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…
As we previously reported, negotiations on the Trans-Pacific Partnership Agreement, for which President Obama has been given fast-track authority to negotiate, are well underway, and leaders have been meeting this week in Maui to iron out what many believe will be the final deal. One of the most contentious issues…
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…
Goodwin Procter announced today the publication of Pharmaceuticals at the Patent Trial and Appeal Board, a guide that addresses proactive measures for pharmaceutical companies involved in litigation before the PTAB. The guide explores key statistics and case studies that reveal how the PTAB is handling pharmaceutical matters and lays out…
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
IPR2015-01537 (Momenta) (U S Patent No 8,476,239) Petitioner: Momenta Pharmaceuticals, Inc. Patent: U.S. Patent No. 8,476,239 Patent Title: Stable Protein Formulations
The Federal Circuit’s split decision in Amgen v. Sandoz answered some pressing questions about the interpretation of the BPCIA – but will the panel’s decision be the last word on the subject, at least for the time being? Here’s a quick look at what will happen next on appeal. September…