it is no more
than that. Above all, it should be borne in mind that the Windsurfing test is
merely a manifestation of judicial inventiveness on how best to pragmatically
interpret and elucidate the requirements of s 15 of the Act.

4.6 Paragraph 3.46 of the UK Manual of Patent Practice (Jul 2010) also reminds us that
when considering an inventive step objection, the examiner should always bear in
mind this warning from Jacob LJ in Angiotech Pharmaceuticals v Conor Medsystems
Inc [2007] EWCA Civ 5:

…one can overelaborate a discussion of the concept of “obviousness” so that


it becomes metaphysical or endowed with unwritten and unwarranted
doctrines, sub-doctrines or even sub-sub-doctrines. …. In the end the question
is simply “was the invention obvious?

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C The Inventive Concept

“The first is to identify the inventive concept embodied in the patent in suit”
Re: Windsurfing [supra].

4.7 Lord Walker of Gestingthorpe in delivering the House of Lord’s decision of Generics
(UK) Limited and others (Appellants) v H Lundbeck A/S (Respondents) [2009]
UKHL 12 explained at [30] that:

“Inventive concept” is concerned with the identification of the core (or


kernel, or essence) of the invention—the idea or principle, of more or less
general application (see Kirin-Amgen [2005] RPC 169 paras 112-113) which
entitles the inventor’s achievement to be called inventive.

4.8 Tan Lee Meng J in ASM Assembly Automation Ltd v Aurigin Technology Pte
Ltd and Others [2009] SGHC 206 at paragraph 39 said:

It is noteworthy that in Unilever v Chefaro [1994] RPC 567, Jacob J stated at


p 580 as follows:

It is the “inventive concept” of the claim in question which must be


considered, not some generalised concept to be derived from the specification
as a whole. Different claims can, and generally will, have different inventive
concepts. The first stage of identification of the concept is likely to be a
question of construction: what does the claim mean? It might be thought that
there is no second stage – the concept is what the claim covers and that is
that. But that is too wooden and not what courts applying Windsurfing stage
one, have done. It is too wooden because if one merely construes the claim,
one does not distinguish between portions which matter and portions which,
although limitations on the ambit of the claim, do not. One is trying to
identify the essence of the claim in this exercise.

4.9 The above case precedents provide the framework for our Examiners to use, when
identifying what an “inventive concept” is, in the course of examination.

D The skilled addressee


“Thereafter, the court has to assume the mantle of the normally skilled but
unimaginative addressee in the art at the priority date and to impute to him
what was, at that date, common general knowledge in the art in question.” Re
Windsurfing.

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4.10 Tan Lee Meng J in FE Global Electronics Pte Ltd and others [supra] said at [22] of
the judgment that:

22 Admittedly when construing a patent, the court determines what a skilled


reader would think and not what the expert thinks. This is not to say that an
expert’s view on what a skilled reader would think is totally irrelevant.

4.11 V K Rajah JA in the case of First Currency Choice Pte Ltd v Main-Line Corporate
Holdings Ltd and another Appeal [supra] explained in [27] and [28] of the
judgment, that:

27 Clearly then, the starting point in patent construction is to ask the


threshold question: What would the notional skilled person have understood
the patentee to mean by the use of the language of the claims? In this
endeavour, the language that the patentee has adopted is more often than not
of utmost importance (see Kirin-Amgen ([25] supra) at [34]).

The notional skilled person with the common general knowledge of the art

28 As stated above, the “audience” whom the patentee is addressing is the


person skilled in the art (per Lord Hoffman in Kirin-Amgen ([25] supra) at
[33]; FE Global Electronics ([26] supra) at [14]). As a general rule, the
notional skilled person should be taken to be the workman or technician who
is aware of everything encompassed in the state of the art and who has the
skill to make routine workshop developments, but not to exercise inventive
ingenuity or think laterally (per Laddie J in Pfizer Ltd’s Patent [2001] FSR
16 at [62]–[63]). His level of skill will depend on the scope of the subject
matter of the patent in question (see Dyson Appliances Ltd v Hoover Ltd
[2001] RPC 26 (“Dyson v Hoover”) at [30]). The notional skilled person is,
thus, usually defined according to the qualities which he possesses. As stated
in McGhan Medical UK Limited v Nagor Limited Case No CH 1999 1720 (28
February 2001) at [23]–[24] and followed in Ng Kok Cheng v Chua Say
Tiong [2001] 3 SLR 487 at [21]:

This notional person is deemed to possess the common general


knowledge of the subject matter in question. It is through the eyes of
the skilled addressee that the [p]atent will fall to be interpreted. And it
is by the standards of this person that the question of inventive step is
to be judged when this topic is addressed in the counterclaim.

A patent is addressed to persons who are likely to have a practical


interest in its subject matter or to act on the directions given in it for it
to be put into practice. The addressee is deemed to be unimaginative
and uninventive but is equipped nevertheless with a reasonable degree

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of intelligence and with a wish to make the directions in the patent
work.

4.12 Judith Prakash J in Ng Kok Cheng v Chua Say Tiong [2001] SGHC 143 summed up
the essential indicators of a skilled person in the art as a person who:

(1) possesses common general knowledge of the subject matter in question;

(2) has a practical interest in the subject matter of the patent or is likely to act
on the directions given in it; and

(3) whilst unimaginative is reasonably intelligent and wishes to make the


directions in the patent work.

4.13 Further guidance can be found in the UK Court of Appeal’s decision of


Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWCA Civ
819 where Jacob LJ said at paragraphs 65, 71 to 75:

65. In the case of obviousness in view of the state of the art, a key question is
generally "what problem was the patentee trying to solve?" That leads one in
turn to consider the art in which the problem in fact lay. It is the notional team
in that art which is the relevant team making up the person skilled in the art.
If it would be obvious to that team to bring in different expertise, then the
invention will nonetheless be obvious. Likewise if the possessor of the "extra
expertise" would himself know of the other team's problem. But if it would
not be obvious to either of the notional persons or teams alone and not
obvious to either sort of team to bring in the other, then the invention cannot
fairly be said to be obvious. As it was put in argument before us the
possessors of the different skills need to be in the same room and the team
with the problem must have some reason for telling the team who could solve
it what the problem is.

The correct approach in this case

71. It follows that the correct approach in this case is to start with the real
problem faced by exploration geophysicists. Did they appreciate they had a
solvable problem? How could they determine whether a thin layer of porous
rock identified by seismics as potentially hydrocarbon bearing in fact does so
or is just a false positive bearing only brine or water? One then asks whether
the notional exploration geophysicist who read the cited prior art would see
that the answer was to use CSEM, or if not that, at least that CSEM had a
sufficient prospect of being useful that it was worth asking a CSEM expert.

72. The problem must also be approached the other way round, from the point

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of view of the CSEM expert. Would he or she know of the exploration
geophysicists' problem and, if so, would he or she appreciate that CSEM had
a real prospect of being useful to solve the problem?

73. In short: was the marriage obvious to either notional partner?

74. One further approach is not necessary: that is to ask whether the notional
team including both types of expert would see that CSEM would solve or
stood a very good chance, of solving the problem. That is because Mr
Thorley's concession provides the answer here.

75. There is danger to be avoided. There are cases where, even though you
can, in retrospect, clearly see that there was a problem and articulate what it
was, workers at the time did not do that. They did not say: "this is our
problem. If only we had a solution to it." Instead they simply put up with
things as they were. Then the essence of the invention is the insight that there
was a solvable problem at all. The Haberman case, see below, is a good
example.
NB. CSEM (Controlled Source Electromagnetic)

4.14 The above case precedents provide the framework for our Examiners to use, when
identifying who the skilled addressee should be, in the course of examination.

E Common General Knowledge


“Thereafter, the court has to assume the mantle of the normally skilled but
unimaginative addressee in the art at the priority date and to impute to him
what was, at that date, common general knowledge in the art in question.”
Re: Windsurfing [supra].

4.15 It is recalled that in assessing novelty, the prior art must, in order to invalidate the
patent, be such that a person of ordinary skill and knowledge of the subject would at
once perceive and understand and be able to practically apply the discovery without
the necessity of making further experiments. Is this knowledge the same as common
general knowledge in the art in question that is imputed onto a normally skilled but
unimaginative addressee in the art at the priority date, when assessing inventive step?

4.16 The Court of Appeal in the case of First Currency Choice Pte Ltd v Main-Line
Corporate Holdings Ltd and Another Appeal [supra] explained at [38]-[41] of the
judgment that:

38 At first blush, there does not appear to be a clear distinction between the

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requirements of novelty and obviousness because both the question of
whether an invention is novel and that of whether it involves an inventive step
appear to be determined by the state of the art at the priority date. This can
be rather confusing because it is well established that the test for obviousness
is significantly narrower than that for novelty. It is also trite law that the state
of the art, as contemplated by s 15 of the Act, ought to be viewed in relation
to the common general knowledge of the notional skilled person, as opposed
to that of “the public” (see s 14(2)). This would exclude knowledge which is
not available to the public. While this genre of knowledge (i.e., knowledge
which is not available to the public) is excluded from the common general
knowledge which the notional skilled person is deemed to possess for the
purpose of assessing obviousness, such knowledge is nonetheless taken into
account in assessing whether an invention is novel under s 14 of the Act. As
explained by Aldous J (as he then was) in Lux Traffic Controls Limited v Pike
Signals Limited [1993] RPC 107 at 133, the requirement of novelty entails
that:

[A]n anticipating description in a book will invalidate a patent if the


book is on a shelf of a library open to the public, whether or not
anybody read the book and whether or not it was situated in a dark
and dusty corner of the library.

39 This conundrum was observed by Lord Reid in Technograph Printed


Circuits Limited v Mills & Rockley (Electronics) Limited [1972] RPC 346
(“Mills & Rockley (Electronics) Limited”), where he stated that it was
doubtful whether the words “having regard to what was known or used”
which appeared in both sub-ss (e) and (f) of s 32(1) of the Patents Act 1949 (c
87) (UK) (“the 1949 English Act”), the then statutory equivalents of ss 14
and 15 of the Act, were intended to bear the same meaning in each case. He
justified his views as follows (at 355):

If they were [intended to mean the same thing,] there would now be
little, if any, difference between novelty and obviousness. Obviousness
would cover practically every case of lack of novelty. In head (e)
[which deals with novelty] these words are used in an artificial sense
and are held to include matter which in fact no one in the United
Kingdom ever knew or was likely to know, such as the contents of
some foreign specification which no one had ever looked at and which
the most diligent searcher would probably miss. I think that in head (f)
[which deals with obviousness] the words should have the more
natural meaning of what was or ought to have been known to a
diligent searcher.

40 However, Lord Reid’s approach was seriously queried in the same case by

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Lord Diplock, who proposed that the phrase “what was known or used”
should not be treated differently under the two subsections. This has led some
academics to question the suitability of using the concept of common general
knowledge to test whether an alleged invention involves an inventive step
(see, inter alia, Lorraine Keenan, “Time to Put Windsurfing to Bed?”
Intellectual Property & IT Law (31 January 2002)). Interestingly, in
Australia, in an attempt to resolve this dilemma, the Patents Act 1990 (Cth)
(“the Australian Act”) encapsulated the concept of common general
knowledge in a statutory form. Section 7(2) of the Australian Act, which deals
with the concept of “inventive step”, states that:

For the purposes of this Act, an invention is to be taken to involve an


inventive step when compared with the prior art base unless the
invention would have been obvious to a person skilled in the relevant
art in the light of the common general knowledge as it existed in the
patent area before the priority date of the relevant claim …

41 In any event, the English courts have remained fixated with the use of the
notional skilled person’s common general knowledge in the test for
obviousness, despite the above criticisms. There are, admittedly, inherent
difficulties in defining both “common general knowledge” and “state of the
art”. Nevertheless, the explanation proffered by Lord Reid in Mills & Rockley
(Electronics) Limited ([39] supra) appears to be the preferable approach as
it injects substance into the legislative intent underlying s 15 of the Act. The
reliance on common general knowledge in the test for obviousness is also
embodied in the oft-cited four-step “Windsurfing test” laid down by the
English Court of Appeal in Windsurfing International Inc v Tabur Marine
(Great Britain) Ltd [1985] RPC 59 (“Windsurfing”) at 73–74 (and adopted
by this court in Merck & Co Inc v Pharmaforte Singapore Pte Ltd [2000] 3
SLR 717 at [50])…

4.17 The above case precedents provide the framework for our Examiners to use, when
identifying what “common general knowledge” entail, in the course of examination.

F Third and fourth steps mentioned in the Windsurfing case

”The third step is to identify what, if any, differences exist between the matter
cited as being “known or used” and the alleged invention. Finally, the court
has to ask itself whether, viewed without any knowledge of the alleged
invention, those differences constitute steps which would have been obvious
to the skilled man or whether they require any degree of invention.” Re:
Windsurfing [supra].

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4.18 The third step requires the Examiner to drill out the differences in features that exist
between the prior art and the invention in question.

4.19 With the differences at hand, the Examiner will then begin his assessment on whether
“those differences constitute steps which would have been obvious to the skilled man
or whether they require any degree of invention”.

4.20 The Court of Appeal in First Currency Choice Pte Ltd v Main-Line Corporate
Holdings Ltd and Another Appeal [2007] SGCA 50 was similarly faced with this
question and they opined at paragraphs 51 and 54 as follows:

51 This final component of the Windsurfing test (see [41] above) formed the
crux of the present appeals. It is up to the court to decide the question, which
is “a kind of jury question” (Windsurfing ([41] supra) at 71): Is the invention
in question obvious? The importance of striking the apposite balance between
encouraging and stifling innovation has been succinctly summarised in Glaxo
Group Ltd’s Patent [2004] RPC 43 at [41] as follows:

It is a question of fact in every case. Both the Scylla of considering


nothing obvious except that to which the skilled man is driven and the
Charybdis of considering every invention obvious that can be
decomposed into a sequence of obvious steps must be avoided. The
former is unfair to industry because it stifles natural development. The
latter is unfair to investors and not countenanced by English patent
law ...

Furthermore, in assessing the obviousness of an alleged invention, it must


always be remembered that simplicity is not equivalent to obviousness.

54 The crucial point was that at the material time, no other party had
introduced an automatic system to implement the process of deciphering a
payment card’s operating currency. Although the step might have seemed,
when all was said and done, Lilliputian, it was no less significant a step
forward, a step which nobody else had taken before (see Peng Lian Trading
Co v Contour Optik Inc [2003] 2 SLR 560 (“Peng Lian Trading”) at [31]).
A helpful analogy can be drawn with the decision in FE Global Electronics
([26] supra). In that case, it was held that the patentee had an inventive
concept for a new type of data storage device that was quite different from
and more convenient to use than the conventional data storage devices. This
court went on further to say that, admittedly, all the elements required for that
invention were available to those skilled in the art. Yet, before the patentee
applied for the patent in question, no one else had thought of combining those
elements together to form a new type of data storage device. Although some
might have viewed the invention as a simple one, this court noted that

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simplicity in itself had never been a bar to inventiveness, and reiterated that
ex post facto analysis could often be unfair to inventors (FE Global
Electronics at [45]–[46]; Peng Lian Trading at [29]). Indeed, it cannot be
gainsaid that the hallmark of many truly remarkable inventions is precisely
their simplicity.

4.21 The following approaches have been considered by our courts in assessing this last
step and we have extracted a few below for our Examiner’s easy reference:

a. Workshop variation of existing prior art

This was one of the factors that laws considered when assessing whether the
invention was obvious in ASM Assembly Automation Ltd v Aurigin
Technology Pte Ltd and Others [2009] SGHC 206 [at paragraph 55]

b. Commercial success

Tay Yong Kwang J at paragraph 47 in Mühlbauer AG v Manufacturing


Integration Technology Ltd [2009] SGHC 45 explains the inconclusive of
this test.

47 Where commercial success of an invention is concerned, this factor


alone is not conclusive. A product that sells well is not necessarily
novel or one involving an inventive step. Good advertising, marketing
and pricing could also play a part. The converse is also true. As stated
in Main-Line Corporate Holdings Ltd v United Overseas Bank Ltd
[2007] 1 SLR 1021 at [71]:

Something that is new and inventive does not automatically


become an overnight success or “the next big thing”. Even if it
is not, like the plaintiff’s Teh Kor Lak said, “a big deal”, it is
nevertheless something new and inventive which, after the
invention is known, others may wish they had thought of or
wonder why they had never thought of it. Some patents
achieve much more commercial success and are more life-
changing than (many) others. The fact that the invention has
not been widely adopted in the credit card industry is therefore
not an adverse reflection on its inventive quality.

c. So obvious

The Court of Appeal in First Currency Choice Pte Ltd v Main-Line


Corporate Holdings Ltd and Another Appeal [2007] SGCA 50 said

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45 Be that as it may, simplicity is certainly to be appreciated, and, in
assessing the obviousness of an alleged invention, it may sometimes
suffice in straightforward cases to refer to the test formulated by Lord
Herschell in Vickers, Sons And Co, Limited v Siddell (1890) 7 RPC
292, where he stated (at 304) that an invention lacked an inventive
step if what was claimed was “so obvious that it would at once occur
to anyone acquainted with the subject, and desirous of accomplishing
the end”. Quite often, it is difficult, in practice, to break down the
Windsurfing test ([41] above) into its component parts. Thus, while
the Windsurfing test remains a useful guide, it is no more than that.

4.22 A list of such approaches can also be found at paragraph 3.74 in Chapter 3 of the UK
Manual of Patent Practice (Jul 2010) and use of these approaches will depend upon
the particular circumstances of the case in question. They include:

• Lying in the road


• Why was it not done before?
• Fulfilling a need
• Advantages of the invention
• Obvious to try

G Combining Prior Art


4.23 Paragraph 3.40 of the UK Manual of Patent Practice (Jul 2010) shed light as follows:
3.40 While it is not possible to combine the disclosure of a given document
with other matter to demonstrate lack of novelty (see 2.09), it is permitted to
combine any of the prior art (whether published documents, instances of prior
use or common knowledge) in order to argue that an inventive step is lacking.
However, although a single disclosure, however remote, of the whole
invention will destroy novelty, in order to establish that a combination of
teachings from the prior art shows an invention to be obvious, it must be
likely that the skilled person would have considered those teachings together.
Laddie J in Pfizer Ltd’s Patent [2001] FSR 16 at paragraph 66 stated:
“When any piece of prior art is considered for the purposes of an
obviousness attack, the question asked is “what would the skilled
addressee think and do on the basis of the disclosure?” He will
consider the disclosure in the light of the common general knowledge
and it may be that in some cases he will also think it obvious to
supplement the disclosure by consulting other readily accessible
publicly available information. This will be particularly likely where
the pleaded prior art encourages him to do so because it expressly
cross-refers to other material. However, I do not think it is limited to

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cases where there is an express cross-reference. For example if a piece
of prior art directs the skilled worker to use a member of a class of
ingredients for a particular purpose and it would be obvious to him
where and how to find details of members of that class, then he will
do so and that act of pulling in other information is itself an obvious
consequence of the disclosure in the prior art.”.

H No rule of thumb
4.24 Finally on this subject, we find an extract in the UK Manual of Patent Practice (Jul
2010) to be very relevant and we have reproduced it below.

No rules of thumb; precedents to be treated with caution

3.54 The decision to raise an objection of lack of inventive step must be


made on a proper consideration of the facts of the particular case and any
kind of rule of thumb approach should be avoided. Caution should be
exercised in relying on precedent cases, since, more than with any other topic
to be decided by the substantive examiner, attempts to line up a particular
case with some decided case can mislead.

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I INVENTIVE STEP ASSESSMENT: IN A NUTSHELL


4.25 The following table summarises the steps to be taken by the Examiner.

Table 5: Steps Involved in assessing inventive step under section 15


Step 1 Identify the date of filing of the invention in question for inventive step
assessment. Then proceed to Step 2.

Step 2 If there is a priority date claim and a prior art falling between the date of
filing and the priority date claimed, proceed to examine the validity of
the priority date claim. The Examiner may inform the IPOS Officer in
the Patents Search and Examination Unit who had previously
forwarded the Search/Examination Request to the Examiner, of the need
to assess the priority document.

In the event where the priority document is not in English, the Examiner
may inform the IPOS Officer in the Patents Search and Examination
Unit who had previously forwarded the Search/Examination Request of
the need for a translation. Then proceed to Step 2A.

Step 2A In the event where the Examiner considers the Search results furnished
by the applicant and the search results refer to any non English
document, in the interest of managing costs, the Examiner should first
attempt to find an English family equivalent and/or use online free
machine translations to get a better idea of the disclosure in the non
English document before deciding to ask for English translations from
the applicant through the IPOS Officer in the Patents Search and
Examination Unit who had previously forwarded the Examination
Request. Then proceed to Step 3.

Step 3 Apply the Inventive Step Test mentioned in this Chapter on the subject
matter in question.

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5 INDUSTRIAL APPLICATION
A Statutory requirements
S16 5.1 Industrial application

Section 16.—(1) Subject to subsection (2), an invention shall be taken to be capable


of industrial application if it can be made or used in any kind of industry, including
agriculture.

(2) An invention of a method of treatment of the human or animal body by surgery or


therapy or of diagnosis practised on the human or animal body shall not be taken to
be capable of industrial application.

(3) Subsection (2) shall not prevent a product consisting of a substance or


composition from being treated as capable of industrial application merely because it
is invented for use in any such method.

5.2 A table of comparison between the various provisions from Singapore, UK and the
EPC is reproduced below to highlight the similarities and differences. It is noted that
all 3 laws share the same phrase “if it can be made or used in any kind of industry,
including agriculture”. On inventions relating to methods of treatment & diagnosis,
in Singapore and in UK (pre 2004 amendments), they are excluded from being
capable of industrial application. The Patents Act in UK (post 2004 amendments) is
aligned with the EPC where patents will not be granted for inventions relating to
methods of treatment & diagnosis. The provisions share a common underlying
objective i.e. inventions relating to methods of treatment & diagnosis should not
considered as patentable inventions in the interests of the public.

Table 6: Comparison of Industrial Application & Method of Treatment & Diagnosis


provisions
Current SINGAPORE UK (Pre 2004 Current UK Current EPC
amendments)
Industrial application Industrial application Industrial application Article 57
Industrial application
16.—(1) Subject to 4.-(1) Subject to 4.-(1) An invention shall
subsection (2), an subsection (2) below, an be taken to be capable of 57. An invention shall be
invention shall be taken invention shall be taken industrial application if it considered as susceptible
to be capable of industrial to be capable of industrial can be made or used in of industrial application
application if it can be application if it can be any kind of industry, if it can be made or used

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Table 6: Comparison of Industrial Application & Method of Treatment & Diagnosis
provisions
Current SINGAPORE UK (Pre 2004 Current UK Current EPC
amendments)
made or used in any kind made or used in any kind including agriculture. in any kind of industry,
of industry, including of industry, including including agriculture.
agriculture. agriculture. (2) [repealed]

(2) An invention of a (2) An invention of a (3) [repealed]


method of treatment of method of treatment of
the human or animal the human or animal
body by surgery or body by surgery or NB: NB:
therapy or of diagnosis therapy or of diagnosis
practised on the human practised on the human Methods of treatment Article 53 (c)
or animal body shall not or animal body shall not or diagnosis
be taken to be capable of be taken to be capable of
European patents shall
industrial application. industrial application.
4A.-(1) A patent shall not not be granted in respect
be granted for the of:
(3) Subsection (2) shall (3) Subsection (2) above
shall not prevent a invention of- (a) …
not prevent a product
product consisting of a (b) …
consisting of a substance
or composition from substance or composition (a) a method of treatment (c) methods for treatment
being treated as capable being treated as capable of the human or animal of the human or animal
of industrial application of industrial application body by surgery or body by surgery or
merely because it is merely because it is therapy, or therapy and diagnostic
invented for use in any invented for use in any methods practised on the
such method. such method. human or animal body;
(b) a method of diagnosis this provision shall not
practised on the human apply to products, in
or animal body. particular substances or
compositions, for use in
(2) Subsection (1) above any of these methods.
does not apply to an
invention consisting of a
substance or composition
for use in any such
method.

B Industry
5.3 Paragraph 4.02 of the UK Manual of Patent Practice [Jul 2010] explains what the
term “industry” refers to.

4.02 "Industry" should be understood in its broad sense as including any


useful and practical, as distinct from intellectual or aesthetic, activity. It does
not necessarily imply the use of a machine or the manufacture of a product,
and covers such things as a process for dispersing fog or a process for
converting energy from one form to another. In Chiron Corp v Murex

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Diagnostics Ltd and other [1996] RPC 535 (page 607) the Court of Appeal
held that the requirement that the invention can be made or used "in any kind
of industry" so as to be "capable of industrial application" carries the
connotation of trade or manufacture in its widest sense and whether or not for
profit. The Court went on to hold that industry does not exist in that sense to
make or use that which is useless for any known purpose. Many of the
matters which are excluded as lacking industrial application would have been
rejected under previous laws as not being manners of manufacture, and in fact
the views of the High Court of Australia in NRDC's Application, [1961] RPC
134, give a good guide to the meaning to be attributed to industrial
application; there must be a product, but this need not be an article or
substance, but must be something in which a new and useful effect, be it
creation or alteration, may be observed. It may for example be a building, a
tract or stratum of land, an explosion or an electrical oscillation, but it must be
useful in practical affairs. A method of eradicating weeds was held to give
rise to a product (an improved crop) because this was an artificially created
state of affairs; moreover it was one whose significance was economic.

5.4 The above UK practice provides a good reference point for our Examiners to use,
when identifying what is “industrial application”, in the course of examination.

C Capable of industrial application: Insufficient if vague and


speculative

5.5 The UK Court of Appeal in the case of Eli Lilly & Co v Human Genome Sciences Inc
[2010] EWCA Civ 33 at paragraphs 66 to 70 referred to the EPO case of Max-Planck
T 0870/04 (May 2005).

66.… Max-Planck was an ex parte appeal from a refusal to grant by the


examining division. The applicants had identified what they called a "BDP1
polypeptide". They sought to justify a claim to it on the basis that it could be
made and used as a tool for research. That was rejected. It is now settled that
the "research tool" justification for a new polypeptide or the nucleotide
sequence encoding for it is not enough to satisfy the Art. 57 test. As the Board
said:

[21] In the board's judgment, although the present application


describes a product (a polypeptide), means and methods for making it,
and its prospective use thereof for basic science activities, it identifies
no practical way of exploiting it in at least one field of industrial
activity. In this respect, it is considered that a vague and speculative
indication of possible objectives that might or might not be achievable
by carrying out further research with the tool as described is not

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sufficient for fulfilment of the requirement of industrial applicability.
The purpose of granting a patent is not to reserve an unexplored field
of research for an applicant.

67. That last sentence is full of importance. If you allow patenting of


chemicals whose use you do not really know you will subvert the patent
system and be likely to stultify research by others rather than encourage it. A
merely "vague and speculative indication of possible objectives" is not
enough.

68. The present case indeed provides an example of the danger of what can
happen if patenting too far upstream is allowed. Both sides (HGS in
collaboration with GlaxoSmithKline) are conducting clinical trials but each is
trying a different antibody to Neutrokine-α and for different conditions. As a
matter of interest the HGS trials are for the treatment of lupus, one of the few
diseases not mentioned in the patent. If the patent were valid, the valuable
research and development work done by Lilly into a field apparently not
researched (and certainly not taken through to clinical trial) by HGS would
potentially be rendered futile. The patent system would not be working as it
should. It would be operating to prevent research, not to encourage it.

69. It is also important to note an earlier paragraph of Max Planck, for the
Boards still regard it as good law:

[6] In cases where a substance, naturally occurring in the human body,


is identified, and possibly also structurally characterised and made
available through some method, but either its function is not known or
it is complex and incompletely understood, and no disease or
condition has yet been identified as being attributable to an excess or
deficiency of the substance, and no other practical use is suggested for
the substance, then industrial applicability cannot be acknowledged.
While the jurisprudence has tended to be generous to applicants, there
must be a borderline between what can be accepted, and what can only
be categorized as an interesting research result which per se does not
yet allow a practical industrial application to be identified. Even
though research results may be a scientific achievement of
considerable merit, they are not necessarily an invention which can be
applied industrially.

70. So the question here is which side of the borderline the case lies – a
question of degree turning on the facts and not a pure question of law.

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5.6 The above reveals the UK and EP approach converging on this point and given that
our provisions are identical in this regard, coupled with the reasoned analysis of what
is required to meet the “industrial application” requirement, our Examiners should
refer to the UK and EP approach, in the course of examination.

D “Methods of treatment & diagnosis” Exception


5.7 Section 16(2) corresponds with UK section 4(2) of the Patents Act prior to the UK
2004 amendments. In Bristol-Myers Squibb v Baker Norton Pharmaceuticals Inc
[1999] RPC 253, Jacob J held as follows at paragraphs 50 and 51:

50. Nor do I accept that on his construction the claim amounts to merely to a
method of treatment. It is to the manufacture of the medicines to be used in
that treatment. I am reinforced in that view by the consideration that the
Article 54(4) provision about methods of treatment is an exception to
patentability and as an exception should be construed narrowly…

51. A like approach is indicated in Plant Genetic Systems/Plant Cells (EPO


[1995] 545, T0356/93 OJ). There is also the limited purpose of the exception
to be considered. It is not so broad as to stop doctors using whatever they feel
they need to treat patients. If that were the purpose then one would not allow
patents for medicines or medical implements at all. The purpose of the
limitation is much narrower, merely to keep patent law from interfering
directly with what the doctor actually does to the patient. Patent monopolies
are permitted to control what he administers to, or the implements he uses on,
the patient. The thinking behind the exception is not particularly rational: if
one accepts that a patent monopoly is a fair price to pay for the extra research
incentive, then there is no reason to suppose that that would apply also to
methods of treatment. It is noteworthy that in the US any such exception has
gone, and yet no-one, so far as I know, suggests that its removal has caused
any trouble.

5.8 In Singapore, our Examiners should read the exception under section 16(2) narrowly.

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E INDUSTRIAL APPLICATION ASSESSMENT: IN A


NUTSHELL
5. 9 The following table summarises the steps to be taken by the Examiner.

Table 7: Steps Involved in assessing industrial application under section 16


Step 1 Determine whether the subject matter disclosed is "vague and
speculative indication of possible objectives". If so, this is not
sufficient to fall within this section.

Step 2 Section 16(2) should be construed narrowly.

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6 OFFENSIVE, IMMORAL OR ANTI-SOCIAL


BEHAVIOUR

A Statutory requirements
S 13 6.1 Patentable inventions

Section 13.—(1) Subject to subsection (2), a patentable invention is one that


satisfies the following conditions:
(a) the invention is new;
(b) it involves an inventive step; and
(c) it is capable of industrial application.

(2) An invention the publication or exploitation of which would be generally


expected to encourage offensive, immoral or anti-social behaviour is not a
patentable invention.

(3) For the purposes of subsection (2), behaviour shall not be regarded as offensive,
immoral or anti-social only because it is prohibited by any law in force in
Singapore.

B Legislative History

6.2 This provision shares its roots with section 1 of the UK Patents Act 1977 and even
though both Section 13 of the Singapore Patents Act and Section 1 of the UK
Patents Act had undergone changes since, the provisions relating to morality
continue to exist albeit in a differently worded text.

6.3 Sections 13(2) & 13(3) of the Singapore provisions correspond generally with
Sections 1(3) & 1(4) of the UK provisions.

Table 8: Comparison of Morality provisions


Current SINGAPORE UK (before the 2000 Current UK Current EPC
amendments)
Patentable inventions Patentable inventions Patentable inventions Article 53
Section 13. Section 1. Section 1. Exceptions to
(2) An invention the (3) A patent shall not be (3) A patent shall not be patentability
publication or granted- granted for an invention European patents shall
exploitation of which (a) for an invention the commercial not be granted in respect
would be generally the publication or exploitation of which of:
expected to encourage exploitation of which would be contrary to (a) inventions the

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Table 8: Comparison of Morality provisions
Current SINGAPORE UK (before the 2000 Current UK Current EPC
amendments)
offensive, immoral or would be generally public policy or morality. commercial exploitation
anti-social behaviour is expected to of which would be
not a patentable encourage offensive. contrary to "ordre public"
invention. immoral or anti-social or morality; such
behaviour. exploitation shall not be
deemed to be so contrary
(b)…. merely because it is
prohibited by law or
regulation in some or all
of the Contracting States;

(b) plant or animal


varieties or essentially
biological processes for
the production of plants
or animals; this provision
shall not apply to
microbiological
processes or the products
thereof;

(c) methods for treatment


of the human or animal
body by surgery or
therapy and diagnostic
methods practised on the
human or animal body;
this provision shall not
apply to products, in
particular substances or
compositions, for use in
any of these methods.
(3) For the purposes of (4) For the purposes of (4) For the purposes of
subsection (2), behaviour subsection (3) above subsection (3) above
shall not be regarded as behaviour shall not be exploitation shall not be
offensive, immoral or regarded as offensive, regarded as contrary to
anti-social only because immoral or anti-social public policy or morality
it is prohibited by any only because it is only because it is
law in force in prohibited by any law in prohibited by any law in
Singapore. force in the United force in the United
Kingdom or any part of Kingdom or any part of
it. it.

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6.4 An extract taken from paragraph 1.33 of the UK Manual of Patent Practice (Jul
2010) explains the changes in UK as follows:

1.33 Sections 1(3) and 1(4) were amended by the Patents Regulations 2000
(SI 2000 No.2037) so that the wording would more closely reflect the
wording of article 27(2) of the TRIPS agreement. Section 1(3)(a) had
previously stated that a patent would not be granted for an invention whose
“publication or exploitation” would “be generally expected to encourage
offensive, immoral or antisocial behaviour”. In practical terms, the effect of
s.1(3) remains the same, which is to prevent the grant of patent rights for
inventions which the general public would regard as abhorrent or from
which the public need protection. It provides a reasonably objective test
which has to be applied to each invention and its particular set of facts and
circumstances. Clearly what is to be regarded as contrary to public policy or
morality will vary according to changes in social attitudes and on no
account ought examiners to allow their own personal and individual beliefs
to colour their judgment on this matter. The decision of Aldous J in the case
of Masterman's Design [1991] RPC 89 under a similar provision of the
Registered Designs Act 1949 deals with issues broadly corresponding with
those which may arise under s.1(3). The Patents Act 1977 (Isle of Man)
Order 2003 (SI 2003 No. 1249) amended sections 1(3) and 1(4) for the Isle
of Man.

[Only in the clearest cases should examiners invoke this subsection and then only
following consultation with their Deputy Director. Any genuine doubt should be
exercised in favour of the applicant with an appropriate minute being created. ]

6.5 The UK also amended her laws to implement Articles 1 to 11 of the European
Directive 98/44/EC on the legal protection of biotechnological inventions. As the
European Directive does not apply to Singapore, they are not replicated in our
Patents Act.

6.6 What is instructive from reading the UK provisions and also the corresponding
provisions in the European Directive 98/44/EC is that these are standards
established within the European Community on the patentability of
biotechnological inventions. For example, they have steered clear from saying that
patenting of processes for cloning human beings, the commercial exploitation of
which would be contrary to public policy or morality. Instead, they merely declare
that such inventions are not patentable inventions, even though the background to
such a declaration could have arisen from an agreement that the commercial
exploitation of such processes would be contrary to public policy or morality.

6.7 In any event, these foreign practices serve as a reference guide for our Examiners in
that they provide assessment tools and tests to be use in the course of Examination.

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C WHAT IS OFFENSIVE, IMMORAL OR ANTI-SOCIAL


BEHAVIOUR

6.8 In the absence of local case precedents, we looked into UK’s and EPO’s practice to
see if they can shed any guiding principles which may be relevant to our
consideration under sections 13(2) and (3).

i. Examiner’s personal beliefs should not colour their judgment

6.9 Paragraph 1.33 of the UK Manual of Patent Practice (Jul 2010) reminds us that

“Clearly what is to be regarded as contrary to public policy or morality will vary


according to changes in social attitudes and on no account ought examiners to
allow their own personal and individual beliefs to colour their judgment on this
matter ”

ii. Abhorrent

6.10 Paragraph 4.1 of the Guidelines for Examination in the European Patent Office
explains as follows:

4.1 Matter contrary to "ordre public" or morality

Any invention the commercial exploitation of which would be contrary to


"ordre public" or morality is specifically excluded from patentability. The
purpose of this is to deny protection to inventions likely to induce riot or
public disorder, or to lead to criminal or other generally offensive behaviour
… Anti-personnel mines are an obvious example. This provision is likely to
be invoked only in rare and extreme cases. A fair test to apply is to consider
whether it is probable that the public in general would regard the invention
as so abhorrent that the grant of patent rights would be inconceivable …

iii. Offensive and non-offensive use

6.11 On “offensive and non-offensive use”, paragraph 4.3 of the Guidelines for
Examination in the European Patent Office explains as follows:

4.3 Offensive and non-offensive use

In some cases refusal of a patent application may be unjustified. This may


result when the invention has both an offensive and a non-offensive use,
e.g. a process for breaking open locked safes, the use by a burglar being
offensive but the use by a locksmith in the case of emergency non

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offensive. In such a case, no objection arises under Art. 53(a). Similarly, if a
claimed invention defines a copying machine with features resulting in an
improved precision of reproduction and an embodiment of this apparatus
could comprise further features (not claimed but apparent to the skilled
person) the only purpose of which would be that it should also allow
reproduction of security strips in banknotes strikingly similar to those in
genuine banknotes, the claimed apparatus would cover an embodiment for
producing counterfeit money which could be considered to fall under Art.
53(a). There is, however, no reason to consider the copying machine as
claimed to be excluded from patentability, since its improved properties
could be used for many acceptable purposes…However, if the application
contains an explicit reference to a use which is contrary to "ordre public" or
morality, deletion of this reference should be required under the terms of
Rule 48(1)(a).

6.12 In sum, we would recall that section 13(2) states that an invention the publication
or exploitation of which would be generally expected to encourage offensive,
immoral or anti-social behaviour is not a patentable invention. The above tests are
useful as a guide and we would advise our Examiners to apply the above tests with
section 13(2) in mind.

D Section 13(3)

6.13 Section 13(3) states that “For the purposes of subsection (2), behaviour shall not be
regarded as offensive, immoral or antisocial only because it is prohibited by any
law in force in Singapore.”

6.14 Paragraph 1.36 of the UK Manual of Patent Practice (Jul 2010)

1.36 Section 1(4) is a rider to section 1(3) to make it clear that an act or
action prohibited by a law is not to be considered as necessarily the same
thing as contrary to public policy or morality. (One reason for this is that a
product which could not lawfully be used in the UK may be manufactured
lawfully in the UK for export to countries where its use is not illegal).
However the existence of a law or regulation may be a material fact to be
taken into consideration in determining whether to refuse an application
under s.1(3). The nature and probable uses of the invention will need to be
considered as well as the exact terms of the prohibition. Thus if the
prohibition is directed unconditionally to the very act which the inventor
proposes very careful deliberation must be given as to whether to invoke
s.1(3). In such cases a useful test is to consider why the prohibition exists.
For example it is considered that the Landmines Act 1998 (implementing
the Ottawa Convention) was passed because the public in the UK generally

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now consider the development, manufacture and use of anti-personnel
mines to be immoral. Alternatively in cases in which an invention can be
exploited legally albeit in accordance with stringent regulations, it would be
very difficult to argue that s.1(3) applies and the application for a patent
refused.

6.15 Hence, the mere fact that a particular behaviour is prohibited by any law (in force
in Singapore) does not necessarily lead one to conclude that the behaviour is
regarded as offensive, immoral or antisocial. On the other hand, a finding of
Section 13(2) can still be raised notwithstanding the presence of a legal prohibition
if the behaviour is regarded as offensive, immoral or antisocial in any event.

6.16 An example is the Human Cloning and Other Prohibited Practices Act in
Singapore. Notwithstanding the existence of this law, an objection under Section
13(2) of the Patents Act should still be raised in a case when the invention relates to
human reproductive cloning. There should still be a finding that the invention the
publication or exploitation of which would be generally expected to encourage
offensive, immoral or anti-social behaviour and is not a patentable invention.

6.17 The Bioethics Advisory Committee (BAC) issued a report in 2001 and it stated (at
paragraph 39, page 31) that:

“There is consensus from all sectors in opposing reproductive cloning. The


BAC is of the view that the implantation of a human embryo created by any
cloning technology in a womb, known as reproductive cloning, or any
other treatment of a human embryo intended to result in its development
into a viable infant, should be prohibited. There are strong public policy
reasons for this position. These include: (a) the view that human
reproductive cloning goes against moral ideas that holds that a human being
is not to be treated as a means to an end, but only as an end. This translates
into the fear that a whole human being may be brought into existence for a
utilitarian purpose; (b) that the social and legal implications of reproductive
cloning are very serious, including issues of identity and responsibility; and
(c) the fear that it will result in a reduction in biodiversity.”

Following the issuance of the BAC report, the Human Cloning Human Cloning and
Other Prohibited Practices Act was enacted and it came into force in Singapore on
1st October 2004. In the Second Reading of the Bill as it then was, the Senior
Minister of State & Health Dr Balaji Sadasivan said that:-

“There will be no unanimous view on this subject and my Ministry


recognises and respects the diversity of views. But in the area of human
reproductive cloning, there is almost unanimous agreement from the
international community, local scientific and religious groups as well as our

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general public that reproductive cloning of human beings is abhorrent and
should not be allowed under any circumstances.".

6.18 The prohibition of human reproductive cloning was codified into law in Singapore
as it is almost unanimous from the international community, local scientific and
religious groups as well as our general public that reproductive cloning of human
beings is abhorrent and should not be allowed under any circumstances. This is
prohibited by law in Singapore because it is regarded as offensive, immoral or
antisocial and as such objections under Section 13(2) should be made over such
inventions.

E Patentability (Sections 13(2)) of inventions relating to


genes
6.19 An assessment on patentability according to Section 13 will be required on the
invention regardless of its area of technology. Inventions relating to genes should
be assessed accordingly.

On the issue of morality with regard to gene inventions, we are reminded of the
case before the Opposition Division of the EPO in Howard Florey Institute
[Relaxin], V8/94 Relaxin, OJ EPO 6/1995 where it separated the arguments from
the patent issues that had to be decided on.

6.20 In Howard Florey Institute [Relaxin], it held that with regard to the isolation of
mRNA from tissue taken from pregnant women, the proprietor stated that the
women who donated tissue consented to do so within the framework of necessary
gynaecological operations. The Opposition Division of the EPO held that the
allegation that human life is being patented is unfounded. They pointed out that
DNA is not "life", but a chemical substance which carries genetic information and
can be used as an intermediate in the production of proteins which may be
medically useful. The patenting of a single human gene has nothing to do with the
patenting of human life. Even if every gene in the human genome were cloned (and
possibly patented), it would be impossible to reconstitute a human being from the
sum of its genes.

6.21 In Singapore, when assessing the issue of morality with regard to gene inventions,
we need to approach the issue in a similar objective manner as was done by the
Technical Board of the EPO in the Howard Florey Institute [Relaxin] case.
Through this process, it allows one to identify the issues at hand before one begins
to apply the Guiding Principles mentioned this Guide to the facts.

6.22 We share the EPO’s view that the patenting of a single human gene has nothing to
do with the patenting of human life. Even if every gene in the human genome were

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cloned (and possibly patented), it would be impossible to reconstitute a human
being from the sum of its genes. Hence, when faced with a claimed subject matter
involving genes per se, the Examiner should proceed to assess whether it meets the
section 13(1) requirements. A section 13(2) issue does not arise.

F Patentability Section 13(2) of inventions relating to


chimeric animals

6.23 Once again, an assessment on patentability according to Section 13 will be required


on the invention regardless of its area of technology. Inventions relating to
transgenic and/or Chimeric animal should be assessed accordingly.

Chimeras in the mythical sense reared their heads in Book 6 of the Iliad (Homer).
In that book, a Chimera was described as a monster, where its head was that of a
lion, its tail was that of a serpent, and its body, was that of a goat.

However, in the modern world when scientists talk about human-animal


combinations in biological medical research, they do not plan the creation of such
monsters. In science, a chimera is an animal or a human whose body contains cells
or tissues from another animal or human. Thus a person with a pig heart valve
transplant is, scientifically speaking, a chimera. Putting animal and human tissues
or cells together, for scientific purposes or for treatment is not new. Chimeras are
usually created in research by introducing human cells such as stem cells into an
animal, or an animal embryo or foetus, and this process does not involve creating
monsters as mentioned in the Iliad.

6.24 Hence, inventions have to be examined as a whole and the term “chimeric animal”
should be read in perspective. It is only in the clearest cases should Section 13(2)
be invoked. Section 13(2) will apply if the grant of patent rights for inventions
which the general public would regard as abhorrent or from which the public need
protection.

G Patentability (Sections 13(2)) of inventions relating to


transgenic animals

6.25 The case of the Harvard/Oncomouse patent was summarised in an Article


published by the World Intellectual Property Organisation (WIPO) dated June 2006
at http://www.wipo.int/wipo_magazine/en/2006/03/article_0006.html.

In brief, it explained the technological background as follows and highlighted the


patent issues that arose:

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Researchers at Harvard Medical School in the early 1980s produced a
genetically modified mouse that was highly susceptible to cancer, by
introducing an oncogene that can trigger the growth of tumors. The
oncomouse (from the Greek word for tumor) was conceived as a valuable
means of furthering cancer research. Harvard College sought patent
protection in the United States and several other countries. The case raised
general ethical issues regarding transgenic technology in itself. But it also
raised two key issues for the patent system:

• should patents be granted at all for animals or animal varieties,


particularly for higher-order animals such as mammals, even if they do
otherwise meet patentablility criteria (novelty, industrial
applicability/usefulness, inventive step etc.)?

• how should moral implications be addressed in relation to specific


cases, e.g. the question of suffering caused to the transgenic animal?

The WIPO article also summarised the positions taken in the US, EPO and Canada
then.

6.26 In Singapore, we would refer to paragraph 14 of the BAC’s Consultation Paper on


“Human-Animal Combinations for Biomedical Research”, where it acknowledged
that:

“…transgenic animals are already widely used in research. Besides enabling


scientists to understand the cause of diseases, and to develop more effective
treatment for these diseases, they have also been used to test the safety of
new products and vaccines and to study the possibility of producing organs
for transplantation that will not be rejected. As transgenic animals are not
thought to raise any new ethical difficulties, they are not considered further
in this Consultation Paper.”.

6.27 In the absence of local laws prohibiting the creation of such transgenic non-human
mammals coupled with the scientific and medical benefits arising from such
researches involving the use of these transgenic non-human mammals, mere
offence to a section of the public, in the sense that that section of the public would
consider the invention distasteful, is not enough for Section 13(2) to apply. Section
13(2) will apply only if the general public would regard the grant of patent rights
for such inventions as abhorrent or where the public need protection from the
publication or exploitation of the invention. Inventions involving transgenic
animals do not attract a section 13(2) objection.

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H Patentability (Sections 13(2)) of inventions relating to the


use of human embryonic stem cells

6.28 The use of the human embryo for commercial or industrial purposes is not
patentable under the UK Patents Act Schedule A2. European Directive 98/44/EC.

However, in Singapore, such use is governed under the Singapore Human Cloning
and other Prohibited Practices Act (http://statutes.agc.gov.sg/) which prohibits the
use of the human embryo after 14 days of its development after fertilisation.

6.29 Methods for generating cloned human embryonic stem cell lines as well as methods
where human blastocysts (an early stage of the embryo) are generated from
fertilised human oocytes should not run foul with the Human Cloning Human
Cloning and Other Prohibited Practices Act. The Senior Minister of State for
Health (Dr Balaji Sadasivan) in the Second Reading of the Human Cloning Human
Cloning and Other Prohibited Practices Bill (as it then was) explained:

Clause 5 of the Bill bans the implantation of any human clone in the body
of a human or animal. Since reproductive cloning, as we know it today,
requires implantation of the embryo into a womb, this effectively prohibits
the development of a human clone. Clause 7 prohibits against developing
human embryo created other than by fertilisation of human egg by human
sperm for a period of more than 14 days. In addition, clause 8 prohibits
against developing any human embryo outside the body of a woman for a
period of more than 14 days. I understand that embryos less than 14 days
old compose of undifferentiated cells. So the Bill allows for stem cell
research to be done on these cells for as long as it takes and so long as the
embryo is not further developed. I understand that the 14-day point was
recommended because it is at this time that the primitive streak appears.
Many groups believe that human life begins to exist only later. Thus,
clauses 7 and 8, read together, address our objections against experimenting
with human life forms while allowing stem cell research.

6.30 Inventions arising from use of human blastocysts in stem cell research not
prohibited under the Singapore Human Cloning and other Prohibited Practices Act
(http://statutes.agc.gov.sg/) will not attract a Section 13(2) objection.

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I SECTION 13(2) ASSESSMENT: IN A NUTSHELL


6.31 The following table summarises the steps to be taken by the Examiner.

Table 9: Steps Involved in assessing the subject matter under section 13(2)
Step 1 Determine whether the subject matter in question is “abhorrent” or
“offensive” mentioned in this Chapter. If so, to proceed with Step 2.

Step 2 Determine whether the publication or exploitation of the subject matter


in question would be generally expected to encourage offensive,
immoral or anti-social behaviour is not a patentable invention.

Step 3 When in doubt, raise the issue to the Patent Quality Management Unit
(Search & Examination), IPOS.

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ANNEX
LIST OF PATENT DECISIONS IN SINGAPORE
CASE NAME COURT/IPOS CASE KEY WORDS Referred in
CITATION* this Guide
(Paragraphs)
1 Merck & Co, Inc v High Court — Suit No [1999] SGHC 323 Pharmaceutical product- 3.17
Pharmaforte 413 of 1999 Product claims-Process
Singapore Pte Ltd Lai Kew Chai J claims-Scope of claims-
23–27 August, 14 Purposive or realistic claim
October, 22 December construction-Infringement-
1999 Lack of novelty-
[2000] SGCA 39 Anticipation by disclosure-
Lack of inventive step-
Utility-Industrial
Court of Appeal — application- -Invalid 2.14, 3.20, 4.16
Civil Appeal No 9 of patent-Difference in purity
2000 unpatentable-Unsuccessful
Yong Pung How CJ, LP shift of burden of proof of
Thean and Chao Hick infringement to infringer
Tin JJA defendants by s68(1)
24 May, 28 July 2000 Patents Act

2 Genelabs High Court — Suit No [2000] SGHC 53 Virus test kit- European 3.18, 3.19
Diagnostics Pte Ltd 1762 of 1998 patent- Transitional
v Institut Pasteur & Tay Yong Kwang JC provision s116(3)
Anor Patents Act-Purposive
31 March 2000
construction-
[2000] SGCA 60 Infringement-Validity-
Court of Appeal — Novelty- Inventive step- 3.20
Civil Appeal No 14 of
Prior art-Disclosure-
2000
Innocent infringement-
Yong Pung How CJ, LP Acquiescence-Grant of
Thean and Chao Hick licence s43 Patents Act-
Tin JJA
Registration of exclusive
21 August, 2 November licence s75 Patents Act
2000
3 Bean Innovations High Court — Suit No [2000] SGHC 219 Letterbox mechanism- -
Pte Ltd and Another 1549 of 1999 Groundless threats-
v Flexon (Pte) Ltd Rubin J infringement-claims
21, 23–25 February, construction-specification
18 April, 12, 23 May,
31 October 2000
[2001] SGCA 42
Court of Appeal —
Civil Appeal No 78 of
2000
Yong Pung How CJ, LP

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ANNEX
LIST OF PATENT DECISIONS IN SINGAPORE
CASE NAME COURT/IPOS CASE KEY WORDS Referred in
CITATION* this Guide
(Paragraphs)
Thean and Chao Hick
Tin JJA
23 April, 26 May 2001

4 Ng Kok Cheng v High Court — Suit No Lock-infringement- 4.11, 4.12


Chua Say Tiong 783 of 2000 [2001] SGHC 143 inventive step-enabling
Judith Prakash J disclosure-insufficiency
12–16, 19–20 March,
24–25 April, 22 June
2001

5 Peng Lian Trading High Court — Suits [2002] SGHC 238 Spectacle frames-lack of
Co v Nos 147/2000 and inventive step-definition-
Contour Optik Inc 371/2001 material difference-
and others Lee Seiu Kin JC revocation-groundless
3-16 October 2001, threats-recordals-
30 September-4
October, 14 October
2002
[2003] SGCA 25

Court of Appeal —
Civil Appeal No 126 of 4.20
2002
Yong Pung How CJ,
Chao Hick Tin JA and
Judith Prakash J
29 April; 24 June 2003
6 FE Global High Court — Suits [2005] SGHC 90 Computer peripheral- 3.16, 4.10,
Electronics Pte Ltd Nos 609, 604 and 672 Innocent Infringement- 4.11, 4.20
and Others v Trek of 2002 Purposive approach-
Technology Lai Kew Chai J subject matter in
(Singapore) Pte Ltd 12–30 April; 4–5 May; amendments-added matter-
disclosure-lack of
10 November 2004; 12
[2005] SGCA 55 inventive step-novelty-
May 2005
assignment of rights-
groundless threat-
Court of Appeal — revocation-
Suits Nos 69/2005, misrepresentation-
70/2005 conspiracy-joint
Yong Pung How CJ, tortfeasorship-undue delay
Chao Hick Tin JA and

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ANNEX
LIST OF PATENT DECISIONS IN SINGAPORE
CASE NAME COURT/IPOS CASE KEY WORDS Referred in
CITATION* this Guide
(Paragraphs)
Tan Lee Meng J
11 November, 30
December 2005

7 Dextra Asia Co Ltd High Court — Suits [2006] SGHC 7 Construction -


and another v Nos 641/2004 and manufacturing process-
Mariwu Industrial 339/2005 Infringement-inventive
Co (S) Pte Ltd and Tan Lee Meng J step-novelty-prior use-
another suit prior disclosure-
5-16 September;
commercialisation
10 October 2005;
[2007] SGHC 51
27 January 2006

High Court — Suit No


641 of 2004
Tan Lee Meng J
20–21 November 2006;
12 January 2007; 12
April 2007
8 Main-Line High Court — Suit No [2006] SGHC 233 Method and system- 4.21
Corporate Holdings 806/2004 Tay Yong Innocent Infringement-
Limited v United Kwang J Inventive step-Novelty
Overseas Bank 21 Dec 2006 objection-Burden of proof-
Limited and Disclosure-Statutory Tort-
Another (First Damages -Remedies
Currency Choice Pte
Ltd, Third Party) Court of Appeal — Suit [2007] SGCA 50 4.3, 4.5, 4.11,
Nos CA 4/2007 and
4.16, 4.20
5/2007
Andrew Phang Boon
Leong JA, Belinda Ang
Saw Ean J,
V K Rajah JA
31 Oct 2007

High Court — Suit No [2009] SGHC 232


806/2004, RA
327/2008, 328/2008
Belinda Ang Saw Ean J
16 October 2009

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ANNEX
LIST OF PATENT DECISIONS IN SINGAPORE
CASE NAME COURT/IPOS CASE KEY WORDS Referred in
CITATION* this Guide
(Paragraphs)
9 Seiko Epson Corp v High Court — Suit No [2007] SGHC 81 Ink cartridges- -
Sepoms Technology 699/2005, RA manufacturing-Innocent
Pte Ltd and Another 375/2006 infringement-defence to
Lai Siu Chiu J liability-accounting records
25 May 2007 [2007] SGCA 52

Court of Appeal — Suit


No CA 19/2007
Andrew Phang Boon
Leong JA and V K
Rajah JA
16 November 2007

10 Mühlbauer AG v High Court — Suit No [2009] SGHC 45 Machine-Electronic 3.16, 4.3, 4.21
Manufacturing 80/2007 components-Inspection-
Integration Tay Yong Kwang J Placement-Infringement-
Technology Ltd 23 February 2009 Invalidity-Novelty-
Anticipation-Inventive
step-Threat of infringement
[2010] SGCA 6 s77 Patents Act-Expert
Court of Appeal — Evidence-Mosaic of prior
Civil Appeal No 34 of art-Commercial success not
2009 conclusive
Chao Hick Tin JA,
Andrew Phang Book
Leong JA, V K Rajah
JA
23 February 2010

11 ASM Assembly High Court — Suit No [2009] SGHC 206 Apparatus-Method-Place- 4.8, 4.21
Automation Ltd v 163/2007 Array of solder balls-
Aurigin Technology Tan Lee Meng J Substrate-Infringement-
Pte Ltd and Others 16 September 2009 Injunction-Revocation-
Novelty- Inventive step-
Serious and effective
preparations to
manufacture s71(1) Patents
Act-Groundless threats of
infringement s77 Patents
Act
12 Cargill International IPOS [2009] SGIPOS 12 Infant formula-Arachidonic -
Trading Pte Ltd v Danielle Yeow DR and acid-Eicosapentaneoic
Martek Biosciences acid-Triglyceride-

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ANNEX
LIST OF PATENT DECISIONS IN SINGAPORE
CASE NAME COURT/IPOS CASE KEY WORDS Referred in
CITATION* this Guide
(Paragraphs)
Corporation Isabel Chng PAR Revocation-Patentability-
3 November 2009 Novelty-Inventive step-
Foreign decisions-
Independence of expert
witnesses-Former or
current employees-Claim
construction-Dimensional
limitation-Enabling
disclosure-Submission of
evidence after close of
proceedings without leave

13 Cargill International IPOS [2009] SGIPOS 16 Infant formula-Arachidonic -


Trading Pte Ltd v Chiam Lu Lin DR and acid-Eicosapentaneoic
Martek Biosciences Simon Seow PAR acid-Triglyceride-
Corporation Revocation-Patentability-
31 December 2009
Novelty-Inventive step-
Insufficiency not just lack
of clarity-Allowability of
amendments-Extend scope
of protection-Independence
of expert witnesses-Foreign
decisions-Independence of
expert witnesses-Former or
current employees
* SG Case citations refer to the revised case citations.

Patent Quality Management Unit (Search & Examination)


Registry of Patents
Intellectual Property Office of Singapore
51 Bras Basah Road #04-01
Plaza By The Park Singapore 189554
Tel: (65) 63398616
Fax (General): (65) 63390252
Fax (Patents): (65) 63399230
http://www.ipos.gov.sg
ipos_enquiry@ipos.gov.sg (attention: Patent Quality Management Unit (Search & Examination)

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