INDIA’S PATENT POLICY

India has a long history of patent policy which was framed after enormous study.
India’s approach to patents differs from those of industrialized countries in that India sees
patents as a tool of public policy. India’s policy is being challenged by the demand to reform
IPR laws to conform to TRIPs. This section provides an overview of India’s patent policy.
India’s Patent Policy in Pre-TRIPs Period. India’s patent policy focused on balancing
developmental concerns with the need for promoting innovations. India viewed patents as a
tool for economic development and restricted the scope and term of patents. The sentiment in
India on the issue of patents, especially on pharmaceuticals, is illustrated by an oft-quoted
statement made by Indira Gandhi at the World Health Assembly in 1982:
“The idea of a better-ordered world is one in which medical discoveries will be free of patents
and there will be no profiteering from life and death”.The philosophy of India’s Patents Act of
1970 varies enormously from the framework being established under TRIPs. There are several
knowledge and information areas which India considers non-patentable. India has a large
community of scientists and researchers among whom publication rather than gaining patents
has been a concern. G.V. Ramakrishna, Chairman of the Disinvestment Commission points
out that in India, “We (Indians) are accustomed to the notion that knowledge is free.
Our whole orientation has to change from one that stresses intellectual attainment to one that
protects intellectual property.” Industrialized nations conceive of patents as a
fundamental right comparable to the right of physical property, whereas developing nations
view it as “fundamentally as an economic policy question. “From the perspective of developed
countries, intellectual property is a private right that should be protected as any other tangible
property, but for developing nations, intellectual property is a public good that should be used
to promote economic development .India has always believed in the Principle of Dharma and
wanted that this Principle be envisaged in the Laws that it enacts. On this basis Patents Law
was legislated so that the fruits of innovation be reached to the least person and no person is
deprived of it as India was against the commercialization of one’s own intellect.

THE MAIN FEATURES OF THE ORIGINAL INDIAN PATENTS ACT, 1970

1. The Act tries to strike a balance between the rights of the patent holder and his obligation to
the society that grants him such rights.
2. The basic philosophy of the Act, as laid down in Section 83, is that patents are granted to
encourage inventions to accelerate indigenous industrial growth by securing their working in
India on a commercial scale. And, those patents are not granted merely to enable patentees to
enjoy a monopoly for the importation of the patented article.

3. The Act totally excludes atomic energy and methods of agriculture from patentability. One
cannot obtain any sort of patent whatsoever in these fields (Section 3).

4. The Act permits product patents for all inventions except food, medicines, drugs and
Substances produced by chemical processes; in these fields only process patent is available
because food and health are crucial for the well-being of the people. Process patents in these
areas enable the other competitors to find new, improved and economical processes for
producing the same product.

5. Section 53 provides patent protection for a period of 14 years from the date of filing. In case
of food and medical drugs the period of protection is limited to seven years from the date of
filing the patent or five years from the date of sealing, whichever is earlier. This shorter period
of protection in case of food and medicines is believed to be necessary to prevent the patentee
from exploiting the needs of society by charging exorbitant prices for the patented article.
Further, in the field of medicine, the rate of obsolescence is high as new and improved
molecules keep replacing the existing ones.

6. The Act contains provisions for compulsory working of a patent. The Working of a patent
means manufacturing the product in India. The patentee cannot hold Chandiramani, Nilima..
“Legal Factors in TRIPs”: Economic and Political Weekly. Centre for Civil Society 8. January
19, 2002. the patent in India and import the product from another country, thereby compelling
the Indian consumer to pay an excessive price.

7. In public interest, patents are subject to strict and extensive governmental control and use.
The provision on Compulsory Licensing under Section 84 of the Act ensures the working of
the patent after three years from the date of sealing. If the patent holder ignores this provision,
any person may apply for compulsory license and he shall be licensed to manufacture the
product. The rationale of compulsory license is that the state undertakes to protect IPRs only
to ensure that new products are available cheaply and in abundance. Hence compulsory license
is issued if it is in public interest or if the manufacturer does not work the patent.

8. Every patent for an invention relating to a method or process for manufacture of Substances
intended for use, or capable of being used, as food, medicines, or drugs, or relating to
substances prepared or produced by chemical process (including alloys, optical glass, semi-
conductors and inter-metallic compounds) shall be deemed to be endorsed “Licenses of Right”
from the date of expiry of three years after the sealing of the patent. This patent law which was
a model for other developing countries like Argentina, Mexico, Egypt, Brazil and Chile, has
been replaced by the Indian Patent Act, 1999, which is modeled on the basis of the TRIPs
(Trade-Related Aspects of Intellectual Property Rights) Agreement. This amendment seeks to
implement the obligations that India has taken in the field of patents by signing the
TRIPs Agreement. The bill generally aims at making the 1970 Patents Act as TRIPs compliant
as possible. Besides TRIPs, India is also a member of the following international treaties
related to intellectual property rights:
a) Convention establishing World Intellectual Property Organization (WIPO)
b) Paris Convention for the protection of Industrial Property with effect from December 7,
1998
c) Patent Cooperation Treaty (PCT) with effective from December 7, 1998

Patents Amendment Act, 1999

Even though India was given exemptions from implementing pharmaceutical/ agrochemical
product patents until 2005, it was mandated to set up a mailbox facility for such product patent
applications filed during the TRIPs transition period and to assign each application a filing
date. Another obligation under TRIPs was the provision dealing with the grant of EMRs for
mailbox applications that met specified conditions during the transition period. India initially
tried to implement the mailbox facility and grant EMRs by way of a presidential order. For
various reasons the Indian parliament failed to pass the law dealing with mailbox facility and
EMRs. This prompted the United States to utilize the WTO’s dispute resolution mechanism to
address India’s failure to enact the mailbox and EMR regime into a law.58 The WTO’s
Appellate Body held in December 1997 that India’s failure to make timely amendments to its
patent laws had resulted in its non-fulfillment of obligations covered by Article 70.8(a) of the
TRIPs Agreement, which mandated that India establish “a means” that adequately preserved
novelty and priority of pharmaceutical product patent applications. Finally, in March 1999, the
amendment was passed by the Indian parliament; India formally implemented the mailbox
procedure for pharmaceutical product patent applications and gave it retroactive application
from January 1, 1995.Mailbox applications were deposited in a “black box,” and they were not
taken out for examination until March 2005. During India’s ten-year TRIPs transition period,
26 mailbox applications were filed in the four branches of the Indian Patent Office. The
framework for filing mailbox applications, in order to comply with the TRIPs transition
requirements, ended for India on December 31, 2004. This means that the provisions dealing
with mailbox applications/ EMRs became obsolete in 2005 and they have been repealed by
way of the 2005 amendment. Few applicants who filed mailbox applications during the TRIPs
transition period took the additional step of seeking EMRs for their inventions. The grant of
an EMR would have conferred the exclusive right to sell or distribute the invention
in India for a period of five years from the date of the grant until either a patent was granted,
or the application was finally rejected, whichever was earlier.An EMR was granted only for
those inventions claimed in mailbox applications that further satisfied the following
requirements:
a. an examination by the Indian Patent Office had established that the invention did not fall
within any of the categories of subject matter considered as non-patentable inventions like
business methods, frivolous inventions, mere admixture, or within the scope of the prohibition
on patenting inventions relating to atomic energy;

b. The mailbox/EMR applicant had filed a patent application for the same invention, claiming
the “identical article or substance” in a “convention country” on or after January 1, 1995;

c. The mailbox/EMR applicant had been granted a patent by the convention country on or after
the date it filed its mailbox application in India;

d. The convention country had issued “approval to sell or distribute the Article or substance”
in the convention country, “on the basis of appropriate tests conducted” in the convention
country on or after January 1, 1995;

e. An authority on behalf of the Indian government had given approval to sell or distribute the
article in India.
 The Patents (Amendment) Act, 2005
The last step in India’s implementation of the changes required to make its patent law TRIPs
compliant happened by way of the 2005 amendment. Through this amendment, Indian law, for
the first time since 1970, allowed patent protection to substances capable of being used as
pharmaceuticals, food, and agrochemicals. The 2005 amendment was preceded by a
presidential ordinance in 2004. After its promulgation, there were intense debates about the
scope of various provisions, but the Indian Parliament enacted the 2005 amendment after
making changes in the ordinance. The 2005 amendments contain many controversial features
that have caused many disputes. They include elaborate provisions concerning what is and is
not considered patentable subject matter, a new definition of the “inventive step” criterion of
patentability, procedures governing both pre- and post-grant opposition,83 and a more liberal
framework for compulsory licensing.

Patent Information Services

The PIS offers patent information services like search & Patent copy supply on payment of
appropriate charges including postal charges for services provided by post. The payment may
be made against a proforma invoice.

OBJECTIVES

Government of India, Ministry of Commerce and Industry, Department of Industrial Policy

and Promotion established Patent Information System (PIS), in the year 1980 with the
following objectives.

 To obtain and maintain a comprehensive collection of patent specification and patent related
literature on a worldwide basis to meet the needs for technological information, of various users
in R&D establishments, Government Organizations, Industries, Business, Inventors and other
users.
 To provide technological information contained in patents through, search services and patent
copy supply service

FUNCTIONS

The PIS caters to user needs on the basis of patent documentation and computerized system for
retrieval and dissemination of patent information.
WHO IS A PATENT AGENT?

A patent agent is a link between the patent office and an applicant. A patent agent facilitates
work at the patent office representing an applicant elating to grant a patent. All the prosecution
related works are handled by a patent agent. A patent agent is authorized to do certain acts in
exclusion of others and to practice before the Controller on the behalf of the applicant or an
inventor

A person who is qualified to prosecute patents (i.e. drafting and filing a patent application) is
known as a patent agent. Given the fact the drafting a patent requires specific technical as well
as legal knowledge, only a person qualified in both domains will be able to fulfill the
obligations of patent prosecution. In India, a patent can be prosecuted through a registered
Indian patent agent. Section 126 of the Indian Patents Act, 1970 envisages the qualifications
for becoming a patent agent.

The statutory requirements for becoming a patent agent are:

a. Be a citizen of India;
b. Have completed the age of 21 years;
c. Have obtained a degree in science, engineering or technology from any University
established under law for the time being in force in the territory of India.
d. Have passed the qualifying exam prescribed for the purpose.

The qualifying exam stated in point (d) is the Patent Agent Exam that is conducted every year
by the Controller General of Patents. Passing this exam is a must in order to qualify as a
registered Indian patent agent.

From the preceding listed qualifications, two things are absolutely clear:

1. In order to become a patent agent, a degree in law is not required. A degree in science,
engineering or technology is a must.
2. An individual with a degree in law does not automatically qualify as a patent agent unless
he meets the above requirements.
 WHAT IS THE ROLE OF A PATENT AGENT?

As stated above a patent agent is qualified for patent prosecution. The role of a patent agent is
described in section 127 of the Indian Patents Act, 1970. According to Section 127, a patent
agent is entitled to:

 Practice before the Controller; and

 Prepare all documents, transact all business and discharge such other functions as may be
prescribed in connection with any proceeding before the Controller under this Act

WHAT IS THE DIFFERENCE BETWEEN A PATENT AGENT AND A PATENT

ATTORNEY?
Particularly, the difference between a patent agent and a patent attorney is on two criteria;
qualification and role. The below table will give a comprehensive view of the differences:

PATENT AGENT PATENT ATTORNEY

Qualification

1. Must possess a degree in science, 1. Degree in science, technology or engineering not

technology or engineering necessary

2. Degree in law is not required 2. Must have a degree in law

3. Must pass the Patent Agent Examination 3. Must be enrolled in any State Bar Council

Role

1. Patent Prosecution 1. Patent litigation

2. Practices before the Controller 2. Practices before the court

 Module 2 :

Documents require to fill an application :

1. Declaration as to Inventorship
2. Statement and Undertaking
3. Proof of right to make an application
4. Authorization of an Agent

1. What are the documents and information required for filing a national phase/
convention application in India?

The documents and information which are required for filing a national phase or a
convention application are summarized in the table below:

S. No. Document/ Information When is it required Can it be submitted later?

Complete specification (in No extensions are available for filing the

1 Along with the application
English) complete specification at a later date

No extensions are available for filing

2 Drawing(s) Along with the application
the drawings at a later date

Name, address and No; although inventor(s) may be added/

3 Along with the application
nationality of inventors’ removed subsequently by filing a request

No; although applicant(s) may be

Name, address and
4 Along with the application added/ amended subsequently by filing
nationality of applicants)
a request

Yes, an extension may be obtained by

Power of Attorney (To be
Within 3 months of the
5 filed in case the application filing a request for extension before the
application date
is filed by a patent agent)
expiry of the time limit or by filing a
 petition after the expiry of time limit.

Assignment Deed or Yes, an extension may be obtained by

Application Form endorsed
Within 6 months of the filing a request for extension before the
6 by the inventor (if the
application date expiry of the time limit or by filing a
inventors are not the
applicants) petition after the expiry of time limit.

Details of corresponding Yes, an extension may be obtained by a

applications filed in other
Within 6 months of the filing a request for extension before the
7 countries (Information and
application date expiry of the time limit or by filing a
undertaking under Section
8) petition after the expiry of time limit.

Verified English translation

of the
Within 3 months of priority
8 Priority application No extensions are available
date
(required for convention
applications)

Verified English translation

of the PCT application
(required only for national
phase applications) Agent Within 31 months of priority
9 No extensions are available
can verify the English date
translation of PCT
application on behalf of the
applicant.

Certified copy of the priority

application, if requested by
the Controller (required Within 3 months of request by
10 No extensions are available
usually for convention the Controller
applications, but may also be
requested for national phase
 application in case the
priority document was not
submitted with the
International Bureau)

Sequence listing in
computer readable text
11 format (if any) (no print Along with the application No extensions are available
form is required to be
submitted)

Permission from National

Biodiversity Authority (in
12 case any Biological material
used in the invention is from patent
India)
The permission may be submitted after
Permission must be requested
for before applying for the filing of the patent application but before
grant.

The accession number (identification

number) may be included in the

Microorganisms must be
deposited with International specification within 3 months from the
Depository Authority (In
Before filing of the date of filing of the application. In case a
13 case microorganisms are
application request for publication is filed, then
used that are not available to
public and cannot be accession number must be included
appropriately described)
before filing of such a request for

publication.

What information and documents are required to be submitted under Section 8 of the
Patents Act?( Statement and Undertaking)

Section 8 of the Patents Act together with Rule 12 of the Patents Rules requires the applicant
to furnish the details of corresponding foreign applications at the Indian Patent Office. Under
this requirement, two types of information are required to be submitted at the Indian Patent
Office, as stated below

a. Information under Section 8 (1):

Section 8 (1) of the Patents Act requires an applicant to voluntarily submit the details of all the
corresponding foreign applications at the Indian Patent Office and keep the Indian Patent Office
informed from time to time of the updated status of these applications. The required details
include name of country, application number, filing date, status and patent number and date of
grant, if available. This information is required in respect of all applications for the same or
substantially the same invention as that of the Indian Application and includes
divisional/continuation in part applications.Briefly, the obligation to file details under Section
8 (1) can be divided into three stages-

 Foreign applications filed on or before the filing date in India: As per Rule 12, the period
within which the applicant is required to file this information is six months from the date
of filing the application in India.

 Foreign applications filed after filing the application in India: The period within which the
applicant shall keep the Controller informed of the details of such applications is six months
from the date of such foreign filing.

 Updating the status of all the corresponding foreign applications

Under Section 8(1), it is pertinent to highlight that the Patents Act prescribes the time limit
only for submitting the details of corresponding foreign applications at the Indian Patent Office.
While the Patents Act does require the applicant to keep the Controller informed of updated
status of all the corresponding applications from “time to time” till grant, it does not prescribe
a time limit for the same. The Act accordingly requires the applicant to inform the Controller
as and when there is any change in the status / details of the corresponding foreign application
but does not require him to update the details of corresponding foreign applications every six
months.
b. Information under Section 8(2):
If requested by the Controller, details of prosecution of a corresponding application in a foreign
country may have to be provided. Such a request is generally made in the examination report.
When requested by the Controller, this information must be submitted within six months of the
request.

Briefly, the requirement under Section 8 (2) can be met by submitting:

a. Examination reports;

b. Any claim amendments made in corresponding applications, and

c. Claims as allowed/ granted in corresponding foreign applications.

Where these documents are not in English, appropriate translation should also be filed

What happens if an applicant fails to submit the information or document required under
Section 8?

Failure to submit information regarding corresponding foreign applications and details of

processing when requested is a ground for both pre- grant and post-grant opposition
proceedings before the Indian Patent Office and revocation proceeding before the Courts and
the Intellectual Property Appellate Board.

INVENTORSHIP AND PROOF OF RIGHT TO APPLY

The inventor is the principal actor in the patent prosecution drama. Section 7 of the Indian
Patents Act prescribes that where the application is made by virtue of an assignment of the
right to apply for a patent for an invention, the applicant is required to furnish, either along
with the application or within six months of the date of filing of the Indian application, a proof
of right to make the application. This is a mandatory requirement under the Rules (Rule 10). A
proof of right must be submitted either along with the application for patents, but if it is not so
furnished, the applicant shall furnish such a proof of right within a period of six months after
the filing of the application in India. The period for filing of the proof of right may be extended
under the provisions of Rule 138, by a maximum period of one month, provided, however, that
the application for extension is filed within the six months period allowable for filing. Under
the Indian patent filing system, there is a very simple method of establishing this proof of right.
In the form of filing a patent application, i.e. Form 1, the inventor/s is/are required to sign a
declaration in original by which it or they declare that the applicant is its/their assignee or legal
representative. This original declaration given by the inventor/s is considered adequate to
satisfy the proof of right requirements. If there are multiple inventors and these inventors are
located in different parts of the world, the patent office also accepts individual signed
documents from each of the inventors and the document does not need to travel throughout the
world for including the inventors’ signature thereon. Some practitioners insist that the actual
assignment deeds or certified copies thereof be filed by which the applicant can show that the
inventor has assigned the right to apply for the invention to the applicant.

Substitution of Applications

Substitute patent application refers to an application which is actually a duplicate of a prior

application by the same applicant abandoned before the filing of the substitute or later filed
application. A substitute application does not obtain the benefit of the filing date of the prior
application

WHAT ARE ‘COMPULSORY LICENSES’ UNDER THE PATENTS ACT?

In simple terms, compulsory licenses are authorizations given to a third-party by the

Government to make, use or sell a particular product or use a particular process which has been
patented, without the need of the permission of the patent owner. The provisions regarding
compulsory licenses are given in the Indian Patents Act, 1970 and in the TRIPS (Trade-Related
Aspects of Intellectual Property Rights) Agreement at the International level. Although this
works against the patent holder, generally compulsory licenses are only considered in certain
cases of national emergency, and health crisis. There are certain pre-requisite conditions which
need to be fulfilled if the Government wants to grant a compulsory license in favor of someone

Patents are granted to encourage the inventors to disclose their inventions and also to grant
them monopolistic right to exploit the invention. The objective of Patent Grant in India is to
ensure that the inventions are worked in India on a commercial scale and to the fullest extent
without any undue delay.
Accordingly, any interested person after expiry
of 3 years from grant of patent even though if he is a license under the patent, may make
an application to the Controller for grant of compulsory license on the grounds that:
(a) the reasonable requirements of the public with respect to the patented invention have not
been satisfied; and

(b) the patented invention is not available to the public at a reasonable price.
(c) the invention is not worked commercially to fullest extent in territory of India.

The circumstances constituting "failure to meet the reasonable requirements'' of public in

respect of a patent are as follows:

(i) Inadequate manufacture in India or failure to grant licenses on reasonable terms with in a
period of 6 months from applying by the applicant resulting in:

(a) Prejudice to an existing trade or industry or its development,

(b) Prejudice to the establishment of a new trade or industry in India,
(c) Prejudice to the trade or industry of any person or class of persons,
(d) Demand for the patented article not being met adequately by local manufacture,
(e) Failure to develop an export market for the patented articles made in India,
(f) Prejudice to the establishment of commercial activities in India;

(ii) Prejudice to the establishment or development of trade or industry in India in goods not
protected by the patent arising from restrictive conditions imposed by the patentee;

(iii) Non-working of the patent in India on a commercial scale;

(iv) Demand for the patented articles being met by importation from abroad; and

(v) Commercial working of the patented invention in India being hindered or prevented by
import of the patented articles from abroad.

Grant of Compulsory license is for the remaining term of patent unless a shorter period looks
reasonable and required in case to the Controller.

Further, it is to be noted that while granting the license the Controller shall take into account
the nature of invention, time elapsed, ability of applicant, his efforts for obtaining a license on
reasonable terms. While granting a compulsory license reasonable royalty is also paid to the
patentee having regard to nature of Invention, its utility, expenses incurred in maintaining
patent grant in India and other factors.

Normally request for grant of Compulsory License is published and Patentee and other
interested persons are afforded reasonable opportunity to defend the grant. But in case of
national emergency and other urgent condition in public interest the Controller may first
grant the License and then notify the Patentee and other interested persons.
Under special circumstances of medical emergency supported by notification by foreign
country in this regard controller may grant compulsory license to meet the medical
emergency in that country.

UNITY OF INVENTION: INDIAN PATENT LAW PERSPECTIVE

As per Indian Patent Law, one patent application shall relate to a single invention. However,
if more than one inventions are to be claimed in single application, it is necessary to establish
that the inventions so claimed have unity and they form a single inventive concept. The golden
rule is that the claim (s) of a complete specification shall relate to a single invention, i.e. the
concept of unity of invention shall be there.

According to Section 10 of the Patents Act 1970, if claims refer to a group of inventions, such
inventions shall form a single inventive concept. The claims shall be clear and succinct and
shall be fairly based on the matter disclosed in the specification and moreover, a single
inventive concept may be recognized between independent claims of different categories.

The invention comprising of a polymer, process to prepare polymer and commercial utility of
polymer can be claimed in the single patent application because even though the invention has
three main components, all of them relate to a single invention and have unity. On the other
hand, the invention relating to two independent formulations used to treat cancer and
HIV/AIDS shall not be claimed in a single patent application as both formulations are
independent of each other and hence lack unity of invention.
The purpose of this requirement of unity of invention is administrative, as well as financial.
That is, the requirement serves to prevent the option of filing one patent application for several
inventions, while paying only one set of fees, such as, fee for filing application, examination,
early publication or annual renewal etc. Moreover, the concept of unity of invention also makes
the technical classification easier.

Under section 16 of the Indian Patents Act, 1970, if a single patent application has been filed
with more than one invention and invention so claimed lacks unity, the applicant may divide
main application into divisional application. However, the further application (divisional
application) and the complete specification accompanying it shall be deemed to have been filed
on the date on which the first mentioned application had been filed, and the further application
shall be proceeded with as a substantive application and be examined when the request for
examination is filed within the prescribed period.

“According to Section 10 of the Patents Act 1970, if claims refer to a group of inventions,
such inventions shall form a single inventive concept. The claims shall be clear and succinct
and shall be fairly based on the matter disclosed in the specification and moreover, a single
inventive concept may be recognized between independent claims of different categories.”
However, during the process of examination of the patent application, the examiner may also
ask the applicant to divide the application into two or more applications and file divisional
application. It is interesting to note that both parent application and divisional application will
have the same priority date though divisional application is often filed later than parent
application. For example:

Date of filing provisional application and priority date: 15th November 2006

Date of filing complete specification: 13th November 2007

Publication and examination of the patent application takes place and the Controller raises the
objection that the invention lacks unity of invention and hence the application shall be split
into two applications i.e., main parent application and divisional application. Here, the date of
filing divisional application will be 10th Jan 2009.

In such a case, both parent application and divisional application will have priority date of 15th
November 2006 even though the divisional application was filed 10th Jan 2009, which also
mean that both parent application and divisional application expire on the same date
irrespective of the date of filing.

A specification in respect of a divisional application under section 16 shall contain specific

reference to the number of the original application from which the divisional application is
made. The request for examination in case of divisional application shall be filed within 48
months from the date of filing or priority of the parent application or within six months from
the date of filing the divisional application, whichever expires later. Request for divisional
application shall be filed only after filing request for the parent application to ensure the
requirement of section 16(3).

Moreover, the complete Specification of a divisional application should not include any matter
not in substance disclosed in the complete specification of the first application. The reference
of parent application should be made in the body of the specification. A divisional application
has to be filed before the grant for a parent application.

Though it sounds economical to club multiple inventions together and file for a single
application, it is logical to follow the concept of unity of the invention and ensure that separate
applications are filed for each invention