Hospira UK Limited v Genentech Inc., Court of Appeal, Lord Justice Longmore, Lord Justice Kitchin and Lord Justice Floyd, 30 November 2016
The Court of Appeal has upheld that the Swiss-form claim of Genentech’s patent relating to the use of the monoclonal antibody trastuzumab in combination with a taxane (paclitaxel) for the treatment of HER2-positive breast cancer, to be invalid for obviousness.
Hospira’s attacks on the validity of the patent were based on a single piece of prior art, a review article called ‘Baselga’ that described a phase III clinical trial of trastuzumab in combination with different chemotherapeutic agents, including paclitaxel. The article did not disclose any results from the phase III trial, but did contain results from earlier phase I and II studies.
On Appeal, Genentech argued that Arnold J had taken the wrong approach as to what amounted to a fair expectation of success, and had considered only whether the existing results ‘justified’ Genentech’s decision to proceed with the phase III trial. Genentech argued that the test should be whether it was “more or less self-evident that what is being tested ought to work”.
Floyd LJ rejected Genentech’s argument, holding that such a rigid application would leave no room for treating an invention as obvious when it was obvious to try. Imposing a requirement for there to be a very high expectation of success for claims which include as part of their technical subject matter a therapeutic benefit or effect, would amount to the creation of a lex specialis for such claims. Instead, Floyd LJ emphasised the test is a flexible one, based on asking whether there is, in all the relevant circumstances, a fair expectation of success.
In the judgement Floyd LJ also considered Genentech’s motivation for conducting the trial and its submission that just because a company may regard conducting a clinical trial to be justified, does not necessarily infer that it conducted such a trial with the required reasonable or fair expectation of success. This is because given the potential for substantive financial reward, companies may often decide, on balance, to pursue research where there is little or no prospect of success. While Floyd LJ agreed with Genentech’s reasoning, he did not agree that the first instance judge had made such an error.
Genentech had also contended that in contemplating the teaching of Baselga at the priority date, the skilled man would have neither trastuzumab nor another anti-HER2 antibody to hand, and would have to balance the arduous task of formulating and testing the antibody with the uncertainties surrounding a successful outcome of the trial described in Baselga, and would have considered “the stakes too high and the odds too long”.
Genentech claimed that the judge had not properly considered whether the skilled person without knowledge of the patent, would have proceeded with the burdensome work when all he had to hand was the level of expectation provided by Baselga. Floyd LJ rejected these arguments, stating that the trial judge had accepted that there was significant burden in reaching the point of being able to conduct phase III trials, but that did not mean that the trials described in Baselga were technically burdensome as they were within the technical capacity of the skilled person.
The judgment can be found here.
Headnote: David Pountney, Simmons & Simmons LLP
