Question Q 159. The need and possible means of implementing the Convention on Biodiversity into Patent Laws

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1 Question Q 159 The need and possible means of implementing the Convention on Biodiversity into Patent Laws National Group Report Guidelines The majority of the National Groups follows the guidelines for the arrangement of their reports and thereby contributes to a quicker and cheaper printing. I am grateful for this support and would like to draw your attention to the guidelines once again: 1. The National Groups are responsible for the contents, spelling and trilingual summaries in their reports. The texts will normally be printed without further correction. 2. Drafts cannot be accepted. 3. Please deliver your reports in the form of computer printouts and, whenever possible, on computer diskettes (DOS or Windows) or by . Our address is: meisserlaw@spin.ch. 4. If you cannot provide such data files, we will try to machine-read the report. For such purpose we will need the original text (no copies or fax transmissions), without corrections, underlines or footnotes. Please make sure that your reports are sent before September 22, J. David Meisser, Editor Introduction The Convention on biological diversity (or biodiversity) was laid open for signature in 1992 in Rio. It entered into force on December 29, Since then, several "Conference of the Parties" meetings, established by the Convention, have been held. The documents concerning the Rio Convention on biodiversity are available on the web site Pursuant to its first Article, the objectives of the Convention are "the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding". 1

2 AIPPI has already examined the incidence of biotechnology and environmental issues on intellectual property rights and more precisely on patent rights. During the Montreal Congress (June 25-30, 1995), the Association adopted two Resolutions related to: - Question Q 114 (Biotechnology - cf Yearbook 1995 / VIII, French p. 351, English p. 375 and German p. 398); - Question Q 128 (Patents and Protection of Environment - cf. Yearbook 1995 / VIII; French p. 367; English p. 390; German p. 414). These Resolutions explicitly refer to the United Nations Conference held in Rio in Moreover, during the Rio Congress, held from May 24 to May 29, 1998, workshop N 5 examined the relationship between genetic diversity and intellectual property, the findings of which are reported in the 1998/IX Yearbook, pages 94 ss. Particular attention should be paid to the highly interesting and well documented contributions by both Professor STRAUS (entitled "Biodiversity and Intellectual Property", Yearbook 1998 / IX, pp ) and Mr MOSSINGHOFF (entitled: "The Biodiversity Convention and Intellectual Property Rights: Conflict or Harmony?" op. cit. pages ). However, AIPPI had not yet thoroughly studied, using its traditional working methods, how the Biodiversity Convention could be implemented concretely into patent law. Groups are therefore invited to think over this topic. As a preliminary, the present working guideline emphasises that the group's works are to be restricted solely to the problems related to the implementation of the Biodiversity Convention in patent law. Even though political considerations are unavoidable and may even appear essential, the group's reports shall nevertheless focus on patent law aspects, bearing in mind the highly prized neutrality which has become the hallmark of our Association. Given that the Rio Convention entered into force and that it contains provisions concerning patent law either directly or indirectly, it cannot be ignored. I. The main patent law-related provisions of the Rio Biodiversity Convention I.1. Articles 1 and 2 Clearly, where article 1 (cited hereinabove) refers to the practical conditions of the utilisation of genetic resources, of their access and transfer as well as of the rights thereto and on techniques, consequences in relation to patent law necessarily arise. The same statement is induced by the definitions contained in article 2 and in annex 1, concerning biological diversity, biotechnology, genetic material, biological and genetic resources, including ecosystems and habitats, species and communities, genomes and genes. I.2. Articles 15 and 16 An in-depth analysis of the provisions contained in articles 15 and 16 of the Rio Convention should be undertaken by the groups as they are the most relevant for the present study, even though other provisions such as those listed in article 19 (Handling of 2

3 biotechnology and distribution of its benefits) and in article 20 (Financial resources) should not be overlooked. I.2.1/ Article 15 Article 15 (Access to genetic resources) sets forth as a principle (paragraph 1) that States have a sovereign right over their natural resources. Consequently, the authority to give access to genetic resources "rests with the national governments and is subject to national legislation". However, pursuant to paragraph 2, said principle must not impose restrictions that run counter to the objectives of the Convention i.e. to facilitate access to genetic resources. Special attention should also be drawn to paragraph 4 which provides that access shall be on mutually agreed terms between the party providing the resources and the party seeking access thereto. Moreover, as concerns the sharing of the results of the research and the benefits arising from the commercial utilisation of genetic resources, paragraph 7 rules that such sharing shall be upon mutually agreed terms. I.2.2/ Article 16 Article 16 (Access to and transfer of technology) confirms that the objectives of the Convention are to provide and/or to facilitate access to and transfer of technology among contracting parties, or to make use of genetic resources. Paragraph 2 explicitly refers to technology being subject to patents and other intellectual property rights, by specifying that "such access and transfer shall be provided on terms which recognise and are consistent with the adequate and effective protection of intellectual property rights". This is a formal recognition by the Convention of the possible appropriation by patent rights of technologies including biotechnology, on the one hand and of the need to take into account said protection when implementing the means of access to and transfer of technology, on the other hand. Access to technology making use of genetic resources and its transfer shall be effected upon mutually agreed terms (paragraph 3) and shall be provided and/or facilitated under fair and most favourable terms when in favour of developing countries. Paragraphs 4 and 5 are important with a view to the concrete implementation of the Convention. First (paragraph 4), the Convention authorises each contracting party to take "legislative, administrative or policy measures with the aim that the private sector facilitates access to, joint development and transfer of technology... for the benefit of both governmental institutions and the private sector of developing countries". Paragraph 5 expressly urges the contracting parties to insure that patent rights are supportive of and do not run counter to the objectives of the Convention, also indicating that "The Contracting Parties... shall co-operate in this regard subject to national legislation and international law...". It results from this provision that the Rio Convention must necessarily take into account national and international patent laws, in particular the TRIPS Agreement (see II.1. hereinafter). 3

4 The lengthy debates preceding the signature of the Convention have led to a compromise between the sometimes contrasting interests of the developed and the developing countries. II. Patent Law II.1 The TRIPS Agreement On an International level, the TRIPS Agreement, adopted on April 15, 1994, i.e. later than the Rio Biodiversity Convention, contains provisions which are immediately or in the short term applicable in all the World Trade Organisation member States. It should then be stressed that most of the Rio Convention member states are also bound by the TRIPS Agreement. Article 27 of TRIPS contains a wide definition of patentable matters, covering fields encompassed by the Rio Convention. Particularly, in the plant field, the protection can be obtained by patents, Plants Variety Certificates or a mixture of both systems. For the needs of the present study, all means provided by the TRIPS Agreement for the protection of biological inventions have to be taken into consideration. II.2 The existing practice Moreover, be it in accordance with the TRIPS Agreement or even at an earlier date, numerous national patent offices have granted patents in the field of technologies that fall within the scope of the Rio Convention, in particular as concerns biotechnologies. Courts of some countries have already handled litigation involving such patents. II.3 A recent example: the European Community Directive of July 6, 1998 The European Community's biotechnnology Patent Directive 98/44/CE of July 6, 1998 contains explicit references to the Rio Convention in its preamble (whereas clauses N 55 and 56), and states, as a matter of principle, in its article 1, paragraph 2, that it shall not affect or alter the undertakings deriving from international Conventions, in particular the TRIPS Agreement and the Biodiversity Convention. Thus, it becomes more and more apparent that patent rights covering inventions falling within the scope of the Rio Convention, already exist or will develop on an international level. Under these circumstances, the study conducted by AIPPI is of immediate interest. III. Questions to be considered by groups Groups shall be invited to answer the questions given below, in a practical perspective. To that end, statistics and examples drawn from concrete practice should illustrate each answer, so that experience gained in some countries should benefit all groups. A) The national situation 1. Is the Rio Convention: - signed by your country? 4

5 - ratified by your country? 2. Is, in your opinion, the Rio Convention already applicable in your country? 3. If the Rio Convention is not yet directly applicable in your country and if its application would require specific legislation, does said legislation already exist? In the negative, are there plans or actual debates for such legislation in your country? 4. Apart from the Rio Convention or possible legislation for its enforcement, does there exist specific national legislation regulating the access to natural resources (genetic) of the country, the export provisions of such resources, the sharing of the results of their use or the transfer of technologies using them? If such legislation exists, does it contain different provisions, in particular more extensive ones, than those of the Rio Convention? Especially, does the access to genetic resources require the prior consent of the owner of said resources? 5. Are the practitioners of your country aware of the impact on patent law of the Rio Convention? Do they consider that relevant provisions of the Convention are still too theoretical and vague to affect patents in practice? Or, on the contrary, do they believe that the Rio Convention is to be taken into consideration at the present time? 6. Is the TRIPS Agreement: - signed by your country? - ratified by your country? 7. Is the TRIPS Agreement already applicable in your country? If not what is the deadline for its applicability? 8. In your opinion, are the decisions of grant of biotechnology-related patents rendered by your national patent office, as well as the rulings of your national Courts, consistent with the Rio Convention? Whether the answer is positive or negative, groups shall illustrate their answer by quoting examples, where possible. B) Possible means of implementing the Rio Convention into patent laws 9. If your country is a member both of the Rio Convention and of WTO, do you consider that contradiction may exist between the Rio Convention and the TRIPS Agreement? Further, if a subject liable to be contradictory does exist, could the Vienna Convention on the interpretation of international Treaties, particularly its Article 3(a), be invoked, if same is applicable in your country? 10. What is your opinion on the reservations of Article 27(2) of the TRIPS Agreement which make it possible to "exclude from patent protection inventions whose commercial exploitation would be detrimental to "ordre public" or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the 5

6 environment"? In this respect, do you consider that AIPPI should confirm the Resolutions adopted in Montreal in 1995 (see hereinabove)? 11. Some problems exist on the patentability of biological material such as DNA, living tissues etc. Do you think that AIPPI can confirm the Resolution adopted in Montreal on Q 114? Attention should also be paid to the position expressed by AIPPI on Q 150 studied during the Executive Committee held in Sorrento in April Do you think that, if national legislation excludes from patentability such inventions, this exclusion would be such as to facilitate the application of the Rio Convention or, on the contrary, that this exclusion would have no influence for putting in practice the provisions of the Rio Convention on the access and use of genetic resources of a country? 12. What do you think of the reservations of Article 27(3) of the TRIPS Agreement which make it possible to exclude plants and animals from patent protection? Do you think that this exclusion by national legislation would be such as to facilitate the application of the Rio Convention or, on the contrary, that this exclusion would have no influence on putting in practice the provisions of the Rio Convention on the access and use of genetic resources of the country? 13. The Rio Convention challenges neither the existence of patents nor the importance of patent rights. Articles 15 and 16 (see hereinabove) are however designed to determine the conditions of access to a technology making use of genetic resources. Groups are invited to provide their comments regarding the possible practical solutions which are to be considered for the allocation of ownership of patent rights where the subject inventions are achieved due to information concerning genetic resources or by means of genetic resources themselves (for example: a plant or a microorganism). Is the signature of research and/or development agreements an appropriate path to explore with a view to solving the patent rights ownership allocation issue? Examples for such agreements have been given during the workshop N V of the Rio Congress, as mentioned in the Introduction. Groups of countries already having experience in this respect are welcome to illustrate their answer with relevant examples. 14. In your opinion, what means could empower a State or an institutional owner of genetic resources to work or allow the working in the host country of patents filed by third parties which make use at least partially of such resources? Do you consider, for example, that a State should be entitled to constrain a patent owner to grant a compulsory licence, or even to sell the subject patent? The reply thereto should take into account the TRIPS Agreement, whose Article 31 in particular provides for the possible working of a patented invention without the owner's consent, subject to the fulfilment of several conditions. 6

7 Groups are invited to report detailed comments as to how States could be theoretically empowered to regulate the utilisation of their natural biological resources, attention being paid to the practical conditions imposed by the TRIPS Agreement for such regulations. As for previous question 13, groups of countries having experience on this subject are warmly invited to illustrate their comments by concrete examples. 15. The Rio Convention distinguishes between the resources which have been acquired prior to its entry into force (in which case the Convention does not apply to their working) and the resources acquired later. For instance, data obtained from collections or data bases established before the date of entry into force of the Convention do not fall within its scope. Groups are invited to report their possible experience regarding the working of resources acquired earlier than the date of entry into force of the Convention so that lessons may be drawn with a view to its application to future resources, as same will be subjected to the Rio Convention. 16. As indicated hereinabove, in particular as concerns article 15 and 16 of the Rio Convention, the latter contains provisions which can be implemented only upon mutually agreed terms. Negotiations between the party providing resources and the candidate desiring access and use will therefore become necessary. Groups are invited to express their opinion as well as their comments on such negotiations. In this respect, it should be noted that article 31(b) of the TRIPS Agreement also provides that the party seeking access to or the transfer of technology must have endeavoured to obtain consent from the patent rights owner before a compulsory licence is granted. Generally speaking, do groups agree that amicable and free negotiations should prevail between contracting parties, including States, without any constraining schedule so that attention could be paid to the specificity of the host country as well to that of the subject resources? On the contrary, should pre-negotiated agreement forms be considered? On this particular subject, as well as for the previous ones, groups are invited to report their experience gained in their country, where Conventions were negotiated regarding the utilisation of natural resources in the sense of the Rio Convention. Conclusion Groups are invited to reply to the questions 1 through 16. They are also requested to raise questions which have not been pointed out so far in the present working guidelines, should the same hold in their opinion a particular importance for the present study. 7