UK High Court denies Eli Lilly’s request to prevent Human Genome Sciences Ltd from obtaining a Supplementary Protection Certificate for the human monoclonal antibody, tabalumab.

Summary

In a judgment dated 18 July 20141, the UK High Court refused to grant an application by Eli Lilly (Lilly) to declare that any Supplementary Protection Certificate (SPC) filed by Human Genome Sciences Ltd (HGS) based on a marketing authorisation granted to Lilly would be invalid.

Background

HGS is the proprietor of a European Patent (UK) 0939804B which claims the protein Neutrokine-α and antibodies which bind to this protein, including belimumab and tabalumab. HGS have received marketing approval in Europe for a belimumab-containing product (BENLYSTA®) for the treatment of active, autoantibody-positive systemic lupus erythematosus (SLE). Lilly had developed a different human monoclonal antibody, tabalumab, which also binds to Neutrokine-α.

Lilly was concerned that HGS would apply for an SPC in the UK for tabalumab based on EP(UK) 0939804B and Lilly’s Marketing Authorization (MA), if the MA was granted before the patent expired. In 2012, Lilly sought a declaration from the UK High Court that any SPC based on EP(UK) 0939804B would be invalid.

Lilly’s application to the Court was based upon two grounds of objection, namely that: (i) tabalumab was not “protected” by a basic patent for the purpose of Article 3(a) of the SPC Regulation as interpreted in Medeva2 (the “Specified Issue”); and (ii) HGS should not be able to file for an SPC based on a competitor’s MA (the “Third Party Issue”).

The “Specified Issue” was referred to the Court of Justice of the European Union (CJEU), which ruled in December 2013 that it is not necessary for the active pharmaceutical ingredient to be identified in the claims of the patent on which the SPC is based by a structural formula. Rather, the active pharmaceutical ingredient may be defined in “functional” terms provided that “the claims relate, implicitly but necessarily and specifically” to the active pharmaceutical ingredient in question.

Following the CJEU decision, the case was heard by the UK High Court in May and June 2014.

Decision by the UK High Court

The UK High Court refused to grant Eli Lilly’s application for a declaration that any SPC filed by HGS based on Lilly’s MA for tabalumab would be invalid.

In reaching its decision, the Court found that both of the antibodies tabalumab and belimumab fall within the scope of EP(UK) 0939804B (as interpreted by section 125 of the UK Patents Act, Article 69 of the European Patent Convention (“EPC”) and the Protocol on the Interpretation of Article 69).

The Court also considered that an assessment following the extent of protection test should be subject to one proviso – namely, that where the claims contain some general word or words extending their scope beyond the principal wording of the claims, a product would not be considered to be specified unless it fell within the claim absent the general words. Therefore, if a patent is directed to an active pharmaceutical ingredient “A” and contains a claim “A pharmaceutical composition comprising A”, then a combination product comprising A+B (where B is an alternative pharmaceutical active ingredient) would not be protected by this patent (within the meaning of Article 3(a) of the SPC Regulation) even though “comprising” is typically interpreted to mean “contains but is not limited to”.

Further, although the CJEU stated that, “…the refusal of a SPC for an active ingredient which is not specifically referred to by a patent… 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…”, the UK High Court stated that this is relevant to the “Third Party Issue” which was not referred to the CJEU. Further, the Court said that the reason for having a SPC regulation is to encourage research. As such, the Court said that it was not right that the satisfaction of Article 3(a) of the SPC Regulation depended on who carried out the research leading to the MA for the product for which the SPC had been sought, and in doing so refused to grant Lilly’s application.

Conclusion

In reaching its decision, the Court made it clear that SPCs are granted to encourage research and innovation into new medicines. As such, it was held that a patentee may file a SPC application with reference to a third party MA, provided the medicinal product is protected by the basic patent in question. The decision also confirms that SPCs may be obtained for products based on claims defined in functional terms. However, there remains some uncertainty as to the degree of “functionality” that is acceptable, which will require assessments to be made on a case-by-case basis until such time as further guidance is given.

Lilly has been granted leave to appeal and it will be interesting to see the UK Court of Appeal’s view of these issues in due course.