These proceedings started with the filing of a nullity action against the Portuguese supplementary protection certificate (SPC) that protects the combination product of the active substances Ezetimibe+Simvastatin, of the pharmaceutical company Merck Sharp and Dohme Corp. (MSD).
This higher court was called upon to analyse whether the grant of the abovementioned SPC was valid in accordance with subparagraphs (a) and (c) of Article 3 of Regulation (EC) No 469/2009 (“Regulation”), and the decision given ruled that the SPC met the requirements to be validly registered.
I. Facts and Background
MSD was the holder of the basic patent EP 0 720 599 B1 (“basic patent”), which has meanwhile expired, containing claims directed to Ezetimibe (claims 1 and 8) and to the combination of Ezetimibe and a cholesterol biosynthesis inhibitor (claim 9). This patent also claims, inter alia, a combination of Ezetimibe with Simvastatin (claim 17).
On the basis of the said basic patent, MSD obtained an SPC which refers to the marketing authorisation (MA) for the drug Adacai® (Ezetimibe), and subsequently an SPC which refers to the MA for the drug Inegy® (combination of Ezetimibe+Simvastatin).
A generic company filed a nullity action against the SPC of MSD for the combination product Ezetimibe+Simvastatin, alleging non-fulfilment of subparagraph (a) of Article 3 of the Regulation.
The Court of Intellectual Property ruled the said action to be inadmissible and therefore did not declare the nullity of the SPC in question.
The generic company appealed against this decision to the High Court of Lisbon, which unanimously upheld the decision of the court of first instance.
II. Issues submitted for assessment by the Supreme Court of Justice (SCJ)
In the appeal on a point of law lodged by the generic company, the issues that were submitted for assessment by the SCJ essentially concerned whether the SPC in question is valid in the light of the requirements laid down in subparagraphs (a) and (c) of Article 3 of the Regulation.
i. Article 3(a) of the Regulation
The SCJ concluded that the combination of the active substances (Ezetimibe+Simvastatin) is protected by the basic patent, within the terms of Article 3(a) of the Regulation.
This understanding was based essentially on paragraph 37 of the judgment of the Court of Justice of the European Union (CJEU) in Teva v Gilead of 25 July 2018 (C-121/17), which ruled that:
It was thus concluded that the requirement of subparagraph (a) was fulfilled, in view of the fact that in the basic patent, namely in claim 17, the abovementioned combination of active substances is expressly provided for.
The SCJ further deemed that for the analysis of the fulfilment of subparagraph (a), the concept of core inventive advance must be excluded, having cited, among others, paragraphs 30-32 of the judgment of the CJEU in Royalty Pharma (C-650/17), rendered on 30 April 2020.
The SCJ quoted the decision of the Court of Appeal of England and Wales issued on 19/12/2019 (case Teva UK Ltd, Accord Healthcare Ltd, Lupine Ltd, Lupine (Europe) Ltd and Generics Ltd (UK) against Gilead Sciences, Inc.), conferring a particular emphasis on the argument of Lord Justice Floyd, who interpreted abovementioned judgment C-121/17 of the CJEU in the sense that it is not required for the product to represent an advance or innovative technical contribution:
“I do not think that by using the term ‘fall under the invention covered by the patent’ the court is intending to refer to the inventive advance or technical contribution of the patent. The court has definitely set its face against the introduction of such a test. Although there is no reference to it in the reasoning of the court in the reference in this case, the retention of such a test would be inconsistent with the proposition in paragraph no. (37] of the court’s judgment. That paragraph states that express mention of the active ingredient in the claim is enough. Express mention in a claim says nothing about whether the added ingredient forms part of the inventive advance. Furthermore, the opinion of Advocate General Wathelet in that case and (since the Second Judgment) that of Advocate General Hogan in Sandoz v Searle, both roundly reject such a test. Whatever might be said for it from a policy point of view, it must now be regarded as wrong.”
ii. Article 3(c) of the Regulation
The SCJ also ruled that the SPC in question fulfils the requirement of subparagraph (c) of Article 3 of the Regulation, that is, the requirement that “[the] product has not [already] been the subject of a certificate”.
Regarding this point, the SCJ concluded as follows: “By understanding, as we understand, that the combination of ezetimibe with simvastatin is a product protected by the basic patent in the sense of Art. 3(a) of Regulation (EC) No 469/2009, it should be understood that the inventions covered by the basic patent are two – ezetimibe and the combination of ezetimibe with HMG CoA reductase inhibitors, such as simvastatin – and that, although ezetimibe had been the subject of a Supplementary Protection Certificate (SPC 150), the combination of ezetimibe with simvastatin could be the subject of Supplementary Protection Certificate 189.”
It must be pointed out that the SCJ considered that since it was concluded that the association or combination of Ezetimibe with Simvastatin is a product protected by the basic patent, within the meaning of Article 3(a), this determines, in substance, the reply in the sense that supplementary protection certificates 150 and 189 have as their subject matter different products protected by the basic patent.
The SCJ based this conclusion particularly on the decision of the CJEU given in respect of the case Georgetown University/Octrooicentrum Nederlandof 12/12/2013 (C‑484/12), which states that:
“In circumstances such as those in the main proceedings, where, on the basis of a basic patent and a marketing authorisation for a medicinal product consisting of a combination of several active ingredients, the patent holder has already obtained a supplementary protection certificate for that combination of active ingredients, protected by that patent within the meaning of Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, Article 3(c) of that regulation must be interpreted as not precluding the proprietor from also obtaining a supplementary protection certificate for one of those active ingredients which, individually, is also protected as such by that patent.”
On the basis of the analysis made, the SCJ drew the following conclusions:
I. – Article 3(a) of the SPC Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products should be interpreted in the sense that a product that is composed of several active ingredients of combined effect is “protected by a basic patent in force” when the combination of the active ingredients of its composition is expressly mentioned in the basic patent claims or, even if not expressly mentioned in the basic patent claims, when it is implicitly, but necessarily, addressed in the basic patent claims.
II. – The combination will be implicitly, but necessarily, addressed in the claims as long as it complies with three cumulative conditions: first, the combination of active ingredients should correspond to the “functional definition included in the claims of a patent”; secondly, “the combination [of] active ingredients should necessarily be encompassed, in the light of the description and the drawings …, by the covered invention [by the patent]” and, thirdly, “each one of the (…) active ingredients should be specifically identifiable, in the light of all the elements disclosed by the said patent”.
III. – In any case, it is not necessary that the product results “in an individualised form, in terms of a concrete composition, from the technical specifications of the (…) patent” – it is sufficient that it results from the combined disclosed elements, considered by a skilled person in the art, “based on his/her general knowledge in the domain under discussion”.
IV. – Article 3(c) of the SPC Regulation (EC) No 469/2009 should be interpreted in the sense that as long as a basic patent protects several distinct products, the holder can, in principle, obtain several supplementary protection certificates, each one being related to each of such products, “provided that namely each one of them is ‘protected’ as such, by that ‘basic patent’ as ruled by Article 3(a) of the SPC Regulation (EC) No 469/2009, interpreted in conjunction with its Article 1(b) and (c)”.