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…
On April 3, 2019, the Board ordered review by the Precedential Opinion Panel (“POP”) of its decision denying institution in Hulu LLC v. Soundview Innovations LLC, IPR2018-01039, Paper No. 15 (December 3, 2018). Hulu requested rehearing of the decision arguing that the Board’s denial of institution conflicts with other Board…
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…
Yesterday, the PTAB issued final written decisions in two IPR proceedings (IPR2017-01884 and IPR2017-01879) it instituted on February 15, 2018 against U.S. Patent No. 8,679,487 (the ’487 patent), held by Immunex. The ’487 patent is directed to isolated human antibodies that compete with a reference antibody for binding to human interleukin-4 (IL-4) receptor. …
On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require aBLA…
Yesterday, December 12, 2018, the Board issued Final Written Decisions finding Claims 1-25 of U.S. Patent No. 7,476,652 (IPR2017-01526) and Claims 1-20 of U.S. Patent No. 7,713,930 (IPR2017-01528) unpatentable as obvious over the prior art. IPR2017-01526 and IPR2017-01528 were two of a number of IPR petitions filed by Mylan against…
Below is a summary of recent updates in biosimilar-related proceedings before the Patent Trial and Appeal Board of the United States Patent and Trademark Office. Trastuzumab: Last month, the Board issued two Final Written Decisions in IPRs of U.S. Patent No. 7,892,549, which is directed to methods for the treatment…
On October 23, 2018, we previously reported that the Federal Circuit ordered Momenta to show cause as to why Momenta’s appeal of a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to BMS’s ORENCIA® (abatacept) product, should not be dismissed as moot. Pursuant to Fed. R. App. P….