A Bumper Crop Of SPC Rulings From The CJEU - Part 2: The Latest Rulings On Article 3


1. Introduction

This article, the second in a series of three, discusses the latest rulings from the CJEU in connection with Article 3 of the Supplementary Protection Certificate (SPC) legislation.

As will be discussed below, although much remains uncertain, there may be some patent drafting and SPC filing strategies that applicants can adopt in order to avoid some of the risks generated by the recent case law.

2. SPCs

SPCs provide additional protection for a "product", which is a (combination of) active ingredient(s).

For both medicines (human or veterinary) and plant protection products (agrochemicals and the like), Article 3 of the SPC legislation defines key criteria that must be satisfied in order for supplementary protection to be awarded. In essence, that Article demands that, on the date that the SPC application is filed, the following must all be true in the country where protection is sought:

  1. the "product" must be protected by an in-force patent;

  2. the "product" must be the subject of a valid Marketing Authorisation (MA);

  3. the patentee cannot already have been granted an SPC for the same "product"; and

  4. the MA mentioned in (b) must be the first in the country for the "product".

    3. The Cases

    On 12 December 2013, the CJEU provided rulings in the following 3 cases:

    1. C-443/12 (Actavis v Sanofi);

    2. C-484/12 (Georgetown University v Octrooicentrum Nederland); and

    3. C-493/12 (Eli Lilly v HGS).

    The provisions upon which these cases touched were Article 3(a) (at issue in both Actavis and Eli Lilly) and Article 3(c) (which was at issue in both Actavis and Georgetown).

    In order to understand the context in which questions were referred to the CJEU in these cases, it is necessary to outline certain facts from those cases.

    1. Actavis v Sanofi

    In 1997, Sanofi obtained authorisation from the European Commission to market the compound irbesartan, which was the sole active ingredient in the medicinal product Aprovel®.

    Upon the basis of the MA for Aprovel® and a patent protecting irbesartan (EP 0 454 511 B1), Sanofi obtained an SPC in the UK, for which the "product" was irbesartan.

    Sanofi subsequently sought and obtained a centralised MA for CoAprovel®, a medicinal product containing both irbesartan and hydrochlorothiazide (HCTZ, a diuretic) as active ingredients.

    The patent protecting irbesartan (EP 0 454 511 B1) also contained claims to a composition comprising irbesartan in association with "a diuretic". Pointing to those claims as providing protection for the "product" consisting of the combination of irbesartan and HCTZ, Sanofi then obtained a second SPC in the UK based upon EP 0 454 511 B1 (SPC/GB99/008).

    Subsequent to expiry of the SPC to irbesartan alone, Actavis sought to clear the way for the marketing of a generic version of CoAprovel® by challenging the validity of SPC/GB99/008. In essence, the grounds for their challenge included allegations that:

  5. Article 3(a) was not satisfied, as EP 0 454 511 B1 did not "protect" the combination of irbesartan and HCTZ; and

  6. the provisions of Article 3(c) were not met, as comments made in connection with prior CJEU cases indicated that it was not possible to obtain more than 1 SPC per patent.

    2. Georgetown University

    A patent was granted to Georgetown University (EP 0 647 140 B1) that contained claims directed towards vaccines based upon certain human papilloma virus (HPV) L1 proteins.

    Vaccines containing such HPV L1 proteins and designed to prevent HPV infections were authorised for sale in the EU. These vaccines were:

    Gardasil® (containing HPV-6, HPV-11, HPV-16 and HPV-18 L1 proteins); and Cervarix® (containing HPV-16 and HPV-18 L1 proteins). Upon the basis of EP 0 647 140 B1 and the MAs for Gardasil® and Cervarix®, Georgetown University filed a number of SPC applications in the Netherlands.

    Two of Georgetown's SPC applications, directed towards the combinations of HPV proteins present in Gardasil® and Cervarix®, were granted in 2008. However, based upon comments made in connection with CJEU cases decided subsequent to 2008 (which comments suggested that no more than 1 SPC can be granted per patent), the Dutch patent office rejected an application to a single antigen, HPV-16 L1 protein.

    When handling an appeal against the rejection of Georgetown's application, the Court of the Hague was uncertain as to whether it really was impermissible to obtain more than 1 SPC per patent (and, if so, whether the SPC application in question could be allowed to proceed if Georgetown surrendered the two granted SPCs based upon the same patent). The court therefore referred questions to the CJEU on these points.

    3. Eli Lilly v HGS

    Eli Lilly, the developer of an antibody (tabalumab) to the protein Neutrokine-α, has for some time been in dispute with HGS, the proprietor of a patent (EP 0 939 804 B2) directed towards the protein Neutrokine-α, and antibodies thereto. The antibodies were claimed using functional terms only, i.e. by reference to the antigen to which they bind.

    The dispute between the two parties has so far included challenges by Eli Lilly (at the EPO and at the UK courts) to the validity of HGS's patent. After the patent survived these challenges, Eli Lilly were faced with a freedom-to-operate issue for tabalumab, as it was common ground between the parties that marketing of tabalumab in the UK would infringe Claim 13 of HGS's patent.

    Based upon current practice in Europe, is it possible for a third party to base an SPC application upon a...

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