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…
Below is our Fall 2016 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 update (Summer 2016).
Last week, Amgen filed a notice of appeal to the Federal Circuit from the district court’s judgment of non-infringement. The Federal Circuit has docketed the appeal as Case No. 17-1010. Amgen’s opening brief will be due in early December, absent any extensions of time or other delays in the appeal…
Last week, Sanofi-Aventis U.S. LLC filed a complaint against Merck Sharp & Dohme Corp. over its proposed follow-on biologic to Lantus (insulin glargine injection). The complaint asserts that Merck will infringe 10 different U.S. patents with its follow-on biologic product. According to the complaint, Merck has submitted an NDA seeking…
The District Court for the Southern District of Florida today ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not infringe the asserted claims of Amgen’s ’138 patent (U.S. Patent. No. 8,952,138). The court, having found in favor of Apotex on the infringement issue, did not reach Apotex’s counterclaim that the…
A recent meta-analysis investigated several factors impacting prescription drug costs in the United States. Doctors associated with the Brigham and Women’s Hospital and Harvard Medical School authored the report. Funding was provided by a grant from the Laura and John Arnold Foundation, with additional support from the Engelberg Foundation. The…
Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product. Please also consult our BPCIA Litigation Summary Chart for additional details.
Yesterday, CVS announced that it would be dropping two brand-name biologic drugs from its standard formulary (list of medications CVS will cover): Amgen’s Neupogen® (filgrastim), and Sanofi’s Lantus® (insulin glargine). CVS will be replacing Neupogen® with Sandoz’s Zarxio® biosimilar product, and will replace Lantus® with Eli Lilly & Co.’s Basaglar® product,…
Sandoz has announced plans to expand its biosimilars offerings within the next five years, including a total of 11 filings by the end of 2017, and 5 launches by 2020. Sandoz says that its next five launches will be biosimilars to Enbrel® (etanercept), Humira® (adalimumab), Neulasta ® (pegfilgrastim), Remicade® (infliximab)…