Today the European Court of Justice (ECJ) has finally issued a long-awaited ruling clarifying one of the requirements that must be met for a supplementary protection certificate (SPC) to be validly granted in the EU.

As is known, if a certain patent relates to a certain active pharmaceutical ingredient (API), and a marketing authorization (MA) is then granted for that API, an SPC can be applied for and granted on the basis of that patent, so as to extend the life of the patent with respect to the API in question and thereby recover some of the patent life spent waiting for the MA to be granted.

Of course, the SPC should only be granted, and is only valid, if the provisions of the relevant European regulation (Regulation (EC) No 469/2009) are met. One of the provisions is, according to Article 3(a) of such regulation, that the API be “protected” by the patent on which the SPC is based.

Today’s ECJ ruling indicates what should be understood under such requirement.

In particular, the cases that triggered the ECJ ruling was a case where
• the basic patent claimed API A,
• the MA had been granted for a combination of A + additional API B, and
• the SPC had been filed at a PTO for such combination but had been refused by the PTO for failure to meet the requirement that the API of the SPC must be “protected” by the underlying patent. An appeal had been filed in Court against such refusal by the relevant PTO.

The question before the Court that made the referral to the ECJ was therefore whether the basic patent claiming A should be held to “protect” A + B (in application of the so-called infringement test) or whether the basic patent claiming A should not be held to “protect” A + B (in compliance with the so-called disclosure test). In the former case, the SPC to A + B could be validly granted on the basis of the patent to A, but in the latter case it should instead be refused.

In its ruling of today, the ECJ has established the following principle:

“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 must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.”

Thus, the ECJ has established that an SPC for a certain API (or combination of APIs) can be granted on a certain basic patent where the API (or combination of APIs) forming the subject-matter of the SPC is “specified in the wording of the claims of the basic patent”. It this appears that there should be a conformity between the subject-matter of the SPC and the wording of the claims of the patent on which the SPC is based.

It appears likely that this ECJ ruling will have a significant impact on the way in which the various PTOs of the various EU member states (which PTOs are responsible for granting SPCs in each member state) will assess the possibility of granting SPCs to combinations of APIs in the future. It also appears likely that this ECJ ruling will have a significant impact on the validity of many SPCs to combinations of APIs granted in the past in various EU member states.

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