Below is our midwinter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016).
Below is our midwinter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016).
Big Molecule Watch frequently posts on BPCIA litigation, a recent summary of which can be found here. As our readers know, the interpretation of various provisions of the BPCIA is currently before the Supreme Court in Sandoz v. Amgen, which we most recently covered when cert was granted, the briefing…
Sandoz filed its opening brief to the Supreme Court on Friday, February 10, 2017. The dispute focuses on the notice marketing provision and the information exchange or “patent dance” procedures of the Biologics Price Competition and Innovation Act (BPCIA). Sandoz’s opening brief addressed: Whether notice of commercial marketing given before…
Sandoz filed its opening brief on Friday. Amicus briefs are due on February 17, and the full briefing schedule is available in our prior post. Big Molecule Watch will provide in depth analysis of the brief soon, so please check back for further updates on this case and other biosimilar-related litigation.
The Supreme Court has ordered a briefing schedule in Amgen v. Sandoz. Because the Court granted and consolidated Sandoz’s petition and Amgen’s conditional cross-petition, the Court has adopted a four-brief schedule, comparable to the procedure used in the courts of appeals. According to the order, the briefing schedule will be as…
Here are our picks for the top-five most significant legal developments in the world of biosimilars in 2016: 5) Congress passed and President Obama signed the 21st Century Cures Act. Among other things, the Act modifies the standards and review processes for FDA evaluation of applications to market new drugs,…
On Tuesday, Amgen filed its supplemental brief opposing Sandoz’s petition for writ and responding to the Solicitor General’s brief, which we discussed here. In sum, the Solicitor General sided with Sandoz, stating that: notice of commercial marketing before FDA approval is consistent with § 262(l)(8)(A); injunctive relief is not available…
As we posted earlier this week, the Acting Solicitor General (“SG”), on December 7th, filed an amicus brief in which it (a) recommended that the Supreme Court grant Sandoz’s cert petition and Amgen’s conditional cross-cert petition regarding how to interpret important provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and…
The Acting Solicitor General has just filed an amicus brief recommending that Sandoz’s cert petition and Amgen’s cross-petition be granted. The Acting Solicitor General also argues that the decision by the Federal Circuit on the 180-day delay was incorrect. Amgen’s supplemental brief in response will be due December 21. The Court will…
The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim, pegfilgrastim) have submitted a joint stipulation to dismiss, without prejudice, Amgen’s U.S. Patent No. 5,824,784 patent from the litigation. The ‘784 patent is directed to certain N-terminally chemically modified protein compositions, as well as methods of treatment and manufacture. With dismissal…