A supplementary protection certificate (SPC) has the effect of extending the duration of the patent on which it is based, but only in respect of the product which is the subject of the SPC. “Product” refers to the active ingredient or combination of active ingredients in a medicinal product or plant protection product. An SPC must be based not only on a patent protecting the product, but also on a marketing authorisation for a medicinal, or plant protection product containing the “product”.

SPCs are granted on a country-by-country basis, by the national patent offices, who apply Europe-wide SPC legislation. On 12 December 2013, the Court of Justice of the European Union (CJEU) issued three judgments, in which answers were provided to questions which had been referred to the Court by national courts who were uncertain about the interpretation of the European legislation.

HOW MANY SPCS PER PATENT?

It was well established that a patent proprietor with several patents in respect of a product could not hope to extend all of those patents in respect of that product, but must choose which was to be the basis for the SPC. It was however less clear whether a patentee whose patent protected several different products could obtain an SPC for each of those products, based on that patent, or was limited to just one SPC per patent. The SPC law does not clearly exclude this possibility, and national patent offices, examining SPC applications had generally been prepared to grant multiple SPCs based on a single patent provided each SPC related to a different product. Uncertainty existed, though, because of incidental remarks made in a number of CJEU decisions. These seemed to imply that there might actually be a restriction to just one SPC per patent.

CJEU Case C-484/12 (Georgetown University v Octrooicentrum Nederland)

Because of this uncertainty, the Dutch Court of the Hague, considering Georgetown University’s appeal from a Dutch Patent Office rejection of their SPC application, sought guidance from the CJEU on this point. Georgetown’s patent related to a vaccine containing at least one recombinantly produced human papilloma virus (HPV) L1 protein or fragment. The various strains of HPV from which the protein might be derived were listed in one of the claims, while other claims specified preferred strains or preferred combinations of L1 proteins. On the basis of this patent, Georgetown had been granted an SPC in respect of a combination of four L1 proteins – those of HPV-6, HPV-11, HPV-16 and HPV-18. The SPC was based on a marketing authorisation for a vaccine containing all four proteins in combination.

As this marketing authorisation was the first, not only in respect of the combination of the four proteins, but also in respect of each individual protein, Georgetown also sought SPCs in respect of each of these different products based on the same patent and marketing authorisation.

The Dutch Patent Office, operating a policy of ‘one SPC per patent’, refused the applications.

The CJEU distinguished the situation in this case from those in its earlier judgments and concluded that, “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 inter alia, that each of these products is “protected” as such by that basic patent” (emphasis added).

Georgetown were, therefore, able to have SPCs for the combination of four proteins and for the individual proteins, as all these products were “protected as such” by the patent. The Court was concerned that the patentee should be adequately compensated for their efforts and expense in bringing each of these patented products to the market, but also noted that all the SPCs would expire together, since all were based on the same first marketing authorisation.

They emphasised, however, that a patentee could not obtain a second SPC for the same product based on the same patent and on a later authorisation of a medicinal product containing it. In this case, Georgetown could not obtain a second SPC in respect of the HPV-16 L1 protein based on a later authorisation of the HPV-16 + HPV-18 combination.

CJEU Case C-443/12 (Actavis Group PTC EHF and Actavis UK Ltd v Sanofi)

By contrast, in a case where questions were referred by the UK Patents Court, the CJEU concluded that the patentee was precluded from obtaining two SPCs based on the same patent, even though it could be argued that the SPCs related to different products.

Sanofi was the holder of an SPC in respect of the anti-hypertensive drug, irbesartan, based on a European patent in respect of that drug and a marketing authorisation in respect of a medicinal product (Aprovel) containing irbesartan as sole active ingredient. The European patent contained claims in respect of irbesartan and described how irbesartan might be included in a pharmaceutical composition also containing other classes of active ingredient, such as a beta-blocker, calcium antagonist, diuretic, non-steroidal anti-inflammatory drug, or tranquilliser. One claim of the patent referred to a pharmaceutical composition containing irbesartan in combination with “a diuretic”. When Sanofi subsequently obtained a marketing authorisation in respect of Coaprovel, a medicinal product containing both irbesartan and another active ingredient – hydrochlorothiazide, which is a diuretic, they applied for and were granted a UK SPC in respect of this new combination of active ingredients. The SPC was based on the same European patent, and the new authorisation, so had a later expiry date than the first SPC. Actavis sought to invalidate this SPC in order to bring their own combination product to the market after expiry of the SPC in respect of irbesartan by itself.

Here the CJEU took the view that the patent relied on did not protect hydrochlorothiazide “as such”. The core inventive concept of the patent was irbesartan and the judgment says, “It cannot be accepted that the holder of a basic patent … may obtain a new SPC, potentially for a longer period of protection, each time he places on the market ..a medicinal product containing .... the principal active ingredient, protected as such by the holder’s basic patent and constituting .... the core inventive advance of that patent, and ... another active ingredient which is not protected as such by that patent.”

Sanofi had already had the benefit of one SPC – that for irbesartan itself, which could have been used to oppose marketing of a medicinal product containing irbesartan in combination with another active, and it was not appropriate for them to receive a second SPC, in respect of the same core invention, and based on the same patent.

The CJEU distinguished this situation from that where a later patent relates to an innovative combination of a previously patented (and authorised) active with another. In these circumstances it should be possible to obtain an SPC in respect of the patentable combination based on this later patent.

Presumably the Court’s conclusions would have been the same even if the known diuretic, hydrochlorothiazide, had been specifically named in the patent; the patent would still not have presented that substance as an invention and so would not have protected it “as such”. Thus, the court found it unnecessary to consider a further question referred to it by the UK Court relating to whether the specific combination of irbesartan and hydrochlorothiazide was “protected” by the patent, and in particular by the claim to the composition containing irbesartan and a diuretic.

DOES THE BASIC PATENT PROTECT THE PRODUCT?

CJEU Case 493/12 (Eli Lilly and Company Ltd v Human Genome Sciences)

Whether a specific compound within the ambit of a broad generic claim of a patent is a product protected by the patent, and so eligible for an SPC based on the patent was, however, considered in C-493/12.

Here Human Genome Sciences (HGS) were holder of a patent in respect of a protein, neutrokine-alpha, and their patent included broad claims to an antibody to that protein, but the antibody was defined entirely functionally, in terms of its binding to neutrokine-alpha. The patent contained no example of an antibody having been made or tested, and the patent did not contain any structural definition of antibodies that might function therapeutically.

HGS hoped to obtain an SPC based on this patent, and so extend the duration of their patent, by relying on Eli Lilly’s marketing authorisation in respect of a particular antibody – tabalumab. Eli Lilly argued that tabalumab was not “protected” by the patent, for SPC purposes, despite the fact that marketing tabalumab during the life of the patent would be an infringement of the patent. Tabalumab was not named or described in the patent.

Following earlier case law, the CJEU rejected the infringement test as a way of determining whether the product was protected, emphasizing that if a patent were to be suitable basis for an SPC the product must be “identified” in the claims of the patent, which tabalumab was not. They explained that a purely functional, rather than structural, definition of a product in a claim might suffice to protect the product, provided that the claim, when interpreted in light of the description, related “implicitly, but necessarily and specifically” to the active ingredient in question. The Court noted that the objective of the SPC law was to encourage research by providing an extra exclusivity period to cover investments put into such research. This objective would be defeated if a patentee were to be granted an SPC when (unlike the marketing authorisation holder) it had “failed to take any steps to carry out more in-depth research and identify his invention specifically, making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients”.