Patent Law Weblog
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Category: Biosimilars
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By Kevin E. Noonan — In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) today in Amgen v. Sandoz. In doing so, the Court limited the information available to biologic drug makers regarding a competitor's application for a biosimilar product (adopting Sandoz's argument). On…
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By Andrew Williams — The Federal Circuit heard oral arguments in the Amgen v. Sandoz case on Wednesday, June 3, 2015. The three judges on the panel were Judge Newman, Judge Lourie, and Judge Chen. This case is on appeal from the U.S. District Court for the Northern District of California, where Judge Seeborg denied…
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BIO and Biosimilars By Andrew Williams — The 2015 BIO International Convention begins in two weeks in Philadelphia. For the past few years, we have provided a series of previews with the goal of making the large amount of information and opportunities available at BIO less daunting for our readers. This year is no exception,…
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By Kevin E. Noonan — About three years ago, and less than two years after Congress passed and President Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law, the U.S. Food and Drug Administration issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in…
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By Donald Zuhn — A group of Senators led by Sen. Lamar Alexander (R-TN), the Chairman of the Senate Committee on Health, Education, Labor, and Pensions, sent a letter last month to Dr. Stephen Ostroff, the Acting Commissioner of the U.S. Food and Drug Administration, "to express concern and raise questions over how the Food…
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By Kevin E. Noonan — The Federal Circuit has granted Amgen’s emergency motion for an injunction against Sandoz, preventing that company from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO® biosimilar product until [the] Court resolves the appeal." The Order also sets a date of no later than seven…
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By Andrew Williams — Amgen is once again seeking a preliminary injunction in the Amgen v. Sandoz case, this time at the Federal Circuit while that Court resolves the issues on appeal from the District Court. Sandoz has only agreed to stay off the market until May 11, 2015. Therefore, this may be Amgen's last…
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By Andrew Williams — On March 19, 2015, U.S. District Judge Seeborg of the Northern District of California denied a motion for a preliminary injunction filed by Amgen to prevent the imminent launch by Sandoz of a biosimilar version of NEUPOGEN® (filgrastrim). In so doing, the Court ruled that the disclosure and notice provisions of…
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By Andrew Williams — Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and exchange provisions described in the Biologics Price Competition and Innovation Act ("BPCIA"). Amgen…
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By Kevin E. Noonan — There has always been a tension between the need for a final arbiter of the law and the inherent power associated with such a role placed in the judicial branch. Jefferson himself was wary of this tendency, writing in a letter to Edward Livingston in 1825: One single object .…
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