In European Union (EU), Intellectual Property Rights (IPR) on plants are protected by both Plant Variety Rights (PVR) and Patents. While the PVRs are granted by the Community Plant variety office (CPVO) established under UPOV Convention (International Union for protection of new varieties of plants), the patents related to plants are granted if the technical feasibility of the invention is not confined to a particular plant variety by the European Patent Office (EPO), which operates under the guidance of European Patent Commission (EPC). Thus, there is a clear distinction between a plant and a plant variety, which is covered under the UPOV Convention. Given below are the provisions relating to patentability of plants and plant varieties in Europe.
Provisions relating to IPR protection of plants in Europe:
As per article 5 of the UPOV convention, the breeder’s right is granted where the variety is new, distinct, uniform and stable.
As per the article 15 of the UPOV convention, exemptions to plant variety protection is granted for (i) acts done privately and for non-commercial purposes, (ii) acts done for experimental purposes and (iii) acts done for the purpose of breeding other varieties, and, except to provisions referred to in Article 14(1) to Article 14(4) which are subject matter off Article 14(5) regarding scope of breeder’s Rights under the UPOV act.
As per article 53 (b) of EPC, which describes exceptions to patentability, “Plant or animal varieties or essentially biological processes for the production of plants or animals are excluded from patentability ; this provision shall not apply to microbiological processes or the products thereof;”
The Guidelines for patent examination of EPO based on EPC exemplifies subject matter related to essential biological processes, which is excluded from patentability as follows.
Method for the production of plants having trait X comprising crossing plants A and B and selecting progeny having marker X.
Use of a (transgenic) plant for generating further plants.
Use of a (transgenic) animal for breeding.
Introgression of a (transgenic) trait X into a plant.
Methods for plant breeding by crossing of whole genomes and selection of plants comprising the step of embryo rescue.
In view of increasing role of biotechnology inventions, the EU issued a directive 98/44/EC in 1998, which is also called as Biotech Directive, for description of various aspects of legal protection of biotechnological inventions. The directive came into force in 1999 (http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31998L0044). The Biotech directive provides guidelines on patentability of biotechnological inventions in Europe.
Despite the clear directives of EU, there were some grey areas and lack of clarity on patentability on the products of essential biological processes and distinction with respect to Plants, Parts of Plants, Plant varieties and biotechnology invention. This led to litigations on issue of patentability in Europe. Given below are some of the landmark cases, which had impact on patent law in Europe.
Case law based on The Novartis (G 1/98) decision (Methods of genetic transformation for production of anti-pathogenic hydrolytic enzymes and lytic peptides in plants): The transgenic plants with synthetic Chitinase gene can be developed in many crops using this method. The EPO refused a grant of a European patent for the Novartis application citing Article 53(b) “plant variety” exception. Novartis appealed to the EPO Technical Board of Appeals. The Technical Board of Appeals further decided that law should be referred to the Enlarged Board of Appeals (EBA-EPO). Taking the substantive and literal approach, the EBA-EPO in 1999 decided that a patent directed to plants can be granted, for an invention when claims are not limited to a particular plant variety. This case specifically highlights the relationship between the plant breeders’ rights for plant varieties under the UPOV Convention and the “plant varieties” exception to patentability under Article 53(b) of the EPC.
Case law based on Tomato-II (G2/12)/Broccoli-II (G2/13) patent decisions finally made in 2015 by EBA-EPO: Both decisions by the EBA of EPO states that “plants or seeds obtained through a conventional breeding methods are patentable.” The “Tomato II” case was on a “method for breeding tomatoes having reduced water content and product of the method;”, while Broccoli case involved a “method for selective increase of the anticarcinogenic glucosinolates in brassica species.” According to the EBA-EPO, the decisions (reached by the EBA state that “Plant products such as fruits, seeds and parts of plants are patentable in principle under the EPC, even if they are obtained through essentially biological breeding methods involving crossing and selection.
The Tomato & Broccoli cases in particular led to conflicts in patenting of plants and plant varieties due to researchers exemptions and other Freedom to Operate (FTO) provisions of plant breeders, due to overlap between plant variety protection and patent protection, thereby questioning the legislator intent of exclusions to patentability under Article 53 (b) of EPC.
Taking cognizance of ongoing patentability issues in EU, the EU parliament deliberated on the matters relating to the patentability of essential biological process and passed resolution on 10 May 2012, “the European Parliament calls on the EPO also to exclude from patenting products derived from conventional breeding and all conventional breeding methods, including SMART breeding (precision breeding) and breeding material used for conventional breeding.
The Expert group itself was constituted by European commission in 2012 for studying the technical and legal positions on patentability of biotechnology inventions based on EU parliament’s resolution in 2012.
A case in a point is, if the provisions of Article 53(b) are applied to plants derived from conventional breeding in the same way as they are applied to genetically engineered plants, the prohibition of patenting plant varieties and the products derived from essentially biological will become meaningless as per the analysis made by the “Expert Group report on implication of biotechnology inventions on patentability in its report submitted to EPC in 2016”.
Based on the above the expert group concluded as follows.
It can be concluded, that in the context of essentially biological processes, patents cannot be allowed if they overlap with the provisions of plant variety protection.
Furthermore, it can be assumed that such an interpretation of patent law can be made without counteracting the intention of the legislator of the EPC or Directive 98/44/EC.
Conversely, such a clarification would be to Article 53(b) EPC that prohibits patents on essentially biological methods for breeding.
Also the expert report concludes that there is no legal basis for an argument saying that those plants that cannot be protected under the plant variety protection (PVP) system should have the possibility to be protected under patent law.
European Commission (EC) Decision on 3rd November 2016: Considering the finding of the Expert committee report, the EC in its notification on 3rd November 2016, concluded that “The European Commission takes the view that the EU legislator's intention when adopting Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes.”
Based on the above EC’s decision, the EPO stayed all proceedings in examination and opposition cases in which the invention is a plant obtained by an essentially biological process on 12th December 2016.
EPO decision: On 29th June 2017, the EPO took a decision by amending rules 27 and 28 of EPC with respect to exclusion of patents from essentially biological processes. The decision came into force from 1st July 2017.
Rule 27: Patentable biotechnological inventions (http://www.epo.org/law-practice/legal-texts/html/epc/2016/e/r27.html)
Biotechnological inventions shall also be patentable if they concern:
Biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;
without prejudice to Rule 28, paragraph 2, plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety;
Rule 28 of the Implementing Regulations to the EPC shall be amended as follows: The current text shall become paragraph 1 (a) to (d). The following new paragraph 2 shall be added:"(2) Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process."
Subsequently in its notification on 3rd July 2017, the EPO announced that all cases relating to essentially biological processes will resume as per the new direction thereby signaling the implementation of the new Rules.
The decision on exclusion of patentability of essential biological processes is an unprecedented decision (as it stands directly in contradiction with the decision of Enlarged Board of appeals in case of Broccoli and Tomato), as it provides clarity with respect to exclusion of any patents directed to the products of essentially biological processes including exclusion of all patents on the plants or plant varieties derived from transgenic plant varieties.
As can be seen from the above, the Indian PPVFR Act is ensuring a more balanced approach to encourage development of GM traits which are indirectly protected through a benefit share mechanism. The UPOV may have to adopt this provision in view of the new ruling of the EPO on biotech inventions.