UK Patents: Claims to antibodies without disclosure of a practical use

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Claims to antibodies without disclosure of a practical use may be sufficient in the UK

In the case of Eli Lilly v Human Genome Sciences, the UK Supreme Court found on 2 November 2011 that the claims were industrially applicable and the case was to be returned to the Court of Appeal for the determination of sufficiency. The Court of Appeal has now decided upon the issue of sufficiency and somewhat surprisingly, the Court of Appeal found claims 13, 18 and 19 all to be sufficiently disclosed.

Claim 13 related to any antibody that binds specifically to Neutrokine-α.  No practical use for these antibodies was disclosed, nor was any single example of such an antibody structurally described.  The Court of Appeal decided that the claim is sufficient as the skilled person can make and identify such an antibody without undue effort, despite the fact that there are “millions” of possible antibodies, not all of which would be “useful”.  That the patent does not enable one to identify a particular disease for which such an antibody might be useful in treating was considered irrelevant to the issue of sufficiency of this claim, because the claim was not limited to “useful” antibodies.

Claims 18 and 19 relating respectively to a pharmaceutical and a diagnostic composition comprising the polypeptide/antibody of the earlier claims were also held to be sufficient, again despite the fact that no specific practical use had been disclosed.  The reasoning given, again, was that the skilled person had the ability to make such compositions.

We wait to see whether this decision will be appealed at the Supreme Court.

Link to decision:
http://www.bailii.org/ew/cases/EWCA/Civ/2012/1185.html

Tagged in: biotech patents
Katherine is a British and European Patent Attorney. She obtained a BSc in Molecular Biology with French from the University of Manchester. Katherine works on, amongst other things, the patenting of nucleic acid arrays and their use in hybridisation assays, methods of oligonucleotide synthesis, diagnostic tests and treatments for several important diseases, and medical devices.