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The End of Patents for Conventionally Bred Crops at the EPO

In what many saw as a surprising and unprecedented move, the European Patent Office's Enlarged Board of Appeal on 14 May 2020 overturned its own previous case law and found that products (exclusively) obtained from essentially biological processes are excluded from patentability under Article 53(b) of the European Patent Convention (“EPC”).


Picture credit: Samantha Beaty, Unsplash.com

Background

According to Article 53(b) EPC, “plant or animal varieties or essentially biological processes for the production of plants or animals” are excluded from patentability. In its previous decisions of 25 March 2015 in cases G2/12 (“Tomato II”) and G2/13 (“Broccoli II”), the Enlarged Board of Appeal held that this exclusion did not cover the products (i.e. plant or animal material) resulting from such essentially biological processes, but only the processes themselves.

In cases G1/08 (“Tomato I”) and G2/07 (“Broccoli I”), the Enlarged Board had already broadly circumscribed such processes as basically any breeding process involving the steps of crossing and selecting, regardless of the addition of technical steps, such as the use of molecular markers.

In the wake of the Tomato II and Broccoli II decisions the Council of the European Union in 2017 adopted[1] the European Commission’s Notice[2] of 2016, essentially claiming that the EU did not want (and never intended for) conventionally bred products to be patented and thus calling on the European Patent Office (“EPO”) to change its (case) law.

The EPO listened and by the decision of 29 June 2017, the Administrative Council of the EPO added a new, second paragraph to Rule 28 of the Implementing Regulations to the EPC, according to which “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”. The decision entered into force on 1 July 2017.


Not everyone within the EPO agreed with this development and on 5 December 2018, in case T 1063/18 (the “blocky pepper” case) [1], the Technical Board of Appeal of the EPO (in an enlarged composition consisting of three technically and two legally qualified members) ruled that the new Rule 28(2) was incompatible with Article 53(b) EPC, as previously interpreted by the Enlarged Board in the Tomato II and Broccoli II decisions. Since, in view of Article 164(2) EPC, the provisions of the EPC prevail, Rule 28(2) EPC was therefore held void.

In turn, the President of the EPO, as a direct result of the decision in case T 1063/18, referred new questions to the Enlarged Board, essentially asking the Board (i) whether it was legally possible for Rule 28(2) to “clarify” Article 53(b) EPC (rather than being in contradiction with it) and (ii) whether it inclined to revise its earlier decisions in Tomato II and Broccoli II.


The Enlarged Board’s “Blocky Pepper” decision of 14 May 2020

In the Tomato II and Broccoli II decisions, the Enlarged Board had declared that neither the EPC nor the EU’s Biotech Directive [2] provided a legal basis for extending the exclusion of essentially biological processes to the plants produced by such methods.


Apart from the fact that many believed the EPO President’s questions were outright inadmissible, it thus came as a surprise to many that on 14 May 2020, the Enlarged Board overturned its own Tomato II and Broccoli II case law (case G 3/19).

The “Blocky Pepper” patent was essentially directed to a pepper plant with new physicochemical characteristics and an extremely dark green color linked to the pigment content of the pepper fruit. It was bred on the basis of a process involving crossing and selection, i.e. an essentially biological process. The Enlarged Board held this invention to be ineligible for patent protection on the ground that the non-patentability of essentially biological processes for the production of plants or animals also extends to plant or animal products that are exclusively obtained by means of such essentially biological processes.


In trying to strike the right balance to justify this unexpected turnaround, the Enlarged Board adopted a “dynamic interpretation” of Article 53(b) EPC. While endorsing its earlier findings in Tomato II and Broccoli II, which were based on a classical (i.e. the grammatical, systematic, teleological and historical) interpretation of the EPC, the Enlarged Board proclaimed that a particular interpretation of a legal provision is never carved in stone, because the meaning of the provision may change or evolve over time. In that regard, the Enlarged Board particularly referred to developments that took place after its previous decisions in the Tomato II and Broccoli II cases, such as the abovementioned Commission Notice, the adoption of Rule 28(2) EPC and the amendments made by several EPC countries (such as The Netherlands, France and Belgium) to their national patent laws to expressly exclude products obtained by essentially biological processes from patentability. On that basis, the Enlarged Board concluded that Rule 28(2) EPC was not in contradiction with the language of Article 53(b) EPC, as many had claimed, but provided a final interpretation of Article 53(b) which now needed to be accepted.


Practical significance

The direct result of the Enlarged Board’s blocky pepper decision is that in the future no further patents can be obtained at EPO level for conventionally bred crops or their propagating material. Bearing in mind that many individual EPO countries have meanwhile introduced similar exclusions from patentability into their patent laws, the result will be the same at the national (i.e. non-EPO) level. That being said, neither those national laws nor the EPO’s blocky pepper decision preclude the possibility to still patent plants resulting from a process of genetic engineering (which in the EU, however, face other, regulatory concerns).


Importantly, in an attempt to secure at least some form of legal certainty for breeders, the Enlarged Board clarified that its blocky pepper decision does not affect the validity of patent claims containing the now excluded subject-matter granted or applied for prior to 1 July 2017 (the date of the entry into force of Rule 28(2) EPC)). If you were lucky enough to have filed a patent application for a conventionally bred plant prior to that date, the EPO will thus commence (if examination had not started yet) or resume (if examination had been suspended pending the outcome in the blocky pepper case) the examination of that application (and approximately 300 others). Despite attempts from certain EU member states to obtain the opposite result, patents for conventionally bred crops applied for or granted prior to the start of this turmoil should, therefore, remain enforceable.


The blocky pepper decision thus marks the end of more than a decade of discussions on this topic. Whether this is the absolute end of the story will have to be seen because, strictly speaking, the EU Court of Justice, in interpreting the similar (but not identical) exclusion provisions of the EU’s Biotech Patent Directive, may still disagree with the Enlarged Board's findings…


[1] Reported here by CIOPORA. [2] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.


About the author:

Philippe de Jong

Partner at Altius, Belgium


Philippe specialises in Intellectual Property law, with particular focus on Patents, Plant Variety Rights and parallel import issues. Philippe also has extensive experience in regulatory matters concerning the life sciences and agri-food industries. Philippe regularly lectures at conferences and seminars and publishes articles in various leading legal journals relating to his area of expertise. Philippe worked as a consultant for the EU Plant Variety Office and is also an active member of the Euroseeds, the European Patent Lawyers Association (EPLAW), the Licensing Executives Society (LES), and CIOPORA.

© 2019 by CIOPORA

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