Darunavir - UK

On Jan 25, 2018, Lord Justice Floyd of court of appeal stayed the appeal proceedings and referred the question to the CJEU in ‘Darunavir SPC’ case.

The SPC in question is “SPC/GB07/038” for a product described in the SPC as “Darunavir or the pharmaceutically acceptable salt, ester, or prodrug thereof”.  The SPC covers a product marketed in Europe by companies associated with the second respondent under the trade mark “Prezista”.  It is a protease inhibitor used in an anti-retroviral medication for the treatment of the HIV virus and AIDS.  The respondents contend that the product described in the SPC was protected by European Patent (UK) No 0 810 209 (“the patent”)

In a decision dated 3 May 2017, Arnold J decided that darunavir was a product protected by the patent. He declined to refer questions to the CJEU on the interpretation of Article 3(a) of the SPC Regulation because he considered that, on all tenable constructions of Article 3(a), darunavir was protected by the patent. Appellants (Sandoz Ltd & Hexal AG) appeal from that decision and his consequent order. 

Below are some Lord Justice Floyd’s comments on the present issue:--

Specifically Lord Justice Floyd of court of appeal said that, “CJEU’s requirement, formulated for the first time in Eli Lilly, that, in order to be protected by the basic patent, the claim must relate to the product implicitly, but necessarily and specifically as “the Lilly requirement”.  If it were possible to say that the Lilly requirement is limited to functional claims, or alternatively, if it applies to all claims, that it is always satisfied by a Markush claim which covers the active ingredient, then it would follow that the appeal must be dismissed.  If the position is not clear, however, we may have to refer a question to the CJEU.”

 “In the case of a SPC with a single active ingredient, the reasoning in Medeva requires that the basic patent protect that active ingredient as such.  The reasoning is not informative as to how specifically the claims must focus on the active ingredient, or what underlies the requirement that they should do so. Also it is not clear that the CJEU's judgment in Eli Lilly takes the matter much further. Eli Lilly was specifically concerned with functional claims. Functional claims and structural claims are fundamentally different in terms of what they require the skilled person to do in order to determine whether a particular product is specified by a claim”. 

“The adoption of the core inventive advance test remains a possibility given the pending references from in Sitagliptin and Teva v Gilead, and the fact that it is becoming clear (see Actavis v Novartis, Actavis v Boehringer) that the possible abuse identified by the Advocate General in Medeva can be dealt with through Article 3(c).  If that test were adopted across the board and applied here, despite Ms May’s (Appellants representative) submissions concerning its application (which I reject), I have no doubt that the SPC would satisfy Article 3(a)”.  

“In case it would assist the Court of Justice I will express my provisional conclusion.  Left to myself, I would have concluded that darunavir was a product protected by the claims of the patent. In the case of a product with a single active ingredient and a patent with a claim which identifies a number of compounds by means of a Markush formula, all of which compounds embody the core inventive technical advance of the patent, the test should be whether the skilled person, considering the claims of the patent on the one hand and the structure of the product in question on the other, would immediately recognise that the active ingredient in question is one of those specified by the formula.  On the facts of the present case as found by the judge, that test is satisfied.  However, for the reasons I have given, it is not clear that this is the correct approach in EU law”.

Lord Justice Floyd therefore proposed that this court should stay the present appeal proceedings and refer the following question to the CJEU:

“Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] is 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?”