IP-Fälle und Artikel

An illusion of clarity – the new Rule 28(2) EPC

The European Patent Office has amended its rules in relation to the patentability of products derived from essentially biological processes.

In December 2016, we reported on events at the EU and at the EPO in relation to the subject matter of plants or animals obtained by an "essentially biological process".

To summarise:

  • 08 November 2016 – The European Commission issued its comments inter alia on how they believed Article 4 of the "Biotech Directive" 98/44/EC should be interpreted (see link, right); their interpretation went against to that decided on by the Enlarged Board of Appeals in G2/12 and G2/13 (the "Tomato" and "Broccoli" cases)
  • 12 December 2016 – The EPO stayed all pending proceedings in respect of patents and applications directed to plants or animals obtained by an "essentially biological process"

Changes to Rules 27 and 28 EPC

The Administrative Council of the EPO on 29 June 2017 amended Rules 27 and 28 EPC, with effect from 01 July 2017.

Essentially, Rule 28 EPC gained a new paragraph (2):

Rule 28(2) EPC: "(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.
Rule 27 EPC has been amended to simply reflect the change to Rule 28:
Rule 27(b) EPC: "(b) 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;

The intention is quite clear – these changes essentially bring the interpretation of the Biotech Directive (which is itself implemented into the EPC) into line with that suggested by the European Commission.

As a result, the stay of proceedings at the EPO has been lifted, and pending examination and opposition proceedings will continue in light of the new rules.

An uncertain future

Prior to the decision of the Administrative Council, CIPA had already submitted their own comments on the proposed changes (http://www.cipa.org.uk). A key issue discussed is the fact the uncertainty over Article 4 of the Biotech Directive – which is at its heart a piece of EU legislation applicable to EU member states – has not been settled by the Court of Justice of the European Union (CJEU). However, its interpretation under new Rule 28(2) EPC can lead to the denial of a right (a patent) to individuals filing within an EU member state by a body which has no competency to refer a question to the CJEU. This can be seen as a contravention of Article 267 TFEU.

There is also the possibility of challenges to the applicability of Rule 28 EPC under the EPC.

The decision of the Administrative Council does not make any reference to G2/12 or G2/13. Under Article 112 EPC, decisions of the Enlarged Board of Appeal are binding, and thus in theory "Tomato" and "Broccoli" remain binding for the interpretation of Article 53(b) EPC. As Article 53(b) EPC itself has not changed, and Article 164(2) EPC states that the Articles prevail over the Rules of the EPC upon conflict, questions will remain over the ultimate effect of the present change.

There is no doubt that this subject will remain in the spotlight for years to come as both examination and opposition cases finds their way to the Boards of Appeal.

Future applications

Notwithstanding the ongoing discussion around the legality of patents directed to plants and animals produced through “essentially biological processes”, it should be expected that applications and patents with claims towards such matters still in pending proceedings before the EPO will likely be refused or revoked respectively unless the offending claims are removed. Despite this, it is still important to highlight that the new rule only relates in a broad sense to products made through classical breeding and selection (see decisions G2/07 and G1/08 for previous interpretations of “essentially biological process”).

  • Transgenic plants and animals with a particular trait characteristic which are not defined by a particular variety or species remain eligible for patent protection, provided the requirements for patentability are met. Similarly, the biotechnological processes used to make them are also eligible.
  • If plants and animals created through breeding remain commercially important, it may still be relevant to include passages pertaining to such products in the claims and/or the description, as different national laws exist on the matter.
  • Plant variety rights can also be important to protect varieties generated through plant breeding.

We remain committed to protecting your commercial interests so please do not hesitate to get in contact with us if you have any further questions in light of this rule change.

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