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Prepared By Neelakamal Mohapatra and Rupalekha Mohapatra

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra INTRODUCTION A patent is very powerful because it protects novel and non-obvious ideas and not just the expression of those ideas. Once an invention is patented, the inventor alone reaps the benefits of his creation and has the right to exclude others from using his invention and in return for this period of exclusive use, the inventor fully discloses his invention to the public1. Patenting life is a new phenomenon as it depends upon the development of biotechnology, which is fairly young. Biotechnology is the utilization of biological processes for the exploitation and manipulation of living organisms or biological systems in the development or manufacture of a product or in the technological solution to a real world problem. Patent laws in most of the countries are tuned for non- biological material. In biotechnology, the basic aspect is biological material or biological process or biological product with industrial application. But issue of whether living organisms, such as, micro- organisms, plants, or animals; or naturally occurring substances, such as DNA and proteins, cloning and bioinformatics may constitute the subject of an invention is still very controversial and hence considered separately. Even in recent past, patenting of life was prohibited for moral ground. Many persons, for a wide variety of reasons, are opposed to the granting of patents for living organisms, and the same persons often consider that someone who patents a human gene somehow acquires control of human life, or even of an individual form whose tissue the gene was isolated. However presently, with the spread of technology and ideas and liberalization of both minds and economics, the question of patenting of life has emerged as an important issue, especially because of the potential benefits that lie from the use of biotechnology. Where the invention can be useful in the diagnosis or treatment of disease, the majority of public may accept the need for such patents, but opposition to genetic modification of food crops, and to patents on the resulting transgenic plants, is more wide spread. The high commercial potential of genetic researches made this branch of science a focal point of trade and investment. Consequently, claims for patents on these living inventions have started coming upon along with a demand for better patent protection for biotechnical inventions. This led to a situation where law and legal systems were compelled to address the issue of getting patents on living beings, particularly in the context of globalization of tirade and investment. TRIPS is the first international treaty, which makes it legal and compulsory to patent life. This is a very controversial system. Most biodiversity is found in developing countries. But that developed countries have much advanced technologies- to extract value from biodiversity. This is the reason why they want patent protection on life forms. TRIPS Art 27.3(b) allows countries to exclude plant and animal from patentability. Developing countries in general will take this exclusion to prohibit such patent domestically.

1. a) US CONST. Art. I, § 8, cl. 8. Congress has the power “to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive rights to their respective Writings and Discoveries.” b) Donald Chisum et. al. Principles of Patent Law 3, 2nd edition (2001)

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 2 However some developed countries like US, will not. This means that Biopiracy-the patenting of the developing countries ‘genetic resources’ and traditional knowledge by developed countries will continue.

DEMAND OF IP ACTIVITY IN THE FIELD OF LIFE FROM

Intellectual Property activities in the field of life forms and related technologies such as biotechnology are continuously growing and gaining importance in diversified uses. Until 1980 patents over microorganisms were confined to processes relating to microorganisms rather than microorganisms per se (as such). The main legal landmark in the extension of patenting to microorganisms is the well- known and widely cited 1980 Supreme Court case Diamond v. Chakrabarty as discussed earlier. Growth in patenting related to microorganisms reflects the importance of microorganisms as a rich and largely untapped source of DNA, amino acids, and proteins such as enzymes for the pharmaceutical, agricultural and chemical industries.2 A specialist group of biotechnology companies have now emerged which focus on the identification and commercialization of the properties of microorganisms. Microorganisms are also a particular focus of attention for public and private genome mapping projects. 3 Existing statistics Some statistical data are available to project the intellectual property activity in the fields related to life forms.4-5 These data analysis were conducted to assess the status and trends in relation to biological and genetic material and it was done with a key word search for patent publications within the online and free patent databases. The results of the search of the esp@cenet “worldwide” database for the key words “microorganism” and “microbe” shows that total of approximately 6,915 patent publications between 1990 and 2000 in which the term microorganism features in either the title or abstract rising to approximately 10,024 if preliminary data for 2001-2003 was taken into account.6 The corresponding totals for ‘microbe’ are 875 for 1990 to 2000 rising to approximately 1,471 publications if preliminary data for 2001-2003 is taken into account.7 In contrast, enzymes accounted for approximately 19,320 publications between 1990 and 2000 rising to approximately 29,105 patent publications if preliminary data for 2001- 2003 is taken into account An alternative approach was also adopted by the same research group to express the trend of IP activity in relation to microorganisms is through use of the International Patent Classification system (IPC) (7th edition)8 suggests that for the main sub-class for microorganisms (C12N) between 1990 and 2000 a total of approximately 188,213 patent claims were published rising to a

2 GRAIN (1999) ‘Bacteria Become Big Business’. Seedling, March 1999, http://grain.org/seedling/?type=17. 3 The Genomes OnLine Database (GOLD) for details of genome mapping projects related to microorganisms ; http://www.genomesonline.org. 4 Paul Oldham, “Global Status and Trends in Intellectual Property Claims: microorganism”Microorganisms ESRC Centre for Economic and Social Aspects of Genomics (CESAGen), United Kingdom; www.cesagen.lancs.ac.uk/resources/docs/microorganisms/microorganismspublished.doc, (January 05, 2006). 5 Paul Oldham, “Global Status and Trends in Intellectual Property Claims: microorganism”Microorganisms ESRC Centre for Economic and Social Aspects of Genomics (CESAGen), United Kingdom ; www.cesagen.lancs.ac.uk/resources/docs/genomics-final.doc , (January 05, 2005). 6 In the case of the USPTO a total of 5,694 references to microorganisms are located in the claims of patent publications between 1976 and August 2004.; www.cesagen.lancs.ac.uk/resources/docs/microorganisms/microorganismspublished.doc 7 The USPTO lists 422 patent publications in which the term “microbe” features in the claims between 1976 and August 2004; www.cesagen.lancs.ac.uk/resources/docs/microorganisms/microorganismspublished.doc 8 Special Union for the International Patent Classification (IPC Union) established under the 1971 Strasbourg Agreement Concerning the International Patent Classification (amended 1979). Location : < http://www.wipo.int/classifications/ipc/en/reform/ipc_reform.html >.

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 3 provisional 299,163 claims if preliminary data for 2001-2003 is taken into account. This is followed by sub-class C12Q with approximately 72,086 claims between 1990 and 2000 rising to a preliminary total of 126,684 if provisional data for 2001-2003 is taken into account. This in turn is followed by C12P which focuses on fermentation or enzyme using processes to synthesize chemical compounds with approximately 80,743 patent publications between 1990 and 2000 rising to a preliminary total of 118,877 patent publications if provisional data for 2001-2003 is taken into account.

This search could be more refined; if the search would have conducted with some efficient databases like Micropat, Delphion or STN etc. India’s IP Demand India’s share in the global biotech market is currently about 2%. Sales of biotech products in India are growing at a CAGR of 8.4%.9 Distribution of Indian biotech companies across different segments are given in the following Fig.2.10 Agro-biotech (including seeds) is the largest sector with 42 companies; followed by human health and contract research. Major 8% Players 1% Agro-biotech Monsanto 24% Bioremediation 12% Biopesticides Biodiagnostics Enzymes Biocon 4% Nicolas Piramal 3% Human health Vaccines Cipla 6% 4% Bioinstrumentation Veterinary 5% 9% Contract research Biocon Bioengineering 18% 6% Other

Total number of companies =175

Fig.2: Distribution of Indian biotech companies across different segments

9 A Report on the Indian Biotechnology market Mindbranch.com http://www.globalsourcingnow.com/GSN_Knowledge.asp 10 Ibid

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 4 COMPANY R&D/REVENUE (%) LINE OF RESEARCH Workhardt 10.5 Genome technology Zydus Cadila 7.5 Genome technology Torrent Pharma 6.4 Pharmaceuticals Ranbaxy 6.0 Pharmaceuticals Biocon 5.0 Enzymes Dr. Reddy’s Labs 4.4 Therapeutic proteins Cipla 4.0 Vaccines Sun Pharma 4.0 Pharmaceuticals Average 5.9 Table-2. R&D expenditure of major Indian companies

Major Indian companies, with their R&D expenditure expressed as a percentage of their revenue, and their key line of research are represented in Table-2.11. Workhardt is found to be the major player followed by Zydus Cadila and Torrent Pharma in terms of R&D expenditure. The average R&D expenditure is found to be 5.9%.The Indian government is also supporting research through various agencies. This can be very well understood from the Table-312 showing research budget allocations to different scientific agencies and The total budgetary allocations amount to ~ Rs. 50 billion. AGENCY BUDGETARY ALLOCATION (RS. CRORE) University Grants Commission (UGC) 1407

Indian Council of Agriculture Research (ICAR) 1399

Council of Scientific and Industrial Research (CSIR) 912

Department of Science and Technology (DST) 779

Indian Council of Medical Research (ICMR) 147

Department of Biotechnology (DBT) 136 Department of Scientific and Industrial Research 58 (DSIR) Table-3: Research budget allocations of agencies

As to comply with the TRIPS agreement, changes in the Indian Patent Act have been made in New (Amendment)Act 2005. Now Drugs will become patentable as products, and not just as processes. Patentable SubjectThe important changes are given in the following Table-4: Matter Before 2005 After 2005

Only process patents for Product and process patents for Term of 11 Ibid Patent 12 Ibid

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra Grant of 5 EMR pharmaceuticals, food products, and pharmaceuticals, food products, and agrochemicals agrochemicals Process patents for these inventions have Process as well as product patents for a term of 5 to 7 years. these inventions will have a term of 20 years Provision for EMR grant to companies Product patents will be issued. Hence, filing product patents. First Indian EMR there is no need for EMRs. granted to Novartis for Glivec in November Table-4: Changes in the New Patent (Amendment) Act-2005

In light of these changes, Indian biotech companies face a number of opportunities • The large Indian market can be captured by gaining IP protection. • There will emerge new revenue streams from patent licensing and litigation. • Strong IP protection increases the lucrativeness of India as a destination for contract research • Indian companies can introduce entry barriers for foreign players in the Indian market by using IP to protect their own innovations. All the above studies show that there is enormous potential in the area of Life form patenting in India. Hope in coming years India will acquire a comfortable position in the Globe in this area.

REDEFINING LIFE The term ‘life’ normally includes both animal and plant life. Presently however there is already an intellectual property regime in place for protection of plant varieties. However even in the absence of any suigeneris protection for plant varieties, the proposition put forward herein would continue to hold good. Also, there are at present a number of techniques such as cloning, the DNA extraction, and the gene manipulation they are extensively used in the modification of life forms. Though equally controversial themselves, they are therapeutic and diagnostic methods and on their own are not connected with the patentability of life.13 Types of Life forms Taking a cell as a basic block of life, all organisms are either unicellular, consisting of one cell or multicellular, consisting of many cells. Though a crude definition, this is what all legal definitions are based on. In many patent statutes they speak on the patentability (or lack of it) of life forms, the term ‘microorganism’ is used. This has not been defined anywhere and is generally loosely understood to mean unicellular life forms such as bacteria, virii and amoeba. These are also referred to as ‘lower’ life forms. Apart from these, all other multicellular organisms are termed ‘higher’ life. Interestingly, Justice Bastrache of the Canadian Supreme Court while ruling against the patentability of a modified mouse 14 has defined higher life as ‘possessing qualities and characteristics that transcended the particular genetic material of which they are composed’. This could be mean that in higher life forms, the whole is greater

13 Li Westurlund, “Biotech Patents” Kluwer Law International, The Hague, p. 1-4 (2000) 14 Havard/Onco-Mouse case T 19/90. 1990. European Patent Office Reports 501

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 6 than the sum of its parts but from a legal point of view this division between higher and lower life is an insignificant one because biologically all these are structurally similar. Man of course is treated differently and in the later chapter it shall be seen how and why that patentability of humans is an ethical problem. Legal Definition The above definition appears fine but what exactly is meant by the term patenting ‘life’? For this a legal definition is needed. Most patents statutes including the TRIPS 15, European Patent Convention (EPC), the Indian Patent Act or the UK Patent Act do not have any definition of life or organisms though they all speak of the patentability of microorganisms. This mention of microorganisms is only to bar patent on higher life forms. The US and the Canadian law have wide and possible limits of patentability as any ‘new or useful process, manufacture, machine, or composition of matters’. The definition of what is life and how far it is a composition of matter is solely judiciary discretion. In the EU however, they the directive by the European Commission on legal protection of Biotechnological inventions under whose rules biological material has been defined as "any material containing genetic information capable of reproducing itself on being reproduced in a biological system"16. This definition points towards DNA as life. Since different species have different DNA, patenting and organism has thus come to mean having a right or a particular DNA molecule. For patentability criteria to be met this DNA molecule must not be naturally occurring and therefore in most cases inserting new strips that code for different physical features genetically modifies it. The result is a hybrid that in most cases does not occur in nature. Therefore, patenting a microbe or a mouse is essentially the same except that the genome of each is different 17. For the purposes of the project therefore, the term “patenting of life" refers to patenting the entire genome. In the US, patent has been granted on particular genes. A gene may be common across species and may be responsible for particular general feature, such as black skin. Thus patenting a gene endows the patent holder the right to use that gene any organism. However there is results in too broad a protection and so it is submitted that patenting of life as to be only patenting of an entire genome only. It is analogous to plant variety protection where plant varieties may be protected, not plant characterists. EVOLUTION OF LIFE IN THE WORLD OF PATENTS

Ever since the Supreme Court in U.S allowed patenting of microorganism in 1980, this subject of patenting of ‘Life Forms’ has been drawing a great-deal of attention all over the world. In other words the patenting of life has become the subject of a growing worldwide campaign. There are basically two groups of people, one of which supports this kind of patenting on the basis of a few precedents. However, there are another group of people who is against the patenting of life forms because they believe that animals, plants, humans, micro-organisms and their parts such as genes and cells are not to be patented, for the reason that they (life forms) are creations of God and nature. They cannot be brought under the term invention, even if they are genetically modified or are the products of human manipulation.

15 This is a contentious issue and several countries including India are pressing for a definition. 16 European Directive On Legal Protection Of Biotechnological Inventions, 98/44 (1998) OJ 213, Rule 28(6)(a)

17 Supra note 2, at 8

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 7 Prior 1980 Scenario Prior to 1980, the microorganisms were considered to be the “product of nature” and so not patentable because for a product to be patentable it must satisfy the three-test of patentability i.e. invented, novel and with industrial application. Post 1980 Scenario However, post 1980 after the one of the most important and foremost judgment of Supreme Court of U.S in the historical case of Diamond v Chakrabarty18 there was a sudden change in the view regarding patentability of life forms. In the above mentioned case. The respondent Chakrabarty sought a patent rights to a genetically engineered micro-organism that break down crude oil, under the title 35, US Code 10119. Title 35 authorizes the patent of any newly made manufacture of composition of matter. Patent was denied to Mr. Chakrabarty. However, this ruling was over ruled by the courts of customs and patent appeal. Opinion, in favour given by the court of customs and patent appeal was that20.  The bacterium in question is an artificially made composition of matter. Hence, man made. This is because the bacterium in this case has capabilities not found in naturally occurring bacterium.  It is a product of a human manipulation and hence similar to any other invention.  Last but not the least the bacterium has a specified use. Thereby, satisfying all the three ingredients under the definition of patentable product.  Hence the case was finally decided in favor of the respondent thereby opening the gates for the ensuring flood of patent petitions for genetically engineered biological materials. In yet another case- patent was granted for the first genetically altered animal, which was a mouse susceptible to cancer. This was called the Havard Mouse case. This case was a Canadian Court decision. GLOBAL LAWS RELATED TO PATENTING LIFE FORMS

TRIPS TRIPS is the first international treaty, which makes it legal and compulsory to patent life. Under TRIPS, Article .27.3(b) mandates patentability of microorganism. There are three optional exceptions:  Public order, health and morality  Environmental protection  Non-micro organic animal life…[higher life forms] Also, plant varieties are to be compulsory protected either to patent or through a sui generis legislation to that effect. In addition, under Art. 31 there is provision to compulsory license a patent in case of emergency. These standards are to be in force in all W. T. O. member nations by 2005.A such, leaving aside Least Developed Countries. Most of them have amended domestic law to allow patentability of

18 Diamond, Sydney A. and Commissioner of Patents and Trademarks and Petitioner Vs. Chakrabarty, Ananda M. et. Al. No. 79-136, 1980. United States Supreme Court Reports, Lawyer’s Edition 2d-65: 144; United States Patents Quarterly 206:193 19 Paul Goldstein,” Copyrights, Patents, Trademarks And Related States Doctrines”, University Casebook Series, p.385-398 (1999) 20 ibid

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 8 microorganisms. Like the US and the EU have gone ahead and allowed patenting of higher life forms also. The United States In the US, the substantive law is 35 USC 101 which reads thus, “Whoever invents or discovers any new or useful process, manufacture, machine, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof" Until 1980, legal interpretation had denied the eligibility of all life forms for patent rights because their creation was considered similar to the discovery of an unknown river. They been equated to products of nature rather than human invention were held not to have met the three criteria. This was known as the Douglas Principal.21 In 1980, the Supreme Court issued a landmark 5-4 decisions that altered patent law dramatically. In Diamond vs. Chakrabarty, Court ruled that a genetically modified strain of bacteria, useful for oil spill clean up, could be patented. The rationale for this decision is centered on the ingenuity required to modify the bacteria. While acknowledging that life forms in their natural state are not patentable, that Court held that altered life forms (transformed from their natural state through human intervention) were patentable. In 1987, the PTO extended this justification to an animal that does not occur naturally when the Harvard Oncomouse was a patented in 1998 as an invention. Under US law therefore, both higher and lower life forms can be patent it provided that they are genetically modified or obtained in a purified state. The European Union The European Patent Office (EPO) following closely the US patent office practices has granted numerous patents on all sorts of biological materials.22 Though not explicitly mentioned, it is generally accepted that EPC allows patent protection for microorganisms.23 The Technical Board of Appeal of the European Patent Office in a number of cases upheld EPO’s decisions in granting patents on plants and seeds.24 The question of patenting an animal came up for consideration before the EPO examination division and the EPO Technical Board of Appeal in the Harvard Oncomouse, patents claims. The decision of the examination division not to accept the claims on animals as such was set aside by the Board of Appeal. The Board held that ‘the exception to patentability under Article 53b of the European Patent Convention applies to certain categories of animals but not to animals as such’. The decision of the Board really reflects the political consideration involved in this issue. The Board finds the probable environmental risks and the sufferings of the animals on one side and the usefulness of the invention on the other side as the two competing rationales. But the Board did not venture to make a valid judgment on the issue. Instead it left the matter for the Examination Division to act upon.

21 So named for Justice Douglas, is who held in 1948 case of Funk Brothers Seeds Co. v.Kalo Inoculant Co. That patent cannot be granted for discovery of the phenomena of nature. 22 a) T 162/86 ‘Plasmid PSGZ/HOECHSTAG b) T 281/86 ‘Preprothasmatin/UNILEVER c) T 288/86, ‘Bovine Growth Hormone/ the Regents of University of California’

23 Article 53(b) of the European Patent Convention says that the exclusion of plants or animal varieties or essentially biological processes does not apply to products of micro-biological processes. 24 Re Ciba- Geigy AG 749/83, (EPO technical Board of Appeal)

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 9 In the Greenpeace25 case, the Board of appeal took an altogether different stand. In this case the Board held that claims on genetically engineered plants are not acceptable. Following this decision, now it will not be possible to obtain an European Patent on genetically engineered plants or seeds because this will include plant varieties which will come under purview of the exclusion provision under Article 53b of the European Patent Convention. The Board was called upon in this case to explain the expressions order public and morality occurring in Article 53a of the European Patent Convention. The Board held; “It is generally accepted that the concept of order public covers the protection of public security and the physical integrity of individuals as a part of the society. This concept encompasses also the protection of environment. Accordingly under Article 53a of EPC, inventions, the exploitation of which is likely to reach public peace or social order or to seriously prejudice the environment are to be excluded from patentability as being contrary to order public”.26 Explaining the concept of morality the Board held that is related to the belief that some behavior is right and acceptable whereas other behavior is wrong. This belief being founded on the totality of the accepted norms which are deeply rooted in a particular culture. 27 Therefore, the Board hoping that an invention, which does not conform to the conventionally accepted standards of conduct, is to be excluded from patentability as being contrary to morality. This seems to be a proper exposition of the new balancing of interest envisaged under Article 53 of EPC but the new biotech directive cuts at the root of this and brings a new set of patentability norms. The European Parliament passed the directive on biotechnological inventions on July 16th 1997. The proposal of a Council directive on the legal protection of biotechnological inventions was first put forward in 1988. After six years of negotiations of the EU institutions at the directive was introduced before the European Parliament 1993. On March 1st 1995, the European parliament rejected the directive. Recently, the proposal was reintroduced before the European parliament and of all the 510 parliamentarians, 378 voted for the directive with 113 voting against and 19 abstentions. Even though the European Parliament has passed the directive to have the force of law it has to be ratified by the European Council of Ministers.28

DIFFERENT ISSUES AND PROBLEMS IN PATENTING LIFE FORMS There are many issues and arguments in granting patent to biological inventions. In some cases, these arguments are valid and are of real concern. However, in other cases they may stem from a general misunderstanding of biotechnology and its potential applications, of the patent system and its limitations, and of other forms of legislation, which control the use of this technology. Arguments against allowing patents for certain biotechnology inventions (specifically genetic material and life forms) include:  Genetic alteration of life forms is immoral;

25 Green Peace Ltd. v Plant Genetic Systems, T 0356/93, February 21, 1995s 26 Ibid p. 14 27 Ibid. p. 15

28 Karen Lutz. "No to Patenting of Life!" http://www.biotech-info.net/no_to_patenting.html (January 01, 2006)

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 10  Allowing patents for these inventions leads to the ownership and commercialization of life, and reduces life forms to 'products of manufacture';  Human, animal and environmental safety may be compromised in the development and subsequent use of these inventions;  Allowing patents for certain life forms and genetic material may lead to unauthorized exploitation of a country's natural resources;  Allowing patents for certain life forms and genetic material may be insensitive to the beliefs of indigenous populations and may exploit their knowledge;  The patent system discourages disclosure of information and collaboration between researchers. It is probably fair to say that opponents of patents for inventions relating to life forms are probably more concerned with the ethical, moral and safety issues surrounding the research, development and use of such inventions rather than the issue of allowing patents for them.29 Legal Issue Legal problems to the patenting of life are cantered around whether or not under existing criteria of patentability, life forms may be patented. In practice this is not a good ground for the denial of patent because is a case specific one. However for the purpose of this project and to clear the fundamentals, it is important to appreciate whether a life form can be per se granted a patent regardless of public policy. For this, the criteria will be explained with respect to life forms. Presently, the requirements for any patent are:  Novelty  Non Obviousness  Industrial Application/utility/usefulness Clearly, the third requirement can be met without any controversy. Short of hybrid virii designed as biological weapons,30 all applications presently pending for life forms envisage some sort of useful medical or industrial utility for the patented product. However, claim procedure needs to be modified to ensure that unlike other patent, the intended use and usefulness of the product is specified clearly and completely. The first two criteria at closely connected. If a life form is to be given a patent it must be so modified that the modified version would not naturally occurring nature. If this were not so, than the life form would be merely discovery, nothing more. But when one gene from one organism (say-or production of insulin) is inserted into a relevant part of another organism's genome (say-the gene from production of milk), the result being the target organism (say-a cow) that gives forth insulin rich milk, than obviously it qualify as a non natural occurring composition of matter although how non obvious it is for experts to determine. Another significant ambiguity there is what counts as human intervention. It revolves around whether copies of expressed DNA material are considered a natural product or human intervention. Patent for such modified copies have been granted on the grounds that obtaining copies, deciding what to copy

29 Shelley A. Rowland & James W. Piper, “Patents and Biotechnology –Issues around Patenting Life Forms”, http://www.piperpat.com/Portals/0/articles/patents/BiotechBasics.pdf (December 25, 2005) 30 Which can be denied on grounds of public order or morality

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 11 where and how, involves significant human ingenuity. This is the reasoning used by the US Supreme Court in Diamond v. Chakrabarty to allow patent are genetically modified bacterium that broke down oil and so could be used to clean oil spills. In that case the court held that the fact that the subject matter is living is not of significance.31 This may sound like reductionism or commodification of life but really the sound. Therefore, are genetically modifie d life form is patentable in theory. It is admitted that of late the USPTO has been far too liberal in granting patents with the result that whole stretches of unmodified DNA is patented.32 A minor issue that is related to the question of whether DNA by itself constitutes an ‘essential biological process’. The answer to this would be that DNA is a chemical that determines the phenotype (structure, behavior, characteristics) of an organism. Ethics and Morality  Life Form: Non-Human Ethics presents a major hurdle in the patenting of life. While legal and economic arguments may be justified and proven on paper, it is difficult to do the same for ethics and morality. For the purpose of this discussion, humans will be treated differently from other life forms. The grant of patents on lower than higher life forms such as genes, bacteria and mice has provoked a numerous ethical objections to the patenting of life. Many of these are rooted in religion with clerics claiming that patenting reduces Gods creatures to mere material objects such objections have been brought up at the time of the Chakrabarty case from the People's Business Commission (PBC), an activist group. These ethical objections were on religious grounds, that to permit patent on life was to imply that life has no ‘ vital’ or sacred property, and that it was merely an agreement of chemicals, or a ‘composition of matter.’ In its ruling on the case, the Supreme Court majority took note of these and other apprehensions, observing however, that genetic research with its risks would likely proceed with or without patent protection for its products and that neither legislative non judicial bar as to patentability would deter scientists. Another concern of religious groups is about a commodification of life forms by which the God-given dignity of life forms is degraded by subjecting fundamental information about them to monetary transactions (through patent). This occurs whether or not they are actually traded in the marketplace. The fear is that the patenting of life forms and of the DNA will edge Society closer to their abuse. Patenting of animals has also been opposed on ethical grounds by animal rights activists. They have contended it that such activities would aggravate the degradation of animals. However this has been successfully countered by the countered-argument that cruelty to animals would be reduced overall as a successful research would reduce the need to have more research animal in the future.33 In contrast to the disregard that the US has shown toward ethical objections to the patenting of life, the European Patenting Convention specifically excludes34 patent for any invention that is contrary to public order or morality. This ‘order public’ is not however defined and the EPO’s guidelines on

31 Although it is, specially if it is human 32 Under US Patent law even unmodified though pure samples of organism are patentable

33 Harvard Oncomouse, 1991 EPOR 525 34 Art 53(a), EPC, 1973

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 12 substantive patent evaluation say that this provision should be invoked only in ‘rare and extreme cases’. 35 Although it has been used in practice only a few times, it is a strong indicator of how moral and ethical considerations find their way into patent law. In fact, the Harvard Oncomouse was initially denied patent by either Technical Board of Appeal (TBA) under Article 53(a). On appeal it cleared, as its usefulness to mankind could not be denied. This position is similar to that in India where section 3 of the Patent Act, 1970 lists among the exclusion to patents, clause (b) that denies patents on "and invention, the primary or intended use…of which could be contrary to public order or morality". However, unlike the developed countries, there is little opposition to life form patenting in India and ethical grounds.  Life Form: Human Humans are another matter. It is submitted that patenting of humans and human DNA should be banned, because it needs far more drastic changes in religious belief than required to make patenting of animals acceptable. It also raises, apart from the arguments enumerated above, other problems such as slavery. Could a patent holder on a modified human genome claim ‘property’ rights over a child produced out of that genome? Would this not lead to a direct clash with the consent of absolute, inalienable human rights36 that has come to be accepted by all these developed countries? It is reasonable to assert that currently Society will be unable to accept patenting of humans. Therefore it is put forward, that for the time being, patenting of humans should be banned so that atleast this will not prove to be a hurdle for patenting of other forms of modified life in that could prove to useful. Environmental Risks While impacts of most biotechnology products are relatively predictable, GMOs do present risk to human health and environment and raised considerable uncertainties, in particular regarding their environmental impacts. Some of the concerns about the new technology include its potential adverse effects on biological diversity, and potential risks to human health. Here, the precautionary principle should be respected. When there are reasonable grounds for concern, even without complete scientific documentation, country should be reluctant to allow patentability, or even commercial use of GMOs until more knowledge is available. GMOs need proper control and an appropriate testing. But in ethics, environmental standards are for another legislature or executive to frame. Parliament may set down health, safety, and environmental standards to be fulfilled by any applicant desirous of getting GMOs patented. INDIA’S STAND IN THE GLOBE FOR PATENTING LIFE FORMS India became a member of the World Trade Organization on January 1, 1995. 37 As a member, it was required to comply with the Trade Related Aspects of the Intellectual Property Systems (TRIPS)

35 EPO, Guidelines for Substantive Examination, Part C, Chapter-IV, http://www.european-patent-office.org/legal/gui_lines/e/ , (December 24, 2005) 36 The UN sub commission on the Promotion and Protection of Human Rights in its resolution on 17th August 2000 held that "there are accurate conflicts between the intellectual property rights regime embodied in the TRIPS Agreement, on the one hand, and in the international human rights law, on the other"

37 Understanding the WTO: The Organization, at http://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm (December 10, 2005).

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 13 agreement.38 TRIPS requires member countries “to provide adequate standards and principles concerning the availability, scope and use of intellectual property rights and effective means for the enforcement of these rights.39” Prior to TRIPS, India’s patent system had been regulated by the country’s Patents Act of 1970 (Patents Act). To begin making India’s law consistent with TRIPS, the Patents Act was amended in 1999 and 2002 along with further modifications in 2005 in order to become fully TRIPS compliant.40 Protecting Microorganisms Louis Pasteur, the famous French scientist, received US Pat No 141,070 on 22 July 1873, claiming ‘yeast, free from organic germs of disease, as an article of manufacture’. With the phenomenal growth of genetic engineering in the late 1970s, the patentability of living microorganisms came into the scene, which involved Ananda Chakrabarty’s invention of a new Pseudomonas bacterium genetically engineered to degrade crude oil. USPTO rejected the claim on Pseudomonas bacterium, but the Supreme Court decision went in favour of Chakrabarty in a, landmark case, Diamond (USPTO commissioner) v Chakrabarty (inventor). Chakrabarty's Pseudomonas bacterium manipulated to contain four plasmids controlling the breakdown of hydrocarbons was ‘a new bacterium with markedly different characteristics from any found in nature’. The Supreme Court stated that new microorganisms not found in nature were either ‘manufactured’ or ‘composition of matter’ within the meaning of US Patent Act §101 and thus patentable. The ‘product of nature’ objection therefore failed and the modified organisms were held patentable. Following the US Supreme Court decision in Chakrabarty case, European Patent Office (EPO) and the Japanese Patent Office (JPO) also started granting patent protection for microorganisms in 198141. A provision of EPC, Article 53(b) is relevant here which states that patents shall not be granted for plant or animal varieties or essentially biological processes for the production of plants or animals, however, the provision does not apply to 'microbiological processes or the products thereof.' The microorganisms and microbiological inventions can be patented in India provided the strain is new under Patents Act, 1970, amendment 2002, implemented from 20 May 2003.42 However, under Section 5 of Patents Act, inventions relating to substances prepared or produced by chemical processes, which include biochemical; biotechnological and microbiological, no patent shall be granted in respect of claim for the substances themselves, but claims for the methods or processes or manufacture shall be patentable. Earlier the inventions on microorganisms were not patentable and this was one of the TRIPS regulations under the Article 27.3(b) that 'parties may exclude from patentability plants and animals other than' microorganisms and essentially biological' processes for the production of plants or animals other than non-biological and microbiological processes43. Thus one, of the conditions of TRIPS regulations has

38 Stephen Barnes, “Pharmaceutical Patents and TRIPS: A Comparison of India and South Africa”, 91 Ky. L.J. 911-917 (2003). 39 Carole De Gaulle, Intellectual Property and Patent in India, News Time, Oct. 2000, at http://www.foxmandal.com/publication/oct2000/oct2kca.html . (December 10, 2005) 40 Indian Patent Act, http://www.patentoffice.nic.in/ipr/patent/patents.htm (December 10, 2005) 41 Japan Patent Office, “ Bio Patent”, 46, http://www.apic.jiii.or.jp/p_f/text/text/6-03.pdf , (January 01, 2006) 42 The Indian Patents Act, 1970, along with The Patent rules, Universal Law Publishing CO., Delhi), 2005

43 Agreement on Trade-Related Aspects of Intellectual Property Rights. In Background Study Material - Vol II for Training on IPR and WTO to NARS scientists, ICAR, Delhi, 2001

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 14 been met and enforced in the country. Inventor has to deposit the new strain in any recognized international depository. Budapest Treaty is an international convention governing the recognition of microbial deposits in officially approved culture collections, which was ignored in Budapest in 1973 and later on amended in 1980. Because of the difficulties and on occasion of virtual impossibility of reproducing a microorganism from description in the patent specification, it is essential to deposit a strain in a culture collection center for testing and examination by others. It obviates the need of describing a microorganism in the patent application and further samples of strains can be obtained from the depository for further working on the patent. There are 34 International depositories for deposition of microbial cultures. India signed the Budapest Treaty on 17 December 2001. In India, Microbial Type Culture Collection and, Gene bank (MTCC) at the Institute of Microbial Technology (IMTECH), Chandigarh, is a recognized international depository of microorganisms. Protecting Plants US Plant Patent Act (PPA), enacted in 1930, allowed patenting of asexually propagated plants, and over 6,500 of such plant patents have been granted mostly for ornamental and fruit trees44. Plant Variety Protection Act (PVPA) was enacted in 197045. In 1985, US Board of Patent Appeals allowed patent protection for asexually, sexually or in vitro propagated plants46. In the Hibberd case involving a tryptophan-overproducing mutant, the US Patent Office in 1985 ruled that plants could be patented. Following the principle established in the Chakrabarty case, it was decided that normal US utility patents could be granted for other types of plants also, e.g. genetically modified plants. It was affirmed by a ruling of US Supreme Court on 10 December 2001, that plant utility patents could be granted to sexually reproduced plants in an infringement lawsuit for sexually reproduced corn hybrids against J E M. A G Supply Inc by Pioneer Hi-Bred International Inc. The court held that newly developed plant breeds fall within the subject matter of 35 USC §101 and neither the PPA nor the PVPA limits the scope of its coverage47. Among transgenic plants, herbicide resistant cotton, canola, soybean, etc; insect-resistant potato, cotton, maize, etc. have been patented. In Japan also plant patents are allowed. Plant patents have been granted by EPO from 1989. According to EPC Article 53(b) patents shall not be granted for plants or animal varieties or essentially biological processes for the production of plants or animals,48. In 1995, Green Peace49 brought a case against a patent on plants incorporating a transgene conferring herbicide resistance granted to Plant Genetic Systems, Belgium. The EPO's Technical Board of Appeal did not uphold any of Green Peace's arguments on the morality point [A provision of EPC Article 53(a) denies patentability to "inventions, the publication or exploitation of which would be contrary to 'ordre public' or morality, provided that the exploitation shall not be deemed to be so contrary merely because it

44 Pental D, Transgenics for productive and sustainable agriculture: Some considerations for the development of a policy framework. Vol. 84, Current Science, p. 413-424 (2003) 45 Manual of patent examining procedure § 2105 (8th ed. 2001). 46 R. Saha, US Supreme Court affirms patent for sexually reproduced plant, Vol. 7 No.11 Bulletin Intellectual Property Rights p. 1-3 (2001). 47 Decision T356/93, Plant cells/Plant Genetic Systems, OJ EPO 545, 1995 48 R Saha, Monsanto gets patent on Na Hal wheat. Vol. 7 No. I I Bulletin Intellectual Property Rights 8 (2003) 49 Dutfield G, Intellectual Property Right, Trade and Biodiversity: The case of seed and plant varieties. In Background Study Material - Vol I for: Training on]?R and WTO to NARS scientists, ICAR, Delhi, 2001

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 15 is prohibited by law or regulation in some or all of the Contracting States"]. But, it did confirm in its ruling that plant varieties could not be patented50. Recently, Indian wheat variety 'Nap Hal' was in news because EPO granted patent on this traditional land race to Monsanto in 2003. This particular variety has good biscuit making qualities. Opposition was filed and in 2004 the patent has been revoked. Life forms of plants and animals except microorganisms are not patentable in India. Also a method or process of agriculture and horticulture is non-patentable. However, methods for rendering plants free of diseases or putting an additive value to a plant can be claimed for patenting3. In pursuance to the TRIPS Agreement Article 27.3(b) plants and animals were left out of the compulsions of strict patent regime. However, members shall provide for the protection of plant varieties either by patents or by an effective suigeneris system or by any combination thereof. Method of Protecting Plant Varieties India and so many other countries do not protect plants by strict patenting system. But there is a mandate in the, TRIPS Agreement that plant varieties must be protected. In pursuance to the TRIPS Agreement, India has enacted 'Protection of Plant Varieties and Farmers' Rights' (PPVFR) Act, 2001, a suigeneris system of plant variety protection. This law is unique which has brought forth the farmers rights under the gambit of law. The model for this was the UPOV Act, an International. Convention [Convention of the Union for the Protection of New Varieties of Plants; original in French 'Union International pour la Protection des Obtentions Vegetales' (UPOV)] was held albeit with few countries to negotiate and provide for the protection of new varieties of plants in Paris in 1961 and came into force in 1968. It was revised in Geneva in 1972, 1978 and 1991. The 1978 Act came into force in 1981 and the 1991 Act in April 1998. There are two main Acts of 1978 and 1991. The Convention had already 54 countries party to it as on 15 April 2004. Under the UPOV, a plant variety qualifies for protection when it meets three essential criteria, (i) distinctiveness, (ii) uniformity and (iii) stability, and the variety should be new in commercial sense. Application for its protection can be filed in the country where developed or in any other UPOV member country.51 The Indian PPVFR Act along with rules, 2003 is in place but yet to be enforced. This act tends to provide a balance between the rights of breeders and farmers. Plant variety protection (PVP) may be provided to new varieties, extant varieties (already in cultivation or of common knowledge) or farmers’ varieties. The essential features are same as distinctiveness, uniformity, stability for extant and farmers varieties, but novelty feature is included in the newly developed variety. It will provide maximum protection for 18 years to trees and vines and 15 years to other crop varieties. Broadly, the Indian Act features a combination of provisions from the UPOV 1978 and UPOV 1991 versions. It provides protection to essentially derived variety and also elaborates provisions for the protection of farmers’ rights52. Protecting Animals

50 UPOV: States Patty to the Convention , http://www.upov.org/en/about/members/pdf/pub423.pdf , (January 01 2006) 51 S. Kochhar , Systems perspective for IPR protection in the plant kingdom, ,Vol. 9 No. 4, Journal of Intellectual Property Rights, p. 342-355 (2004) 52 The Protection of Plant Varieties and Farmers' Rights Act, 2001 (Universal Law Publishing Co, Delhi), 2002

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 16 The question of whether multicellular animals could be patented was examined by the USPTO in 1980s. In 1987, Ex Parte Allen case, the key issue was the patentability of polyploid pacific coast oysters that had an extra set of chromosomes53. The applicant sought to patent a method of inducing polyploidy in oysters as well as the resulting oysters as products-by-process. However, USPTO rejected the patent application on the ground of obviousness. On 12 April 1988, USPTO issued the first patent on transgenic non-human animal 'Harvard Mouse' (US Pat No 4,736,866) developed by Philip Leder (Harvard University) and Timothy Stewart. The 'Harvard Mouse' was created through a genetic engineering technique of microinjection. To the fertilized egg, a gene known to cause breast cancer was injected and then this egg was surgically implanted into the mother so that she may bring it to the term. The resulting transgenic mice were extremely prone to breast cancer. After initial reluctance by the EPO, European patent was issued in 1992. By 2002, more than 300 patent applications for transgenic animals have been filed but so far few have been granted by EPO. The new provisions of EPC in 1999, Rule 23c states that inventions concerning biological materials, such as DNA, microbiological process, plants, and animals are patentable only if the technical feasibility of the invention is not confined to a particular plant or animal variety' 54. Further, the EPC has prohibited patents on plants and animals as per EPC Article 53 (b) mentioned in the category of plants and on ordre public or morality:[Article 53 (a)]. EPC has stated that certain inventions are excluded from patentability whose exploitation is contrary to ordre public or morality, namely, processes for cloning human beings; processes for modifying the germ line genetic identity of human beings; use of human embryos for industrial or commercial purposes; and processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes55. In Japan, animals became patentable subject matter after 1988 when the 'Harvard Mouse' patent was issued, by USPTO. By the end of 1998, nineteen animal patents were issued by JPO, majority of them were the products of genetic engineering56. Indian Patents Act, 1970, amendment 2002, has excluded from patentability under Section 3(j), plants and animals as a 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 and Section 3(i) 'any process for medical, surgical, curative, prophylactic (diagnostic, therapeutic), or other treatment of human beings, or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products,}. This is in pursuance to the TRIPS Agreement Article 27.3 (a) and (b). Further TRIPS Article 27.2 mentions that States may exclude from patentability inventions, whose commercial exploitation within their territory needs to be prevented to

53 2 U.S.P.Q.2d (BNA) 1425 (Bd. Pat. App. & Interferences 1987) 54 European Patent Office, Implementing Regulations to the Convention on the Grant of European Patents, Oct 5, 1973, Rule 23c, http://www.european-patent- office.org/legal/epc/e/r23c.html#R23c , (December 31, 2005) 55 European' Patent Office, European Patent Convention, Part II, Chapter 1: Patentability, Art.53, Industrial Application http://www.european-patent- office.org/legal/epc/e/ar53.html , (December 25, 2005) 56 Japan Patent Office, “Bio Patent”, 46, http://www.apic.jiii.or.jp/p_f/text/text/6-03.pdf, (January 01, 2006)

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 17 protect ordre public or morality including to protect human, animal or plant life or health or to avoid serious prejudice to the environment' provided that such exclusion is not made merely because the exploitation is prohibited by law4. Thus, human beings or their treatment procedures are neither patentable in India nor anywhere else. Modified animals are patentable in USA, Japan, Korea, Hungary, South Africa and few other countries. Like-wise patent offices of USA, Japan and Australia grant patents on human body parts such as limbs, organs and. tissues. The making of human body parts is not viewed as invention since they exist in nature, but modified or isolated body parts are viewed as multicellular organisms and treated as such for patentability if they meet the statutory requirements57.

CASE STUDY

Here are some famous cases which deal with life form patents. Some of them are analyzed in the other chapters; but here it would be discussed in details.

DIAMOND, COMMISSIONER OF PATENTS AND TRADEMARKS v. CHAKRABARTY

This is the most influential decision regarding patents and living matter came in 1980, when the Court decided Diamond v. Chakrabarty.58 In this case, Chakrabarty applied for a general utility patent for his invention of a man-made, genetically engineered bacterium capable of breaking down crude oil, a property possessed by no naturally occurring bacteria. The Patent Office Board of Appeals affirmed a patent examiner’s rejection of the patent application on the ground that living things were not patentable subject matter under the Patent Act of 1952.59 The Court of Customs and Appeals reversed, and the U.S. Supreme Court granted certiorari.60 The Court ruled that a live, human-made micro-organism is patentable subject matter under section 101 of the Patent Act.61 Section 101 of the Patent Act provides for the issuance of a patent to anyone who invents or discovers any new and useful manufacture or composition of matter.62 Thus, the issue for the Court was whether a micro-organism constituted a “manufacture” or “composition of matter” within the meaning of the statute. The Court first examined the text of the statute. The Court gave

57 K. V. Swaminathan, Patenting in Biotechnology, In Proc. Roving Seminar on IPR in Biotechnology, CIMAP, Lucknow, 2002

58 Diamond v. Chakrabarty, 447 U.S. 303 (1980). 59 Prior to Chakrabarty, Patent Board decisions represented a general policy that living matter was not within the subject matter of the Patent Act of 1952. See In re Mereat, 519 F.2d 1390 (1975); In re Bergy, 596 F.2d 952 (1979). 60 Chakrabarty, 447 U.S. at 303-305. 61 Id. at 307-18 62 35 U.S.C. § 101 (2000).

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 18 “manufacture” and “composition of matter” their common ordinary meanings,63 because they were not otherwise defined within the statute itself. Given these expansive terms, the Court found that Congress plainly contemplated that the patent laws would be given wide scope.64 Additionally, the Court examined the legislative history behind the Act and found it too supported a broad construction of the Act.65 When the Patent Act was amended in 1952, Congress replaced the word “art” with “process.” “Process” gave a more expansive meaning.66 The Court found the Committee Reports accompanying the 1952 Act to reveal that Congress intended the statutory subject matter to “include anything under the sun that is made by man.”67 Thus, the Court found living matter patentable subject matter under the general Patent Act, so long as the “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.”68 The Court distinguished the invention in Chakrabarty from that in Funk Brothers, finding the patentee in Funk Brothers merely discovered handiwork of nature, but the patentee’s discovery in Chakrabarty was “not nature’s handiwork, but his own.”69 He produced a new bacterium possessing characteristics unfound in nature. Diamond, the Commissioner of Patents and Trademarks, urged the Court to find that the Patent Act did not include living things. He argued that the enactment of the Plant Patent Act of 1930 (PPA), which afforded patent protection to certain asexually reproduced plants, and the 1970 Plant Variety Protection Act (PVPA), which authorized protection for certain sexually reproduced plants but excluded bacteria from its protection, evidenced Congress’ intent that living matter was not within the general Patent Act. Diamond believed if Congress intended living matter to be patentable under the general Patent Act, then neither the PPA nor the PVPA would have been necessary.70 The Court disagreed. The Court stated that the PPA was enacted for two primary reasons. First, prior to 1930 there was a belief that plants, even those biologically created by man, were products of nature. 71 Also, prior to 1930, “plants were thought not amenable to the ‘written description’ requirement of the patent law.” 72 Congress addressed these concerns when it enacted the PPA, allowing patents for certain asexually reproduced plants with a relaxed description requirement.73 Similarly, the Court found the enactment of the PVPA did not evidence Congress’ intent that living matter was excluded from protection by the general patent law. The PVPA was enacted in 1970 when it

63 The Court found “manufacture” to mean “the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery. Chakrabarty, 447 U.S. at 308. The Court found “composition of matter” to mean “all compositions of two or more substances and . . . all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids.” Id. 64 Id. at 308. 65 Id. at 308-310. 66 Id. 67 Id. at 309. S. Rep. No. 82-1979 (1952); H.R. Rep. No. 82-1923 (1952). 68 Chakrabarty, 447 U.S. at 309-310 (quoting from Hartranft v. Wiegmann, 121 U.S. 609, 615 (1887)). 69 Chakrabarty, 447 U.S. at 310. 70 Id. at 310-311. 71 Id. at 311-312. The Court cited Ex parte Latimer, 1889 Dec.Com.Pat. 123, which set forth the general belief that plants were natural products not subject to patent protection. 72 Chakrabarty, 447 U.S. at 312. See 35 U.S.C. § 112 (2000) (Patent Act of 1952 written description requirements). 73 Chakrabarty, 447 U.S. at 312. See 35 U.S.C. § 162 (2000) (PPA written description requirements require a “description … as complete as is reasonably possible”).

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 19 became evident to Congress that true-to-type sexual reproduction was possible. Thus in enacting the PVPA, Congress extended plant patent protection beyond the PPA’s requirement of asexual reproduction, to sexually reproduced plants. Nothing in the history of the PVPA suggested it was enacted because the general Patent Act did not include living things.74 Finally in Chakrabarty, the Court found that Congress’ failure expressly to authorize protection for living matter under the Patent Act was not dispositive. Congress defined patentable subject matter in section 101 of the Act, and the Court took the text of the Act, along with the legislative history to determine that Congress unambiguously drafted the subject matter provision to be broad. 75 The wide scope fulfills “the constitutional and statutory goal of promoting ‘the Progress of Science and the useful Arts’… for the social and economic benefits envisioned by Jefferson. Broad general language is not necessarily ambiguous when congressional objectives require broad terms.”76 The Court found Congress used such broad language because many inventions, such as the one in Chakrabarty, are often unforeseeable. Congress created the subject matter provision with this in mind.77 A narrow interpretation of “matter” and “composition of matter” within section 101 would frustrate the purpose of the Act, because an invention clearly envisioned to be within the subject matter of the Act could not meet the standards of novelty and non-obviousness. “A rule that unanticipated inventions are without protection would conflict with the core concept of the patent law that anticipation undermines patentability.”78

HARVARD ONCO-MOUSE

This is a transgenic mouse which has a particular susceptibility to developing cancer. Such mouse is claimed to be particularly valuable in researching cures for cancer in human beings. The University of Harvard received US patent 4736866 for the invention claimed as ‘a transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated onco gene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage.’ A mouse produced in this way was described as a preferred embodiment of the invention. The patent document explained the benefits of such animals as useful in testing potential carcinogens, thus minimizing one source of criticism of current methods, that their validity is questionable because the amounts of the tested material used is greatly in excess of amounts to which humans are likely to be exposed. Equivalent patent applications in the European Patent Office and in Canada were initially rejected by patent examiners. In the EPO, the case revolved around the terms of the European Patent Convention, Article 53, which provided that European patents shall not be granted in respect of: inventions the publication or exploitation of which would be contrary to ordre public or morality …. [and] plant or animal varieties or essentially biological processes for the production of plants or animals …

74 Chakrabarty, 447 U.S. at 313. 75 Id. at 315. 76 Id. 77 Id. at 316. 78 Id.

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 20 The claims of the EPO patent application included: 1. A method of producing a transgenic non-human mammalian animal having an increased probability of developing neoplasms, said method comprising introducing an activated oncogene sequence into a non-human mammalian animal at a stage no later than the 8-cell stage. 17. A transgenic non-human mammalian animal whose germ cells and somatic cells contain an activated oncogene sequence introduced into the said animal, or an ancestor of said animal, at a stage no later than the 8-cell stage 18. An animal as claimed in Claim 17 which is a rodent. These claims were rejected by the EPO Examining Division, on the grounds that they claimed animals, which were not patentable under the EPC. Claims 17 and 18 were also rejected because they included further generations or descendants of the animal, which would be produced by biological processes – thus falling within the prohibition on patents on essentially biological processes. As to whether the claimed invention was contrary to morality, the office observed that patent law was not the right legislative tool for resolving the questions of the morality of using animals for testing in this way. In other words, if animal testing using transgenic mice raised ethical issues, these were better addressed by direct legislation rather than indirectly through patent law. The issue was then considered at the higher review level, by the EPO Technical Board of Appeal, which overturned the decision on these claims. It concluded that the claims were directed to non- human mammals and rodents, and not an animal variety as such (which was what the EPC excluded) – in other words, the claim was at a different taxonomic level than an animal variety. It also concluded that the animal was the product of a biological process, not a biological process as such (which was what the EPC excluded). But the Board said that it was correct for the Examining Division to consider the morality test, and remitted the case for reconsideration. The Examining Division considered three different issues that needed to be balanced: the interest of mankind in providing remedies for dangerous diseases; the interest in protecting the environment against uncontrolled dissemination of unwanted genes; and the interest in avoiding cruelty to animals.

It concluded that in this case, the benefits to humanity outweighed the disadvantages: cancer is a frequent cause of death; the invention meant that fewer animals would be needed for testing, thus lowering the overall amount of animal suffering; animal testing is indispensable in cancer research; and the invention does not envisage release into the environment, so the uncontrolled spread of the gene was unlikely. To demonstrate how these issues may be weighed, this case can be contrasted with a similar case concerning a patent application filed by Upjohn for a transgenic hairless mouse that was genetically engineered and bred in order to test restorative products to cure human baldness and wool production techniques. In this instance, the EPO assessed that the advantages of this invention were not so great as to outweigh the ethical disadvantages, and did not allow the patent to be granted.

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 21 FUNK BROTHERS SEED COMPANY V. KALO INOCULANT COMPANY

Early decisions of the Court regarding the patentability of living matter involved discussion of a foundational premise: Discoveries in nature are not patentable, only inventions. In Funk Brothers Seed Company v. Kalo Inoculant Company,79 the Court focused on the theory that the discovery of a previously unknown phenomenon in nature was not a proper subject matter for a patent. In Funk Brothers, Kalo Inoculant Company (“Kalo”) held a patent on a product that contained a mixed variety of different species of Rhizobia bacteria, which was capable of inoculating seeds of leguminous plants that belonged to several different cross-inoculation groups.80 Kalo brought a patent infringement suit against Funk Brothers Seed Company (“Funk Brothers”), wherein Funk Brothers filed a counterclaim asking for a declaratory judgment that the patent was invalid.81 The Court had to determine whether the mixed bacteria product was patentable. The Court ruled the product a handiwork of nature and therefore not patentable.82 The court stated that Bond, who created the bacteria mixture, did not create the characteristics in the bacteria; instead, what he did was discover the strains and discover that they could be combined into one particularly useful product. 83 The Court said the qualities of the bacteria strains were the work of nature, and combining the species produced no new bacteria or change in the bacteria. Each species had the same effect as before they were mixed. To be patentable, a product must satisfy the requirement of invention.84 “For patents cannot issue for the discovery of the phenomena of nature. The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.”85

J.E.M. AG SUPPLY, INC. V. PIONEER HI-BRED INTERNATIONAL, INC. The decision in Chakrabarty led to the United States Patent and Trademark Office’s (PTO) issuance of patents for living things pursuant to section 101 of the Patent Act, including hundreds of patents for plants, plant parts and seeds.86 However, it was more than twenty years after the Chakrabarty decision that the U.S. Supreme Court issued a clear-cut decision that plants were in fact

79 Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948). 80 Id. at 127-30. Rhizobium infects the roots of leguminous plants, causing them to form nodules so they are able to take nitrogen from the air and fix it in the plant for conversion to organic nitrogenous compounds. Rhizobium includes at least six different species, and not one species will infect the roots of all leguminous plants, but each species will infect a certain group of leguminous plants. The method of packaging Rhizobium bacteria so it may be used in the inoculation of leguminous plant seeds was well known. However, Kalo discovered that there are strains of each species of root-nodule bacteria which can be used in mixed cultures. Thus, he provided a product capable of inoculating seeds of several different plants. Prior to the invention, farmers would have to buy separate strains of Rhizobium for each crop. 81 Id. at 127. 82 Id. at 130-31. 83 Id. at 130. 84 Id. at 131. 85 Id. at 130. 86 See J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l., Inc., 534 U.S. 124, 127 (2001). See also In re Hibberd, 227 USPQ 443, 444 (1985) (Board of Patent Appeals and Interferences held that plants were within the understood meaning of “manufacture” or “composition of matter” and therefore were within the subject matter of section 101).

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 22 patentable subject matter under the Patent Act, despite their coverage under the plant-specific Acts, the PPA and PVPA. In J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc.,87 Pioneer Hi-Bred International, Inc. (“Pioneer”) held utility patents issued under the general patent law to protect its inbred and hybrid corn seed products.88 Pioneer filed a patent infringement suit against J.E.M. Ag Supply, Inc. (“J.E.M.”). J.E.M. filed a counterclaim alleging the patents were invalid because plants were not patentable subject matter within section 101 of the Patent Act. J.E.M. argued that the PPA and PVPA were the exclusive statutory means for protecting plant life. J.E.M. conceded that some living matter was patentable under the Patent Act pursuant to Chakrabarty, but sought to differentiate this case by urging that protection under the Patent Act extended only to living matter not protected under another Act, such as micro- organisms.89 The PPA and PVPA were specifically enacted for plants. J.E.M. therefore maintained the patentable subject matter of each of these Acts (plant life) was carved out of the general Patent Act.90 The U.S. Supreme Court held that plants fall within the subject matter of the Patent Act, and neither the PPA nor the PVPA limits this coverage. 91 In J.E.M., the Court first recognized its decision in Chakrabarty, where it found the language of section 101 to be extremely broad. The Court noted that Chakrabarty held a man-made micro-organism patentable under section 101, because living matter fell within the broad terms of “matter” or “composition of matter.”92 The Court also noted that its decision rested on its finding that the relevant distinction for patentability was between products of nature and man- made inventions, not between living and non-living things.93 In J.E.M., the Court also acknowledged early in its decision the requirements for a utility patent: novelty, utility and non-obviousness, as well as the written description requirement.94 Thus, for a plant breeder to meet the stringent requirements of the general Patent Act, the breeder must show the plant is new, useful and non-obvious. In addition, the breeder must meet the written description requirements and deposit seed.95 Finally, the Court found the two plant-specific statutes did not foreclose utility patent coverage for plants.96 The PPA of 1930 provides protection for asexually reproduced plants. However, nothing within the statute or its legislative history indicates it was intended as the exclusive protection for asexually

87 J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l., Inc., 534 U.S. 124 (2001). 88 The plant life at issue in J.E.M. was not created through agricultural biotechnology (i.e. crossing genes in a lab), but through traditional cross-breeding. 89 In Chakrabarty, Diamond urged the Court to decide that living matter did not fall within the Patent Act because if it did, Diamond argued, Congress would not have enacted the Plant Patent Act or the Plant Variety Protection Act. The Court did not agree and found living matter patentable under the Act. In J.E.M., J.E.M. accepts that living matter falls within the Patent Act (pursuant to the decision in Chakrabarty), but argues that the Chakrabarty decision encompassed only living matter that did not fall under another act, such as the bacteria strain mixture at issue in Chakrabarty. There is no law specifically targeted to the patentability of micro-organisms, but because there are Acts specifically targeted to the patentability of plants and plant life (the PPA and PVPA), J.E.M. believed plant life should not fall within the subject matter of the Patent Act. The Court did not agree. J.E.M. at 132. 90 J.E.M., 534 U.S. 124 (2001). 91 Id. at 145. 92 Id. at 130. 93 Id., citing Chakrabarty at 313. 94 J.E.M. at 131. See 35 U.S.C. §§ 101-103 (2000) (novelty, utility and non-obvious requirements) and 112 (written description requirement). 95 J.E.M. at 131. See CFR §§ 1.801-1.809 (2001) (Section 1.802(a) provides: “Where an invention is, or relies on, a biological material, the disclosure may include reference to a deposit of such biological material”). 96 J.E.M., 542 U.S. at 132.

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 23 reproduced plants.97 As addressed in Chakrabarty, the PPA was enacted to provide patent protection for plants because prior to 1930, plants, even those made by man, were considered products of nature, and thus not patentable.98 Also, plants were thought not amenable to the written description requirement of the Patent Act. The Court found that this did not mean that prior to 1930 plants could not have fallen within the subject matter of section 101.99 “Plants have always had the potential to fall within the general subject matter of section 101, which is a dynamic provision designed to encompass new and unforeseen inventions.”100 After Chakrabarty, we know that living things may be patentable subject matter. Also, due to biological advances we now know that plants may satisfy the stringent description requirement of the Patent Act. “Denying patent protection under section 101 simply because such coverage was thought technologically infeasible in 1930…would be inconsistent with the forward-looking perspective of the utility patent statute.”101 Thus, the Court refused to deny general utility patent protection to plants because it was unforeseen in 1930 that plants could receive such protection.102 Similarly, the PVPA does not preclude plant coverage under the general Patent Act. The PVPA, passed in 1970, offers patent-like protection to sexually reproduced plants.103 However, the Court ruled that the PVPA is not the exclusive statutory means of protecting sexually reproduced plants. 104 Neither the text of the PVPA, nor its legislative history, supports a finding that Congress intended the PVPA to provide exclusive statutory protection.105 Also, the Court found the differences between the PVPA and the Patent Act reconcilable “because the requirements for obtaining a utility patent under section 101 are more stringent than those for obtaining a PVP certificate, and the protections afforded by a utility patent are greater than those afforded by a PVP certificate.”106 Because the Court found the statutes reconcilable, it concluded that the PVPA, which was passed later than the Patent Act, could not alter the Patent Act

97 Id. at 132-133. 98 See Ex parte Latimer, 1889 Dec. Com. Pat. 123 (finding plants are products of nature and therefore not subject to patent protection). 99 Id. at 134. 100 Id. at 135. 101 Id. 102 Id. 103 See 7 U.S.C. § 2402(a) (2000), “The breeder of any sexually reproduced or tuber propagated plant variety (other than fungi or bacteria) who has so reproduced the variety . . . .” 104 J.E.M. at 138. 105 Id. at 138. and 140-141. 106 Id. at 142. The Patent Act provides broader protection than the PVPA. First, the PVPA has three exemptions to patent infringement: the Research Exemption, Public Interest Exemption, and Farmer’s Exemption, see 7 U.S.C. §§ 2544, 2404 and 2543 (2000), respectively. Also, utility patent protection exceeds a PVPA certificate because a breeder can use a plant that is protected by a PVP certificate to “develop” a new inbred line while he cannot use a plant patented under § 101 for such purpose, sSee 7 U.S.C. § 2541(a)(4) (2000), infringement includes “use of the variety in producing (as distinguished from developing) a hybrid or different variety therefrom.” Also, it is more difficult to obtain a utility patent because the Patent Act’s requirements are more stringent than the PVPA. Under the Patent Act, the plant must be new, useful and nonobvious, see 35 U.S.C. §§ 101-103 (2000). Under the PVPA, the plant variety must be new, distinct, uniform and stable, see 7 U.S.C. § 2402(a) (2000). Thus, there is no requirement for usefulness or nonobviousness for a PVPA patent certificate. Also, to obtain a utility patent a breeder must describe the plant with sufficient specificity to enable others to make and use the invention after the patent term expires, see 35 U.S.C. § 112 (2000). The PVPA does not require as strict of a description as the Patent Act. The PVPA requires a “description of the variety setting forth its distinctiveness, uniformity and stability and a description of the genealogy and breeding procedure, when known,” see 7 U.S.C. § 2422(2) (2000).

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 24 subject matter by implication.107 The Court found the two statutes able to mutually coexist, despite their partial overlap.108

CONCLUSION In the present era, patenting of life forms have become important aspect areas. Biotechnological inventions were earlier interpreted in different ways by different patent offices of the world but discussions and unification of ideas have emerged in some cases while differences on stem cell research, human cloning and some other aspects still persist. In the near future, these will also be solved and common grounds will be laid in the context of present TRIPS regulations. The Indian Patents Act sets forth the requirements for patents, specifically detailing patent rights and terms, and describes that subject matter which cannot be patented. Although the Act was not always TRIPS compliant, the Dispute Settlement Body of the World Trade Organization declared in May 1999 that India is now in full compliance with its “international obligations” to the WTO, including TRIPS. Given the existing technological gap between developed and developing countries and the capital-intensive nature of product development, the best way forward for developing countries seems to be collaboration and not confrontation. Multilateral developmental institutions should also be encouraged to help developing countries make the transition to higher level of capabilities in biotechnology through both financial and technical assistance for R&D projects, including obtaining and defending IPRs at home and abroad.

BIBLIOGRAPHY Articles/Presentations  P.K Ghosh & T.V Ramanaiah, “IPR Issues in Biotechnology in the context of Developing Countries and India”, Vol 6, Journal of Intellectual Property Rights, January 2001  Shilpi Jha , “Patenting Of Life Forms”, Vol 26 The Patents and trade marks Cases, 2003  Srividhya Raghavan, “The 1999 WTO Review Of Life Patenting Under TRIPS”; http://www.nalsarpro.org/PL/articles.htm (January 04, 2006)  V. K. Unni, “ Legal Issues of Biotechnology Patents”, http://www.nalsarpro.org/PL/Presentations/38.Biotech%20Patents_V.K.Unni.pdf, (January 04, 2006)

Books

107 J.E.M. at 141-142. See also (court cites) Morton v. Mancari, 417 U.S. 535, 550 (1974) (“. . . [T]he only permissible justification for a repeal by implication is when the earlier and later statutes are irreconcilable”). 108 J.E.M. at 143-144.

Prepared by: Neelakamal Mohapatra and Rupalekha Mohapatra 25  Philip W. Grubb, Patent for Chemicals, Pharmaceuticals and Biotechnology- fundamentals of Global Law, Practice and Strategy, Oxford University Press, Fourth Edition (2004)  Japan Patent Office, “Bio Patent”, 46, http://www.apic.jiii.or.jp/p_f/text/text/6-03.pdf, (January 01, 2006)  Li Westurlund, Biotech Patents,Kluwer Law International,(The Hague),2000  Jayashree Watal, Intellectual Property Rights In the WTO and Developing Countries, Oxford University Press (New Delhi), 2001  Paul Goldstein, Copyrights, Patents, Trademarks And Related States Doctrines, University  Casebook Series,1999,Terell On Law of Patents,Sweet & Maxwell,(London),2000  Report of the FAO Panel of Eminent on Ethics in Food and Agriculture report, 2000,at p.15  The Patents Act, 1970 as amended by The Patents (Amendment) Ordinance, 2004 (Ord. 7 of 2004) along with The Patent Rules, 2003 as amended by The Patents (Amendment) Rules, 2005 (Effective 1-1-2005), Universal Law Publishing Co. Pvt. Ltd.; 2005  G. S. Srividhya, Introduction to Intellectual Property Rights & Patents, Study Material for P.G. Diploma in Patent Law, Module I, Editor, V.C. Vivekanandan, Nalsar Pro, 2005

Websites  http://jekyll.comm.sissa.it/articoli/art04_03_eng.htm  http://www.okjolt.org/webdox/wdoc/Jeter1.doc  http://www.ecap- project.org/fileadmin/ecapII/pdf/en/activities/national/thailand/20050719_20/rouse_mattei_v2. pdf  http://members.ozemail.com.au/~pxc/iplocus/patents.html  www.organicconsumers.org/patent/lifeform112003.cfm  http://www.american.edu/TED/enola-bean.htm  http://cbac-cccb.ic.gc.ca/epic/internet/incbac-cccb.nsf/vwapj/IPPHL_IntComparison_e.pdf/ $FILE/IPPHL_IntComparison_e.pdf  http://www.thehumanfuture.org/topics/genepatents/policy.html  http://www.mrc.org.mu/Themes/BiotechnologyReport.pdf  http://www.intelliwareint.com/gls-cdrom/GLSPapers/Azariah.htm  http://www.apecipeg.org/library/documents/Module02.pdf

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