The District Court for the Southern District of Florida today ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not infringe the asserted claims of Amgen’s ’138 patent (U.S. Patent. No. 8,952,138). The court, having found in favor of Apotex on the infringement issue, did not reach Apotex’s counterclaim that the…
Last week, Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Genentech’s Herceptin (trastuzumab). Trastuzumab is indicated in Europe to treat certain breast cancers and gastric cancers that overexpress the HER2 protein. As we reported previously, Mylan…
A couple of updates on Amgen v. Hospira (epoetin alfa): Amgen has requested that the district court (D. Del., J. Andrews) grant it leave to file a second amended complaint “to add three additional defendants” who, Amgen alleges, “have directly or indirectly infringed Amgen’s patent-in-suit, United States Patent No. 5,756,349.” Meanwhile, Hospira…
Majority Leader Mitch McConnell said that the Senate will not vote on the TPP agreement this year, seemingly foreclosing the possibility of passage during President Obama’s tenure. Administration officials continue to push for the deal and hold out hope as Treasury Secretary Jack Lew noted in comments at the Brookings Institute. Meanwhile,…
Yesterday, Mylan filed two petitions for inter partes review of Genentech’s U.S. Patent No. 6,407,213. According the petitions, the patent is directed to humanized antibodies, and Mylan expects that Genentech will rely on data regarding Herceptin® (trastuzumab) in its arguments regarding secondary considerations. We will continue to monitor and report…
A recent meta-analysis investigated several factors impacting prescription drug costs in the United States. Doctors associated with the Brigham and Women’s Hospital and Harvard Medical School authored the report. Funding was provided by a grant from the Laura and John Arnold Foundation, with additional support from the Engelberg Foundation. The…
The FDA today approved Sandoz’s application for a biosimilar version of Amgen’s Enbrel product (etanercept). Sandoz’s biosimilar is called Erelzi. It is the first biosimilar etanercept approved by FDA, and the third product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars (first was Sandoz’s Zarxio (filgrastim)…
As we posted previously, the District Court in Janssen v. Celltrion has ruled that the ‘471 patent is invalid for obviousness-type double patenting on the two grounds raised in the defendants’ motions for summary judgment on that patent. The defendants last week moved for an entry of final judgment on the plaintiffs’ infringement allegations for the…
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) announced that Brenzys, an etanercept biosimilar, “could be marked as equivalent” to the branded antibody Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS). Considering the clinical evidence presented, PBAC recommended that there was “comparative safety and effectiveness of Brenzys and Enbrel.” Therefore, by substituting…
Yesterday, Celltrion filed a petition for inter partes review of Genentech’s U.S. Patent No. 7,976,838, which is directed to the use of rituximab to treat rheumatoid arthritis. We will continue to monitor and report on updates for IPR2016-01667 and will post key documents on our IPR tracker page.