Patents on plants 20 April Intellectual property rights are necessary to promote research in all fields of technologies

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1 Patents on plants 20 April 2016, Brussels Thomas Bouvet Paris Lyon Introduction: The role of IP rights Intellectual property rights are necessary to promote research in all fields of technologies Research requires funds to be invested and the exclusive rights confered by IP rights enable the right holders to get a return on such investments by prohibiting others from using the technology, thus getting a commercial advantage, or by granting licences to use said technology IP rights are in the interest of the public because they are granted in exchange of: the disclosure of the invention, which otherwise would be kept secret, thus enriching the state of the art and stimulating further research (patent) making the new variety available for further development (plant breeders rights) 2 Thomas Bouvet, Véron & Associés 1

2 IP rights applicable to plants Patents apply to any invention in all fields of technology including agriculture Can cover a product or a process Patent law contains provisions regarding patentability and scope of protection which are specific to plants Plant breeders rights (UPOV Convention 1961, 1978, 1991) Sui generis protection for plant varieties (created because conditions to obtain patent protection were not appropriate to traditional breeding) No cumulative protection by a patent and by a plant breeder s rights 3 EU law and CJEU in IP rights EU laws regarding patents and PBR Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (the «biotech directive») Implemented in national laws Introduced into the Implementing regulations to the European Patent Convention (EPC) as a complementary mean of interpretation Regulation No 2100/94 of 27 July 1994 on Community plant variety rights (CPVR) CJEU interpretation of EU law (examples) Brüstle v. Greenpeace case, CJEU, C-34/10, 18 October 2011; International Stem Cell (ISCO) v. Comptroller General of Patents, CJEU, C-364/13, 18 December 2014 CJEU, 9 March 2010, Monsanto / Cefetra BV Several decisions regarding Regulation on CPVR Caselaw of CJEU is followed by the European Patent Office (EPO) and caselaw of EPO boards of appeal and enlarged board is followed by national courts 4 Thomas Bouvet, Véron & Associés 2

3 Protection conferred by plant breeders rights Exclusive rights on the exploitation of variety constituents and harvested material of the protected variety and of essentially derived varieties Exceptions and exemptions tailored made for the plant industry Full breeders exemption: right to use the protected variety for the purpose of breeding, or discovering and developing other varieties Farmers priviledge: use of farmed saved seeds Experimental use Breeding of further varieties is thus possible, without limitation, as well as the exploitation of said further varieties (except EDV) 5 Protection conferred by patents Exclusive rights of exploitation of the patented product, or of the patented process and of the product directly obtained by the patented process The protection conferred by a patent on a biological material possessing specific characteristics or on a process that results in those characteristics, extends to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics (Art. 8 of Biotech Directive) Exception and exemptions are more limited: Experimental use Farmers priviledge (art Biotech Directive) No breeders exemption (exists in limited way in some countries e.g. France L CPI and under the Unified Patent Convention) Varieties obtained by traditional breeding from a patented product or using a patented process may fall within the scope of a patent (Compulsory licensing may be requested by the breeder in exchange of payment of royalties) 6 Thomas Bouvet, Véron & Associés 3

4 1. Patent eligibility Principle: Patents should be granted for any inventions in all technical fields of technology, provided they meet the patentability requirements. Article 3 of the Biotech 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 7 Non patent eligible subject-matters Art. 53 EPC (Art. 4 of Biotech Directive): «European patents shall not be granted in respect of: (a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States; (b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof; (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods. 8 Thomas Bouvet, Véron & Associés 4

5 Patent eligible subject-matters in relation to plants Patents may thus be granted on: Plants when the technical feasibility of the invention is not confined to a particular plant variety (EPO G1/98, Novartis, 20 December 1999): because this is not protected by PBR Processes which are not essentially biological (in particular microbiological processes): because these processes cannot be protected by PBR and because only essentially biological processes must remain available for traditional breeding Question: can there be patents on products obtained by an essentially biological processes? 9 2. The tomato and brocoli saga before the EPO G2/12, the tomato saga (EP patent ) G 1/08 on 9 December 2010 T 1242/06 on 31 May 2012 G 2/12 on 25 March 2015 G2/13, the brocoli saga G 2/07 on 9 December 2010 T 83/05 on 8 July 2013 G 2/13 on 25 March Thomas Bouvet, Véron & Associés 5

6 The tomato saga Granted claim 1 relating to a process «A method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of: crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to produce hybrid seed; collecting the first generation of hybrid seeds; growing plants from the first generation of hybrid seeds; pollinating the plants of the most recent hybrid generation; collecting the seeds produced by the most recent hybrid generation; growing plants from the seeds of the most recent hybrid generation; allowing plants to remain on the vine past the point of normal ripening; and screening for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin.» 11 First referral to the Enlarged Board of Appeal Question relating to the definition of an «essentially biological process»: under which circumstances processes for the production of plants have to be regarded as «essentially biological»? Reply by the Enlarged Board of Appeal in G 1/08: the claimed process is essentially biological and, therefore, not patentable (because no step of technical nature (other than steps of crossing and selecting) introduces itself a trait into the genome or modifies a trait in the genome of the plant produced) 12 Thomas Bouvet, Véron & Associés 6

7 The tomato patent as amended by the patentee in the light of G 1/08 The patentee deletes the process claims The tomato claims as granted remain on file: «A tomato fruit characterized by a capability of natural dehydration while on a tomato plant, natural dehydration being defined as wrinkling of skin of the tomato fruit when the fruit is allowed to remain on the plant after a normal ripe harvest stage, said natural dehydration being generally unaccompanied by microbial spoilage.» NB: The only process for obtaining such tomatoes, described in the patent, was an essentially biological process 13 Second referral to the Enlarger Board on 31 May 2012, question 2 Question 2: In particular, is a claim directed to plants or plant material other than a plant variety allowable even if the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application? Reply of G2/12: 2. In particular, the fact that the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application does not render a claim directed to plants or plant material other than a plant variety unallowable.» 14 Thomas Bouvet, Véron & Associés 7

8 The brocoli saga Relates to a method for selective increase of the anticarcinogenic glucosinalates in brassica species Similar scenario to the tomato case: G 2/07 on 09 December 2010 T 83/05 on 8 July 2013 G 2/13 on 25 March The brocoli saga One additional question: "Is a product-by-process claim directed to plants or plant material other than a plant variety allowable if its process features define an essentially biological process for the production of plants» Main reply of G2/13 «a) The fact that the process features of a product-by-process claim directed to plants or plant material other than a plant variety define an essentially biological process for the production of plants does not render the claim unallowable.» 16 Thomas Bouvet, Véron & Associés 8

9 Reasoning of the Enlarged Board of Appeal There is no general exclusion of patents in the sphere of nature, only a list of specific inventions for which a patent shall not be granted (e.g. Art. 3 Biotech Directive): this suggests that the exceptions to patent eligibility are to be construed narrowly The EU legislator never intended to exclude patent: for plants other than «plant varieties», i.e. other than subject-matter for which protection under PBR system was available for products obtained by an essentially biological process, other than plant varieties 17 Reasoning of the Enlarged Board of Appeal Broadening the scope of the process exclusion to the extent that it included also the products obtained by essentially biological processes for the production of plants would introduce an inconsistency in the system of the EPC, as plants and plant material other than plant varieties are generally eligible for patent protection Those countries that are of the view that plant products obtained by essentially biological processes should not be patentable have chosen to amend their legislation in this respect (Germany, The Netherlands) NB Draft French law on "Biodiversity", forwarded to the Sénat on 18 March 2016: Patents shall not be granted in respect of «products exclusively obtained from an essentially biological process, including the elements constituting these products and the genetic information they contain» 18 Thomas Bouvet, Véron & Associés 9

10 A conclusion consistent with patent rules about product and product-by-process claims This type of claim is clearly a product claim: it protects only the product, not the process The process is only a way to define the product, when there is no other possible definition As a result, the validity of a product-by-process claim does not depend on the patentability of the process What is prohibited is not the use of the process, but only the production of the product, regardless of the used process Resolution of the European Parliament In the Resolution of 17 December 2015 on patents and plant breeders rights the European Parliament expresses its concern that the decisions of the Enlarged Board of Appeal could lead to more patents being granted by the EPO in respect of natural traits introduced into new varieties by means of essentially biological processes such as crossing and selection. 20 Thomas Bouvet, Véron & Associés 10

11 Resolution of the European Parliament The European Parliament : Calls on the Commission and the Member States to ensure that the Union will safeguard guaranteed access to, and use of, material obtained from essentially biological processes for plant breeding Calls on the Commission to clarify the scope and interpretation of Directive 98/44/EC in order to ensure legal clarity regarding the prohibition of the patentability of products obtained from essentially biological processes Calls on the Commission to pursue the exclusion from patentability of essentially biological processes in the context of multilateral patent law harmonisation discussions Questions for debate Should there be patents on plants obtained by an essentially biological process? Should the Biotech Directive be amended? Consider the negative economic consequences of the US Supreme Court case law on laws of nature and products of nature Should the protection conferred by patents on plants be amended so as to match that conferred by plant breeders rights? What is the good balance? 22 Thomas Bouvet, Véron & Associés 11

12 Contact information 1, rue Volney Paris Tel. +33 (0) Fax +33 (0) Thank you for your attention 3, cours Charlemagne Lyon Tel. +33 (0) Fax +33 (0) Thomas Bouvet, Véron & Associés 12