Super Thursday for SPCs No.2: Eli Lilly v Human Genome Sciences

Case C‑493/12, Eli Lilly and Company Ltd v Human Genome Sciences Inc., a reference for a preliminary ruling from the Court of Justice of the European Union (CJEU), was handed down this morning. 

HGS owned European Patent (UK) No 0 939 804, granted on 17 August 2005 and due to expire on 25 October 2016. The patent, which related to the discovery of a new protein, Neutrokine alpha (α), both disclosed and claimed that protein, and also related to antibodies that bind specifically to that protein. Since Neutrokine-α acts as an intercellular mediator in inflammation and immune response, so that too much or too little of it may cause diseases of the immune system, antibodies that bind specifically to it may inhibit its activity and be useful in the treatment of autoimmune diseases.

13 Claims 13, 14 and 18 of this patent read as follows:

‘13. An isolated antibody or portion thereof that binds specifically to:

(a) the full length Neutrokine-α polypeptide (amino acid sequence of residues 1 to 285 of SEQ ID No: 2); or

(b) the extracellular domain of the Neutrokine-α polypeptide (amino acid sequence of residues 73 to 285 of SEQ ID No: 2).

14. The antibody or portion thereof of claim 13 which is selected from the group consisting of:

(a) a monoclonal antibody; ...

18. A pharmaceutical composition comprising … the antibody or portion thereof of any one of claims 13 to 17 and, optionally, a pharmaceutically acceptable carrier.’

Eli Lilly wanted to market a pharmaceutical composition for use in the treatment of autoimmune diseases, containing as its active ingredient an antibody, LY2127399 (Tabalumab), that binds specifically to Neutrokine-α, which Eli Lilly refers to as  (now also known as ). However, it it marketed that composition before the expiry of HGS’s patent, LY2127399 would infringe claim 13 on the basis that LY2127399 was an antibody as defined in claim 13, being an isolated antibody or portion thereof which binds specifically to Neutrokine-α polypeptide. Any pharmaceutical composition containing LY2127399 was thus a pharmaceutical composition as defined in claim 18 of that patent.

Eli Lilly brought an action before the Patents Court, England and Wales, for a declaration that any SPC relying on HGS’ patent and based on a marketing authorisation for a medicinal product containing LY2127399 would be invalid: that antibody was not covered by a ‘basic patent’ within the meaning of Article 3 of Regulation 469/2009, in so far as claim 13 of HGS’s patent was too broadly drafted for it to be possible for that antibody to be regarded as being ‘specified’, for the purpose of the Case C-322/10  Medeva test. Said Eli Lilly, for an SPC to be granted on the basis of HGS’s patent, the patent would have had to contain a structural definition of the active ingredients and the claims would have had to be significantly more specific.

Claim 13 of HGS’s patent was broadly worded, covering a large number of antibodies: the antibody was defined functionally, but not structurally, the definition thus covering an unknown number of otherwise unspecified antibodies, this being the broadest way of claiming an antibody. The patent specification contained no example of an antibody having been made or tested; nor did it contain any structural description of antibodies that might function as therapeutic antibodies. HGS disagreed, pointing out that its form of claim was a standard one that was routinely granted by the European Patent Office (EPO) and that its patent had been held valid in proceedings both before the EPO and in the UK.

The Patents Court decided to stay proceedings and refer the following questions to the Court for a preliminary ruling:

‘(1) What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation [No 469/2009]? [the first question posed, but found unnecessary to answer, in Case C-443/12 Actavis v Sanofi, here]

(2) Are the criteria different where the product is not a combination product, and if so, what are the criteria?

(3) In the case of a claim to an antibody or a class of antibodies, is it sufficient that the antibody or antibodies are defined in terms of their binding characteristics to a target protein, or is it necessary to provide a structural definition for the antibody or antibodies, and if so, how much?’

This morning the CJEU ruled as follows:

"Article 3(a) ...  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) ... 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".

At [42] and [43] the CJEU observed:

"42 As stated in recital 4 in the preamble to Regulation No 469/2009, the purpose of that additional period of exclusivity is to encourage research and, to that end, it is designed to ensure that the investments put into such research are covered.

43 In the light of the objective of Regulation No 469/2009, the refusal of an SPC application for an active ingredient which is not specifically referred to by a patent issued by the EPO relied on in support of such an application may be justified – in circumstances such as those in the main proceedings and as observed by Eli Lilly – where the holder of the patent in question has 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. In such a situation, if an SPC were granted to the patent holder, even though – since he was not the holder of the MA granted for the medicinal product developed from the specifications of the source patent – that patent holder had not made any investment in research relating to that aspect of his original invention, that would undermine the objective of Regulation No 469/2009, as referred to in recital 4 in the preamble thereto".