Written by Daniel K. Yarbrough, Ph.D. and Kerry S. Taylor, Ph.D.

Bevacizumab (Avastin®) is the subject of the widely watched “patent dance” dispute between Genentech and Amgen regarding Amgen’s proposed biosimilar. Hospira, however, (now owned by Pfizer) has chosen a different path in challenging Genentech patents before the Patent Trial and Appeal Board (PTAB).

On March 15, 2017, the PTAB instituted an IPR against ten of twelve claims from U.S. Patent No. 7,807,799, regarding methods of purifying antibodies, including claims to purifying anti-VEGF antibodies. The following day, the same 3-judge panel instituted a second Hospira IPR against a Genentech patent, this time challenging all five claims of U.S. Patent No. 7,622,115, drawn to methods of treating cancer using bevacizumab (the generic name for Genentech’s Avastin® product).

These two instituted IPR proceedings have now entered the IPR trial phase, and both patent owner responses are due June 6.

Hospira filed these petitions for IPR of the ’799 and ’115 patents on September 9 and September 16, 2016, respectively. In January of 2016, Hospira filed five IPR petitions challenging 4 other Genentech patents. These challenged patents were directed to trastuzumab (the generic name for Genentech’s Herceptin® product). One of the challenged patents also had claims drawn to the use of anti-VEGF antibodies for use in combination with trastuzumab therapy. Thus, Hospira has pursued IPRs challenging patents directed to two of Genentech’s significant anticancer products.

The Board has not yet issued an institution decision for any of these five later-filed IPRs. Presently, Genentech’s preliminary responses are due in late April or early May 2017.