Patenting Issues Related to Microbial Biotechnology

Biotechnology can be defined as the collection of technologies that capitalize on the

attributes of biological systems, processes and organisms along with their contributions to
manufacturing industries and put molecules such as DNA and proteins to work for us.
The foundations of modern biotechnology were laid in the first half of the twentieth
century with a transition from the Age of Chemistry to the Age of Biotechnology that has
and is going to witness an expansion of the global economy, increasing wealth while
reducing humankind’s dependence on environment.

The products of the innovative efforts need to be protected including the financial
investments by strong intellectual property (IP) laws. Patents are the most important way
in which researchers can protect the income that might come from ideas or technologies
they have developed. The steps involved and the considerations needed for successful
granting of a patent have been described by Latimer [1]; for instance, inventions must be
novel and non obvious, adequately described, and industrially applicable. The patent
rights being territorial in nature are enforceable only within the country, which grants the
patent. The non-patentable conditions generally differ from country to country with
different subject matter considered fit for patenting.

Effective intellectual property protection and enforcement contribute to the growth,

development and success of human invention involving biotechnology [2]. Countries
across the globe are now vying for competitive edge for leadership in the global market
through technological growth and development. Various companies in recent times have
started registering intellectual property in their name. Patents are now seen as a potent
indicator of the status and competitiveness in the modern world.

Recent decades have seen an increase in intellectual property protection worldwide [1].
The ruling that a live, human-made, genetically engineered bacterium (that was modified
to break down components of crude oil) could be patented initiated an era of progressive
private investment in biotechnology and of rapid expansion in the patenting of new
biotechnological innovations and products (US Patent No. 4259444). Many
biotechnology companies and universities have since applied for and been granted
patents on a wide range of biotechnology processes and products, involving genes,
viruses, bacteria and even higher living organisms.

Patenting Criteria

For patenting an invention either process or product has to meet criteria, of novelty,
involving an inventive step and being capable of industrial application and also sufficient
disclosure of the invention.

Trade Related Aspects of Intellectual Property (TRIPs) does permit certain plants and
animals, other than microorganisms, to be excluded from patenting, as well as essentially
biological processes. TRIPS also allows inventions to be excluded from patenting if it is
necessary to protect human, animal or plant life, the environment or morality. Diamond
v. Chakrabarty and Harvard Oncomouse are two important cases in the field of
biotechnology patents that have been raised in relation to patenting live organisms. At the
national/regional level, various approaches have been taken in different countries on
patenting of higher life forms, and to take account of moral issues (WIPO Course Module
2008) [3]. For example, the European Patent Convention (EPC) provides that patents for
animal and plant varieties are specifically excluded (EPC Article 53(b)). Also, the
European Patent Office will not grant patents containing claims to the treatment of a
human being via biological or other means. In Australia, for example, the Patent Act
1990 (s18(2)) allows patenting of inventions using microorganisms, plants and animals
but not human beings and the biological processes for their generation. The US patent
law (Title 35 U.S.C. 101) provides for the issuance of a patent to a person who invents or
discovers “any” new and useful “manufacture” or “composition of matter.” In 1988, a
patent was granted to an invention of the oncomouse (US Patent No 4736866). It was the
first patent for a genetically modified animal for medical research. The Supreme Court of
Canada, on the other hand, has ruled that higher life form, such as a transgenic mice, is
not patentable because it is not a “manufacture” or “composition of matter” within the
meaning of invention. In Japan, the law excludes from patentable subject matter mere
discoveries of microorganisms existing in nature and inventions of microorganisms per se
which are incapable of industrial application because their utility is either not described
in the patent application or cannot be inferred. In India, under Section 3(j) of the Patent
Act, plants and animals in whole or any part thereof other than microorganisms but
including seeds, varieties and species and essentially biological processes for production
or propagation of plants and animals, are not considered as inventions and are therefore
not patentable.

When an Invention involves a microorganism, it is very difficult for the patent applicant
to describe in writing inventions relating to food and pharmaceutical products that
involve microorganisms. And also after the patent term is finished it is very difficult for a
person in the community to work an invention that refers to a microorganism unless they
actually have access to it. To overcome these difficulties a treaty is conveyed in 1977 at
Budapest and it is named as Budapest Treaty (1977) provides an easier way for patent
applicants to satisfy the requirement for full description of biotechnology patents. The
Treaty does this by providing for the deposit of a microorganism at a recognized
“International depositary authority”. Members of the Budapest Treaty must recognize
the deposit of a microorganism with any international depositary authority. This allows
patent applicants to make one deposit with an international deposit authority rather than
having to arrange deposits in each country in which patent protection is sought. This
procedure benefits patent applicants by saving them money. The Treaty also sets up a
mechanism to facilitate appropriate access to deposits by others.

Summary

With the advent of this new trend of patenting, there has been an increase in
apprehensions about the methods of implementation of these new technologies and
distribution of the same. Such concerns are normally associated with new and rapidly
changing landscape of intellectual property rights (IPRs). Biotechnology patents are no
different. With the growing industrial importance of biotechnology and the massive
investments and efforts being made in R&D all over the world, the question of securing
adequate protection for the new and revolutionary technologies in this field has assumed
considerable importance [4] [5].

To summarize the above points, the foremost observation is that the IP scenario has
undergone significant changes over the past few decades, especially with regard to
biotechnological innovations. What was an upcoming field a couple of decades ago, is
now a force to reckon with. As has been discussed earlier, biotechnological patents now
form a major chunk of all patents, in particular the academic ones filed by educational
institutes across the globe. Among biotechnology patents, the fastest growing are
applications for novel pharmaceuticals [6]. While other fields like nanotechnology and
genetically modified organisms (GMOs) are close behind.

References

[1] Latimer MT. Patenting inventions arising from biological research. Genome Biology
2004; 2(6): 203-203.9.
[2] A Singh, S Hallihosur, L Rangan. Changing landscape in biotechnology patenting
World Patent Information 2009, 31: 219-225
[3] WIPO Academy DL Course on Biotechnology and Intellectual Property 2008.
[4] Gupta RK, Subbaram NR. Patenting Activity in the Field of Biotechnology: Indian
Scenario. World Patent Information 1992; 14(1): 36-41.
[5] Karki MMS, Garg KC. Patenting activity in the third world - a case study of
biotechnology patents filed in India. World Patent Information 1993; 15:165-
170.
[6] Moreira AC, Almeida Müller AC, Pereira Jr N, Antunes DE Souza AM.
Pharmaceutical patents on plant derived materials in Brazil: Policy, law and
statistics. World Patent Information 2006; 28: 34-42.

Case Study: Diamond versus Chakrabarty

SUMMARY

In 1972, Ananda Mohan Chakrabarty, a microbiologist, filed a patent application,

assigned to the General Electric Co. The application asserted 36 claims related to
Chakrabarty' s invention of "a bacterium from the genus Pseudomonas containing therein
at least two stable energy-generating plasmids, each of said plasmids providing a separate
hydrocarbon degradative pathway." This human-made, genetically engineered bacterium
is capable of breaking down multiple components of crude oil. Because of this property,
which is possessed by no naturally occurring bacteria, Chakrabarty' s invention is believed
to have significant value for the treatment of oil spills.

Chakrabarty' s patent claims were of three types: first, process claims for the method of
producing the bacteria; [447 U.S. 303, 306] second, claims for an inoculums comprised
of a carrier material floating on water, such as straw, and the new bacteria; and third,
claims to the bacteria themselves. The patent examiner allowed the claims falling into the
first two categories, but rejected claims for the bacteria. His decision rested on two
grounds: (1) that microorganisms are "products of nature," and (2) that as living things
they are not patentable subject matter under 35 U.S.C. 101.

Chakrabarty appealed the rejection of these claims to the Patent Office Board of Appeals,
and the Board affirmed the examiner on the second ground. Relying on the legislative
history of the 1930 Plant Patent Act, in which Congress extended patent protection to
certain asexually reproduced plants, the Board concluded that 101 was not intended to
cover living things such as these laboratory created micro-organisms.
However, the Court of Customs and Patent Appeals overturned the case in Chakrabarty' s
favor, writing, "the fact that micro-organisms are alive is without legal significance for
purposes of the patent law." Sidney A. Diamond, Commissioner of Patents and
Trademarks, appealed to the Supreme Court. The Supreme Court case was argued on
March 17, 1980 and decided on June 16, 1980, in favor of Chakrabarty.

FACTS

Patent claims for human-made, genetically engineered bacterium, a Pseudomonas, that

was capable of breaking down multiple components of crude oil (hydrocarbons) was
based on title 35 U. S. C. § 101 which provides for the issuance of a patent to a person
who invents or discovers "any" new and useful "manufacture" or "composition of
matter."

The US Patent Office had allowed patent claims to the method of producing the
bacterium and an inoculum, but objected to a claim of ‘a bacterium from the genus
pseudomonas containing therein at least two stable energy generating plasmids, each of
said plasmids providing a separate hydrocarbon degradative pathway.’ It rejected this
claim on the basis that ‘as living things, microbes are not patentable under § 101.

Following an appeal, the Supreme Court of the United States rejected the argument of the
patent office board of appeals that 35 U.S.C. § 101 was not intended to cover living
things such as laboratory created micro-organisms.

The Supreme Court held: A live, human-made microorganism is patentable subject

matter under § 101. Respondent' s microorganism constitutes a "manufacture" or
"composition of matter" within that statute.

(a) In choosing such expansive terms as "manufacture" and "composition of matter,"

modified by the comprehensive "any," Congress contemplated that the patent laws should
be given wide scope, and the relevant legislative history also supports a broad
construction. While laws of nature, physical phenomena, and abstract ideas are not
patentable, respondent's claim is not to a hitherto unknown natural phenomenon, but to a
non-naturally occurring manufacture or composition of matter - a product of human
ingenuity having a distinctive name, character [and] use.

(b) The passage of the 1930 Plant Patent Act, which afforded patent protection to certain
asexually reproduced plants, and the 1970 Plant Variety Protection Act, which authorized
protection for certain sexually reproduced plants but excluded bacteria from its
protection, does not evidence congressional understanding that the terms "manufacture"
or "composition of matter" in § 101 do not include living things.

(c) Nor does the fact that genetic technology was unforeseen when Congress enacted §
101 require the conclusion that micro-organisms cannot qualify as patentable subject
matter until Congress expressly authorizes such protection. The unambiguous language
of § 101 fairly embraces respondent' s invention. Arguments against patentability under §
101, based on potential hazards that may be generated by genetic research, should be
addressed to the Congress and the Executive, not to the Judiciary.

The ruling granted Chakrabarty his patent by a 5-to-4 margin. The dissenters in the case,
the four judges, held that this really was a charged social issue. It arose at the time of the
recombinant DNA wars in the United States and in Europe, and which opened up the
prospect of the engineering of all of life. In addition, given the charged nature of the case
and its implications, the dissenters held that really this should come before the Congress.
However, the majority disagreed and went on to rule on the case.

DISCUSSION

The court had to consider whether the fact that a bacterium was a living thing was
sufficient to exclude it from patent protection. It reviewed the purpose of the patent
system, including the statement by legislators accompanying the 1952 Patent Act that
Congress intended statutory subject matter to "include anything under the sun that is
made by man."

The Court acknowledged that ‘the laws of nature, physical phenomena, and abstract ideas
have been held not patentable … Thus, a new mineral discovered in the earth or a new
plant found in the wild is not patentable subject matter. Likewise, Einstein could not
patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity.
Such discoveries are manifestations of . . . nature, free to all men and reserved
exclusively to none.’ However, the Court decided that the microorganism ‘plainly
qualifies as patentable subject matter. His claim is not to a hitherto unknown natural
phenomenon, but to a non-naturally occurring manufacture or composition of matter - a
product of human ingenuity having a distinctive name, character and use.’

The Court compared this case with an earlier case (Funk), in which “the patentee had
discovered that there existed in nature certain species of root-nodule bacteria which did
not exert a mutually inhibitive effect on each other. He used that discovery to produce a
mixed culture capable of inoculating the seeds of leguminous plants. Concluding that the
patentee had discovered "only some of the handiwork of nature," the Court ruled the
product non patentable:

‘Each of the species of root-nodule bacteria contained in the package infects the same
group of leguminous plants which it always infected. No species acquires a different use.

The combination of species produces no new bacteria, no change in the six species of
bacteria, and no enlargement of the range of their utility. Each species has the same effect
it always had. The bacteria perform in their natural way. Their use in combination does
not improve in any way their natural functioning. They serve the ends nature originally
provided and act quite independently of any effort of the patentee.’

Here, by contrast, the patentee has produced a new bacterium with markedly different
characteristics from any found in nature and one having the potential for significant
utility. His discovery is not nature'
s handiwork, but his own; accordingly it is patentable
subject matter under [US Patent Law].”

Diamond versus Chakrabarty case declared that the "relevant distinction is not between
animate and inanimate things but whether living products could be seen as human-made
inventions". This extraordinary decision by the US Supreme Court heralded a new era in
which living organisms could be patented.