A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday, 6 April 2018

An SPC Hat-trick: a THIRD referral under Article 3(a) heads to the CJEU

Many thanks to Nicholas Fischer and Andrew Hutchinson (Simmons & Simmons) for sharing their article (here) on the latest referral to the CJEU on SPCs from the UK Court, which will be published in Bio-Science Law Review.

In short summary, the UK Court of Appeal referred another question to the CJEU seeking clarity concerning the correct interpretation of Article 3(a) of the SPC Regulation. This makes it a hat-trick of referrals (England 2 – Germany 1) trying to understand what it means for a product to be ‘protected’ by a patent. This referral follows Sandoz’s appeal of Arnold J’s first instance decision, in which the outcome was held to be clear (in favour of SPC grant), even if the legal test was not. The UK Court of Appeal has overturned Arnold J’s decision, stayed the appeal and referred another question to the CJEU.

The question asked by the Court of Appeal is:
“Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?”
Following the CJEU hearing the Teva v Gilead referral on Article 3(a) on 20 February (sitting as a Grand Chamber of 15 Judges) it will be interesting to see whether they deliver an overarching decision on Article 3(a) or approach this step-wise via the subsequent referrals from Germany and now the UK. We have heard that there will be an AG opinion in that case on or around 25 April so watch this space.

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