We have been closely following the Amgen v. Apotex case. On September 9, 2016, Apotex petitioned the Supreme Court for certiorari to review the Federal Circuit’s decision. In its petition, Apotex presents two questions for the Supreme Court: Whether the Federal Circuit erred in holding that biosimilar applicants that make…
On September 16, Hospira filed a petition for an inter partes review of Genentech’s U.S. Patent No. 7,807,799 which is directed to methods of purifying proteins, including trastuzumab. Trastuzumab is marketed by Genentech under the brand-name Herceptin®, and is indicated for the treatment of certain sub-types of breast cancer. The petition…
As we previously reported, over the past year several petitions requesting Inter Partes Review (IPR) of patents that claim foundational inventions for biologic drug production were filed. Here we discuss the scope of two of the foundational patents that are currently under consideration by the Patent Trial and Appeals Board…
As we reported in August, the Federal Circuit denied Hospira’s motion to dismiss Amgen’s interlocutory appeal from the district court (D.Del., J. Andrews) regarding a discovery dispute. The court ordered the parties to brief the merits of the discovery dispute and the issue of whether the circuit court had jurisdiction…
According to Business Wire, on September 12, 2016, Samsung Bioepis announced that it has added Canada to its growing list of jurisdictions in which it has received regulatory approval for its biosimilar of Amgen’s Enbrel® (etanercept). The biosimilar will be marketed in Canada under the brand Brenzys® as a treatment…
On September 9, 2016, Hospira filed a petition for an IPR of U.S. Patent No. 7,622,115, owned by Genentech. The ‘115 patent claims methods of treating various cancers with bevacizumab, which is marketed by Genentech under the brand name Avastin®. Please see our IPR tracker page for all important IPR…
On September 8, 2016, the Board instituted an IPR of U.S. Patent No. 6,331,415, one of the Cabilly patents owned by Genentech. The Petitioner in IPR2016-00710 is Mylan. The ’415 patent was the subject of two other IPRS that were terminated last week following settlements between Genentech and those Petitioners, Sanofi-Aventis and…
On September 2, 2016, the PTAB terminated IPR2015-01624 and IPR2016-00460, both of which challenged U.S. Patent No. 6,331,415, one of Genentech’s Cabilly patents. The Petitioners in those IPRs were Sanofi-Aventis and Genzyme, respectively. The parties in each IPR had filed a joint request for termination following a confidential settlement agreement….
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…