27 May 2020 in Newsletter
European Patent Office Declares Plants and Animals Exclusively Obtained by Essentially Biological Processes Are Not Patentable
On May 14th, 2020, the Enlarged Board of Appeal of the European Patent Office (EPO) might have ended a legal saga involving a string of G-decisions, by issuing opinion G 3/19 (“Pepper”) and concluding that plants and animals exclusively obtained by essentially biological processes are not patentable.
Article 53(b) of the European Patent Convention (EPC) is the main legal basis with respect to this field. It excludes from patentability “plant or animal varieties or essentially biological processes for the production of plants or animals,” and also states that the exclusion “shall not apply to microbiological processes or the products thereof.” “Microbiological processes,” which may introduce or modify traits in the genome of a microorganism (including bacteria, yeasts, fungi, algae, protozoa and human, animal and plant cells, plasmids, viruses), are distinguished from “essentially biological processes” which involve mere crossing and selection or technical steps that merely assist in crossing and selecting (see, decision G 2/07, called “Broccoli I”, consolidated with G 1/08, called “Tomato I”). On the patentability of biotechnological inventions, Rule 27(c) EPC further stresses that “Biotechnological inventions shall also be patentable if they concern a microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.” The broad term “variety” is important, since it left open the substantial question as to whether specific plants or plant material such as fruit or plant parts could be patented.
In the consolidated cases G 2/12 (“Tomato II”) and G 2/13 (“Broccoli II”), the Enlarged Board of Appeal was indeed concerned with the question whether the exclusion of essentially biological processes for the production of plants in Art. 53(b) EPC had a negative effect on the allowability of product claims or product-by-process claims directed to plants or plant material which are directly obtained and/or defined by an essentially biological process. The EPO concluded that it did not.
However, in another twist in the “Broccoli” saga, following heavy lobbying by various groups, on November 3rd, 2016, the European Commission adopted a notice on certain articles of Directive 98/44/EC on the legal protection of biotechnological inventions (“the EC Biotech Directive”). The notice sets out the Commission’s view that plants and animals obtained by means of “essentially biological processes” are not patentable under the Directive. Therefore, the exclusion of Article 53(b) EPC for “essentially biological processes” was after all to be interpreted broadly to encompass the products thereof. This clarification by the legislator was supposed to overcome the decisions in Tomato II and Broccoli II, which allowed product-by-process claims (i.e. protection for the product) even though the process itself was prohibited under Article 53(b) EPC.
Technically, the EPC is not implemented by the EU and, therefore, the EPO is not really bound by the EU’s interpretations. However, given that most EPC countries are also EU countries, the EU “guidance” by the EU Commission could not be ignored. As a result of this pressure, the Administrative Council of the EPO amended Rule 28 EPC by adding Rule 28(2), in an attempt to align the EPC with the EC Biotech Directive. Rule 28(2) EPC now states: “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.”
In yet another legal twist, in decision T 1063/18, a Technical Board of Appeal ignored the politically motivated change of the law, and decided on December 5th, 2018 that such addition to the EPC Rules was irrelevant, as the Articles are supposed to prevail over the amended Rules in case of conflict (in line with Article 164(2) EPC), and since the case had already been legally decided by the Enlarged Board of Appeal. The Technical Board of Appeal decided that Rule 28(2) EPC was in conflict with Article 53(b) EPC as interpreted by the Enlarged Board of Appeal in Tomato II and Broccoli II, and therefore should be considered void.
On April 4th, 2019 the President of the EPO referred to the Enlarged Board of Appeal points of law on the interpretation of Article 164(2) EPC and the assessment of Rule 28(2) EPC. Under Art. 112(1)b) EPC the following questions were referred to the Enlarged Board of Appeal:
- Having regard to Art. 164(2) EPC, can the meaning and scope of Art. 53 EPC be clarified in the Implementing Regulations to the EPC without this clarification being a priori limited by the interpretation of said Article given in an earlier decision of the Boards of Appeal or the Enlarged Board of Appeal?
- If the answer to question 1 is yes, is the exclusion from patentability of plants and animals exclusively obtained by means of an essentially biological process pursuant to R. 28(2) EPC in conformity with Art. 53(b) EPC which neither explicitly excludes nor explicitly allows said subject-matter?
By answering yes to both questions in decision G 3/19 (“Pepper”), the Enlarged Board of Appeal has adopted a dynamic interpretation of the exception to patentability under Article 53(b) EPC. The Enlarged Board endorsed its earlier findings on the scope of Article 53(b) EPC, which were based on the classical (i.e. the grammatical, systematic, teleological and historical) methods of interpretation. However, the Enlarged Board found that “a particular interpretation which has been given to a legal provision can never be taken as carved in stone, because the meaning of the provision may change or evolve over time.” Plants and animals exclusively obtained by essentially biological processes are thus not patentable, which should at least mitigate the tension over the overlap between patent rights and plant breeder’s rights.
Patent proprietors and Applicants in this field should also note that the Enlarged Board further ruled that the new interpretation of Article 53(b) EPC given in Pepper has no retroactive effect on European patents containing such claims which were granted before July 1st, 2017, (i.e., when Rule 28(2) came into force) or on pending European patent applications seeking protection for such claims which were filed before that date.