Last week, the Federal Circuit affirmed invalidation of claims to methods for reducing Protein A leaching in affinity column chromatographic methods important inter alia in purifying monoclonal antibodies, in Genentech, Inc....more
Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
Here are our picks of some legal developments to keep an eye out for in the new year: 1. Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s...more
The 2011 America Invents Act (AIA) provided a variety of new ways to administratively challenge patents, including the now widely used inter partes review (“IPR”) procedure. In two recent appeals of IPR decisions, Genentech...more
Genentech recently submitted two opening appellate briefs to the Federal Circuit in connection with its appeals from the Board’s final written decisions in Hospira’s IPRs, IPR2016-01771 and IPR2016-01837, which found that the...more
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in...more
Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more
At least 19 IPRs have been filed against seven of Genentech’s patents covering its blockbuster antibody drug Herceptin® (trastuzumab). On July 27, 2017, the PTAB instituted IPRs filed by Hospira, Inc. (a subsidiary of Pfizer)...more
The Board granted Hospira a mixed result in its numerous challenges to Genentech’s patents directed to different aspects of Genentech’s trastuzumab product: ...more
About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Pain Point Medical Systems, Inc. v. Blephex LLC - PTAB Petition: IPR2016-01670; filed August...more
About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Smith & Nephew, Inc. v. ConforMIS, Inc. PTAB Petition: IPR2017-00778; filed January 26, 2017....more
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...more
The PTAB has instituted inter partes review of Genentech’s U.S. Patent 7,622,115, granting Hospira’s petition in IPR2016-01771. According to the institution decision, the patent is directed to methods for treating cancer in...more
The PTAB has instituted IPR2016-01837, in which Hospira challenges Genentech’s U.S. Patent 7,807,799. The institution decision extends to all challenged claims, claims 1-3 and 5-11. ...more
Hospira filed two petitions for inter partes review of Genentech’s U.S. Patent 7,371,379 (IPR2017-00805) and U.S. Patent 6,627,196 (IPR2017-00804). According to the petitions, these patents are directed to methods of treating...more
On Friday, Hospira filed the following petitions – IPR2017-00731 (U.S. Patent No. 7,846,441), and IPR2017-00737 and IPR2017-00739 (both for U.S. Patent No. 7,892,549). According to these petitions, the patents are drawn to...more
On September 16, Hospira filed a petition for an inter partes review of Genentech’s U.S. Patent No. 7,807,799 which is directed to methods of purifying proteins, including trastuzumab. Trastuzumab is marketed by Genentech...more
On September 9, 2016, Hospira filed a petition for an IPR of U.S. Patent No. 7,622,115, owned by Genentech. The ‘115 patent claims methods of treating various cancers with bevacizumab, which is marketed by Genentech under...more
WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more