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    • Legal

    The PTAB Denies Institution of Two IPRs Involving a Patent Directed to the Treatment of Hemophilia B

    By Seth Cockrum January 31, 2019 Comments are off

    The PTAB recently denied institution of two IPRs filed by CSL Behring LLC, CSL Behring GMBH, and CSL Behring Recombinant Facility AG...

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    Tagged with: Aprolix®, Bioverativ Therapetutics, BLA, CSL Behring, Idelvion®, IPR, PTAB

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  • Posted in:

    • Legal

    Litigation Spotlight Update: Epogen® Litigation Status in Face of Retacrit Regulatory Approval

    By Spencer Johnson May 22, 2018 Comments are off

    As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a...

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    Tagged with: Amgen, BLA, BPCIA, Epogen®, FDA, Featured, Federal Circuit, Hospira, Legal, Pfizer, Retacrit®

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  • Posted in:

    • News

    District Court Grants Genentech’s Motions to Dismiss Celltrion’s Declaratory Judgment Actions in Herceptin® and Rituxan®-Related Suits

    By Seth Cockrum May 11, 2018 Comments are off

    As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a number of patents...

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    Tagged with: BLA, BPCIA, Celltrion, District Court, Genentech, Herceptin®, News, Patent Dance, Rituxan®, Rituximab, trastuzumab

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  • Posted in:

    • News

    Final Judgment Entered in Amgen v. Coherus Neulasta Litigation

    By Seth Cockrum April 26, 2018 Comments are off

    Last week, on April 18, 2018, Judge Stark in the District of Delaware entered the Final Judgment and Order dismissing the patent...

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    Tagged with: Amgen, BLA, BPCIA, Coherus, Neulasta®, pegfilgrastim

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  • Posted in:

    • Legal

    A Rare Successful Challenge of a Patent for a Method of Manufacturing Biologic Drugs

    By Aydin Harston March 12, 2018 Comments are off

    Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are...

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    Tagged with: Amgen, Apotex, BLA, FDA, Federal Circuit, filgrastim, IPR, Neulasta®, Neupogen®, pegfilgrastim, PTAB

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  • Posted in:

    • Legal

    Genentech’s Carter ’213 Patent Asserted and Challenged

    By Spencer Johnson March 5, 2018 Comments are off

    In October, we reported on a growing number of IPR challenges to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) to...

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    Tagged with: BLA, Boehringer Ingelheim, BPCIA, Celltrion, District Court, Genentech, Herceptin®, IPR, Litigation, Mylan, Pfizer, Samsung Bioepsis, Teva, trastuzumab

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  • Posted in:

    • Legal

    Sanofi Files Suit Against Merck Sharp & Dohme Over Second NDA for Insulin Glargine Biologic: A Look at the Differences in Biosimilar Approval Pathways

    By Nicole DeAbrantes October 19, 2017 Comments are off

    On August 8, 2017, Sanofi-Aventis (“Sanofi”) filed a patent infringement suit in the United States District Court for the District of...

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    Tagged with: 351(k) pathway, 505(b)(2), BLA, District Court, Guidance, Merck, NDA, Patent Dance, Sanofi

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