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Wednesday, 26 July 2017

EPO takes an ‘about turn’ on the patentability of products obtained by essentially biological processes

The IPKat faces down Broccoli 
At the end of June the EPO published a notice (see here) stating from 1 July 2017 plants and animals exclusively obtained by means of an essentially biological process will no longer be patentable.  With thanks to Gemma Barrett (Bristows) who explains what this means:  
"Many readers will be aware that the EPO's Notice represents a U-turn for the EPO following the decisions of the Enlarged Board of Appeal (EBA) in 2015 in the Tomato II and Broccoli II cases (G2/12 and G2/13). Here the EBA conducted a lengthy and in-depth legal analysis leading to the conclusion that a narrow interpretation of Art 53(b) EPC was appropriate and as a result plants and animals derived from essentially biological processes were in principle patentable, even if they were inevitably derived from such processes.

The law seemed settled until the European Parliament asked the EU Commission to consider various issues concerning the Biotech Directive (Directive 98/44/EC). The exclusion to patentability in the Biotech Directive is framed much like that in Article 53(b) EPC i.e. it expressly excludes from patentability essentially biological processes for the production of plants and animals but does not mention products derived from such processes. The Commission reviewed the context and provisions of the Biotech Directive and published a notice on 3 November 2016 (Notice 2016/C 411/03) concluding that the European Union legislators’ intention when adopting the Biotech Directive was to exclude such products from patentability. 
In response to the Commission Notice in November last year the EPO stayed all proceedings in relevant examination and opposition cases ex officio. This remained the situation until the EPO notice published at the end of last month.
The Commission’s Notice states that it is intended only as guidance and, in any event, the EPO is not bound by the views of the Commission nor any decision of the Court of Justice of the European Union (CJEU) on interpretation of these provisions. So why the change in position by the EPO? The EPO notice states that the decision has been taken by the Administrative Council to safeguard uniformity in harmonised European patent law. It seems the EPO wanted to avoid future divergent decisions on this issue around Europe for example between EU member states and between these member states and the EPO. In addition, the Biotech Directive itself is relevant to the EPO when considering patentability. The EPC Implementing Regulations were amended to include its main provisions and it is used as a supplementary means of interpretation (see Rule 26(1) EPC). In these circumstances the possibility of legal disharmony seemed inevitable.

Following the EPO notice the Administrative Council has amended Rules 27 and 28 of the Implementing Regulations to the EPC and these changes came into force on 1 July and apply to European patent applications filed on or after this date, as well as European patent applications pending at that time. The key provision in Rule 28(2) now reads:
“(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.”
This may at first sight appear to be the end of the saga but is it? The Commission Notice is clear that it is a guideline document only, merely to assist in the application of the Biotech Directive, and only the CJEU is competent to rule on the interpretation of EU law. Hence there could still be a reference to the CJEU in the future."

8 comments:

Anonymous said...

Not that I (a non biologist type) followed the recent EBA decisions deeply, but it seems odd that the EBA decision's have been overruled in this way??

Perhaps I am thinking about this too simply.

Anonymouse

Albert R. Broccoli said...

Well, you're NOT thinking too simply about it - in fact, people who think the situation has now been clarified might be the ones thinking too simply about it.
The Examining Division and the Opposition Division are probably going to apply the new rule and reject these types of plants, but these decisions will typically be appealable, so appealers gonna appeal. The boards might then consider the new Rule to be inconsistent with the Article and their own case law, and therefore choose to ignore the new Rule. Thus, in appeal the plants might still turn out to be patentable. The future will tell.

Patented Potatoe said...

In its decision Art 23 1/16 the EBA explicitely stated that it felt threatened by the President of the Office, and not protected by the Administrative Council, in a disciplinary case which a few weeks ago culminated in the dismissal by the AC of a member of the boards of appeal, in violation of Art 23 EPC.
Can anybody in these circumstances reasonably expect the boards to question the new rule?

Anonymous said...

The new rule is illegitimate. CIPA have produced an excellent position paper on this:

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

THE US anon said...

Nice - do you all want to borrow the concept of stare decisis from us in the US?

;-)

James said...

Rule 26 EPC refers to the Biotech Directive, and Directives need to be interpreted via the EU. Therefore there is an argument that the EPO is bound by the interpretation of the EU on any rules that derive from the Biotech Directive. I understood that is what the purpose was of referring to Biotech Directive in the EPC, and so surely the logical thing to do in this situation is to follow the EU line on the issue of products of biological processes. Having a divergent interpretation between the EPO and EU creates too many problems otherwise.
___________
Rule 26
General and definitions

For European patent applications and patents concerning biotechnological inventions, the relevant provisions of the Convention shall be applied and interpreted in accordance with the provisions of this Chapter. Directive 98/44/EC of 6 July 1998[ 33 ] on the legal protection of biotechnological inventions shall be used as a supplementary means of interpretation.

Anonymous said...

If I understand those smart folks at CIPA correctly - its not just odd, but cat-on-hot-tin roof odd!!

Anonymouse

Anonymous said...

I'm knowledgeable neither in biotech nor in international law, but what I find especially baffling is that (unless I missed something big) this "about turn" will also have effects in non-EU EPC states, e.g. Turkey, Serbia, Switzerland, and so on. What about the obligations of those states with respect to e.g. TRIPS? Will deep-pocketed patent applicants try to mount challenges before the courts of these member states as well?

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