As we covered in a previous post, confidential negotiations regarding the Trans-Pacific Partnership Agreement (TPP) are ramping up: the Senate passed fast-track legislation in June, which limits Congress to a yes-or-no vote on the eventual trade agreement with no amendments, and a meeting of the TPP Trade Ministers is scheduled…
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. …
Last Friday, July 10th, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill will now go to the Senate for consideration. The text of the bill, as considered and passed by the House, can be found here, and a complete summary of…
In a move that may impact the continuing debate over how to name and label biosimilar biologics, the World Health Organization (“WHO”) has released a new draft of its proposal for assignment of Biological Qualifiers (“BQ”). The BQ proposal aims to standardize naming of biologics by giving each approved and marketed…
On June 23, 2015, the U.S. Senate authorized President Obama to negotiate on a “fast-track” basis the Trans-Pacific Partnership agreement (TPP). TPP is a proposed trade agreement between several pacific countries concerning a variety of matters, including intellectual property and pharmaceutical products. Negotiations over TPP, which have been taking place…
On June 26, 2015, the Third Circuit issued its long-awaited decision in King Drug Company of Florence v. Smithkline Beecham Corp. The Third Circuit adopted a broad reading of the Supreme Court’s 2013 decision in FTC v. Actavis, 133 S. Ct. 2233, holding that a patent settlement that includes a…
On Friday, June 26, 2015 Amgen Inc. filed IPR petitions (IPR2015-01514 and IPR2015-01517) against two Humira (adalimumab) patents owned by AbbVie Inc., in an effort to clear the way for its Humira biosimilar, ABP 501. The patents, 8,916,157 and 8,916,158, are directed to improved formulations of Humira, which Amgen argues are…