IS NEW RULE 28(2) EPC UNENFORCEABLE? - PLANT PATENTS AT THE EPO AND EXCLUSIONS FROM PATENTABILITY

By: Jim Robertson - Patent Attorney | Partner - Life Sciences

FOR THE LATEST UPDATE, SEE OUR ARTICLE HERE: https://wynne-jones.com/news-events/2018/12/epo-board-of-appeal-finds-that-plants-stararestar-patentable-at-the-epo-rule-28-2-epc-is-unenforceable/

Summary

New Rule 28(2) EPC^[1]came into force on 1 July 2017, and states that:

"(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."

Classical plant breeding processes qualify as "essentially biological processes", as do processes involving the use of technical means which assist in the process^{^[2]}. So this means that according to new Rule 28(2) EPC, plants obtained using classical plant breeding methods (even using modern technical means in the process) should not be patentable.

However, as detailed below, this new Rule 28(2) EPC directly conflicts with (indeed, it is explicitly intended to conflict with) Article 53(b) EPC, as interpreted by the Enlarged Board of Appeal in its decisions G2/12^{^[3]} and G2/13^{^[4]}. As such, it should be unenforceable. Exactly whether that will happen, and how it will happen, is uncertain and so this introduces potential risk and cost for patent applicants and patentees.

The immediate question is therefore what can be done to mitigate any risks for existing patent applications and patents, and what can be done for future patent applications.

In this article, we review the background to the current situation, the legal issues, what will happen next, and look at strategic issues for patent applicants and patentees to take into consideration.

Although this article focuses on the patenting of plants, the same issues apply equally to the patenting of animals.

Background

In its March 2015 decisions G2/12^[3] and G2/13^[4], the Enlarged Board of Appeal found that although essentially biological processes (i.e. methods) for the production of plants cannot be patented, novel and inventive plants or plant material other than a plant variety obtained by means of an essentially biological process can be patented.

These decisions caused some upheaval among various groups including plant breeders and at the European Parliament. Following a European Parliament Resolution^{^[5]}, the European Commission issued a Commission Notice^{^[6]} in which it took the view (note the word "view" here) 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."

The Commission Notice states that "The Notice is intended to assist in the application of the Directive, and does not prejudge any future position of the Commission on the matter. Only the Court of Justice of the European Union is competent to interpret Union law.", i.e. recognises that it is absolutely non-binding and that it has no legislative or judicial effect.

Following the Commission Notice (and despite its non-binding nature), the EPO President then issued a notice^{^[7]} stating that "all proceedings before EPO examining and opposition divisions in which the decision depends entirely on the patentability of a plant or animal obtained by an essentially biological process will be stayed ex officio."

On 29 June 2017 the EPO Administrative Council (most of whose members represent governments of European Union member states) adopted changes^[1] to the Implementing Regulations to the EPC (i.e. to the "Rules"). The changes came into effect on 1 July. New Rule 28(2) has been introduced which reads as follows (emphasis 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."

So this is explicitly intended to directly block the patenting of the products of plant breeding processes which were found to be patentable subject-matter in Enlarged Board of Appeal decisions G2/123 and G2/134.

This action by the representatives of European Union member states at the Administrative Council may itself have been illegal^[8]. However, resolving that may be a long and drawn out process - assuming that a legislative resolution is unlikely, it will ultimately require a referral to the CJEU.

On 1 July 2017 the EPO President lifted the stay on proceedings ^[13] following the Administrative Council decision.

Legal issues - separation of power at the EPO and the impact of new Rule 28(2) EPC

The impact of new Rule 28(2) EPC hinges on the separation of power at the EPO (i.e. legislature, judiciary and executive).

The legislature is the contracting states to the EPC.

The judiciary is the Enlarged Board of Appeal. Its powers are set out in Article 22 EPC^{^[9]}, which says that the Enlarged Board of Appeal is responsible for deciding on points of law referred to it by the Boards of Appeal. Article 112 EPC^{^[10]} confirms that the decisions of the Enlarged Board of Appeal are binding, i.e. that the decisions of the Enlarged Board of Appeal are binding case law.

The executive includes the Administrative Council. Its powers are defined in Article 33 EPC^[11] amongst other things, it is able to amend the Implementing Regulations to the EPC.

Critically, Article 164(2) EPC^{^[12]} says that "In case of conflict between the provisions of this Convention and those of the Implementing Regulations, the provisions of this Convention shall prevail."

Therefore, decisions of the Enlarged Board of Appeal are binding case law for the EPO, and where they relate to the meaning/interpretation of the EPC Articles (the Convention), they can only be overturned by amendment to the EPC itself (not the Implementing Regulations to the EPC, i.e. not the Rules).

So we now have a situation where new Rule 28(2) EPC has been brought into force at the EPO, but it should be unenforceable.

So what will happen next?

Since the stay of proceedings on all affected cases before opposition and examining divisions has been lifted^[13], this should now be a live issue in all of those cases. Indeed, it should be the only issue in all of those cases. Our expectation is that an interpretation of the law similar to the one given above will be submitted by the applicants/patentees in those cases. We expect that many applicants and patentees will be proactive in submitting their comments and observations (rather than waiting for the opposition / examining division to contact them).

Considering the clear conflict between new Rule 28(2) EPC and the interpretation of Article 53(b) EPC given by the Enlarged Board of Appeal, our hope is that the new Rule 28(2) will not be enforced. However, if it is then decisions will inevitably be appealed.

Strategy for patent applicants

So the take home message is that although at first sight new Rule 28(2) EPC is a problem, in real terms it might be much less of an issue. In particular, it should still be possible to obtain parents at the EPO for plants and plant products obtained using essentially biological processes.

For new applications (particularly priority applications), it may be worth trying to side-step this whole issue by checking to see whether the process for the production of plants is really an “essentially biological process” or whether it falls outside of the term as interpreted by decisions G2/07 and G1/08^[2].

For pending applications where proceedings were previously stayed, it may be appropriate to proactively submit comments/observations with regard to the validity/enforceability of new Rule 28(2) EPC.

For pending applications which are earlier in the patenting process at the EPO, it may be worth slowing prosecution until this issue has been finally resolved.

[1] OJ EPO 2017, A56 - Notice from the EPO dated 3 July 2017: https://www.epo.org/law-practice/legal-texts/official-journal/2017/07/a56.html

[2] Decisions G2/07 and G1/08 of the Enlarged Board of Appeal at Reasons 6.4.2.3 ("Conclusions") and ORDER http://www.epo.org/law-practice/case-law-appeals/recent/g070002ex1.html; http://www.epo.org/law-practice/case-law-appeals/recent/g080001ex1.html

[3] G2/12: http://www.epo.org/law-practice/case-law-appeals/recent/g120002ex1.html

[4] G2/13: http://www.epo.org/law-practice/case-law-appeals/recent/g130002ex1.html

[5] Resolution on patents and plant breeders’ rights 2015/2981(RSP): http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2015-0473

[6] Commission Notice 2016/C 411/03: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOC_2016_411_R_0003&from=EN

[7] OJ EPO 2016, A104: https://www.epo.org/law-practice/legal-texts/official-journal/2016/12/a104.html

[8] http://www.cipa.org.uk/policy-and-news/latest-news/observations-of-cipa-on-proposals-to-exclude-organisms-produced-by-biological-processes-from-patentability/

[9] Article 22 EPC: https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar22.html

[10] Article 112 EPC: https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar112.html

[11] Article 33 EPC: https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar33.html

[12] Article 164 EPC: https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar164.html