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.

More questions for the CJEU from the High Court

In two separate decisions handed down last Friday, Teva UK Limited & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) and Abraxis Bioscience LLC v The Comptroller-General of Patents [2017] EWHC 14 (Pat), Mr Justice Arnold has decided to send more questions to the CJEU for a preliminary ruling.

In Teva UK Limited & Ors v Gilead Sciences Inc, at [95], Mr Justice Arnold repeats question 1 of the Actavis v Sanofi case:

"What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation?"

In Abraxis Bioscience LLC v The Comptroller-General of Patents, the question is (at [62]):

"Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?"

High Court upholds IPO's decision on Circadin

In December 2009, we reported that the Intellectual Property Office refused an SPC application for Circadin on the grounds that the application did not comply with Article 3(d) of the SPC Regulation.

The High Court has upheld the IPO's decision. Following a review of the provisions of Regulation 469/2009 and case law of the Court of Justice (Pharmacia, MIT and Yissum), Arnold J. held that "Yissum is fatal to Neurim's case on this appeal". He also considered that the interpretation of Article 3(d) is acte claire.

You can read the decision here.