On July 13, 2011, the Advocate General rendered its opinion in the matter of two referrals pending before the European Court of Justice (ECJ) and relating essentially to the validity of supplementary protection certificates (SPCs) on combination products. Here, we will focus on one of the two referrals, namely the Medeva referral. The origin of such referral is the following: Medeva had filed several British SPC applications for various combinations of active ingredients. The applications were based on a patent which did not explicitly claim or disclose all active ingredients forming the subject-matter of the applications. The applications had thus been refused by the British PTO, and while the High Court of England and Wales had confirmed this decision, the Court of Appeal had made a referral to the ECJ. The referral was aimed at obtaining clarifications from the ECJ regarding the interpretation of art. 3(a) of the EC regulation on SPCs, whereby an SPC can be granted if the product forming its subject-matter is “protected by a basic patent in force.”

In the main question, the Court of Appeal had thus asked ECJ to indicate, in the absence of Community harmonization of patent law, what is meant in art. 3(a) of the SPC regulation by “the product is protected by a basic patent in force” and what the criteria should be for deciding this.

As is usual in ECJ referrals, the Advocate General has now issued an opinion indicating a possible answer to the various questions before the ECJ, including the main question in the Medeva referral.

According to the Advocate General, the main question of such referral should be answered as follows: “Whether an active ingredient or combination of active ingredients of a medicinal product forms the subject-matter of a basic patent within the meaning of Article 1(c) [of the SPC regulation] and whether that active ingredient or combination of active ingredients is protected by a basic patent in force in accordance with the requirement of Article 3(a) [of the SPC regulation] are determined, in principle, according to the rules governing the basic patent. However, the definition of the basic patent laid down in Article 1(c) of the regulation precludes use of the protective effect of the basic patent from being invoked as a criterion for the purpose of answering the question whether an active ingredient or combination of active ingredients of a medicinal product forms the subject-matter of a basic patent.”

The next main event in the ECJ referral should now be the issuance of the actual decision of the ECJ. This decision is eagerly awaited by both SPC owners and generic companies alike, both in the pharmaceutical and agrochemical field, as it will likely set out decisive criteria for determining the validity of the many already granted SPCs, and pending SPC applications, having as their subject-matter a group of active ingredients comprising more active ingredients than those explicitly disclosed and claimed in the basic patent.

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