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Category: Biosimilars
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By Kevin E. Noonan — As reported earlier today in IP Law360, Sandoz has petitioned the U.S. Supreme Court for certiorari to review the Federal Circuit's decision that reversed the District Court in Amgen v. Sandoz. In its decision, two members of the Federal Circuit panel (Judges Lourie and Newman) held that the BPCIA required…
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By Andrew Williams — Earlier today, the FDA's Arthritis Advisory Committee recommended approval of biologics license application ("BLA") 125544 submitted by Celltrion, Inc. for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-α antibody. According to a press release from Celltrion, the committee voted 21-3 to recommend approval for all sought indications, including…
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By Donald Zuhn — After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories. For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest 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 ninth annual list of top patent stories. For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and…
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By Kevin E. Noonan — The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the District Court correctly determined that the provisions of the BPCIA requiring disclosure…
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By Andrew Williams — On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act ("BPCIA"). As we reported at the time, the decision from the three judge panel was…
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By Kevin E. Noonan — Sandoz is having a good year. The company succeeded in having their NEUPOGEN® (filgrastrim) biosimilar product, Zarxio™, approved by the FDA in March, a mere ten months after filing its biosimilar application last July. The biosimilar applicant also avoided the disclosure provisions of the Biologics Price Competition and Innovation Act…
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By Kevin E. Noonan — Sandoz successfully (at least for now) has overcome conventional wisdom, the plain language of the Biologics Price Competition and Innovation Act (BPCIA) (or, at least those provisions regarding patent litigation) and Amgen in obtaining approval for its figastrim biosimilar product, Zarxio™ in Amgen v. Sandoz. The only thing standing between…
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By Andrew Williams — As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. — a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for approval of biosimilar drug products. Unfortunately, the decision was, much like the BPCIA itself, anything…
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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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