European Directive on the Legal Protection of Biotechnological Inventions: History, Implementation, and Lessons for Canada

The Canadian Biotechnology Advisory Committee Project Steering Committee on Intellectual Property and the Patenting of Higher Life Forms

Table of Contents

1. Executive Summary
2. Introduction
3. Part I: The Biotech Directive
4. Part II: History of the Biotech Directive
5. Part III: Aftermath and Implementation
6. Part IV: Analysis and What Canada Can Learn
7. Conclusion

1. Executive Summary

   Following a decade of debate and controversy, the Council of the European Union and the European Parliament finally adopted the Directive on the Legal Protection of Biotechnological Inventions (the Biotech Directive) on July 6, 1998. The drafters of the Biotech Directive aimed to establish a unified European approach to biotechnology patents.

   The Biotech Directive adds a level of harmonisation with respect to European patents. It establishes a detailed set of rules concerning the patentability of biological materials within Member States. The Biotech Directive builds on the general principle of patent law that only inventions that are new, non-obvious, and have an industrial application can be patented. It provides that this same set of rules applies to biological materials. It attempts to clarify certain difficulties in determining the difference between patentable inventions and unpatentable discoveries. It does so by stating that biological material still qualifies as an invention even if the material is structurally identical to that found in nature so long as it is in a different form than exists in nature.

   The same rules that apply to the patenting of biological materials in general apply to patenting materials derived from the human body, but with further clarification. The Biotech Directive requires that the inventor of a human biological material disclose not only the invention itself, but also its industrial application. It sets out certain rules with respect to what constitutes industrial application in respect of human DNA sequences. It also states that the human body itself, at every stage of its development, cannot be patented.

   The Biotech Directive provides that plant and animal varieties are not themselves subject to patent protection but that invented plants and animals are patentable provided that claims are not restricted to a particular variety. It does not, however, define the meaning of “variety” in relation to animals (plant varieties are already defined under European law).

   The Biotech Directive builds on the public order and morality exception to patent law in Europe. In conformity with international trade agreements, it provides that patents will be withheld where the commercial exploitation of an invention would violate public order or morality. It also deems certain inventions to be violations of public order or morality. These involve cloning human beings, modifying human germ line identity, using human embryos for commercial purposes, and causing suffering to animals without substantial medical benefit to humans or animals.

   The Biotech Directive provides that patent protection flows down to biological material produced through propagation or multiplication of patented material or using a patented process of production. It similarly provides patent protection over material containing patented biological material (other than the human body) in a functional state. It balances this extension of patent rights to material produced by or incorporating a patented invention by permitting farmers to reproduce patented plants and animals under certain conditions and by making available compulsory licenses to both plant patent holders and those wishing to exploit plant variety rights.

   The Biotech Directive contains two review mechanisms to ensure that it conforms, in practice, with ethical considerations related to biotechnological innovations. These include regular reports by the Commission to the European Parliament and ongoing review of biotechnological research by a group of expert bioethicists.

   The European Commission introduced the first draft of the Biotech Directive in 1988 to establish uniform guidelines within Europe on the patenting of biotechnological innovations. At the time, the Commission felt that Europe needed to remain competitive with the United States in terms of biotechnological research and development.

   In April and October 1992, Parliament introduced a number of amendments to the draft Biotech Directive aimed at clarifying certain ethical issues arising out of biotechnological research. In response, the Commission proposed an amended draft of the Biotech Directive in December 1992.

   The European Parliament remained unsatisfied with the amended draft Biotech Directive and therefore proposed further amendments. The Council of the European Union accepted some, but not all, of these amendments in February 1994. Nevertheless, Parliament proposed further amendments. The Council did not accept all of these, leading to mandatory conciliation proceedings between the Council and the Parliament. The conciliation committee agreed upon a joint text in January 1995. Despite the success of the conciliation committee, Parliament rejected the Biotech Directive on March 1, 1995.

   The Commission drafted a new Biotech Directive in December 1995. It stated that the human body itself was unpatentable but that inventions made from the human body could be patented. Parliament approved a revised version of this draft Biotech Directive in May 1998. The Council of the European Union adopted Parliament’s revised version on June 16, 1998. Only The Netherlands voted against the Biotech Directive while Belgium and Italy abstained. The Biotech Directive was finally adopted on July 6, 1998 and published on July 30, 1998. It was due to be implemented by July 30, 2000. In October 1998, The Netherlands commenced a challenge against the Biotech Directive before the European Court of Justice. This challenge has yet to be heard.

   Most Member States have still to transpose the Biotech Directive into their national laws. Member States often fail, however, to implement directives by their implementation dates. Nevertheless, some Member States have delayed transposition of the Biotech Directive because of ethical concerns. The principal of these concerns is that patenting human DNA sequences will stifle health-related research.

   The Biotech Directive applies directly within a Member State whether or not it has been transposed into national law. This is so for three reasons. First, since the European Patent Office (EPO) has already implemented the Biotech Directive; it will issue patents in accordance with its provisions. Second, national courts in the Member States will apply the Biotech Directive in any case that comes before them challenging a patent issued by the EPO. Third, either the European Commission or an aggrieved person (either directly or through national courts) can ask the European Court of Justice to impose a penalty on a Member State that fails to transpose the Biotech Directive into national law.

   The Biotech Directive points to some important lessons for Canada. First, it illustrates the importance of a public debate over biotechnology and militates against an approach that relies on judge-made law to solve current concerns. Second, Canada’s solution to both ethical and commercial concerns over biotechnology must be flexible and transparent. Third, Canada needs to clearly define the role that industry plays in advancing biotechnology. Fourth, Canada ought to explore the possible use of a public order and morality clause, an exemption to permit farmers to re-use patented seeds, compulsory licensing to avoid conflicts between plant variety legislation and patent law, and a clarification of the experimental use exception in Canada.

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2. Introduction

   Following a decade of debate and controversy, the Council of the European Union and the European Parliament finally adopted the Directive on the Legal Protection of Biotechnological Inventions¹ (the Biotech Directive) on July 6, 1998. The Directive called for Member States² of the European Union to transpose the Biotech Directive into national legislation by no later than July 30, 2000. This date has come and gone with only a few of the Member States having met the deadline.

   The drafters of the Biotech Directive aimed at establishing a unified European approach to biotechnology patents. The final draft of the Biotech Directive consists of a compromise between the European Commission and the European Parliament. The compromise Biotech Directive essentially follows the United States’ lead in permitting broad patenting over human and other DNA sequences, cells, geneticallyengineered micro-organisms, and genetically-engineered plants and animals. Nevertheless, the Biotech Directive tempered this openness to patenting by incorporating exclusions for a narrow set of moral concerns. This was accomplished by the elucidation of non-patentable inventions due to moral concerns, by permitting farmers to reproduce breeding animals and propagating plant material, and by establishing a procedure whereby plant-variety owners can obtain compulsory licenses to platform technology. In addition, the Biotech Directive included non-binding language regarding the need for researchers to obtain the informed consent of their research subjects and to list the geographic origin of plant and animal material.

   The compromise draft of the Biotech Directive was approved by the Council of the European Union meeting of June 16, 1998 by all Member States except for The Netherlands, which voted against the Biotech Directive, and Belgium and Italy, which abstained. While many European directives are often not transposed into national legislation by their implementation dates due to procrastination,3 the Biotech Directive has attracted significant and high level criticism in some of the Member States. In particular, several countries have expressed concerns over the ethical implications of the Biotech Directive. For example, The Netherlands finds the requirement that patents be granted over plants and animals to be morally objectionable.⁴ It has commenced a challenge to the Biotech Directive before the European Court of Justice claiming that the Biotech Directive breaches fundamental human rights and violates Community and international law.⁵ The French, Belgians, Austrians, and Italians are concerned about the appropriation of the human genome by the private sector and fear negative effects that DNA sequence patents may have over health care.⁶

   In addition to these enunciated concerns, there may also be a broader, systemic reason for some of the problems that the Biotech Directive currently faces: the lack of a full public dialogue on the role of biotechnological innovation within European society. Europeans are more wary of biotechnology now than they were even a few years ago although they are generally supportive of medical and environmental uses of biotechnology.⁷ Strikingly, approximately 80% of Europeans feel uninformed about biotechnology.⁸

   While the Biotech Directive is now the law of Europe, its rocky history provides important lessons to Canadian policy-makers contemplating the incorporation of biotechnology into Canada’s patent system. In this report, the authors will examine these lessons, particularly the need to build public confidence in biotechnological innovation. First, however, the authors will discuss the Biotech Directive and how it came to be.

   Directives within the European Union

   The European Union uses several different legal instruments to create Community law. One of these instruments is the directive. A directive consists of a set of binding provisions that each Member State must transpose into national law. The way in which a Member State does so is up to it provided that it implements the directive’s provisions by the end of the implementation period. Through the directive process, Member States have the opportunity to select the type of legal instrument—legislation, regulation, decree, or judicial rulings—that best meets its internal needs. This is in accord with the Subsidiarity Principle of European Union law that provides that, to the extent possible, decisions ought to be made at the national rather than at the European level.

   Directives being binding on Member States, the European Commission or an aggrieved person can bring a Member State that fails to implement a directive by the implementation date before the European Court of Justice. If the Court finds against the Member State, the Court has the power to impose financial penalties on it. In addition to the option of proceeding to the European Court of Justice, many national courts will directly apply the provisions of a directive into domestic law if the legislating body has failed to do so by the implementation date.

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3. Part I: The Biotech Directive

   Background: Where the Biotech Directive Fits

   In Each country is responsible for its own particular patent system and rules concerning the grant, enforcement, and definition of patentable inventions within that country. Nevertheless, a series of international intellectual property and trade agreements establish binding international standards on these issues. In addition, many European countries—some of which are and some of which are not members of the European Union—have entered into the European Patent Convention.⁹

   The European Patent Convention established the European Patent Office (EPO) with the power to grant patents in each of the countries that participate in the Convention. These patents continue to be governed by national legislation with respect to both their enforcement and invalidation.

   Role and Structure of the Biotech Directive The Biotech Directive adds another level of harmonisation with respect to European patents. It establishes a detailed set of rules concerning the patentability of biological materials within Member States. The Biotech Directive also extends beyond the strict membership of the European Union. First, even though Norway, Iceland, and Liechtenstein are not members of the European Union, they are members of the European Free Trade Association and the European Economic Area. As members of this Area, they have to comply with certain measures adopted by the European Union. Depending on several factors, the Biotech Directive may be among these.¹⁰ Still other countries are affected by the Biotech Directive through their membership in the European Patent Convention. Although not a member of the European Union, the EPO has implemented the Biotech Directive within its implementing regulations.

   The Biotech Directive has two components: recitals and articles. The articles are directly binding on Member States. This means that should a Member State fail to implement an article of the Biotech Directive, the European Commission or a person could bring that State before the European Court of Justice for a remedy. Recitals provide a context in which both Member States and the courts can interpret the articles. Recitals also serve to set out moral obligations that are, nevertheless, unenforceable unless also contained in a binding article. Therefore, where a subject is dealt with in a recital but not in a corresponding article, the obligations contained in that recital are not enforceable against the Member States.

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   Patentability of Biological Material

   The Biotech Directive builds on the general principle of patent law that only inventions that are new, nonobvious, and have an industrial application can be patented. It provides that this same set of rules applies to biological materials.¹¹ European patent law also distinguishes between inventions and discoveries; only the former are entitled to patent protection. A discovery is something found as it exists in nature whereas an invention is something that would not exist in its present state but for human intervention. Drawing the line between invention and discovery is not always easy, especially in the field of biotechnology. The Biotech Directive attempts to clarify the difference between patentable invention and unpatentable discovery by stating that biological material still qualifies as an invention even if the material is structurally identical to that found in nature as long as it is in a different form than exists in nature.¹² Thus, the act of isolating biological material from its surroundings or producing it in an artificial way is sufficient to place the material so isolated or so produced in the realm of invention.

   The same rules that apply to the patenting of biological materials in general apply to patenting materials derived from the human body but with further clarification.¹³ The Biotech Directive requires that the inventor of a human biological material disclose not only the invention itself, but its industrial application.¹⁴ This again is a reiteration of basic patent law principles. The Biotech Directive takes a step further, however, in clarifying what kind of industrial applications count for obtaining a patent. While it does not do so directly through its articles, several recitals make clear that industrial application, in the context of DNA sequence patent applications, requires that the inventor disclose the function of the sequence.¹⁵ In the case of DNA sequences that the body uses to produce proteins, it is also necessary to disclose the identity and function or technical use of the protein produced by the expression of that sequence.¹⁶ The human body itself, at every stage of its development, cannot be patented.¹⁷

   Provisions Dealing with the Patentability of Human and Other Biological Materials

   Article 3

   1. For the purposes of this Directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.
   2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.

   Article 5

   1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.
   2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

   3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.*

      *In the French version of Article 5(3), the words “concrètement décrite” are used instead of “disclosed”

   The rules that apply to plants and animals are more difficult. The Biotech Directive provides that plant and animal varieties are not themselves subject to patent protection but that invented plants and animals are patentable provided that what is revealed by the invention is not confined to a particular plant or animal variety and no such variety is claimed.¹⁸ The definition of “variety” in relation to animals will need to be established (plant varieties are already defined). The Biotech Directive provides a second exclusion from patentability. It states that no one is entitled to a patent to a process for the production of plants and animals consisting entirely of natural phenomena such as cross fertilisation or selection.

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   Public Order and Morality

   Many countries around the world prohibit the granting of patents over inventions that would violate public order or morality. The European Patent Convention incorporates this exception which has been transposed into the national law of the signatories to the Convention.¹⁹ These exceptions are now subject to the language of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) under the World Trade Organisation.²⁰

   The Biotech Directive confirms the public order and morality exception for biotechnology patents. In conformity with TRIPs, it provides that patents will be withheld where the commercial exploitation of an invention would violate public order or morality.²¹ In addition, the Biotech Directive deems certain inventions to be violations of public order or morality.²² These inventions involve cloning human beings, modifying human germ line identity, using human embryos for commercial purposes, and causing suffering to animals without substantial medical benefit to humans or animals.

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   Patents Extending to Progeny

   Given that the Biotech Directive is aimed at granting patents over biological materials that naturally reproduce, the Biotech Directive seeks to balance the interests of the patent holders with those who use the patented inventions. It does so in three steps.

   The Biotech Directive provides that patent protection flows down to biological material produced through propagation or multiplication of patented material or using a patented process of production.²³ It similarly provides patent protection over material containing patented biological material (other than the human body) in a functional state.²⁴

   The Biotech Directive balances this extension of patent rights to material produced by or incorporating a patented invention by permitting farmers to reproduce patented plants and animals under certain conditions. First, where the patent holder permits the sale of patented biological material for the purpose of reproducing it, the farmer is permitted to do so without violation of the patent. Subsequent reproduction of the reproduced material does violate, however, the patent holder’s rights.²⁵ Second, the Biotech Directive recognises existing European regulation permitting farmers to keep the seeds of plants grown using certain listed plants, even if patented, and use those seeds on the farmer’s land.²⁶ In some cases farmers are required to pay a fee for the use of those seeds.²⁷ Third, the Biotech Directive extends this protection for farmers to cover breeding animals and animal reproductive material.²⁸

   The third step in balancing interests is the availability of compulsory licenses to both plant patent holders and those wishing to exploit plant variety rights. These licenses are available where a person is either prevented from acquiring or exploiting a plant variety right without violating an existing patent or is prevented from exploiting a patent without violating a plant variety right.²⁹ In either case, however, the person seeking a compulsory license must first have tried without success to obtain a license to the blocking technology.³⁰ In addition, the technology that the person hopes to exploit must be a significant advance (in commercial terms) over the blocking technology.³¹

   Public Order and Morality

   Article 6

   1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.
   2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:
      1. processes for cloning human beings;
      2. processes for modifying the germ line genetic identity of human being;
      3. uses of human embryos for industrial or commercial purposes;
      4. 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 processes.
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   Non-Binding Provisions

   The Biotech Directive addresses two ethical issues in a non-binding manner. Through two recitals, the Biotech Directive recognises that researchers ought to ensure that all human donors of biological materials provide their fully informed consent to the removal of those materials.³² Second, the Biotech Directive provides that when an inventor files a patent application over animal or plant biological material, the inventor discloses the geographic origin of that animal or plant in the patent application.³³

   Initial drafts of the Biotech Directive did not contain provisions requiring informed consent and attribution of origin. This led to considerable controversy. Nevertheless, the final draft of the Biotech Directive contained no binding obligation in relation to these provisions. The reason for this is Europe’s obligations under TRIPs. TRIPs provides that the only permissible criteria for patentability of an invention are that the invention is new, not obvious, has an industrial application, and that the invention is fully disclosed to the public.³⁴ If the Biotech Directive were to establish other criteria for patentability— such as evidence of informed consent and attribution of geographic origin—the European Union would be in violation of the TRIPs obligations. This would have been unacceptable.³⁵

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   Ethical Review

   The Biotech Directive contains two review mechanisms to ensure that it conforms, in practice, with ethical considerations related to biotechnological innovations. The first review mechanism is the requirement that the European Commission report to the European Council and European Parliament on both the ethical and research implications of the Biotech Directive. Specifically, the Biotech Directive contemplates that the Commission will submit annual reports on developments in patent law relating to biotechnology, a report after two years examining the effects of failures to publish or delays in publishing basic research in fields subject to patent rights, and a report every five years on the relationship between the Biotech Directive and international human rights conventions.³⁶

   The second review mechanism is that an expert group of ethicists—the European Group on Ethics in Science and New Technologies—continue to review the basic ethical aspects of biotechnology including in respect of patent law.³⁷ This group of ethicists has only advisory power.

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   Implementation

   The Biotech Directive was finally adopted on July 6, 1998 by the Council of the European Union and the European Parliament. It was published on July 30, 1998 and called for full implementation by July 30, 2000.³⁸

   Procedure and the Biotech Directive

   Within the European Union, legislation is generally proposed by the European Commission. The Commission itself has no legislative authority beyond the introduction of legislation. Legislative authority rests with the Council of the European Union—made up of Ministers from the governments of the Member States—and, depending on the subject-matter, the European Parliament. Unlike in Canada, the European Parliament has limited authority and has, generally, less power than the Council in formulating European legislation.

   In amendments made in 1992 to the Treaty establishing the European Community, the European Parliament was given more power. In particular, decisions over certain defined subject-matter had to be made through the so-called “Co-decision” procedure. Under this procedure, both the European Parliament and the Council of the European Union have to agree upon legislation.

   The Biotech Directive was the first directive to follow this procedure.

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4. Part II: History of the Biotech Directive

   Its Origins

   The European Commission introduced the first draft of the Biotech Directive in 1988 to establish uniform guidelines within Europe on the patenting of biotechnological innovations. At the time, the Commission felt that Europe needed to remain competitive with the United States in terms of biotechnological research and development.³⁹ The United States had recognised patents in genetically-modified living organisms in 1980 and in higher life forms in 1988. The Commission feared that a failure to address biotechnological innovations would detrimentally affect research and development in this area in Europe.

   The European Commission was not the only international body to recognise the need for competitiveness with respect to biotechnology. As early as 1981, the Organisation for Economic Co-operation and Development (OECD) had begun an investigation into patent protection in the biotechnology field. At that time, only the United States and Japan out of all of the OECD’s members had adequate patent laws in place to deal with biotechnology. This was followed, in 1983, by the establishment of a “Committee of Experts” by the World Intellectual Property Organisation to examine differences in the legal protection of biotechnological inventions worldwide. The Committee concluded that countries should build awareness of biotechnology and patent issues and work toward harmonious patent rules. The Committee viewed this as being crucial for economic and scientific development.⁴⁰

   Under the Treaty on the Establishment of the European Community (EC Treaty), the European Union had jurisdiction over the harmonisation of national laws and regulations needed to ensure the functioning of the European internal market.⁴¹ The Commission introduced the draft Biotech Directive under this power in October 1988. Its intention was to set out the manner in which traditional patent law rules apply to biotechnology. In particular, the Commission did not intend to broach ethical issues related to biotechnological research. The Commission based its draft Biotech Directive on the policy of the United States on patenting of biotechnological innovations tempered by requirements set out in international treaties dealing with intellectual property, international trade, human rights, and the environment.

   The European Parliament reviewed the draft Biotech Directive through several working committees. Parliament became more interested in the ethical dimensions of the Biotech Directive than in its technical elements. In April and October 1992, Parliament introduced a number of amendments to the draft Biotech Directive aimed at clarifying certain ethical issues arising out of biotechnological research.

   In July 1989, before Parliament reviewed the draft Biotech Directive, the Examining Division of the EPO rejected the patenting of a genetically engineered mouse made susceptible to cancer on the basis that the European Patent Convention prohibited the patenting of animals. The Board of Appeal overturned this ruling in October 1990. It sent the case back to the Examining Division to determine whether a geneticallymodified animal was an animal variety (and thus excluded from patent protection) and whether the patenting of the animal violated the European Patent Convention’s provisions dealing with breaches of public order or morality. In doing the latter, the Board of Appeal suggested that the Examining Board analyse whether the usefulness of the invention to human beings outweighed the suffering caused to animals and risk to the environment.⁴² The patent was finally issued in May 1992—one month after the European Parliament met for the first time to consider the draft Biotech Directive but before its second consideration of the matter in October 1992—when the Examining Division concluded that the mouse was not an animal variety, and therefore was patentable. The Division also held that the use of the invention would not violate morality or public order since the benefits of the mouse to medical science outweighed any suffering caused to the mouse and that there was no environmental risk posed by the invention.

   In response to Parliament’s suggested amendments to the draft Biotech Directive, the Commission prepared an amended Biotech Directive in December 1992. The Commission recognised the need to incorporate ethical principles into the draft Biotech Directive. Because jurisdiction over the Biotech Directive rested on the harmonisation of patent laws, the Commission acknowledged that any discussion of ethical principles could concern only those that fell within the sphere of patent law. It therefore proposed to address ethical issues only through an elucidation of the public order and morality exception. The Commission’s amended Biotech Directive therefore explicitly recognised that “the human body or parts of the human body per se,”⁴³ processes to genetically modify human beings for non-therapeutic purposes, and processes to modify the genetic identity of animals that are likely to cause suffering or physical handicaps to those animals without benefit to human beings or animals, were all unpatentable.⁴⁴

   The European Parliament remained unsatisfied with the amended draft Biotech Directive and therefore proposed further amendments. The Council of the European Union accepted some, but not all, of these amendments in a Common Position on the draft Biotech Directive in February 1994.⁴⁵ After receiving the Common Position from the Council, Parliament proposed amendments to it. The Council, for its part, refused to accept Parliament’s amendments in September 1994, leading to mandatory conciliation proceedings involving an equal number of members from each of the Council and the Parliament. The conciliation committee agreed upon a joint text in January 1995. Despite the success of the conciliation committee, Parliament rejected the Biotech Directive on March 1, 1995.

   The need for harmonisation had, if anything, increased between the introduction of the first draft Biotech Directive in 1988 and Parliament’s rejection of it in 1995. This was due to two reasons. First, there was increasing concern over the possibility of divergent decisions by national courts of the Member States with respect to the same patent issued by the EPO. Second, there was a risk that European patent law would be further fractured through the adoption by Member States of their own bioethics laws. France, for example, did so in 1994.⁴⁶

   Given this continuing need to clarify the patentability of biological material, the Commission drafted a new Biotech Directive in December 1995. This draft gave explicit expression to the well-established European patent principle that only inventions— requiring human intervention—rather than discoveries are patentable. The proposal thus stated that the human body itself was unpatentable but that inventions made from the human body could be patented. Parliament approved a revised version of this draft Biotech Directive in May 1998. The Council of the European Union adopted Parliament’s revised version on June 16, 1998. Only The Netherlands voted against the Biotech Directive, on the grounds that it called for patents over plants and animals, while Belgium and Italy abstained. The Biotech Directive was finally adopted on July 6, 1998 and published on July 30, 1998.

   Opposition Proceedings Regarding Genetically-Modified Mouse Patent

   In February 1993, numerous nongovernmental organisations and political parties lodged an opposition to the mouse patent asking for its revocation. In November 1995, the Opposition Division organised a public hearing regarding this opposition. The Opposition Division reserved judgment. No decision has yet been issued.

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5. Part III: Aftermath and Implementation

   Court Challenge

   In October 1998, The Netherlands commenced a challenge against the Biotech Directive before the European Court of Justice.⁴⁷ The Netherlands based its challenge on the following arguments:
   • The procedure followed in passing the Biotech Directive was incorrect under European law. The Netherlands argued that the Biotech Directive was not aimed at harmonising the European internal market but was a completely new initiative in which unanimous approval of the Member States was required.
   • The Biotech Directive violates the Subsidiarity Principle.
   • The Biotech Directive is incompatible with obligations under the 1992 Rio Convention on Biological Diversity to share the benefits of genetic resources with the sources of those resources, to encourage the protection of biodiversity, to provide incentives to developing countries to protect their biodiversity and to access their genetic resources.
   • The Biotech Directive fails to respect general principles of international and European law. Italy later joined The Netherlands in its complaint against the Biotech Directive with the support of Norway. The European Parliament and the Council of the European Union, with the support of France, defended the Biotech Directive against this challenge. The Council has filed a defence in which it sets out its refutation of the arguments put forward by The Netherlands. Although this defence is not public, the Council’s position has always been that the Biotech Directive harmonises the European internal market and does not breach international agreements, including the 1992 Rio Convention on Biological Diversity. In fact, the Biotech Directive makes explicit reference to the Rio Convention. In particular, it refers to Article 16(2) of the Rio Convention, the second sentence of which states that benefit sharing with respect to biological resources must be consistent with intellectual property rights.⁴⁸ This sentence seems to indicate that there is nothing inconsistent between the grant of patents over biological material and the Rio Convention.

   The challenge launched by The Netherlands has not yet proceeded. In fact, it is unclear when it will do so. In the meantime, the Biotech Directive remains in force.

   Status of Directive in Member States

   The following Member States have transposed the Biotech Directive into national law:

   • Denmark on 31 May 2000
   • Finland on 15 July 2000
   • The United Kingdom on 28 July 2000
   • Ireland on 30 July 2000

   The following Member States either have legislative proposals or are working on proposals designed to transpose the Biotech Directive into national law but have not yet implemented the Biotech Directive:

   • Austria
   • Belgium
   • Germany
   • Luxembourg
   • The Netherlands
   • Spain
   • Sweden
   • Portugal

   The following Member States have not implemented the Biotech Directive and have no current legislative proposals to do so:

   • France
   • Greece
   • Italy
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   Transposition into National Law

   Most Member States have still to transpose the Biotech Directive into their national laws. This failure to do so by the implementation date should not, however, be taken to demonstrate widespread disenchantment with the Biotech Directive. In fact, Member States often fail to implement directives by their implementation dates. This is due more to procrastination than anything else. Sweden, for example, expects to implement its legislation next year.⁴⁹ Greece has no present legislative proposal in place to transpose the Biotech Directive into national law.⁵⁰

   Some Member States have delayed transposition of the Biotech Directive because of ethical concerns. France’s former Minister of Justice, Elisabeth Guigou, announced in June 2000 that the Biotech Directive violated France’s 1994 bioethics law in that it permits patents over human genetic information.⁵¹ France faces, therefore, the need to revise its bioethics laws (which exclude the patentability of the human body and its elements and products) in parallel with the transposition of the Biotech Directive into national law. France is currently contemplating how to do this but is expected to act in the near future. The Biotech Directive faces opposition in Austria now that the Freedom Party, which had opposed the Biotech Directive in 1998 when it was in opposition, is in the government alliance. Germany has prepared a draft bill following the language of the Biotech Directive. Nevertheless after scientists raised fears over access to DNA sequences in the summer of 2000, the German Minister of Research, Edelgard Bulmahn, announced that the German government would issue interpretative comments on the legislation implementing the Biotech Directive to ensure that patents would be given a narrow interpretation.⁵² In October 2000, the German Council of Ministers issued a decision in which it called for careful scrutiny of the implementation of the Biotech Directive into the national laws of the Member States. It suggested that modifications may be necessary to address issues related to the scope of biotechnology patents.

   Belgium has drafted legislation to transpose the Biotech Directive into Belgian law. Unlike other states that have simply implemented the Biotech Directive almost verbatim, Belgium has created legislation that attempts to address its ethical concerns with the Biotech Directive. It placed this draft legislation on the Internet for comment until 31 October 2000.⁵³ The draft statute introduces a definition of “invention,” something that other countries have avoided in order to provide flexibility within the patent system. The definition includes the requirement that an invention must be the result of human activity that comprises a technical solution to a technical problem.⁵⁴ The Belgian draft also expands the notion of public order and morality contained in the Biotech Directive. Instead of restricting this exception to those inventions the commercial exploitation of which is contrary to public order or morality, the Belgian proposal also excludes from patentability inventions produced through means that are contrary to public order or morality. For example, the legislation states that inventions produced in violation of human rights, without fully informed prior consent (including with respect to the eventual industrial or commercial use of the invention), or using biological materials used or exported in violation of the Rio Convention on Biological Diversity are unpatentable.⁵⁵

   While the Belgian draft legislation does address a broader range of ethical concerns than does the Biotech Directive by excluding patents over inventions that were discovered in a way that violates public order or morality, it does not seem to conform to either the requirements of the Biotech Directive or of TRIPs. Both the Biotech Directive and TRIPs only permit a country to exclude patent coverage where the commercial use of the invention violates public order or morality. That is, neither permits an exclusion where the process of creating the invention violates these norms. It was because of TRIPs that the European Commission had resisted the European Parliament’s desire to include binding provisions in the Biotech Directive covering informed consent and attribution of origin.⁵⁶

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   Competence of European Union over Biotech Patents

   The European Commission claimed that the European Union had jurisdiction over biotechnological innovation pursuant to the Union’s powers over the harmonisation of the European internal market. Measures dealing with harmonisation trigger the co-decision procedure set out in the EC Treaty. Under this procedure, both a majority of the European Parliament and of the Council of the European Union must pass the measure for it to be adopted.

   The Commission based jurisdiction over the Biotech Directive on Article 100A (currently Article 95) of the EC Treaty. That article provides that the Council and the Parliament can, in consultation with the Economic and Social Committee, “adopt measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.”⁵⁷ The French version of the EC Treaty makes clear that “approximation,” as used in the Treaty, means “harmonisation.”⁵⁸

   The Netherlands claimed that the Biotech Directive could only be justified on the basis of Article 235 (currently Article 308) of the EC Treaty. That Article states as follows:
   If action by the Community should prove necessary to attain, in the course of the operation of the common market, one of the objectives of the Community and this Treaty has not provided the necessary powers, the Council shall, acting unanimously on a proposal from the Commission and after consulting the European Parliament, take the appropriate measures.59

   There are two significant differences between Articles 100A and 235 of the EC Treaty. The first is that under the former provision, the Council of the European Union need only pass a measure by a majority while under the latter provision unanimity is required. Second, under Article 100A, the European Parliament must also approve the measure by a majority while under Article 235, Parliament need only be consulted. If the Biotech Directive needed to be approved under Article 235, and given the fact that The Netherlands voted against the Biotech Directive in June 1998, it would not have passed.

   It is evident from the original draft of the Biotech Directive that it was directed at harmonising patent law and did not intend to create a new legislative framework in relation to biotechnological research and innovation. The later introduction of ethical elements through the elucidation of the morality and public order exception and the clarification of the application of patent standards to biotechnological innovations did not alter the fundamental character of the Biotech Directive. It therefore seems that the Commission’s reliance on Article 100A was appropriate.

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   Effects of Failure to Implement

   The Biotech Directive applies directly within a Member State whether or not it has been transposed into national law. This is so for three reasons.

   First, since the EPO has already implemented the Biotech Directive, it will issue patents in accordance with its provisions. Therefore, even if a Member State that is party to the European Patent Convention fails to implement the Biotech Directive, the EPO will grant patents on behalf of that Member State in accordance with the provisions of the Biotech Directive.

   Second, national courts in the Member States will apply the Biotech Directive in any case that comes before them challenging a patent issued by the EPO. Thus, a challenger will not be successful in arguing before a national court that a patent violates domestic law as long as the patent is in accord with the Biotech Directive.

   Third, either the European Commission or an aggrieved person (either directly or through national courts) can ask the European Court of Justice to impose a penalty on a Member State that fails to transpose the Biotech Directive into national law. Since the Court now has the power to award damages against a Member State that fails to meet its obligations to implement European law, this becomes a real threat.

   Given this situation, those wishing to rely on the Biotech Directive to patent biological material can do so despite national legislation to the contrary. So, for example, French biotech companies could apply to the EPO for and be granted patent rights over human DNA sequences applicable in France without worrying about the effects of France’s bioethics laws. In fact, if the biotech firm were willing to pursue a court challenge, it could seek a patent from the French patent office which, in the case of rejection, will be required by either the Paris Court of Appeal or the European Court of Justice to comply with the Biotech Directive.

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6. Part IV: Analysis and What Canada Can Learn

   It is too early to judge the effects that the Biotech Directive will have in encouraging biotechnology research and development in Europe. At the very least, it signals a move by countries to openly address the needs of the biotech industry and of public health.

   Structural Lessons

   Despite the lack of concrete evidence as to the effects of the Biotech Directive, Canada can learn several things from the European process. The most obvious is that the topic of biotechnological innovation raises a greater magnitude of ethical and social concerns than do many subjects of legislation. The purpose of the Biotech Directive is to bring European patent law into conformity with that of its major competitors, the United States and Japan. Europe’s reason for doing so was to maintain a vibrant research and development community that would not only benefit public health, but would enable Europe to retain a degree of independence from its trading partners. Canada ought to contemplate the degree to which these goals apply to it.

   Of course, patenting of biological materials raises ethical and social issues in addition to independence and a strong public health system. Canada would, therefore, be wise in assuring that whatever legislation it drafts seeks to balance the commercial needs of industry with the ethical and social concerns of First Nations, developing nations, patients, environmentalists, and others. This will be neither straightforward nor easy.

   Europe’s experience at reaching a compromise in the Biotech Directive just to see the expression of renewed concern over its ethical implications only two years later leads to a second important lesson: the need for flexibility. As our knowledge of the science behind biotechnology advances, the appropriate role of patents changes. This may explain, in part, some of the reluctance expressed by Austria, Germany, and Belgium in implementing the Biotech Directive. These countries are concerned that the grant of too many or too broad patent rights over genetic information, particularly human DNA sequences, will stifle further research. This concern arose recently in the academic literature⁶⁰ due both to the pace of change in biology and to developments in patent law. With the end of the first phase of the Human Genome Project, we can expect more such concerns to arise.

   The European experience also teaches us about the importance of public opinion. As polls and studies continue to indicate, the public feels uninformed about the science behind biotechnology.⁶¹ Worse, the public distrusts the information that both industry and organised civil society provide to it.⁶² Recent concerns in Europe, unrelated to either biotechnological innovation or patent law, have inflamed public fear. Nevertheless, to the public, these concerns are linked with patents and biotechnological innovation. These concerns include disputes with North America over beef hormones,⁶³ Mad Cow Disease, dioxin-laden chicken, the Belgian Coca- Cola scare,⁶⁴ tainted blood trials in France,⁶⁵ and worries over the introduction of genetically-modified plants. Added to this, the EPO’s recent mistaken decision to grant a patent that apparently covered geneticallymodified human organs and cells has further linked these concerns with patents in the public mind.⁶⁶

   These three factors—the complexity of the issues, the need for flexibility, and the need to educate the public—need to be addressed by Canada in formulating its policy with respect to biotech patents. The first step in addressing these factors is to separate two different sets of decisions that Canada needs to make in terms of biotechnology.

   The first set of decisions that must be made are those that involve the initial allocation of rights and responsibilities regarding biotechnology.⁶⁷ These constitute threshold issues that need to be addressed before Canada addresses the regulation of biotechnology. These issues include whether biotechnological innovation is in accord with moral principles—the majority opinion is that it clearly is—whether Canadian society is prepared to accept the risks that biotechnology may imply for health and the environment, the allocation of roles to industry and the public sector, and the allocation of liability between stakeholders.

   Once these threshold issues are determined, Canada needs to develop mechanisms to both encourage industry to perform its role within the general framework that Canada has chosen and to prevent or, at least, address problems that inevitably will arise. Canada needs, therefore, to establish mechanisms to monitor developments in science and industry.⁶⁸ These mechanisms must be flexible enough to lead to changes in the way that Canada regulates biotechnological innovation including the types and extent of patent rights it grants over biotechnological inventions. Through such a flexible system, Canada can monitor both the impact of biotechnology (positive and negative) on the environment and human health, on competition, and on the developing world and adjust its regulations accordingly.

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   Specific Lessons

   In addition to lessons Canada can learn about the way to structure its solution to the question of biotech patenting, the European experience with the Biotech Directive also leads to more specific measures that Canada ought to consider. These include the role of a public order and morality clause within Canadian patent law, the inclusion of exceptions to patent rights, the use of compulsory licensing for platform technologies, and the interaction between Canada’s biotech patenting policies and its international treaty obligations.

   The Biotech Directive specifies that patent offices are not to award patents over inventions that, if commercialised, would lead to a disruption of public order or morality. While the term “public order” is used in a variety of international treaties where it generally means public policy,⁶⁹ the term is given a significantly narrower meaning within the context of the European Patent Convention. Within this Convention, public order covers the protection of public security, the physical integrity of individuals, and the protection of the environment.⁷⁰ On the other hand, morality relates to the belief that some activity is overwhelmingly accepted as wrong within the totality of deeply held European norms.⁷¹ For example, the EPO has recently announced that it found an invention involving the cloning of a fused human and pig cell to be contrary to morality.⁷²

   The European Patent Convention provides that a patent should not be issued if the publication or exploitation of an invention would be contrary to public order or morality. As discussed earlier, the Biotech Directive takes a narrower approach to the exception, in conformity with TRIPs, by stating that patents ought only to be withheld where the commercial exploitation of the invention would be contrary to public order or morality. Thus, mere publication of an invention is not sufficient, under the Biotech Directive, to trigger the public order and morality clause.

   The list of sample inventions that would violate public order or morality given in the Biotech Directive speaks to its narrow scope. The use of embryos, interventions into the human germ line, and cruelty to animals illustrate that the exception is designed to prohibit only the most obvious cases of a breach of public order and morality.

   Canada could implement a public order and morality exception clause to act as an ethical filter over patents issued in Canada.⁷³ Prior to 1994, Canada’s Patent Act excluded patents over illicit inventions. In contrast to that provision, a public order and morality clause is better directed at balancing the positive aspects of biotechnological innovation against its potential negative social repercussions. Nevertheless, a public order and morality exception would put Canadian law out of line with that of the United States.

   Canada should be cautious in reading the Biotech Directive as being indicative that a public order and morality exception is necessarily the best way to approach ethical issues relating to biotechnology. As discussed earlier, the European Commission had limited scope, within the jurisdiction provided by Article 100A (now 95) of the EC Treaty, to explicitly address ethical issues. Given that the Biotech Directive was justified on the basis of the need to harmonise patent law within Europe, it would have been inappropriate for the Biotech Directive to contemplate means outside of patent legislation to regulate ethical issues.⁷⁴ Thus, the Biotech Directive could not contemplate other measures, such as the establishment of a separate procedure to directly address ethical issues or liability rules that may have more carefully targeted the ethical questions raised by biotechnology research and innovation.

   In Europe, the decision whether an invention violates public order or morality rests first with the applicable patent office. Should Canada opt to include such a clause, it would have to decide whether patent officers are adequately equipped to make these decisions or whether a separate administrative process is required.

   In addition to the exclusion of inventions that violate public order or morality, the Biotech Directive provides farmers with an exclusion from the scope of patent rights held by a patent holder. This exclusion permits farmers to collect the seeds of certain patented plants they have grown and to breed patented animals bought for breeding purposes. This exclusion is not explicitly contemplated in TRIPs and could potentially violate TRIPs unless the European Union can demonstrate that the exclusion does “not unreasonably conflict with a normal exploitation of the patent and do[es] not unreasonably prejudice the legitimate interests of the patent owner.”⁷⁵

   This exclusion—called a farmers’ privilege—is already an integral part of existing plant breeders rights legislation in Canada.⁷⁶ Internationally, farmers’ privilege, which was once required under international agreement,⁷⁷ is now optional under the 1991 UPOV Convention, which details the rights of plant breeders over plant varieties.⁷⁸ This may signal ambivalence at the international level, with respect to these privileges.

   The Biotech Directive implicitly adopts a second exclusion from the scope of the patent holder’s rights: an experimental use exemption. This exemption is found in the Community Patent Convention.⁷⁹ While this Convention has not yet been ratified, Member States uniformly comply with its provisions dealing with experimental use of a patented invention. The Convention provides that researchers—even those employed by competitors—are permitted to conduct research on the subject-matter of a patented invention without violating the patent right. When combined with the provisions of the Biotech Directive, this means that researchers will be able to conduct research on patented DNA sequences without violating that patent if the research relates to improving, further developing, or testing the DNA sequence. Research aimed at discovering another function of the DNA sequence, its interrelation with other DNA sequences, or its involvement in the development of disease, for example, all arguably fall within the meaning of improving or further developing the DNA sequence.

   While Canada’s Patent Act does not contain an experimental use exception, courts have read one into the statute.⁸⁰ It is unclear, however, to what degree this judge-made law would permit Canadian researchers to use genetic material patented in Canada. This is clearly an area where legislation would be helpful.

   The Biotech Directive contemplates another exception to the scope of the patent holder’s rights: compulsory licensing. As discussed earlier, the Biotech Directive provides that a holder of a plant variety right may seek a compulsory license to use a patented plant or that the holder of a patented plant may seek a compulsory license to use a protected plant variety under certain circumstances. TRIPs permits countries to grant compulsory licenses on terms similar to those set out in the Biotech Directive.⁸¹

   Canada currently complies with the 1978 UPOV Convention, which does not permit the application of both patent protection and plant variety protection to the same plants. Should Canada decide to implement the 1991 UPOV Convention, which does permit both forms of protection, Canada should consider the wisdom of implementing provisions similar to those contained in the Biotech Directive with respect to farmers’ privilege and compulsory licensing. Without these rights, Canadian farmers and breeders may find that patents prevent them from carrying on business without undue costs. Canada ought to be careful, however, in introducing these rights. If compulsory licensing rights are limited to plants and animals, it is possible that these rights would violate TRIPs provisions dealing with nondiscrimination between technologies.⁸² This problem does not exist in Europe where similar compulsory licensing practices apply to all technologies. This is not the case in Canada. Nevertheless, given the importance of resolving conflicts between patents and plant variety protection rights in Canada, it is likely that such compulsory licensing provisions would not be considered as discriminatory.

   Much of the debate in Europe over the Biotech Directive surrounded the manner in which the industrial application standard used in European patent law ought to apply to human biological material. In part, this clarification was needed because the ordinary industrial application standard in Europe did not require a high enough knowledge of the function of DNA sequences. While Canada and the United States use the utility standard—which is more robust than industrial application—the United States still saw the need to clarify its application to biotechnological innovation.⁸³ Canada has not yet explicitly broached this subject either in legislation or by the issuance of guidelines by the Canadian Intellectual Property Office.

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7. Conclusion

   Europe’s struggles in implementing the Biotech Directive provide Canada with important lessons in resolving debates over biotechnological innovation. First, it points to the importance of a public debate over biotechnology and militates against an approach that relies on judge-made law to address current concerns. Second, Canada’s solution to both ethical and commercial concerns over biotechnology must be flexible and transparent. Third, Canada needs to clearly define the role that industry plays in advancing biotechnology. Canada must then make a commitment to both simplify barriers faced by industry in conducting business and implement methods to resolve disputes between commercial enterprises and between public sector and private sector researchers. Fourth, Canada ought to explore the possible use of a public order and morality clause, an exemption to permit farmers to re-use patented seeds, compulsory licensing to avoid conflicts between plant variety legislation and patent law, and a clarification of the experimental use exception in Canada.

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¹ EC, Directive 98/44 of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, O.J. Legislation (1998) No L213 at 13 [hereinafter Biotech Directive].

² The following are the Member States of the European Union: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, and the United Kingdom.

³ This is certainly the case in several Member States. See, for example, Letter from M. Kleen, Public Relations Officer, Swedish Parliament to L. Iding, student to E.R. Gold (30 June 2000) and Letter from C. Sahl, Responsable législation, Ministère de l'Economie, Direction de la Propriété intellectuelle, to L. Iding, student to E.R. Gold (7 July 2000) with respect to Sweden and Luxembourg respectively.

⁴ Letter from Y.C. van Drimmelen, Public Relations Officer, Dutch IP office to L. Iding, student to E.R. Gold (29 June 2000).

⁵ EC, Case C-377/98: Action brought on 19 October 1998 by Kingdom of the Netherlands against European Parliament and the Council of the European Union, O.J. Information (1998) No 98/C378/13 [hereinafter Netherlands v. Parliament].

⁶ The former French Minister of Justice, Elisabeth Guigou, is perhaps the highest profile politician to speak out against the Directive. See P. Lemaître and J-Y Nau, “La directive européenne sur le génome humain est incompatible avec le droit français, selon Mme Guigou” Le Monde (9 June 2000) 9.

⁷ G. Gaskell et al., “Biotechnology and the European Public” (2000) 18 Nature Biotechnology 935.

⁸ Ibid.

⁹ Convention on the Grant of European Patents (European Patent Convention), done at Munich, 5 October 1973 [hereinafter European Patent Convention].

¹⁰ Netherlands v. Parliament, supra note 5.

¹¹ See Biotech Directive, supra note 1 at Article 3 supported by Recital 22. The Biotech Directive defines biological material as “any material containing genetic information and capable of reproducing itself or being reproduced in a biological system” in Article 2(1)(a).

¹² Ibid. at Article 3(2) that provides that “biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.”

¹³ Ibid. at Article 5(2) and Recitals 20 and 21.

¹⁴ It does so explicitly with respect to biological materials of human origin in Article 5(3) and through the statement of principle in Recital 22.

¹⁵ Biotech Directive, supra note 1 at Recital 23.

¹⁶ Ibid. at Recital 24.

¹⁷ Ibid. at Article 5(1).

¹⁸ Ibid. at Articles 4(1) and 4(2).

¹⁹ European Patent Convention, supra note 9, Article 53(a).

²⁰ Agreement on Trade Related Aspects of Intellectual Property Rights, 15 April 1994, 33 I.L.M 1197 [hereinafter TRIPs] at Article 27(2).

²¹ Biotech Directive, supra note 1 at Article 6(1).

²² Ibid. at Article 6(2) and Recitals 40, 41, 42, and 45.

²³ Ibid. at Article 8.

²⁴ Ibid. at Article 9.

²⁵ Ibid. at Article 10.

²⁶ Ibid. at Article 11(1). This article confirms the obligations of the Member States under Article 14 of EC, Council Regulation No 2100/94 of 27 July 1994 on Community plant variety rights, O.J. Legislation (1994) No L227 at 1 which lists the plant varieties that are subject to the farmer’s privilege. See also Recitals 47 and 48 of the Biotech Directive.

²⁷ Article 14(3) of EC, Council Regulation No 2100/94 of 27 July 1994 on Community plant variety rights, O.J. Legislation (1994) No L227 at 1

²⁸ Biotech Directive, ibid. at Article 11(2). The article recognises the need for domestic legislation to implement this right. See also Recitals 50 and 51.

²⁹ Ibid. at Article 12(1) and 12(2).

³⁰ Ibid. at Article 12(3)(a).

³¹ Ibid. at Article 12(3)(b) and recitals 52 and 53.

³⁴ TRIPs, supra note 20 at Article 27(1) and 29(1).

³⁵ Interview with D. Vandergheynst, Internal Market Directorate General Brussels (25 May 1998) Belgium.

³⁶ Biotech Directive, supra note 1 at Article 16.

³⁷ Ibid. at Article 7 and Recital 44.

³⁸ Ibid. at Article 15.

³⁹ D.O. Perdue, "The Changing Landscape for Patenting Transgenic Plants in Europe" (2000) 7:2 CASRIP Newsletter online: (http://www.law.washington.edu/casrip/newsletter/newsv6i 1Perdue.html) (date accessed: 8 October 2000).

⁴⁰ G.M. Gradi et al., "Patenting Biotechnologies: the European Union Directive 98/44/EC of the European Parliament and of the council of 6th July 1998 on the Legal Protection of Biotechnological Inventions" online: (http://www.accmed.net/anm/it/editoria/riviste/forumsup/9 3303fosup.htm) (date accessed: 8 October 2000).

⁴¹ Article 95 of the EC, Treaty establishing the European Community, done at Rome, 1 January 1958 , as revised 1 July 1987, 1 November 1993, and 1 May 1999 [hereinafter EC Treaty]

⁴² EC, Case No T19/90 of 3 October 1990, (1990) O.J. No 476.

⁴³ EC, Amended Proposal for Council Directive on the legal protection of biotechnological innovation, COM(92) 589 of 16 December 1992 at Article 2(3)(a).

⁴⁴ Ibid. at Article 2(3)(b) and (c).

⁴⁵ (CE)4/94 of 7 February 1994.

⁴⁶ Loi no. 94-653 du 29 juillet 1994 relative au respect du corps humain.

⁴⁷ Netherlands v. Parliament, supra note 5. See also A. Scott, “The Dutch Challenge to the Bio-Patenting Directive” (1999) 21 E.I.P.R. 212.

⁴⁸ Biotech Directive, supra note 1 at Recital 55.

⁴⁹ Letter from M. Kleen, Public Relations Officer, Swedish Parliament to L. Iding, student to E.R. Gold (30 June 2000).

⁵⁰ Letter from John C. Kyriakides, Kyriakides – Georgopoulos to E.R. Gold, Assistant Professor (7 September 2000); Letter from A. Pliakos, Greek Parliament to E.R. Gold, Assistant Professor (18 September 2000).

⁵¹ P. Lemaître, J-Y. Nau, supra note 6; S. Louet, “French Refuse to Implement Biotech Patent Directive” (2000) 18 Nature Biotechnology 669.

⁵² Q. Schiemeier, “German Government takes a Narrow View of Gene Patents” (2000) 406 Nature 664.

⁵³ Belgium, Minister of Economic Affairs, online: (http://www.mineco.fgov.be/biotech2/home_fr.htm) (date accessed: 20 October 2000).

⁵⁶ Interview with D. Vandergheynst, Internal Market Directorate General, Brussels, Belgium (25 May 1998).

⁵⁷ EC Treaty, supra note 40 at Article 95.

⁵⁸ The French version of Article 95 of the EC Treaty uses the following language to describe the jurisdiction: “les mesures relatives au rapprochement des dispositions législatives, réglementaires et administratives des États membres qui ont pour objet l’établissement et le fonctionnement du marché intérieur.”

⁵⁹ EC Treaty, supra note 40 at Article 308.

⁶⁰ See, for example, M.A. Heller and R.S. Eisenberg, “Can Patents Deter Innovation? The Anticommons in Biomedical Research” (1998) 280 Science 698.

⁶¹ G. Gaskell et al. “Biotechnology and the European public” (2000) 18 Nature Biotechnology 935; Canadian Biotechnology Secretariat, Public Opinion Research Into Biotechnology Issues (Ottawa: Canadian Biotechnology Secretariat, 2000); S.H. Priest, “US public opinion divided over biotechnology?” (2000) 18 Nature Biotechnology 939.

⁶² Canadian Biotechnology Secretariat, ibid.

⁶³ E.L. Andrews, “Europe Says it Will Continue Ban on Beef Produced with Growth Hormones”, NY Times Update (24 May 2000).

⁶⁴ F. Dufour, “Les savants fous de l’agroalimentaire”. Le Monde Diplomatique (July 1999) 1, 6 and 7. breeder, restrict the breeder's right in relation to

⁶⁵ C.R. Whitney, “Top French Officials Cleared Over Blood With AIDS Virus” NY Times (10 May 1999) A1.

⁶⁶ J. Grisham, “EPO admits patent mistake” (2000) 18 Nature Biotechnology 366.

⁶⁷ E.R. Gold and W.A. Adams, “Xenotransplantation: Models of Consent” (forthcoming).

⁶⁸ Ibid.

⁶⁹ See Netherlands v. Sweden, [1958] I.C.J. 55.

⁷⁰ EC, Case No T 356/93, O.J. (1995) No 545.

⁷¹ Ibid. and Howard Florey/Relaxin [1995] E.P.O.R. 541.

⁷² Reuters, 6 October 2000.

⁷³ See B.M. Knoppers, “Biotechnology: Sovereignty and Sharing” in T. A. Caulfield and B. Williams-Jones, eds, The Commercialization of Genetic Research: Ethical, Legal, and Policy Issues (New York: Kluwer Academic/Plenum Publishers, 1999) at 1; B.M. Knoppers, “Status, sale and patenting of human genetic material: an international survey” (1999) 22 Nature Genetics 23; B.M. Knoppers, M. Hirtle, and K.C. Glass, “Commercialisation of Genetic Research and Public Policy” (1999) 286 Science 2277.

⁷⁶ Plant Breeders’ Rights Act, R.S.C. 1990, c. 20.

⁷⁷ International Convention for the Protection of New Varieties of Plants of December 2, 1961, as Revised at Geneva on November 10, 1972, and on October 23, 1978.

⁸⁰ Micro Chemicals Ltd. v. Smith Kline & French Laboratories Ltd., [1972] S.C.R. 506.

⁸¹ TRIPs, supra note 20 at Article 31.

⁸² Ibid. at Article 27(1).

⁸³ United States Patents and Trade Marks Office, Interim Utility Guidelines (1999).