1999 Genetics, Law and Society Conference, Saint Paul, Minnesota

Should the American Legal System Change the Way it Treats Genetically Modified and Artificially Engineered Products?
by S Thambisetty, DPhil. Student, Faculty of Law, Exeter College, University of Oxford 

Developments in intellectual property and its uneasy bedfellow, biotechnology, have spawned a great deal of entertaining literature on westlaw and lexis. Amusing titles abound. "Tip of the biotechnology iceberg", "Playing god", "Vampire project", "Slippery slope", "building mousetraps", are some that paint dire scenarios of berserk scientists, hungry populations, actualising mythical creatures, exploited indigenous people, unheard of drug prices and messianic biotechnology companies. At the core of these real and imagined concerns is a patent and regulatory system that faces contradictory mandates.

In the patent system itself, Biotechnology has caused certain breaches in conventional requirements. The discovery-invention controversy, the breadth of claims, necessity for biological sample deposit, and moral issues are some remarkable developments. It has been pointed out in "difficult cases" that the patent itself does not give the holder the right to exploit the invention. What he gets is the right to prevent others from doing so for a limited period. It is then left to other regulatory procedures to say, control drug prices, carry out environmental impact assessments, ensure compliance with ethical research protocols, further trade interests etc. The grant or denial of a patent and subsequent regulatory procedures are powerful tools of steering the entire biotech industry (worth an estimated $10 billion in the USA) in the direction of chosen goals and values.

A characteristic that marks the patent system as distinct is the belief that it is hermetically sealed, and to be isolated from all matters political, cultural and ethical. This belief perpetuates the further fallacy that the patent system is neutral and the technical invention uncontroversial. At least this seemed to be the situation until Mr Monster Biotechnology tripped along and the positivist language of the patent system was subjected to moral scrutiny.

The most important Intellectual Property players significant to the legal system in America are the Patent and Trademark Office (PTO), an administrative agency with a restricted statutory mandate, the courts, and the policy scouts, consisting of interest groups and individual legislators. Recent European concerns bring home the lack of a comparative dialogue as regards moral issues within the American legal system.

"Hush, and Hope That No One Will Notice Us"

Once again, the Harvard mouse takes centre stage in Europe as well , in that it is the first time the European Patent Office (EPO) had occasion to juridically discuss Art 53 (a) of The EPC1. In taking ethical concerns into account on a reassessment it was decided by the examining division that the Onco - mouse was patentable, partly on the basis that granting the patent would not violate the ethical exclusion in Art 53 (a).

The EPO's approach resolved the ethical questions by identifying and balancing contradictory interests as a matter of procedure. The case is more remarkable for the sort of debate and measuring up of values that took place. According to one of the lawyers for the patent applicants, "hundreds of moral objections" to granting the Harvard mouse patent were received by the EPO's examination division.2 Under Art 99 (1) of the EPC, notices of opposition may be filed till nine months after a patent is granted. In America, in interpreting the law, neither patent examiners nor the courts are asked to weigh the benefits. Indeed the US PTO's policy decisions, coupled with judicial holdings, suggest that the United States has adopted a pro-patent practice far in excess of Canadian and European developments.

The European concern with the larger picture has resulted in the recent Biotechnology Directive3 which, since 1988 had a troubled gestation. The driving force behind the felt need for such a Directive was the apprehension that without a harmonising Directive there would be no internal market in patented biotechnological products in Europe, no free movement of such goods, and that European research would be discouraged. These concerns do not expiate the ethically problematic aspects of the Directive. The biotechnology industry has broadly welcomed the new law, which it is thought will allow the European industry to recover lost ground on its American and Japanese competitors. On the other hand, representatives of the environmental lobby have been vocal in denouncing the basic concepts of patents on life as "anti research", "anti science" and "anti democratic".

Subsequent case law in various European countries will have to deal with the provisions of the Directive, and Art 27.2 of the TRIPS agreement, in addition to the EPC and national legislation of contracting states. This makes the moral criteria for European patent applications far more ambiguous. Another matter of concern will be the extent to which the political histories of these provisions indicate the moral content of each.4

Efforts to achieve a unified regulatory framework at the European community level have come into conflict with sharply differing European national attitudes. The result on occasion has been counter productive. For example, Germany has severely restricted the manufacture of genetically engineered products. As a result, genetically engineered human insulin with a 15 year history of safety and effectiveness in the treatment of diabetes is not manufactured in Germany at all. To cite another example, opposition to the Directive has prompted the Dutch government to seek an annulment.5 The Directive legitimises the patenting of biological material which because of the Netherlands' particular interpretation of the EPC, had not previously been possible in national law. What has emerged in Europe is a broad spectrum of moral attitudes and concerns.

Contrast this with the statement of the US Commissioner of patents way back in 1987, that the patent and trademark office now considers non naturally occurring, non human multicellular living organisms, including animals to be patentable subject matter.6 This startling readiness to regard patenting of biological material, genetically modified and artificially engineered products as uncontroversial needs re-examination.

Patent lawyers who opposed the temporary moratorium in the United States in 1987 argued that the PTO should be "morally neutral" and should not function as "... a forum for assessing the consequences of introducing new technology"7. Moral neutrality camouflages vested interests and presents as settled that which is in fact a matter of profound dispute.

Historically, treating inventions as closed and stable entities made it easier for the patent to be trusted, relied upon and used. This stability is at stake with the introduction of ethics into the patent system. The pressing concern is therefore of balancing efficiency with moral concerns and public interest.

Recognition of the difficulty of negotiating world-wide patent protection through unilateral, bilateral and multilateral agreements has led to the push toward globalisation of patent law. This, as seen in the formulation of TRIPS, highlights the increasing political, cultural and economic nature of Intellectual Property rights Thus to retain a non political view of the patent system domestically is untenable, especially when the expense of research and distribution of genetic resources make the multinational biotech firm commonplace. Further, it is too simplistic to equate commercial and industrial innovation with public interest as the patent system suggests. The moral concerns spread across different cultures and legal jurisdictions are compounded by fears of uncontrolled or harmful research and commercial exploitation. In this situation a monolithic approach to the values underlying the patent system is on shaky ground.

What would best address the ethics versus efficiency argument is to follow a common law method of close, contextualised and particular reasoning based on trial and error. The law in this area must be allowed to develop gradually, and the courts should flush out the issues for a few years. Such an approach will allow ethical issues to be properly identified and possibly for moral issues to evolve to second, third generation concerns. Abstract rules and doctrines made by the judiciary or legislation before its time, will otherwise be made in a vacuum of reasoned debate.

Point Out the Tip and Patent the Iceberg?

Intellectual property regimes coupled with trade regulations have serious implications for third world economies. The 1985 decision that plants constitute patentable subject matter in the United States magnifies this.8 Agricultural research has developed much faster on plants than on animals. And there is insufficient reason to expect that if species patents on plants are upheld, the practice of granting such patents will be restricted to them. It seems from developments so far that the patent blitzkrieg is inching its way to higher life forms

Protection and enforcement strategies for plant based technology are implemented through four different forms of intellectual property; utility patents, plant patents, plant variety protection certificates and trade secrets. Since patenting provides a broader range of protection and costs less, this has potential to be the preferred means of protecting plant based inventions by private companies in the US.9 New utility patents form more aggressive property rights than ever existed in biological material before.

Utility patents can establish property rights in broad classes of organisms in radically different species as long as the organisms have the same traits and functional properties. The Harvard oncomouse patent is actually a onco mammal patent. Harvard thus owns any mammal with any recombinant cancer causing gene, (and there are about forty of them known) inserted into any mammal or its ancestors at an embryonic stage. This allows biotechnicians to patent organisms they have never actually produced.

Broadly worded patent rights (as in the case of cotton or soybean), or the taking out of a large number of patents effectively suppress competition through the threat of infringement suits. On a global scale this allows patent holders to exert control on the production of a variety of agricultural commodities leading to unprecedented competitive advantage. The enormity of this possibility has led to "biocolonial" concerns in the developing world.

Utility patents also prohibit farmers from the common practice of saving and using seeds from previous crops or from breeding animals, as well as restricting research exemptions. This could create a barrier to further innovation. Most nations have in place a research exemption analogous to the fair use doctrine in copyright law.

The price of patented, genetically engineered seeds places them beyond the reach of many developing country farmers. This effect would not only reduce the competitiveness of developing countries exports of agricultural commodities, but also reduce the economic viability of production for domestic consumption. The question is, should the American Legal system care about what happens to domestic food production in the developing world?

What has led to the development of a robust Intellectual property system in the United states is a monolithic understanding of property, use of trade related threats, and the running over of ethical concerns by market driven values. Biopatents in the American Legal System make a interesting foil for pure legal reasoning. But this, though a fun way to fill up law reviews does nothing to mitigate the sense of injustice that persists in half the worlds nations in the method and manner of the patent system, or the acute ethical concerns that seems to dwindle to a whisper where a deafening roar is called for.

A reimagination of the way genetically modified and artificially engineered products are treated is essential if the American legal system aims to ground itself in sustainable values.

Notes

1. Art 53 (a) of the European Patent Convention provides that patents will not be granted for inventions, the publication or exploitation of which would be contrary to ordre public or morality, provided that the exploitation will not be deemed so merely because it is prohibited by law or regulation in some or all of the contracting states. ^

2. R Bizley, “Patenting Animals in Europe”, Bio/Technology 9 (July 1991), 620. ^

3. On June 16th 1988, Directive 98/44 on the Legal Protection of Biotechnological inventions was passed by the Council of Ministers, having been previously accepted by the European Parliament. ^

4. The Agreement on Trade related Aspects of Intellectual Property Rights (TRIPS) was introduced under the General Agreement of Tariffs and Trade (GATT) in order to set an international minimum standard for the protection of intellectual property. one of the goals of the United States in the Uruguay round was to seek broad patent protection for all patentable subject matter, including plants and living organisms. The United States Biotechnology industry sought two additional concessions during negotiations of the TRIPS agreement. First, to secure a minimum term of patent protection of twenty years from the date of filing, second an expansion of what constitutes patentable subject matter. The developing countries sought, however, to shorten the term of patent protection, and to narrow the definition of patentable subject matter by excluding plants and living organisms. While the first concession was granted, the second aspect continues to be extremely controversial. ^

5. Under Art 173 of the EPC. ^

6. Office of Technology Assessment, US Congress pub no: OTA-BA-370, New Developments in Biotechnology; Patenting Life, A special Report, 93 (1989). ^

7. Clash Looming, NYT, July 23, 1987. ^

8. Ex p Hibberd 227 U.S.P.Q 2d 443 (PTO Bd. App. & Inter. 1985.) ^

9. Buttel and Belsky, “Biotechnology, plant breeding, and intellectual property : Social and Ethical dimensions”, Science, Technology and Human Values 12 (1987), 35. ^

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