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…
On June 24, 2015, the UK’s High Court of Justice Patents Court invalidated a Genentech patent (EP 1037926 (“the ’926 patent”)) for the combined use of Herceptin (trastuzumab) in combination with the chemotherapeutic taxane for treatment of HER2-positive breast cancer. Hospira brought this action as part of a series of patent…
The Federal Circuit recently received additional briefing on the bond issue from the parties in Amgen v. Sandoz, which remains under advisement. Our earlier posts on Amgen, which can be found here, here, and here, describe the issues raised and the procedural background of this case of first-impression involving the patent…
In what appears to be the first time a drug patent has been so challenged, Amneal Pharmaceuticals LLC, Par Pharmaceutical Inc., and Roxane Laboratories Inc. have asked the U.S. Patent Trials and Appeals Board to invalidate U.S. Patent No. 7,895,059, assigned to Jazz Pharmaceuticals Inc., under the America Invents Act’s (AIA)…
On June 12, 2015, the Court of Appeals for the Federal Circuit (CAFC) held the DNA detection method claims at issue in Ariosa v. Sequenom invalid as directed to non-patentable subject matter. The decision is the latest in a line of recent Supreme Court and CAFC decisions constricting the scope of…
On May 21, 2015, the Energy and Commerce Committee voted unanimously to advance the 21st Century Cures Act, which the Committee has presented as “a bill to help modernize and personalize health care, encourage greater innovation, support research, and streamline the system.” The legislative text of the proposed bill spans…
AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose three labeling requirements on biosimilar applicants. “Biosimilars are not generic drugs and should not be labeled like generic drugs” AbbVie stated, and demanded that the FDA require biosimilars to contain various statements in their labels to distinguish…