Search Results: test U.S. Biosimilar Litigation News

Dance Fever: A Recap of Recent BPCIA Litigation

With the Supreme Court’s pending decision in Sandoz v. Amgen, the interpretation of the patent dance provisions of the BPCIA has been a hot topic here on the blog.  For an in-depth analysis of patent dance strategies employed by biosimilar applicants to date, check out this article in Bloomberg’s Life Sciences…

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Delaware Court Declines to Enter "Judgment" in Genentech v. Amgen

We have previously reported on letters submitted by Genentech and Amgen to the District of Delaware regarding Genentech’s decision not to file an amended complaint.  In its letter, Genentech requested entry of judgment without prejudice, which Amgen argued was unnecessary given the court’s prior order of dismissal without prejudice.  This morning,…

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Janssen v. Celltrion: Motions to Exclude or Limit Evidence and Testimony from the Upcoming Trial

With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony that may be offered at trial. Expert Testimony Celltrion has filed a motion to exclude the opinions of Janssen’s proffered expert…

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Janssen v. Celltrion: Janssen Appeals Judgment Invalidating the ’471 Patent

As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid.  Today, Janssen filed a notice that they are appealing the district court’s judgment to the Federal Circuit. Meanwhile, Celltrion’s partner Pfizer announced last week that it will begin shipping…

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FDA CALL FOR COMMENTS ON OFF-LABEL COMMUNICATIONS

The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications about unapproved uses of their approved/cleared medical products, including biologics. The public hearing will be held on November…

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