Trastuzumab - UK

On Nov 30, 2016, The Court of Appeal (UK) handed down judgment in the Hospira v Genentech case related to Genentech’s blockbuster drug trastuzumab (Herceptin®) (Hospira v Genentech [2016] EWCA Civ 1185).

The concerned patent EP 1,037,926 relates to use of the antibody trastuzumab in combination with taxane, for the treatment of HER-2 positive breast cancer. Arnold J in his decision in 2015 held that the patent was obvious in light of a review article (Baselga 97). Baselga 97 disclosed that the Phase III trial described in the patent was being carried out, but did not disclose the results.

On appeal, Genentech argued that the Judge had made two major errors in his analysis of inventive step. First, it was said, the Judge had taken the wrong approach to what was a fair expectation of success. Second, Genentech argued that Arnold J had failed to take proper account of the position of the skilled person.

The Court of Appeal found no error of principle on which to overturn the Judge’s finding of obviousness and the appeal was dismissed.