We previously reported on the biosimilar trade secrets case, Genentech v. JHL. Genentech asserted claims including trade secret misappropriation under state and federal law, breach of contract, and breach of state and federal computer fraud and abuse acts. On March 20, the district court entered a case management order ,…
As we have reported, Samsung Bioepis is engaged in U.S. patent litigation and proceedings against Genentech in connection with Samsung Bioepis’s ONTRUZANT (trastuzumab-dttb) biosimilar product, which the U.S. FDA approved earlier this year. In addition to litigating a BPCIA case in federal district court that is currently scheduled for a…
As we previously reported, Pfizer recently filed a notice that it will not participate in the appeal of the final written decision of IPR2017-01168, which found all claims of U.S. Patent No. 8,821,873 unpatentable. The ‘873 patent is directed to a method of treating lymphoma with anti-CD20 antibodies. On March…
On March 7, 2019, Kashiv Biosciences filed two IPR petitions (IPR2019-00791 and IPR2019-00797) against Amgen process patents – U.S. Patent Nos. 8,940,878 and 9,643,997. The ‘878 and ‘997 patents are directed to methods to purify proteins expressed in a non-native soluble form in a non-mammalian expression system. Kashiv asserts that claims 7-8, 11-12,…
Earlier this month, a bipartisan group of six senators introduced the Biologic Patent Transparency Act (“BPTA”), which the senators say will “help increase patent transparency, promote biosimilar competition, bring needed biosimilar treatments to patients faster, and ultimately, lower drug prices for consumers.” The sponsors further state that the bill will…
Today, Pfizer filed a notice that it will not participate in the appeal of the final written decision of IPR2017-01168, which found all claims of U.S. Patent No. 8,821,873 unpatentable. The ‘873 patent is directed to a method of treating lymphoma with anti-CD20 antibodies. Yesterday, Pfizer and Biogen filed a joint…
On March 18, 2019, UFCW Local 1500 Welfare Fund, a New-York based grocery union, filed a putative class-action lawsuit against AbbVie and seven adalimumab biosimilar manufacturers alleging misconduct and antitrust violations in connection with AbbVie’s assertion of patents to prevent the sale of biosimilar versions of Humira® in the United States….
Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab biosimilar. According to the press release, the “global settlements resolve all pending disputes between the parties related to Coherus’ adalimumab biosimilar,” with Coherus’s…
On March 4, 2019 FDA announced the availability of a draft guidance titled Nonproprietary Naming of Biological Products: Update (“Naming Guidance”). According to FDA’s announcement the Naming Guidance reflects FDA’s current thinking on biological products licensed under Section 351 of the Public Health Service Act (“PHS Act”). This draft guidance serves…
Yesterday, the U.S. FDA approved Pfizer’s Trazimera™ (trastuzumab-qyyp), a biosimilar of Genentech’s Herceptin®, for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. These indications are the same as those for which the reference product is approved. Trazimera™ is the fourth trastuzumab biosimilar, and the…