On June 24, 2015, the UK’s High Court of Justice Patents Court invalidated a Genentech patent (EP 1037926 (“the ’926 patent”)) for the combined use of Herceptin (trastuzumab) in combination with the chemotherapeutic taxane for treatment of HER2-positive breast cancer. Hospira brought this action as part of a series of patent challenges to clear the way for introduction of its own generic trastuzamab, now that Genentech’s patent covering the amino acid sequence of Herceptin, and its SPC have expired. The decision is of potential significance to the U.S. because Herceptin is often given in combination with a taxane, and EP ’926 corresponds with several U.S. patents, including U.S. 5,770,195, U.S. 5,772,997, U.S. 5,702,954, U.S. 6,399,063, U.S. 6,387,371, and U.S. 6,165,464.
In its decision, the court found the ’926 patent obvious in light of Baselga et al., “HER2 Overexpresssion and Paclitaxel Sensitivity in Breast Cancer: Therapeutic Indications,” Oncology 11, Supp. 2, 43-48 (March 1997),(“Baselga 97”), and therefore invalid. The courts analysis focused on whether Baselga 97 would give a POSA an expectation that a Phase III trial would demonstrate increased efficacy of the trastuzumab -taxane combination over taxane alone. Ultimately, the court found that the “skilled person would agree with the assessment of the authors of Baselga 97, namely that results of the previous studies were ‘positive’ and ‘encouraging’ and justified the decision to move forward to a Phase III trial even though there had been no Phase II trial of the combination of trastuzumab and taxane.” (Opinion at ¶ 131)
Currently, there are no pending litigations or post-grant proceedings associated with the corresponding U.S. patents.