Bevacizumab - USA

On Jul 31, 2019, Federal Circuit affirmed (Rule 36 judgment) PTAB’s decision that found method of use patent covering cancer drug, Avastin® obvious over prior arts.

Genentech appealed the decision of PTAB from IPR2016-01771 which found the claims 1–5 of the US 7,622,115 unpatentable.  Hospira filed this petition to institute an IPR of these claims.

Claim 1 reads:

1. A method for treating cancer in a patient comprising administering an effective amount of bevacizumab and assessing the patient for gastrointestinal perforation during treatment with bevacizumab.

In summary, PTAB said that the central question before us is whether a person of ordinary skill in the art would have modified the disclosures of Kabbinavar or the 2000 Press Release to include “assessing the patient for gastrointestinal perforation.” Kabbinavar and 2000 Press Release disclose all limitations of claims except gastrointestinal perforation. PTAB credited the testimony of Dr. Neugut that the standard of care and the knowledge of a person of ordinary skill in the art would have guided a physician to assess patients receiving bevacizumab for GI perforation. Such an assessment necessarily begins with evaluating patients for symptoms of GI perforation, such as nausea and abdominal pain, and in the event of a showing of such signs, a physician would have assessed the patient for GI perforation. The physician would have also known that chemotherapy promotes GI injury by killing tumor cells and effectively eroding away the tumor as well as by killing epithelial cells that line the gut wall. The physician would also have known that GI perforation was associated with a high rate of death, and thus the physician would have been particularly concerned with a life-threatening complication such as GI perforation.

Thus, in view of the above arts, PTAB found the subject matter of claims 1–5 of the ’115 patent obvious.