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HGS’s antibody claims held to be sufficient

HGS’s antibody claims held to be sufficient


The UK Court of Appeal has recently decided on the validity of Human Genome Sciences’ (HGS) patent for Neutrokine-α, a member of the TNF ligand super family.

On 25 February 2010, we reported the Court of Appeal’s earlier decision to invalidate the patent for a lack of industrial applicability, a decision which was later reversed by the Supreme Court on appeal (see our report of 16 December 2011).  The most recent ruling deals with the Supreme Court’s remittal of the case back to the Court of Appeal to decide on the outstanding issues of Eli Lilly’s action for invalidity, namely whether certain claims of the patent were sufficient.

Claim 13 of the patent referred to an isolated antibody that binds specifically to Neutrokine-α.  Claims 18 and 19 referred to pharmaceutical and diagnostic compositions respectively comprising the antibodies of claim 13. 

Eli Lilly argued that claims 13, 18 and 19 were insufficient on the basis that the patent did not disclose which of the antibodies, if any, had the desired practical use, and that evaluating each antibody’s pharmaceutical or diagnostic utility would place an undue burden on the skilled person. 

Insofar as claim 13 was concerned, it was held that, at the level of generality of the patent, all of the claimed antibodies had a use.  All that claim 13 called for was an antibody that specifically binds to Neutrokine-α; that in itself is a potential utility, as decided by the Supreme Court.  All of the claimed antibodies could be made, and it was held that the claim did not contain any additional limitation to “useful”, which therefore should not be read-in unless the context compellingly so required. 

Turning to claims 18 and 19, the Court favoured HGS’s interpretation, namely that, read in the context of this specification as a whole, the skilled person would not expect the patentee to have intended these claims to be directed to compositions having immediate practical use as pharmaceuticals or diagnostics.  On the contrary, it was held that the specification made it clear that what had been discovered was Neutrokine-α and its antibodies.  Following the principles of claim construction laid down in Kirin-Amgen [2005] RPC 9, the Court concluded that the claims should be interpreted to cover compositions which could be formulated to be suitable for administration as pharmaceuticals or diagnostics. Accordingly, claims 13, 18 and 19 were held to be sufficient.