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
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…
The Federal Circuit issued a split decision on the appeal in Amgen v. Sandoz today, July 21, 2015. As we’ve covered in previous posts (here, here, and here), the questions at issue in Amgen v. Sandoz were: Whether a subsection (k) (biosimilar) applicant “may elect not to disclose its [abbreviated biologic…
BREAKING NEWS – Split decision in Amgen v. Sandoz – the dance is “optional” but notice of commercial marketing can only be given after approval. Decision here. Our summary of oral argument here. Detailed discussion of today’s decision to follow later today.
As we’ve covered in previous posts and in the IPR section of this blog, several IPR petitions have been filed against patents relating to the biologic products Humira (adalimumab) and Rituxan (rituximab). The PTAB has now issued decisions on whether it will institute IPR on the three Rituxan (rituximab) IPR…
On Tuesday, July 7, 2015, the USPTO granted U.S. Patent No. 9,073,994, directed to a method of treating metastatic melanoma using an anti-PD-1 antibody to Ono Pharmaceuticals, a partner of Bristol-Myers Squibb Co. BMS makes Opdivo (nivolumab), an anti-PD-1 antibody, approved to treat metastatic melanoma and non-small cell lung cancer. …