Presentation on theme: "Measures Necessary for the Balanced Co-Existence of Patents and Plant Breeders‘ Rights - From a European Perspective – Joseph Straus, Munich WIPO-UPOV."— Presentation transcript:
1Measures Necessary for the Balanced Co-Existence of Patents and Plant Breeders‘ Rights - From a European Perspective – Joseph Straus, Munich WIPO-UPOV Symposium on the Co-Existence of Patents and Plant Breeders‘ Rights in the Promotion of Biotechnological Developments Geneva, October 25, 2002Factual & Legal Anomaly of the Interface Issue in EuropeRemarks on Patentability of Plants, Scope of Patent Protection and its LimitationsMeasures for the „Balanced Co-Existence“ of Patents & PBRsSome Reflections on the Necessary Balance
3Fig. 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.
4US „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]
5China a global leader in the field? Research work on over 50 plant species and more than 120 functional genesOn some hectars - compared with 2000 in 199790 % of field trials target insect and disease resistanceApproved for commercialisationCotton: insect resistance – reduced pesticide use by ~ 13 spraying (49.9kg/per hectare/season (i.e. $ 762 hectare/season))Tomato: virus resistance; Shelf-life alteredSweet pepper: virus resistancePetunia: colour alteredTotal benefits from the adoption of BT cotton in $ 334 millionHuang et al., 295 Science 675 (2002)
6Annex 1: The agricultural sector in Europe: Field trials and venture capital investment betweenFig. 1: Field trials in Europe E. Magnien
7International 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 metMembers may exclude from patentability plants and essentially biological processes for their production other than non-biological and microbiological processesMembers have to protect plant varieties either by patents or by an effective sui generis system or by any combination thereofHowever: Plants have to be protected as direct products of patented non-biological and microbiological processes.
8Patentable 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 naturePlants, if the technical feasibility of the invention is not confined to a particular plant variety (plant varieties generally excluded)
9EU 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 toAll 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 processTo 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
10Limits of the Scope of Protection Statutory 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
11Compulsory 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 interestPayment of an appropriate royalty
12Balancing 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 consideredIn Europe – with its not yet tested regime in practice – respective clarifications should be envisagedIn 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
13Some 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 plantsBoth 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 plantsAll contributing must get a fair share in resulting benefits – free riding at the expense of others not tolerable and counter productive