As we previously reported, in October 2018, Pfizer persuaded the Patent Trial and Appeal Board (PTAB) that the claims of Biogen’s U.S. Patent No. 8,821,873, directed to a method of treating lymphoma with anti-CD20 antibodies and covering the cancer therapeutic RITUXAN (rituximab), were unpatentable on obviousness grounds. After appealing to…
As previously reported, in February 2019, the Patent Trial and Appeal Board issued final written decisions in two IPR proceedings initiated by Sanofi challenging the U.S. Patent No. 8,679,487 (the ’487 patent) owned by Immunex. In IPR2017-01884, the Board held that the challenged claims of the ‘487 patent were unpatentable…
As we previously reported, Mylan filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection). On May 29, 2020, the PTAB issued Final Written Decisions in eight of Mylan’s pending petitions concerning four patents finding most of the challenged claims…
We are pleased to present the second in a series of webinars relating to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S. which provides expert guidance and practical know-how for lawyers working in this growing area of the law. The second webinar, Biosimilars Patent Challenges At The PTAB,…
The Supreme Court yesterday narrowed the scope of judicial review of proceedings before the Patent Trial and Appeal Board (PTAB) in Thryv, Inc. v. Click-to-Call Technologies, LP. Thryv had petitioned the PTAB to institute an IPR of Click-to-Call‘s patent. Thryv’s predecessor had been sued on that patent more than one…
We previously covered the Patent Trial and Appeal Board’s (the “Board”) institution of inter partes reviews filed by Mylan challenging the validity of various Sanofi patents relating to devices for administering insulin glargine: IPR2018-01675, IPR2018-01676 (Patent 8,603,044 B2); IPR2018-01678, IPR2018-01679, IPR2019-00122 (Patent 8,992,486); IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2); and IPR2018-01684 (Patent…
As previously reported, earlier this year Fresenius filed a petition for inter partes review of claims 9-10, 13-21 and 23-30 of Amgen’s pegfilgrastim patent – U.S. Patent No. 9,643,997 (“997 patent”). The challenged claims of the ’997 patent relate to methods for purifying proteins of interest expressed in a non-native…
As we previously reported, earlier this year Kashiv Biosciences filed two inter partes review (IPR) petitions challenging certain claims of Amgen’s U.S. Patent Nos. 8,940,878 and 9,643,997, which are directed to methods to purify proteins expressed in a non-native soluble form in a non-mammalian expression system. Amgen is asserting the ’878 and…
We have previously reported on IPR2016-01542, in which Apotex challenged US Patent No. 8,952,138, directed to a protein refolding process. On February 15, 2018, the PTAB issued a final written decision finding claims 1-17 and 19-24 of the ’138 patent invalid. On March 16, 2018, Apotex requested a rehearing relating…
On April 11, 2019, in Novartis Pharmaceuticals Corp. v. Par Pharmaceutical Inc., a Hatch-Waxman case concerning the small-molecule drug Zortress® (everolimus), Judge Andrews of the District of Delaware ruled that IPR estoppel could apply on remand to the District Court even after a trial on the issue of invalidity had been…