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In 2012 Member States and the European Parliament agreed on the "patent package" - a legislative initiative consisting of two...

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The litigation between Eli Lilly (Lilly) and Human Genome Sciences (HGS) reported in this edition of Patent issues, rumbles on before the Patents Court and the Court of Justice for the European Union (CJEU) over a side dispute as to whether HGS can extend their patent protection by means of an SPC based on Lilly's own marketing authorisation.

HGS's patent for Neutrokine-α was granted in 2005 and is due to expire in October 2016. Lilly has obtained a marketing authorisation for their own product LY2127399. Lilly is concerned that HGS might seek and obtain an SPC based on Lilly's own marketing authorisation. They filed a pre-emptive request at the Patents Court to make an immediate reference to the CJEU to prevent this. The Patents Court agreed to a reference, but not until the validity dispute is concluded ([2012] EWHC 2290 (Pat)).

Mr Justice Warren decided that the holder of a basic patent can indeed make such an application even when the two persons have no connection with each other, and he considered this issue (the so-called "third party SPC" issue) to be clear enough not to be referred to the CJEU, but the CJEU has previously held (in the Medeva and Georgetown cases ) that an SPC should not be granted which covers active ingredients which, though falling within the scope of the claims of the patent, are not specified and identified in those claims (the so-called "specification" issue) and this question remains open in this case. Lilly's claim is that a valid SPC cannot be obtained, because the Patent does not specify or identify Lilly's LY2127399 in its claims.

Since a number of references have already been made to the CJEU in relation to the SPC Regulation, and the law remains unclear in many aspects, and since the "specification" issue is a matter of European Law, Warren J. agreed to refer the entire matter to the CJEU.

Now that the Court of Appeal has given its decision about the validity of all the claims of the patent (and subject to any further appeal to the Supreme Court), this action can proceed with a new reference to the CJEU.