On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and IPR2022-00579. The appeals concerned...more
The U.S. Patent Trials & Appeals Board (Board) recently issued an Order granting Celltrion’s motion to submit supplemental information in its IPR (2022-00578) against U.S. Pat. No. 8,580,264, owned by Chugai Seiyaku...more
On March 3, 2022, the PTAB instituted another inter partes review of U.S. Patent Nos. 8,580,264 (“the ’264 patent”), owned by Chugai and Roche. Fresenius filed a petition for inter partes review of the ‘264 patent,...more
The Federal Circuit affirmed the Patent Trial and Appeal Board's (PTAB) claim construction (and inter partes review (IPR) decision invalidating claims for obviousness) in it recent Genentech, Inc. v. Iancu decision, and also...more
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
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
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
Last month, the PTAB issued decisions on two petitions, IPR2017-02063 and IPR2018-00016, filed by Pfizer against one of Genentech’s Herceptin® (trastuzumab) patents, U.S. Patent No. 7,846,441 (“the ‘441 patent”). The ‘441...more
About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Micro Labs Ltd. v. Santen Pharmaceutical Co. - PTAB Petition: IPR2017-01434; filed May 12,...more
On November 17, 2017, Genentech filed suit against Pfizer in the District of Delaware, alleging that Pfizer’s biosimilar of Herceptin® infringes forty Genentech patents covering Herceptin® and its methods of use and...more
The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...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
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
The PTAB has denied institution of IPR2016-01608, in which Bioeq IP AG sought review of Genentech’s U.S. Patent 6,716,602. That patent is directed to methods for increasing the yield of a heterologous recombinant protein...more
In this case, the Federal Circuit determined that in its nearly 35-year history, it had not established the legal standard for demonstrating standing in an appeal from a final agency action. The underlying dispute arose from...more
It has been four years since the first inter partes review proceedings were filed in the United States. The first IPR petition, filed on September 16, 2012 (the first day IPRs became available), made it all the way to the...more
About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH - PTAB Petition: IPR2016-01665;...more
About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Illumina, Inc. v. Scripps Research Institute - PTAB Petition: IPR2016-01619; filed...more
In July of 2015, Sanofi filed petition for an inter partes review (IPR2015-01624) for 15 claims of U.S. Pat. No. 6,331,415 (“Cabilly II”). In the antibody field, the Cabilly family of patents is well known and is believed to...more