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…
On July 21, 2015, the Federal Circuit issued a split decision in the Amgen v. Sandoz appeal. As we anticipated in our analysis of the oral argument, Sandoz won with its interpretation of the first issue: an applicant can choose between disclosing its (k) application and manufacturing information, or not disclosing such…
IPR2015-01624 (Sanofi-aventis and Regeneron) (U S Patent No 6,331,415) Petitioners: Sanofi-aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. Patent: U.S. Patent No. 6,331,415 Patent Title: Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein