Patent Law Weblog
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Category: Biosimilars
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By Kevin E. Noonan — Late last week, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This Guidance, entitled Nonproprietary Naming of Biological Products, extends to both reference biologic drug products and…
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By Andrew Williams — On Friday, the Supreme Court granted both petitions for writs of certiorari and consolidated the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals. Sandoz had petitioned the Court on February 16, 2016 for a writ of certiorari to review one of the issues decided by the Federal…
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By Kevin E. Noonan — On December 29, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This Guidance, entitled Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product,…
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By Donald Zuhn –- After reflecting upon the events of the past twelve months, Patent Docs presents its tenth annual list of top patent stories. For 2016, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and…
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By Donald Zuhn –- After reflecting upon the events of the past twelve months, Patent Docs presents its tenth annual list of top patent stories. For 2016, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and…
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By Donald Zuhn –- After reflecting upon the events of the past twelve months, Patent Docs presents its tenth annual list of top patent stories. For 2016, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and…
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By Kevin E. Noonan — The Federal Circuit's decision in Amgen v. Sandoz, regarding litigation "under" (or at least based upon) the Biologics Price Control and Innovation Act (BPCIA), interpreted for the first time two provisions of the law. The first was whether the requirement in the law that the biosimilar applicant (BA) disclose its…
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By Andrew Williams — On April 5, 2016, the FDA approved Celltrion's application to market a biosimilar to Janssen Biotech Inc.'s REMICADE® (infliximab) anti-TNF-α antibody (see "FDA Approves Inflectra – Celltrion's REMICADE® Biosimilar"). Presumably because of the Notice-of-Commercial-Marketing provision, Celltrion notified Janssen at the time that it would not begin selling its biosimilar drug product until…
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By Andrew Williams — On Friday, the FDA approved Amgen's application to market Amjevita (adalimumab-atto), a biosimilar to AbbVie's HUMIRA (adalimumab) fully human anti-TNF-α antibody. This marks the fourth biosimilar approved by the FDA pursuant to the BPCIA. Amgen submitted Biologics License Application ("BLA") 761024 on November 25, 2015 pursuant to subsection (k) of the…
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By Andrew Williams — To date, Amgen has been the reference product sponsor for many biosimilar applications. Correspondingly, Amgen has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price Competition and Innovation Act ("BPCIA"). For example, Amgen's lawsuit against Sandoz was one of the first…
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