The Court of Justice of the European Union (CJ) issued three judgments on grant of Supplementary Protection Certificates (SPCs) on 12 December 2013 in the cases:

C-493/12 Eli Lilly v HGS,

C- 443/12 Actavis v Sanofi, and

C-484/12 Georgetown v Octrooicentrum. 

1. Clarification of the meaning of “specified in the wording of the claims” by decision C-493/12 Eli Lilly v HGS: the functional disclosure of the active ingredient suffices

According to Article 3(a) of Regulation No 469/2009 (SPC Regulation), a product subject to an SPC must be “protected by a basic patent.” According to the CJ’s Medeva judgment (case C-322/10), and
AG Trstenjak’s opinion in that case, earlier cases left uncertain the level of specificity required in the patent and how to construe the requirement that the active ingredient be “specified in the wording of the claims.” In Medeva, the CJ held that under Article 3(a) of the SPC regulation, no SPC could be granted for an active ingredient not specified in the claims.

In Eli Lilly, The CJ answered the following question:

“By its three questions, which it is appropriate to consider together, the referring court asks, in essence, whether Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that, in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, the active ingredient must be identified in the claims of the patent by a structural formula, or whether the active ingredient may also be considered to be protected where it is covered by a functional formula in the patent claims.” (Point 24)

The CJ ruled that patent claims need not identify the active ingredient by structural formula:

“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 meaning that, in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patents Office, Article 3(a) of that regulation does not, in principle, preclude the grant of a supplementary protection certificate for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court.”

Consequently, a mere generic disclosure of the active ingredient by its functional formula can meet the requirement of Article 3(a) that the active ingredient be “specified in the wording of the claims,” and as such can lead to the grant of an SPC. This decision is a good step toward clarifying the Medeva decision, but might lead to new debates on the determination whether “the claims relate, implicitly but necessarily and specifically, to the active ingredient in question.” The national patent offices and the national courts will make this determination, and may adopt different criteria in doing so.

It appears certain, however, that the more specifically the patent’s claims identify the active ingredient, the higher the chances will be of getting an SPC. Accordingly, it is advisable to pay close attention when drafting dependent claims of the patent.

2. Can more than one SPC be granted on a single basic patent under Article 3(c) of the SPC Regulation?

2.1. After the grant of an SPC for one active ingredient alone, an additional SPC cannot be granted for the claimed combination of that active ingredient with another active ingredient not itself protected by the patent. C-443/12 Actavis v Sanofi

Sanofi had been granted an SPC for irbesartan, and later sought an SPC for the combination of irbesartan and hydrochlorothiazide based on the same basic patent.

The question to the court was as follows:

“By its second question, which it is appropriate to examine first of all, the referring court asks, in essence, whether, in circumstances such as those in the main proceedings, in which, on the basis of a patent protecting an innovative active ingredient and an MA for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained an SPC for that active ingredient, Article 3(c) of Regulation No 469/2009 must be interpreted as precluding the holder of that patent from obtaining, on the basis of that same patent but an MA for a different medicinal product containing that active ingredient in combination with another active ingredient which is not protected as such by the patent, a second SPC relating to that combination of active ingredients.”

The CJ ruled:

“In circumstances such as those in the main proceedings, where, on the basis of a patent protecting an innovative active ingredient and a marketing authorisation for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained a supplementary protection certificate for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, Article 3(c) 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 that patent holder from obtaining – on the basis of that same patent but a subsequent marketing authorisation for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent – a second supplementary protection certificate relating to that combination of active ingredients.”

In deciding not to grant a second SPC, the court considered that the scope of the first SPC allowed its owner to prevent others from marketing any product including the active ingredient covered by the first SPC. As a result, the court reasoned it was not within the objective of the SPC regulation to allow, upon the expiration of the first SPC covering only one active ingredient, an additional protection for a combination based on the same basic patent. The court considered that upon expiration of the first SPC, competitors should be free to use the active ingredient, combined or not.

Importantly, this decision involved a subsequent SPC application for a combination product on the basis of the same basic patent as the first SPC covering a single active ingredient. The result might have been different if the combination arose out of a divisional patent application. Patent applicants should thus consider filing divisional applications to cover combinations of active ingredients covered by the parent patent. It shall be noted that after 1 April 2014, a European divisional patent application may be filed at any time, so long as the parent application is still pending; therefore slowing down the prosecution of pending applications might be advisable.

2.2 An SPC for one active ingredient can be granted after the grant of an SPC for a combination of this active ingredient with another. C-484/12 Georgetown v Octrooicentrum

Article 3(c) of the SPC Regulation provides that an SPC shall be granted only where the product has not already been the subject of a certificate.

However, after the Medeva decision, it was disputed whether several SPCs may be sought on the basis of the same patent to cover different drugs subject to different marketing authorisations.

In Georgetown v. Octrooicentrum, the question to the court was as follows:

“By its first question, the referring court asks, in essence, whether, in circumstances such as those in the main proceedings, where, on the basis of a basic patent and an MA in respect of a medicinal product consisting of a combination of several active ingredients, the patent holder has already obtained an SPC for that combination of active ingredients, which is protected by the basic patent within the meaning of Article 3(a) of Regulation No 469/2009, Article 3(c) of that regulation must be interpreted as precluding that patent holder from also obtaining an SPC in respect of one of those active ingredients which is also protected as such, individually, by that patent.”

The court ruled:

“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.”

The CJ ruled, “it is possible, in principle, on the basis of a patent which protects several different ‘products’, to obtain several SPCs in relation to each of those different products, provided, (…), that each of those products is ‘protected’ as such by that ‘basic patent’ within the meaning of Article 3(a) of Regulation No 469/2009, in conjunction with Article 1(b) and (c) of that regulation”

The court continues, highlighting that this “interpretation is also borne out by the objective pursued by that regulation, which (…) is to encourage research in the pharmaceutical sector by granting one SPC per product, a product being understood to mean an active substance in the strict sense. Any other interpretation might, moreover, give rise to circumvention tactics, entailing additional costs which may discourage innovation, in the sense that those concerned would be minded to apply for a separate basic patent for each of their ‘products’.”

We welcome these decisions, which give better guidance on SPCs in Europe, even though some uncertainties remain. Debate is ongoing. For example, in Actavis Group PTC EHF & Anor v Boehringer Ingelheim Pharma GmbH & Co, KG [2013] EWHC 2927 (Pat) (23 September 2013), the UK High Court recently referred several questions to the CJ relating to combinations of active ingredients and amendment of the basic patent, and notably including the question whether the patent can qualify as ‘a basic patent in force’ under the SPC Regulation where, at grant, it did not explicitly identify two active ingredients in combination, but was amended to do so. (To be continued…)

Further debates about the grant of SPCs, which are still within the jurisdiction of national patent offices, will be taking place in the coming months while finalizing the rules of procedure for the upcoming Unitary Patent.

The author thanks associate Derek Brader (Philadelphia) for his contributions.