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Sandoz Initiates Declaratory Judgment Action Against Amgen Concerning Manufacturing of Filgrastim and Pegfilgrastim Biosimilars

On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. The ’997 patent relates to a method of protein purification and is in the same patent family…

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Biosimilar IPR Appeal Updates

Following the Celltrion and Pfizer settlements of the trastuzumab litigation, the Federal Circuit granted the request of the Director of the PTO to intervene under 35 U.S.C. § 143 (i.e., defend a PTAB decision when a petitioner withdraws on appeal) in the Genentech appeals of final written decisions of unpatentability in Case…

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Health Canada Drops Suffix in Biologic and Biosimilar Naming Convention

Last week, Health Canada announced that biologic drugs, including biosimilars, will be identified “by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix. Both the brand name and non-proprietary name should be used throughout the medication use process so that biologics that share the…

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Pfizer Receives European Approval For Avastin® (Bevacizumab) Biosimilar

Pfizer announced today that the European Commission has approved its Avastin® (bevacizumab) biosimilar ZIRABEV™ for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma…

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PTAB Issues Final Written Decision Finding Immunex’s Patent at Issue in Dupixent® Litigation Unpatentable

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. …

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Court Grants BI Motion to Compel Discovery in Adalimumab Litigation (Updated)

On Monday, Magistrate Judge Lloret, who is visiting the U.S. District Court for the District of Delaware from the Eastern District of Pennsylvania, granted Boehringer Ingelheims’s (“BI’s”)  motion to compel discovery relating to its unclean hands defense in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning BI’s aBLA for a biosimilar version of AbbVie’s…

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Motion For Summary Judgement of Invalidity Denied in Praluent® Litigation

On January 18, 2019, in Amgen v. Sanofi, the ongoing litigation concerning Sanofi and Regeneron’s Praluent® (alirocumab) product, Judge Andrews of the District of Delaware denied Sanofi’s motion for summary judgment that the asserted genus claims directed to monoclonal antibodies that inhibit PCSK9 (such as Amgen’s Repatha® and Sanofi/Regeneron’s Praluent® products)…

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