Factual & Legal Anomaly of the Interface Issue in Europe

1. Measures Necessary for the Balanced Co-Existence of Patents and Plant Breeders‘ Rights- From a European Perspective –Joseph Straus, MunichWIPO-UPOV Symposium on the Co-Existence of Patents and PlantBreeders‘ Rights in the Promotion of Biotechnological DevelopmentsGeneva, October 25, 2002 • Factual & LegalAnomaly of the Interface Issue in Europe • Remarks on Patentability of Plants, Scope of Patent Protection and its Limitations • Measures for the „Balanced Co-Existence“ of Patents & PBRs • Some Reflections on the Necessary Balance

3. Fig. 2: Venture capital investments in the life sciences sectors in Europe. VC investments in biotechnology and medical health increased steadily in recent years and are now at 3,5% and 5% of total investment respectively. The VC investments in the agri sector have strongly decreased from the mid 90s (2% of total VC investment) and now represent only 0.25% of total VC investment.

4. US „Experimental Use Defense“ “..., regardless of whether a particular institution or entity is engaged in an endeavour for commercial gain, so long as the act is in furtherance of the alleged infringer‘s legitimate business and it is not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental use defense. Moreover, the profit or non-profit status of the user is not determinative.“ [US CAFC of October 3, 2002 – John M.J. Madey v. Duke University]

5. China a global leader in the field? • Research work on over 50 plant species and more than 120 functional genes • On some 700.000 hectars - compared with 2000 in 1997 • 90 % of field trials target insect and disease resistance • Approved for commercialisation • Cotton: insect resistance – reduced pesticide use by ~ 13 spraying (49.9kg/per hectare/season (i.e. $ 762 hectare/season)) • Tomato: virus resistance; Shelf-life altered • Sweet pepper: virus resistance • Petunia: colour altered • Total benefits from the adoption of BT cotton in 1999 - $ 334 million Huang et al., 295 Science 675 (2002)

6. Annex 1: The agricultural sector in Europe: Field trials and venture capital investment between 1995-2001 Fig. 1: Field trials in Europe 1995-2001 E. Magnien

7. International Mandatory Standards for Protecting Inventions in Plants under TRIPS Agreement • Patents must be available for inventions whether products (also foodstuff, pharmaceuticals, etc.) or processes in all fields of technology, provided the usual patentability requirements are met • Members may exclude from patentability plants and essentially biological processes for their production other than non-biological and microbiological processes • Members have to protect plant varieties either by patents or by an effective sui generissystem or by any combination thereof • However: Plants have to be protected as direct products of patented non-biological and microbiological processes.

8. Patentable under EU Directive 98/44 of July 98 – New EPC Rules • Biological material, i.e. material containing genetic information and capable of self replication, or reproduction in a biological system, isolated from its natural environment or produced by means of a technical process even it it previously occurred in nature • Plants, if the technical feasibility of the invention is not confined to a particular plant variety (plant varieties generally excluded)

9. EU Directive 98/44/EC - Scope of Protection • Product protection on a biological material extends to: • Any biological material derived from the patented one through propagation or multiplication in an identical or divergent form and possessing those same characteristics. • Protection of a product containing/consisting of genetic information extends to • All material in which the product (e.g. DNA sequence) is incorporated and in which the genetic information is contained and performs its function. • Process protection extends to: • Biological material directly obtained through that process • To any other biological material derived from the directly obtained one through propagation or multiplication in an identical or divergent form and possessing those same characteristics

10. Limits of the Scope of ProtectionStatutory Research Exemption Based on Article 27 (b) CPC • Covers any use of patented material for its further development, improvements, detection of further uses, etc. – even if in pursuit of commercial interests [UK Court of Appeals – Monsanto v. Stauffer; BGH - Clinical Trials I & II, confirmed by Federal Constitutional Court] • Access to patented plant material secured through deposits in publicly accessible depository institutions

11. Compulsory Cross-licensing(EU Directive 98/44) • If unsuccessfully applied for a contractual one, • If the variety constitutes significant technical progress and if of considerable economic interest • Payment of an appropriate royalty

12. Balancing Measures to be Attempted • In the U.S. and other laws without statutory „research exemption“ – introduction of such exemption clearly covering R & D activities for developing new varieties of plants and plant germplasm in general should be considered • In Europe – with its not yet tested regime in practice – respective clarifications should be envisaged • In both systems rules of compulsory cross-licensing – i.e. of patents and PBRs – either do not exist or are inadequate – therefore in need of careful review based on empirical evidence

13. Some Reflections on the Necessary Balance • Abelson‘s vision: „Ultimately, the world will obtain most of its food, fuel, fibre, chemical feed stocks and some of its pharmaceuticals from genetically altered vegetation and trees.“ [279 Science 219 (1998)] requires: • Equal treatment of those contributing generic inventions in plants and those breeding new varieties of plants • Both groups necessitate and should have free access to protected germplasm for R & D activities for the production of new plant material and new varieties of plants • All contributing must get a fair share in resulting benefits – free riding at the expense of others not tolerable and counter productive