The English Patents Court examines the law on enablement in the context of lack of novelty based on both prior publication and prior use.

By Neil Jenkins, Ning-Ning Li


Earlier this year (17 July 2019) in Takeda UK Limited v F. Hoffmann-La Roche AG Mr Justice Colin Birss of the Patents Court of the English High Court of Justice handed down a judgment holding that Roche’s European Patent (UK) number 2,007,809 titled “Glycosylated Antibodies” was invalid for lack of novelty, lack of technical contribution and insufficiency. Birss J also held that Takeda’s allegedly infringing product fell within the scope of the claims. A copy of the decision can be found here.

The claims of the Roche Patent relate to a monoclonal antibody of human IgG1 or IgG3 type with at least 99% fucose (as well as less than 0.5% 1, 3 alpha-gal and less than 0.5% NGNA) in the sugar chain attached at Asn 297 as determined by a calculation method set out in the claim.

Takeda brought revocation proceedings in respect of the Roche Patent in April 2018 and Roche counterclaimed for infringement by Takeda’s recombinant antibody product Entyvio® (vedolizumab). Entyvio® is a gut-selective biologic approved for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

Of particular note is Birss J’s review of the law on enablement in the context of a novelty attack on a claim to an antibody.

View the full article in our BioTalk blog.