As we reported in an earlier post, the 180-day commercial notice provisions of the BPCIA at issue in Amgen v. Sandoz are also being litigated in Janssen v. Celltrion, an action pending in the District of Massachusetts. The parties’ cross-motions for partial summary judgment [here and here] on whether Celltrion’s pre-FDA-licensure…
Following the parties’ petitions for rehearing en banc in Amgen v. Sandoz, Amgen has filed an emergency motion for an injunction to block the launch of Sandoz’s FDA-approved biosimilar filgrastim product, pending the Federal Circuit’s en banc consideration and review. Sandoz is currently enjoined from marketing its biosimilar product, Zarxio,…
As we reported in an earlier post, Amgen v. Apotex is the first biosimilar litigation in which the parties have actually danced the entire “patent dance” through the “first wave.” The case, which concerns Apotex’s application to market a biosimilar version of Neulasta, has already been scheduled for trial beginning July…
IPR2015-01792 (Coalition for Affordable Drugs V LLC, et al.) (U.S. Patent No. 8,163,522) Petitioners: Coalition for Affordable Drugs V LLC; Erich Spangenberg; Hayman Capital Management, LP; Hayman Captial Master Fund, LP; Hayman Credes Master Fund, LP; Hayman Investments, LLC; Hayman Offshore Management, Inc.; Hayman Orange Fund SPC – Portfolio A;…
In the latest development in the closely-watched Amgen v. Sandoz appeal, Amgen and Sandoz have filed cross-petitions seeking en banc review of the panel’s July 21, 2015 decision holding that (1) a biosimilar applicant may opt out of the BPCIA “patent dance”; and (2) when the applicant opts out, the 180…
As we covered in an earlier post, the PTAB has instituted two IPR proceedings concerning patents related to Rituxan® (rituximab) (see IPR2015-00417 (U.S. Patent No. 7,976,838) and IPR 2015-00415 (U.S. Patent No. 7,820,161)). The PTAB had denied institution on a third rituximab IPR petition filed by Boehringer Ingelheim (see IPR2015-00418 (U.S. Patent No. 8,329,172))….
On August 7, 2015, Judge Engelmayer of the U.S. District Court for the Southern District of New York granted the preliminary injunction sought by Amarin Pharma against the FDA in Amarin Pharma Inc. et al v. Food and Drug Administration et al, No. 15cv3588 (S.D.N.Y. 2015). The court held that…
Please join us on August 12, 2015 at 12:30 pm EDT for a lively discussion about the Amgen v. Sandoz Federal Circuit decision as Goodwin Procter partners Elaine Herrmann Blais and Robert Cerwinski analyze the outcome and discuss what is likely to happen next, along with how the decision impacts biosimilars strategy…
On August 6, 2015, Amgen filed a complaint against Apotex in what appears to be the first biosimilar litigation in which the parties have actually danced the entire “patent dance” through the “first wave.” The complaint alleges that Apotex submitted a BLA “pursuant to 42 U.S.C. § 262(k)” seeking “authorization from…
On July 23, 2015, Janssen Biotech, Inc. and New York University filed a brief appealing the rejection of all claims of U.S. Patent No. 6,284,471, a patent covering Remicade (infliximab), to the USPTO’s Patent Trial and Appeal Board. The ’471 patent was put into ex parte reexamination in 2013, and…