NATIONAL LAW UNIVERSITY ODISHA, CUTTACK

9TH SEMESTER, BATCH OF 2013-18

BIOTECHNOLOGY LAW PROJECT

TOPIC:

SUBMITTED TO: SUBMITTED BY:

DR. AMRENDRA KUMAR AJIT BHUPENDRA CHOUDHARY 13/BBA LLB/009

Table of Contents
Hypothesis....................................................................................................................................... 4

Research Questions ......................................................................................................................... 4

Scope and Limitations..................................................................................................................... 4

Objective ......................................................................................................................................... 4

Sources ............................................................................................................................................ 4

Introduction ..................................................................................................................................... 5

Historical perspective of Biotechnological Era .............................................................................. 6

I. Public Apprehension ............................................................................................................ 6

II. Patenting a living organism .............................................................................................. 6

III. Novelty ............................................................................................................................. 8

IV. Enablement and Description ............................................................................................ 8

V. Prosecution Delays ........................................................................................................... 9

Contemporary Era of Modern Biotechnology Law ...................................................................... 10

I. New Technologies ............................................................................................................. 10

II. The Human Genome Project .......................................................................................... 11

III. Transgenic Animals........................................................................................................ 11

IV. Internationalization of the Law ...................................................................................... 12

V. Interpretation of Claim ................................................................................................... 13

VI. Involvement of Judiciary................................................................................................ 13

Transformation from a Scientific to a Commercial Industry ........................................................ 14

Challenges posed by Biotechnology before Existing Sysytem..................................................... 15

Patentability of Biotechnology in the USA .................................................................................. 17

I. Biotechnology as a Patentable Subject Matter................................................................... 17

Scope of Patent Laws .................................................................................................................... 19

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 II. Limitations ..................................................................................................................... 19

Nature and Subject Matter of Biotechnical Inventions ................................................................. 21

III. Plant as a Patentable Subject Matter .............................................................................. 24

IV. Animal as Patentable Subject Matter ............................................................................. 24

Contemporary Services and Committees In US ........................................................................... 25

I. ABA- Biotechnology Law Committee .............................................................................. 25

II. Biological Product Deviations ....................................................................................... 25

III. Animal and Plant Health Inspection Service (APHIS) .................................................. 25

IV. FDA’s Biotechnology Policy ......................................................................................... 25

V. Federal Food, Drug, and Cosmetic Act .......................................................................... 26

VI. Federal Issuance of Experimental Use Permits .............................................................. 26

VII. Food Biotechnology in the United States- Science, Regulation, and Issues .................. 26

VIII. Microbial Products of Biotechnology: Final Rule (62 FR 17910) ............................. 26

IX. Microbial Products of Biotechnology: Final Regulation Under the Toxic Substances
Control Act................................................................................................................................ 27

X. Office of Science and Technology Policy ...................................................................... 27

XI. Office of Science Coordination and Policy Biotechnology Team ................................. 27

XII. Biotechnology Information Series ................................................................................. 28

XIII. Stem Cell Therapeutic and Research Act of 2005 ...................................................... 28

XIV. The Plant Protection Act (PPA).................................................................................. 28

XV. US Regulatory Agencies- Unified Biotechnology ......................................................... 28

Conclusion .................................................................................................................................... 30

Bibliography ................................................................................................................................. 31

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 HYPOTHESIS

The current patent laws do not adequately encourage continued growth and research in
biotechnology industry.

RESEARCH QUESTIONS

1. What is the scope of patent laws with respect to biotechnological inventions?

2. Are living matters eligible for patent protections?
3. What are the challenges posed by biotechnology before existing patent system?

SCOPE AND LIMITATIONS

Project takes into consideration the impact that Diamond v Chakrabarty had on the prevailing
patent system and how it helped defining the scope of patent laws with respect to biotechnology
inventions. Project also examines the acts and statutes that exist in U.S. which provide patent
protection to products as well as process of biotechnology. Some of these acts are over 50 years
old.

OBJECTIVE

Project examines the developments made in the patent system in order to accommodate the new
biotechnological inventions within its scope. It also makes a comparative analysis of the laws
prevailing in U.S. and Europe that relate to patenting of living matters.

SOURCES

The data collected for this project work is from secondary sources which include articles,
textbooks and other internet sources.

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 INTRODUCTION

“Biotechnology is generally defined as the manipulation of microorganisms to perform certain

processes and is largely identified with genetic engineering. The procedure usually involves the
transfer of genes from one living entity into another, or into a synthetic compound, using
advanced recombinant DNA technology. It covers any technological application that uses
biological systems, living organisms, or their derivatives, to create, manufacture, modify or adapt
plants, products, goods, animals or processes for specific use. Its applications are useful in the
medical field (red biotechnology), the aquatic field (blue biotechnology), the agricultural field
(green biotechnology), and the industrial field (white biotechnology). It is involved in the
development of new medicines and therapies; new research tools; increasing crop yields;
creating hardier crops and plants; decontamination; removal of manmade pollutants and waste;
and much more. With biotechnology, the development time between working theory and a
tangible product is far longer than that of other companies, generally seven to ten years. And
these are very costly endeavors, ranging from $250 million to $300 million to create, develop,
test and prepare a drug/product for market. The nature of these types of innovations and the
rapidly evolving laws and regulations regarding biotechnology make this legal practice area both
difficult and challenging. Lawyers, companies and scientists must struggle with complex issues
involving necessary and applicable financial backing and how best to develop and create
business agreements; intellectual property rights; convoluted, drawn-out regulatory proceedings;
and many other challenges and obstacles spread over a lengthy time period.”

“Despite its specialized nature, this area of law does overlap with a few other main practice areas:
intellectual property law;patent law (and specifically, patent prosecution); licensing law;
litigation; business law; and venture capital law. Based on this it can be said that the American
biotechnology industry has, in the recent times experienced a major boom in the sector, ranging
from to almost negligible number of industries to about seven hundred active firms in less than
two twenty five years. It is believed that the birth of this industry is essentially intertwined with
the development of the underlying science in a way which has not been previously considered
for this industry or any other in either the economics or the organizations literature.”

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 HISTORICAL PERSPECTIVE OF BIOTECHNOLOGICAL ERA

“The era of biotechnology began in 1973 when Stanley N. Cohen and Herbert W. Boyer reported
that a gene could be cut from the DNA of one organism, recombined in vitro with DNA of a host
organism, and re-introduced into cells of the host to confer the gene's characteristic trait to the
host. The industry which sprang up to exploit the potential of Cohen and Boyer's recombinant
DNA technology has now existed for seventeen years-the lifetime of a United States patent.1”

I.PUBLIC APPREHENSION

“It has been witnessed by the times that biotechnology grew up under intense public scrutiny and
debate. Many of the new companies formed to exploit the commercial potential of the scientific
advances of the preceding two decades generated publicity to aid in attracting investors.
Scientists publicly debated their concerns about the possible hazards or disastrous consequences
of certain types of experiments. Some feared the possible creation of new pathogens which, if
improperly contained, could spread into the environment.2 In response to the concerns, the
National Institutes of Health promulgated guidelines for conducting recombinant DNA research.
Subsequently, these guidelines underwent a series of revisions that resulted in an increased
number and scope of allowable activities. The revisions were a result of improved understanding
of the actual risks involved from working with genetically engineered microorganisms.3 Today,
risks from "recombinant DNA" research are considered to be much lower than originally
estimated, and more specifically defined.”

II.PATENTING A LIVING ORGANISM

“The issues of patentability that first confronted patent practitioners were more pedestrian, but
acquired a certain cachet in the light of the intense public interest in the safety and morality
debates. Whether a living organism was patentable subject matter under section 101 of the Patent
Act was a prominent issue. The Patent and Trademark Office (Patent Office) rejected two

1
Cooper, Iver P. Biotechnology and the Law. C. Boardman Company, 1982.
2
Zucker, Lynne G., Michael R. Darby, and Marilynn B. Brewer. Intellectual capital and the birth of US
biotechnology enterprises. No. w4653. National Bureau of Economic Research, 1994.Carroll, Amy E. "Not Always
the Best Medicine: Biotechnology and the Global Impact of US Patent Law." Am. UL Rev. 44 (1994): 2433.
3
Carroll, Amy E. "Not Always the Best Medicine: Biotechnology and the Global Impact of US Patent Law." Am. UL
Rev. 44 (1994): 2433.

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applications claiming a microorganism per se as if it were a device or a composition of matter.4
The Court of Customs and Patent Appeals held that the microorganisms were patentable subject
matter. The United States Supreme Court reviewed the lower courts' decisions and held that an
invention was not unpatentable merely because it was alive.5 The Supreme Court stated that the
range of the patent laws was intended to encompass "anything under the sun that is made by
man." The Court, however, did not specify in which category under section 101 microorganisms
belonged." This exercise of judicial restraint may ultimately prove most wise. It is no
coincidence that the patentability of living matter became an issue when it did. Microorganisms
were in common use for producing antibiotics by fermentation since the 1950s. Patents for
methods of synthesis using a specified microorganism strain were not uncommon. Vaccines
made using microorganisms or containing killed or attenuated microorganisms were also the
subject of patents. In fact, patents to organisms per se had already been granted. The concept that
the property of being alive could constitute a bar to patentability gained notoriety concurrently
with the extensive public debate on the hazards of recombinant DNA and genetic engineering.
The politics of the times generated this issue, abetted by misperceptions of the chemical and
physical underpinnings of biological science. As one of the amicus curiae to the Chakrabarty
Court pointed out, the issue before the Court constituted yet another last gasp of the vitalistic
fallacy.6 When viewed in this light, it is not only remarkable that the patentability of living
matter became an issue, but also remarkable that the Supreme Court agreed to decide it. Other
cases interpreting the scope of patentable subject matter under section 101 in the context of other
technologies also affected biotechnology patent law. In particular, Parker v. Flook7 and several
cases involving geophysical prospecting dealt with inventions using information in the form of
programs, algorithms, read-only memories, and other embodiments of information in
combination with other process steps. DNA is a molecule that embodies genetic information, a
read-only memory for programming biological systems. Consequently, the approaches taken in
these cases also ultimately affected the direction of biotechnology patent law.”

4
Kevles, Daniel J. "Ananda Chakrabarty wins a patent: biotechnology, law, and society, 1972-1980." Historical
studies in the physical and biological sciences 25.1 (1994): 111-135.
5
Adler, Reid G. "Can patents coexist with breeders' rights? Developments in US and international biotechnology
law." (1986).
6
Id.
7
437 U.S. 584 (1978)

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 III.NOVELTY

“Although biotechnology has experienced rapid and expansive progress, the field could not be
characterized as crowded. Issues of anticipation under section 102 have not been encountered
with great frequency. Those items which have been confronted could be categorized as matters
of interpretation.8 Scripps Clinic & Research Foundation, Inc. v. Genentech, Inc.9 suggests that a
protein synthesized by recombinant means is anticipated by the naturally occurring protein in
purified form. Patent examiners occasionally consider whether an unpurified mixture of DNA
fragments sorted into vectors anticipates a cloned gene. The rationale behind this is uncertain,
since pure compounds are not deemed anticipated by impure mixtures.10 Similar to the product
of nature rule, such situations are best analyzed by determining how obvious the cloned gene
would be to one skilled in the art, given knowledge of the library.11”

IV.ENABLEMENT AND DESCRIPTION

“A variety of issues have arisen in the biotechnology art regarding description and enablement
under section 112 of the Patent Act. Many fall into the category of adequacy to support desired
claim breadth, while others fall into the category of deposits of living organisms. The initial
success of Cohen and Boyer in obtaining broad patent protection for a process that is the basic
tool of the industry encouraged other pioneers in the field to hope for similar broad coverage. For
a time, researchers feared that a number of broad blocking patents could limit opportunities for
later entrants into the field. As the industry has grown, however, it now appears that problems of
securing adequate claim breadth are more likely to be encountered. Biotechnology is a field
where functionally equivalent -variants abound. Despite the fact that at critical loci a single base
change in a nucleic acid sequence or a single amino acid substitution in a protein can drastically
alter function, many non-critical loci occur which tolerate all sorts of sequence variations without
affecting function. A claim limited to one sequence, or even half a dozen functionally equivalent
sequence variants, is virtually worthless if a competitor can simply make another functional

8
Barton, John H. "The impact of contemporary patent law on plant biotechnology research." Intellectual property
rights III global genetic resources: Access and property rights intellectualpro3 (1998): 85-97.
9
678 F. Supp. 1429 (N.D. Cal. 1988)
10
Armitage, Robert A. "The Emerging US Law for the Protection of Biotechnology Research Results." European
Intellectual Property Review 11.2 (1989): 47-57.
11
Giesecke, Susanne. "The contrasting roles of government in the development of biotechnology industry in the US
and Germany." Research Policy 29.2 (2000): 205-223.

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variant outside the claim. Given that literally thousands of functionally equivalent sequence
variants exist, and that defining each of them is an impossible task (and useless since no new
function is achieved thereby), practitioners have resorted to claiming a combination of sequence
and function to obtain adequate claim coverage. Such claims, while they purport to be drawn to a
family of compounds, take on the character of mechanical claims having means plus function
language. The case law relevant to the field of biotechnology is not limited to the field of
chemical practice. Until the field develops its own body of precedents, precedents from other arts
will be influential.12”

V.PROSECUTION DELAYS

“A serious threat is presented by the infrastructural problems within the Patent Office. A recent
report from the General Accounting Office stated that the backlog of biotechnology applications
swelled by twenty-seven percent, from 6200 in January, 1989, to 7914 in May, 1989. As a result,
long delays occur, often as long as seven years, from the filing date to the issue date. Despite the
promulgation of new rules intended to resolve interferences within two years, cases are
frequently suspended from prosecution for more than six months before interference is declared.
“Litigants must frequently wait a year for decisions on preliminary motions. Prosecution delays
create incalculable consequences for the industry. As long as ownership rights remain unclear,
companies continue to invest in research and development, and to introduce new products. By
the time the patents issue, products are already in the market and litigation may be the only
recourse. Litigation, interferences and even protracted prosecution are serious economic burdens,
especially for small companies. Because most innovation takes place in smaller companies, the
ultimate effect of the exaggerated costs and economic burden of procuring and enforcing patent
protection is to stifle innovation rather than to promote it.13

12
Id.
13
Id.

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”

CONTEMPORARY ERA OF MODERN BIOTECHNOLOGY LAW

“It is to be noted that the contemporary era of biotechnology and related laws are majorly
influenced by many of the factors, listed herein.”

I. NEW TECHNOLOGIES

“Several recent developments in the biological sciences suggest new directions that may expand
the scope of biotechnology. Recently, several papers have been published describing processes
that open the door for new "biological" materials that have no counterpart in living organisms.
Novel proteins and nucleic acids can be developed by a combination of selection methods and
specific amplification methods that yield molecules having a desired function. The ability to
generate an endless number of new functions using variants of a single method will further
emphasize the differences in rationale between chemical and biotechnology patent practice. The
technologies of the foregoing type will include a basic set of steps, modified only by varying a
selection step. The starting material is the same-a pool of randomized sequences from which one
having the desired function is ultimately isolated. Structure will not be predictable, however, the
selected structure will be one of those present in the starting mixture.14 The method can isolate
other structures having the same function, but those may have different sequences. While the
structures would be patentable under conventional analysis as an unpredictable structure, once a
technique for isolating structures having a particular function is known, other compounds with
the same (equivalent) function can be generated. Techniques of this sort inherently possess
means for generating a compound having a function. Similar to nonchemical inventions, such
processes shift the emphasis from the structure of the resulting compound (sequence of amino
acids or nucleotides), to its function. The same situation is reflected in existing technology where
alternative functional sequences abound.15 The technological trend seems to be toward ever more
predictable methodologies that permit those skilled in the art to attain alternative functional
equivalents. As the trend progresses, chemical structure will become less important than function

14
Weston, Cliff D. "Chilling of the Corn: Agricultural Biotechnology in the Face of US Patent Law and the
Cartagena Protocol." J. Small & Emerging Bus. L. 4 (2000): 377.
15
Nies, Helen W. "Patent Protection of Biotechnological Inventions)-American Perspectives." International Review
of Industrial Property and Copyright Law 21.4 (1990): 480-487.

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in patenting biological macromolecules. In this respect, biotechnology patent law may diverge
from the precedents of chemical patent laws.16”

II.THE HUMAN GENOME PROJECT

“The human genome project represents another area of biotechnology whose results may affect
the development of biotechnology patent law. The process of mapping and sequencing the
human genome is a departure from traditional avenues of scientific inquiry. Segments of human
DNA will be cloned and sequenced without concomitant information regarding the function. An
enormous amount of position and sequence data will be added to the databases, often without
correlated information of associated functional properties.17 The prior art effect of such data is
difficult to predict. It remains an open question whether Dillon is applicable where the prior art
reveals only structure, with no hint of functional properties. The debate in Dillon over the
relative significance of "structure" and "properties" as factors in establishing a prima facie case
of obviousness can be expected to continue. The results, however, may be different in the
biotechnology field than in the chemical field.18”

III.TRANSGENIC ANIMALS

“The parameters of patentability for transgenics are currently unknown. Both genotype (the
structure of the introduced gene and its control elements) and phenotype (the characteristics of
the transgenic animal attributable to the introduced gene) are key features of a transgenic animal
that serve to characterize it and to distinguish it from the prior art. The question of which of these
features is more significant to determine obviousness or to establish a prima facie case of
obviousness is likely to occupy examiners, practitioners, and the courts for some years.19 The
parallel to the debate over "structure" versus "properties" in the chemical field is inescapable.
The problems of patent enforcement for self-replicating products are likely to be particularly
serious for products sold in a mass market. For patent holders, the prospect of extending
transgenic animal technology to agriculture presents unusual problems. Congress has proposed
special legislation that would provide exemptions for farmers, permitting them to breed and sell

16
Byrne, Noel J. "Patents on life." European intellectual property review 1 (1979): 297.
17
Sawicki, Mark P., et al. "Human genome project." The American journal of surgery 165.2 (1993): 258-264.
18
Id.
19
Surani, Azim M., Michael S. Neuberger, and Marianne Bruggemann. "Production of antibodies from transgenic
animals." U.S. Patent No. 5,545,807. 13 Aug. 1996.

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patented transgenic animals without infringement. Underlying such legislation is the fear that
effective patent protection for valuable farm breeding stock might dislocate farm economics in
socially unfavorable ways.20 Whether such dislocations would occur and whether legislation of
the sort proposed would have the effects desired by its sponsors may become a matter of political
debate.”

IV.INTERNATIONALIZATION OF THE LAW

“In addition to legal issues driven by new science, there are issues generated by changes in
business economics, and by current political and legal trends. The internationalization of
commercial enterprise and the increasing worldwide interdependence of national economies
creates pressure to develop a more uniform set of national patent laws. Talks leading to a Patent
Harmonization Treaty have been in progress over the past few years. The prospects for
successful internationalization are encouraged by the strength and quality of the European Patent
Convention. The pros and cons for the United States patent system presented by the Patent
Harmonization Treaty have been discussed by many commentators.21 As a practical matter, the
international character of the modern market economy is such that even small businesses must
take into account foreign laws governing patentability and enforcement. The present trend
toward increasing harmonization and standardization of patent laws seems likely to continue.
The nationalistic view of patents as a means to protect local proprietary interests is being
displaced by a view of patents as a means of providing world-wide proprietary rights, regardless
of the invention's origin. If the United States adopts a first-to-file system, interferences will
eventually be phased out, although oppositions may come to occupy a substantial part of the
practitioner's docket22. Canada has abandoned its first-to-invent system for a first-to-file system.
Although changes occur with glacial slowness in the international patent arena, the prospect of
an international patent agency, along the lines pioneered by the European Patent Office,
providing a unified patent enforceable throughout the industrialized world is entirely feasible by
the end of the next seventeen years.23”

20
Id.
21
Koenig, Dorean M. "The Regulation of Modern Biomedical Techniques." DePaul L. Rev. 38 (1988): 1013.
22
Ihnen, Jeffrey L. "Patenting Biotechnology: A Practical Approach." Rutgers Computer & Tech. LJ 11 (1985): 407.
23
Kinderlerer, Julian, and Diane Longley. "Human genetics: the new panacea?." The Modern law review 61.5
(1998): 603-620.

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 V.INTERPRETATION OF CLAIM

“While issues of patentability have been dominant in the first patent lifetime, issues of
infringement, equivalence and claim interpretation may come to dominate the second. Issues of
fact, such as whether an accused organism is identical to a claimed organism, may entail
amassing significant amounts of evidence to be resolved. By the end of the next patent term, the
body of case law on equivalence and reverse equivalence is likely to be greatly expanded in
breadth and sophistication. Indeed, many terms used in biotechnology claims, while definable in
ways that reasonable people would consider clear, may require resort to an equivalence type of
analysis when litigants are involved.24”

VI.INVOLVEMENT OF JUDICIARY

“The composition of the judiciary may be affected by the growing number of practitioners and
patent examiners that have advanced degrees in science. In both the examining corps and the
practicing bar, the number of persons with PhDs or Master's degrees in a biotechnology-related
discipline has increased in response to the technical demands of the subject matter.A familiarity
with scientific language and practices ought to be as valuable in court as a familiarity with
business practices and terminology. Both administrative and judicial decision making may be
enhanced. The infusion of a greater degree of scientific knowledge into decision making, both in
patent law and in general law, will be a side benefit of the growth of biotechnology.25”

24
Krosin, Kenneth E. "Are plants patentable under the utility patent act." J. Pat. & Trademark Off. Soc'y 67 (1985):
220.
25

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 TRANSFORMATION FROM A SCIENTIFIC TO A COMMERCIAL INDUSTRY

“Although the term ‘biotechnology’ gives an impression of modern, cutting-edge technology, its
traces have remained present in early human settlements in the form of selective plant and
animal breeding. Microorganisms have been employed for brewing and baking purposes for
thousands of years. However, it was in early twentieth century, when the term biotechnology
came into use. Karl Ereky, a Hungarian engineer, is said to have coined the term ‘to refer to
science and methods that permits products to be produced from raw materials with the aid of the
living organisms’. He first used the term Biotechnology in a 1917 article (written in German)
describing his pig fattening plant. Taking the analogy of chemical technology, he suggested the
word Biotechnology to cover the area of technology associated with the living beings.26”

“Technology was generally associated more with chemistry and physics and less with biology,
however, with the great advancements in biological sciences, this trend has anomalously
changed. Although from the 1880s analogies between physiological and technological structures
did suggest a link between technological and biological evolution, however, biotechnology
acquired a professional engineering dimension when the Americans took the biotechnics and
biotechnology in the 1930s and 1940s. Swedes emphasized on microbiology and Germans gave
it institutional strength. America became a pioneer in the integration of molecular biology and
engineering.”

“The major breakthrough in the field of molecular biology and genetics was the discovery of
deoxyribonucleic acid (DNA) in 1953 by Francis Crick and James Watson. It was considered as
the discovery of secret of life. The discovery had been a grand success as the modern
biotechnological advances in DNA technology have demonstrated that ‘the DNA not only
explains the very essence of every living cell but it promises great possibilities for future’. 27”

26
Bizley, Richard. "The Life Patenting Issue—The Current Position and the practical Approach for Applicants—
Morality and Patents." IIR Conference “Extending and Protecting Patents in Pharmaceuticals & Biotechnology
Industries,” Gloucester Hotel, London, 1992.
27
Nightingale, Stuart L. "Emerging Technologies and FDA Policy Formulation: The Impact of Government
Regulation on Developing Drugs from New Technologies." Food Drug Cosm. LJ37 (1982): 212.

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 CHALLENGES POSED BY BIOTECHNOLOGY BEFORE EXISTING SYSYTEM

“The Biotechnology industry is primarily made up of small, single product start-up companies.
There is a close relationship between basic and applied science in the biotechnology field, and
the biotechnology industry has a highly educated workforce. Due to the close association
between academic laboratories and industrial laboratories, biotechnology companies developed a
culture that borrows several features of university setting. The highly skilled work force required
for the biotechnology industry can only be made available when the industry continues to attract
academic scientists to the industry.28 Here, it becomes pertinent for the biotechnology industry to
maintain a university like atmosphere and provide good economic incentives to the researchers,
encouraging them to maintain a high level of innovation. Further, due to the influence of
academic research on biotechnology industry, the research ethos is encouraged with the
encouragement of publication and sharing of results.”

“Patents offer a viable option in this regard. Some form of economic incentive is sine qua non for
the development of any start-up technological industry and patent offers such an incentive.
Patents also encourage public disclosure of the invention so that society can be benefitted from
that. Whether biotech patents fulfill the overall social goal for which patents are intended is still
a debatable issue but there is no doubt that patents are critical for the protection of biotechnology
industry. Due to the high level of uncertainty involved in biotechnology, investors are reluctant
to invest into biotechnology ventures where the patent protection is lacking, or where the rights
of patent holders are not clear. This necessitates the conjunction of biotechnology and patent
law.29”

“Though patents are seen as an effective protection for biotechnology inventions, however,
concerns have been made in recent years that current patent laws do not adequately encourage
continued growth and research in biotechnology industry. Arguments have been made that a

28
Carroll, Amy E. "Not Always the Best Medicine: Biotechnology and the Global Impact of US Patent Law." Am.
UL Rev. 44 (1994): 2433.
29
Id.

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patent system designed to accommodate older technologies produces undesirable results when
applied to a new and radically different technology such as biotechnology.30

“The commercial potential of biotechnology has led to the existing patent systems to
accommodate fairly new subject matters such as DNA sequences, microorganisms, plants and
animals which were not intended at the time of the framing of patent laws. Since a very high
economic incentive has been involved with these subject matters, biotechnology industries and
patent community have persuaded courts and legislatures that these subject matters should be
treated no differently from mechanical and chemical invention. In recent years, it has been
realised that this analogy has failed to ensure a clear and adequate protection for modern
biotechnology.31 Modern biotechnology differs significantly from chemical inventions with
regard to structure and function and the manner and circumstances in which modern
biotechnology and chemical inventions being created have been shown to differ markedly. Apart
from subject matter, modern biotechnological advances have posed new challenges before the
existing patentability criteria such as novelty, non-obviousness, utility etc.

30
Darby, Michael R., and Lynne G. Zucker. "Change or die: The adoption of biotechnology in the Japanese and US
pharmaceutical industries." Comparative Studies of Technological Evolution. Emerald Group Publishing Limited,
2001. 85-125.
31
Arora, Ashish, and Alfonso Gambardella. "Complementarity and external linkages: the strategies of the large firms
in biotechnology." The journal of industrial economics (1990): 361-379.

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 PATENTABILITY OF BIOTECHNOLOGY IN THE USA

“The USA has been a pioneer in the field of biotechnology and patent law. Initially, it has
adopted relatively liberal approach while dealing with biotechnology patents but in due course of
time it has developed its patent laws to fairly deal with the biotech challenges and the abuse of
patent system in a matured way. It has therefore pioneered both the commercialization of
biotechnology applications and products and the development of patent law to protect them.”

“The authority to grant patent is provided under the constitution of the USA. Congress is
authorized ‘to promote the Progress of Science and useful Arts, by securing for limited Times to
Authors and Inventors the exclusive Right to their respective Writings and Discoveries’. The
basic requirement for obtaining a patent is set forth in Sections 101, 102, 103 and 112 of the
Patent Act of 1952.”

I. BIOTECHNOLOGY AS A PATENTABLE SUBJECT MATTER

“In the USA, patenting life forms was uncertain until 1980. Biotechnology products and
processes were precluded from patenting and considered as product of nature. The product of
nature doctrine implies that organisms or substances that occur in nature cannot be considered as
inventions and are therefore not patentable. Very few patents were issued on ‘mixtures or
compounds that included microorganisms in modified form’. It was only Pasteur’s yeast culture
product patent that exclusively covered living organisms. In 1873, Louis Pasteur was granted a
patent by the USPTO, claiming ‘yeast free from organic germs of disease, as an article of
manufacture’. Nevertheless, since the 1880s USPTO apparently disallowed the patenting on any
further life forms by applying product of nature doctrine. The patent attorney, Grubb, rightly
mentioned: ‘In the USA, in spite of the precedent of the Pasteur patent…it has become practice
of the Patent Office to refuse claims to living systems as not being patentable subject matter.32”

“Establishment of the Court of Appeal for Federal Circuit In the year 1980 and onwards, there
had been a sea change in granting patents over life forms, heralding a new era of biotechnology
patents. Three major developments have contributed to this remarkable change: the US Supreme
Court’s decision in Diamond versus Chakrabarty case; the BayhDole Act; and the establishment

32
Lee, Peter Yun-hyoung. "Inverting the Logic of Scientific Discovery: Applying Common Law Patentable Subject
Matter Doctrine to Constrain Patents on Biotechnology Research Tools." Harv. JL & Tech. 19 (2005): 79.

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of Court of Appeal for Federal Circuit (CAFC). The initial trend of USPTO to disallow patenting
of life forms as a product of nature subsisted before the Supreme Court decision in Diamond
versus Chakrabarty. Until the said decision, it was generally assumed within the emergent
biotechnology sector that microorganisms could not be patented. The Supreme Court decision in
Diamond versus Chakrabarty allowed a patent on a new man made oil eating bacterium, paving
way for biotechnology patents.33”

“The 1980 Bayh-Dole Act encouraged universities to patent, and thereby commercialise,
inventions arising out of government sponsored research. It has allowed public institutions to
own inventions resulting from federally sponsored research and exclusive license to those
inventions. Further, it requires from the institutions to establish patent policies for its employees,
enabling them to seek patent protection of their invention. This Act has provided a great deal of
discretion to the institutions, encouraging the growth of biotechnology patents.”

“The third major development was the establishment of the Court of Appeal for Federal Circuit
(CAFC) by the Congress in 1982. The establishment was backed by a large group of high
technology firms and trade associations in the telecommunications, computer and pharmaceutical
industries, believing that a court devoted to patent cases would better represent its interest. The
US government was also one of the main actors in the creation of CAFC as it was interested to
support its science-based corporations by strengthening intellectual property protection
worldwide. Other underlying reasons were that the early Supreme Court decisions seemed to
reflect an anti-patent mentality and lower courts had issued extremely inconsistent decisions on
patent issues. The CAFC has adopted a pro-patent approach which allows for the protection of
biotechnology inventions. It has also issued decisions awarding high damages to patent owners
in patent infringement cases, providing them additional protection.34

33
Id.
34
Rai, Arti K. "Intellectual property rights in biotechnology: Addressing new technology." Wake Forest L. Rev. 34
(1999): 827.

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 SCOPE OF PATENT LAWS

“Regarding the scope of patent law, Berger C. J. held that ‘In choosing such expansive terms as
“manufacture” and “composition of matter”, modified by the comprehensive “any”, Congress
plainly contemplated that the patent laws would be given wide scope’. He added that the relevant
legislative history also supports a broad construction and referred to the Patent Act of 1793,
which embodied its author, Thomas Jefferson’s philosophy that ‘ingenuity should receive a
liberal encouragement’.35

“The Act defined statutory subject matter as ‘any new and useful art, machine, manufacture, or
composition of matter, or any new or useful improvement’. This broad language remained intact
in subsequent patent statutes in 1836, 1870 and 1874. In 1952, when the patent laws were
recodified, Congress replaced only the word ‘art’ with ‘process’, keeping the remaining
Jefferson’s language intact. Berger C. J. had provided a much broader scope to the patent laws
by referring to the Committee Reports accompanying the 1952 Act: ‘The Committee Reports
accompanying the 1952 Act inform us that Congress intended statutory subject matter to
“include anything under the sun that is made by man36”

II.LIMITATIONS

“While interpreting the scope of the statutory subject matter broadly to include ‘anything under
the sun made by man’, the Supreme Court did not rule out limitations to such scope. The court
recognized certain exclusions such as the laws of nature, physical phenomena and abstract ideas,
which have been held not patentable in several cases. In Chakrabarty, the Supreme Court did not
concur with the then prevailing product of nature doctrine, propounded by it in the case of Funk
Bros Seed Co versus Kalo Inoculant Co.37 The court made a distinction between the
Chakrabarty’s claims for the genetically engineered microorganism to Funk Brothers Seed Co.
versus Kalo Inoculant Co., in which the claimant had discovered certain naturally occurring
bacteria, useful for agricultural purposes, could be combined into a single package without
adverse effects and sought a patent on the packaged bacteria. The court in Funk Brothers’ Case

35
Drahos, Peter. "Biotechnology patents, markets and morality." European Intellectual Property Review 21.9 (1999):
441-449.
36
Id.
37
333 U.S. 127 (1948)

19 | P a g e
ruled the packaged bacteria non-patentable by concluding that the patentee had discovered ‘only
some of the handiwork of nature.”

“The Supreme Court rejected the argument made by petitioner that the passage of sui generis
legislations, 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, evidences
congressional understanding that the terms ‘manufacture’ or ‘composition of matter’ do not
include living things; if they did, neither Act would have been necessary.”

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 NATURE AND SUBJECT MATTER OF BIOTECHNICAL INVENTIONS

“In 1980, In the US, Biotechnology industry received a decisive contribution from the Supreme
Court with the decision of Diamond v. Chakrabarty38. It was regarding “the patentability of a
microorganism not existing in nature and produced through genetic engineering” 39. Also, the
court added that ‘anything under the sun made by man’ is a subject matter to patent protection.
This basically identified human intervention as the key factor which differentiated patentable
inventions from non-patentable inventions. From the Chakrabarty ruling on, in the United States,
and from the 1990s in Europe, thousands of patents related to inventions based on genetic
material or information have been granted40.”

“Some of these inventions have played a key role in providing innovators with a sufficient period
of exclusivity in order to recover the significant investments needed to develop and secure
market interest for biotechnology products.41”

“In 2001, the Patent and Trademark Office of the United States published formal Guidelines42, in
which they illustrated what the position of law is regarding the patentability of inventions based
upon genes, provided that there is enough human intervention to fulfill the need of ‘made by
man’ standard which was propounded in the Chakrabarty decision.”

“In Europe, in 1998, in any case, following an arduous procedure, the European Union adopted a
directive on biotechnology inventions, through which Member states were asked to allow the
patentability of genes.43 Despite these developments, patentability of genes remains a highly
debated issue, even in the United States of America, and those opposed to it have been asking for

38
Diamond v. Chakrabarty, 447 U.S. 303 (1980)
39
ibid
40
See C.A. Fowler, ‘Ending Genetic Monopolies: How the TRIPs Agreement’s Failure to Exclude Gene Patents
Thwarts Innovation and Hurts Consumers Worldwide’ (2010) 25 American University International Law Review
1073 et seq.
41
See J.H. Graham et al., ‘High Technology Entrepreneurs and the Patent System: Results of the 2008 Berkeley
Patent Survey’ (2010)
42
‘Utility Examination Guidelines’, 66 Fed. Reg. 1092 (5 January 2001)
43
Directive 98/44/EC of the European Parliament and the Council of 6 July 1998 on the legal protection of
biotechnological inventions.

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some time that the possibility be brought to an end, or at least that the sphere of patents for
innovations based on genetic sequences existing in nature be greatly limited44.”

“Biotechnology, further, also offers, besides the opportunities referred to above, new tools for
information and operations regarding human life,45 which raise fundamental questions regarding,
on the one hand, the preclusive effects of genetic patents (in particular with regard to their
impact on subsequent innovation and access to genetic diagnostic tests),46 and on the other, the
moral and bioethical profiles of the same.”

“There are several issues for inventors in regard to the development of patent legislation at both,
national and international levels. Inventors today are facing two kinds of problems, the nature of
the technology (where living material is being used) and lack of international regulations
regarding patents.”

“The regulatory framework on the subject of patent came into being by the experiments of man
with normally inanimate materials. Patent protection basically came into being with respect to
mechanical sector, which only concerned specific devices and mechanical subjects have
basically certain specific characteristics, one of them being that they carry out generally one
function and are not capable of reproducing to the next generation. ”

“In 1800s, the patent system policy was essentially based on ‘quid pro quo’ mechanism because
the policy underlying the patent system was first recognized within the U.S constitution.47 The
quid pro quo mechanism granted strong protection through an exclusive right granted for a
limited time – intended at delivering the inventor with pecuniary encouragement for research and
progress of the invention – in exchange for the public disclosure of information regarding the

44
For a systematic framework of the debate see C.M. Holman, The Impact of Human Gene Patents on Innovation
and Access: A Survey of Human Gene Patent Litigation, cit. in UKMC Law Review, 2007, accessed 12 October
2015 at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1090562, p. 295 et seq.
45
In this regard, see among others: Nuffield Council on Bioethics, ‘Ethical Principles: Respect for Human Lives and
the Human Body’ (April 1995) Human Tissue Ethical and Legal Issues p. 39 et seq
46
On this point see, for instance: Department of Health & Human Services (USA) – Secretary’s Advisory
Committee on Genetics, Health, and Society, Gene Patents and Licensing Practices and Their Impact on Patient
Access to Genetic Test’, April 2010, accessed 12 October 2015 at http://oba.od.nih.gov/oba/
SACGHS/reports/SACGHS_patents_report_2010.pdf.
47
On the basis of Article 1, Section 8(8), according to which: ‘The Congress shall have Power… To promote the
Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to
their respective Writings and Discoveries’.

22 | P a g e
same.48 The field of biotechnology majorly deals with living matter, poses significant challenges
for patent law. It is a known fact that biotechnological inventions do not fall so precisely under
the conventional model, as do those of mechanics.”

“Whereas, the reasons at the establishment of patent protection, which in particular are the reason
to innovation and revelation of information regarding inventions, according to the predominant
modernization are also deemed to be crucial to the matter of biotechnological research – which
often requires substantial investment and long time frames – justifying then the granting of
patents in regard to their comparative findings.49 Given that pre-existing legislation was not
drafted with the particular characteristics of biotechnological inventions in mind, significant
difficulties emerge in the application of patent law to such a constantly developing and rapidly
changing state as that which is under discussion.50 The circumstances of novelty and originality
are where much of the ambiguity lies with regard to the conclusion as to if and when
biotechnological inventions are patentable. The condition of novelty requires that the discovery
not be available to others prior to the filing of the patent request. The issue is not if the subject of
the request already exists, but if it is already known. The situation of originality requires, in
addition, that the invention not be obvious to the average expert in the field.”

“When we talk about the patenting of biotechnological inventions, the most important question
which is prevalent in today’s time is the concern regarding the interpretation of provisions of
exclusion from patentability,51 also in consideration of their close link with the moral/bioethical
profiles52 of biotechnology. U.S.A and Europe have been using the science of biotechnology for
a long time, but there still exist confusion the nature of the technology, its benefits and the
restrictions which should be set in order to prevent related risks. In this regard, the most crucial
and appropriate issues of the deliberation concern the matters connected, in fact, to the hazards
that biotechnology poses, on the one hand, for the environment, and on the other, for human
beings.”

48
See, ex multis, O. Mills, Biotechnological Inventions. Moral Restraints and Patent Law, cit., p. 41
49
See Mills, Biotechnological Inventions. Moral Restraints and Patent Law,
cit., p. 14.
50
B. Sherman, ‘Patent Law in a Time of Change: Non-obviousness and Biotechnology’ (1990) 10 Oxford Journal of
Legal Studies 278 et seq.
51
Provided by article 53 of the European Convention on Patents
52
B. Bryan, ‘Biotechnology, Bioethics and Liberalism: Problematizing Risk, Consent and Law’ (2003) 11 Health
LawJournal 119 et seq.

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 III.PLANT AS A PATENTABLE SUBJECT MATTER

“In a 1985 case, Ex parte Hibberd, 102 the Board of Patent Appeals and Interferences reversed
the USPTO’s earlier rejection of a patent claiming corn plants and seeds as well as plant tissue
cultures. The claims were related to plants produced through conventional cross-breeding but
relied on new techniques such as cell culture and genetic analysis (but not recombinant
DNA).103 This case paved the way for patenting plants as by 1988, 42 patents on crop plants
had been issued.53”

IV.ANIMAL AS PATENTABLE SUBJECT MATTER

“In response to the decision of the Supreme Court of the USA in Diamond versus Chakrabarty
and the ruling of the Board of Patent Appeals and Interferences in Ex Parte Allen, the
Commissioner of the USPTO, Donald Quigg, released a notice, announcing that animals could
constitute patentable subject matter. The notice states: ‘[t]he Patent and Trademark Office now
considers non-naturally occurring nonhuman multicellular organisms including animals, to be
patentable subject matter within the scope of 35 U.S.C. 101’.117 The notice also made it clear
that the Board’s decision does not affect the principle and practice that products found in nature
will not be considered to be a patentable subject matter under USC 101 and/or 102. It ensures
that a patent will not be granted to an article of manufacture or composition of matter occurring
in nature unless given a new form, quality, properties or combination not present in the original
article existing in nature in accordance with the existing law.54”

“The Wisconsin Democrat Robert Kastenmeir introduced the Transgenic Animal Patent Reform
Bill 1989 (US) into the United States Congress. The Bill was aimed to provide patent defences
for farmers in respect of the reproduction, use and sale of a patented transgenic farm animal and
its offspring. Although the Bill was passed in the House of Representative, it was not debated in
Senate before the end of Congress. In 1990, Kastenmeir had lost his seat in the 1990 Congress
elections and the Bill was never reintroduced into the USA Congress.55”

53
Gruner, Richard S. "Intangible Inventions: Patentable Subject Matter for an Information Age." Loy. LAL Rev. 35
(2001): 355.
54
Golden, John M. "Patentable Subject Matter and Institutional Choice." Tex. L. Rev. 89 (2010): 1041.
55
Id.

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 CONTEMPORARY SERVICES AND COMMITTEES IN US

I. ABA- BIOTECHNOLOGY LAW COMMITTEE

“The Biotechnology Law Committee, part of the ABA Section of Science & Technology Law,
keeps abreast of various topics relating to biotechnology including research, commercial,
regulatory and patent issues. The committee also covers biotechnology issues relating to clinical
medicine, such as gene therapy, forensic medicine, such as DNA fingerprinting, and other areas
of biotechnology raising ethical and/or evidentiary issues. The committee follows pending
legislation designed not only to control the availability of products of biotechnology, but also to
protect the proprietary rights of biotechnology developments in the U.S56.”

II.BIOLOGICAL PRODUCT DEVIATIONS

“On November 7, 2000, the Food and Drug Administration published a final rule to amend the
requirements of reporting errors and accidents in manufacturing of products. The rule amended
the regulation at 21 CFR 600.14 for licensed biological products, and added a requirement at 21
CFR 606.171 applicable to all manufacturers of blood and blood components.57”

III.ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS)

“APHIS uses the term biotechnology to mean the use of recombinant DNA technology, or
genetic engineering (GE) to modify living organisms. APHIS regulates certain GE organisms
that may pose a risk to plant or animal health. In addition, APHIS participates in programs that
use biotechnology to identify and control plant and animal pests. Below is a list of the regulatory
requirements for genetically engineered organisms and facilities.58”

IV.FDA’S BIOTECHNOLOGY POLICY

“In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of
Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified
the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with

56
http://apps.americanbar.org/dch/committee.cfm?com=ST103102
57
https://www.fda.gov/biologicsbloodvaccines/safetyavailability/reportaproblem/biologicalproductdeviations/default
.htm
58
https://www.aphis.usda.gov/aphis/banner/aboutaphis

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respect to human foods and animal feeds derived from new plant varieties and provided guidance
to industry on scientific and regulatory issues related to these foods.59”

V.FEDERAL FOOD, DRUG, AND COSMETIC ACT

“The FDA's online reference edition of the Federal Food, Drug and Cosmetic Act is based on the
publication Compilation of Selected Acts Within the Jurisdiction of the Committee on Energy
and Commerce; Food, Drug, and Related Law, As Amended Through December 31, 2004,
prepared for the use of the Committee on Energy and Commerce, U.S. House of Representatives,
March 2005. Updates have been made in the online edition as the act was amended since that
time. Notes in the text indicate when the online version was updated, rather than the date the
change was enacted.60”

VI.FEDERAL ISSUANCE OF EXPERIMENTAL USE PERMITS

“An experimental use permit (EUP) is generally required for testing of any unregistered pesticide
or any registered pesticide being tested for an unregistered use. However, as described in
paragraph (b) of this section, certain of such tests are presumed not to involve unreasonable
adverse effects and, therefore, do not require an EUP61.”

VII.FOOD BIOTECHNOLOGY IN THE UNITED STATES- SCIENCE, REGULATION, AND ISSUES

“This report provides basic information on the science of food biotechnology. It discusses
regulatory policies and issues of concern about the use of biotechnology to modify foods through
genetic engineering. It describes the scientific processes used and current products available. It
explains how all three major federal agencies - the Food and Drug Administration, the U.S.
Department of Agriculture, and the Environmental Protection Agency - regulate these foods.\”

VIII.MICROBIAL PRODUCTS OF BIOTECHNOLOGY: FINAL RULE (62 FR 17910)

“The regulation under which the TSCA Biotechnology Program functions is titled "Microbial
Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act",
promulgated in the Federal Register on April 11, 1997. This rule was developed under TSCA
59
https://www.fda.gov/Food/GuidanceRegulation/.../Biotechnology/ucm096095.htm
60
https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/FederalFoodDrugandCosmeticActFDCAct/FD
CActChapterVDrugsandDevices/default.htm
61
https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-12-applying-experimental-use-
permit

26 | P a g e
Section 5, which authorizes the Agency to, among other things, review new chemicals before
they are introduced into commerce. Under a 1986 intergovernmental policy statement,
intergeneric microorganisms (microorganisms created to contain genetic material from
organisms in more than one taxonomic genera) are considered new chemicals under TSCA
Section 5. The Biotechnology rule sets forth the manner in which the Agency will review and
regulate the use of intergeneric microorganisms in commerce, or commercial research.”

IX.MICROBIAL PRODUCTS OF BIOTECHNOLOGY: FINAL REGULATION UNDER THE TOXIC

SUBSTANCES CONTROL ACT

“EPA is promulgating this final rule under section 5 of the Toxic Substances Control Act
(TSCA), 15 U.S.C 2604, to establish notification procedures for review of certain new
microorganisms before they are introduced into commerce. &&New'' microorganisms are those
formed by deliberate combinations of genetic material from organisms classified in different
taxonomic genera. This review process is designed to prevent unreasonable risk of injury to
human health and the environment without imposing unnecessary regulatory burdens on the
biotechnology industry. This final rule describes notification procedures and the microorganisms
that would be exempt from notification.”

X.OFFICE OF SCIENCE AND TECHNOLOGY POLICY

“The mission of the Office of Science and Technology Policy is threefold; first, to provide the
President and his senior staff with accurate, relevant, and timely scientific and technical advice
on all matters of consequence; second, to ensure that the policies of the Executive Branch are
informed by sound science; and third, to ensure that the scientific and technical work of the
Executive Branch is properly coordinated so as to provide the greatest benefit to society62.”

XI.OFFICE OF SCIENCE COORDINATION AND POLICY BIOTECHNOLOGY TEAM

“The Biotechnology Team located in EPA's Office of Science Coordination and Policy (OSCP)
coordinates scientific, technical, and policy development activities within the Office of Chemical
Safety and Pollution Prevention (OCSPP). The OSCP Biotechnology Team is also a focal point

62
https://www.whitehouse.gov/ostp

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for coordination with other Federal agencies on any issues involving biotechnology, including
international activities.63”

XII.BIOTECHNOLOGY INFORMATION SERIES

“The United States Department of Agriculture (USDA), the Food and Drug Administration
(FDA), the Environmental Protection Agency (EPA), and most state governments closely
monitor the development and testing of a genetically engineered product and can provide pages
of test results concerning its safety. However, in the end, only consumers themselves can decide
if using a product, whether it is developed by genetic engineering or traditional methods, is right
for them64.”

XIII.STEM CELL THERAPEUTIC AND RESEARCH ACT OF 2005

“On May 23, 2005, Representative Christopher Smith (R-NJ) introduced H.R. 2574, the Stem
Cell Therapeutic and Research Act of 2005. The bill to provide for the collection and
maintenance of human cord blood stem cells for the treatment of patients and research, and to
amend the Public Health Service Act to authorize the C.W. Bill Young Cell Transplantation
Program65.”

XIV.THE PLANT PROTECTION ACT (PPA)

“The Plant Protection Act (PPA) became law in June 2000 as part of the Agricultural Risk
Protection Act. The PPA consolidates all or part of 10 existing USDA plant health laws into one
comprehensive law, including the authority to regulate plants, plant products, certain biological
control organisms, noxious weeds, and plant pests. The Plant Quarantine Act, the Federal Pest
Act, and the Federal Noxious Weed Act are among the 10 statutes the new Act replaces66.”

XV.US REGULATORY AGENCIES- UNIFIED BIOTECHNOLOGY

“The Federal Government of the United States of America has a coordinated, risk-based system
to ensure new biotechnology products are safe for the environment and human and animal
health. Established as a formal policy in 1986, the Coordinated Framework for Regulation of

63
http://www.expertglossary.com/superfund/definition/office-of-science-coordination-and-policy-oscp
64
https://www.ncbi.nlm.nih.gov/
65
https://www.congress.gov/congressional-report/114th-congress/house-report/242/1
66
https://www.aphis.usda.gov/plant_health/downloads/plant-protect-act.pdf

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Biotechnology describes the Federal system for evaluating products developed using modern
biotechnology. The Coordinated Framework is based upon health and safety laws developed to
address specific product classes. The U.S. Government has written new regulations, policies and
guidance to implement these laws for biotechnology as products developed. This framework has
allowed the United States to build upon agency experience with organisms and products
developed using conventional techniques67.”

67
http://ucbiotech.org/biotech_info/PDFs/Food_Drug_Adm_Cent_Food_Saf_Appl_Nutr_2007_Biotechnology.pdf

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 CONCLUSION

“The existing precedents, based primarily in the chemistry field, served adequately during the
early development of biotechnology. Major threshold questions of patentability, relative to living
organisms and products of nature, are now largely resolved. The courts now accept products of
biotechnology as patentable subject matter, subject to the same statutory criteria of novelty, un-
obviousness, description and enablement as inventions in other fields. Applying the statutory
criteria to the facts of biotechnology inventions is an ongoing process, whose outlines in the case
law are only beginning to take shape. As biotechnology patent practice matures, it is being
viewed less as a direct descendant of chemical practice than as a cousin. The body of
biotechnology precedents is expected to take on a more individualistic character separate from
chemical practice and drawing from precedents in other arts as well. The future will be
characterized by further definition of a body of biotechnology case law, which in turn will be
affected by new technologies that further accent differences between biotechnology practice and
chemical practice. General trends toward internationalization of business and harmonization of
patent laws can be expected to bring about more uniform treatment of biotechnology in patent
systems around the world.”

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 BIBLIOGRAPHY

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3. B. Bryan, ‘Biotechnology, Bioethics and Liberalism: Problematizing Risk, Consent and
Law’ (2003) 11 Health LawJournal 119 et seq.
4. Drahos, Peter. "Biotechnology patents, markets and morality." European Intellectual
Property Review 21.9 (1999): 441-449.
5. Koenig, Dorean M. "The Regulation of Modern Biomedical Techniques." DePaul L.
Rev. 38 (1988): 1013.
6. Ihnen, Jeffrey L. "Patenting Biotechnology: A Practical Approach." Rutgers Computer &
Tech. LJ 11 (1985): 407.
7. Kinderlerer, Julian, and Diane Longley. "Human genetics: the new panacea?." The
Modern law review 61.5 (1998): 603-620.
8. Rai, Arti K. "Intellectual property rights in biotechnology: Addressing new
technology." Wake Forest L. Rev. 34 (1999): 827.
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