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…
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…
We joined a packed courtroom at the Federal Circuit Court of Appeals yesterday to observe oral arguments in the Amgen v. Sandoz appeal. Judge Newman, Judge Lourie, and Judge Chen were on panel for the hearing. As we’ve covered in other posts (here and here), this case has drawn a…
Amgen appealed the district court order on March 25, 2015, and sought an expedited briefing schedule and an injunction to delay the launch of Sandoz’s Zarxio product while the Court considers Amgen’s appeal. The Federal Circuit granted the motion for an expedited schedule, and set oral argument for June 3,…
As discussed in our introductory post, the BPCIA lays out a series of steps to resolve patent disputes involving biosimilars. According to these steps, once a biosimilar applicant receives notice from FDA that its application has been accepted for review, the applicant provides the reference product sponsor with a copy…