As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s application to market a biosimilar of Avastin® (bevacizumab). Today, Amgen filed a letter in response, informing the court that, on March 24, Genentech…
As we previously reported, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen, finding a lack of subject matter jurisdiction over Genentech’s declaratory judgment complaint under the Federal Circuit’s holding in Amgen v. Sandoz. The court granted the motion with leave for Genentech to amend its complaint…
On March 31, Sandoz filed its consolidated response and reply brief in Sandoz v. Amgen. We have previously covered Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief. Amgen’s final reply brief was filed today, and argument is scheduled for April 26, 2017. Sandoz’s brief replied to Amgen’s counterarguments regarding whether an…
Aragen Bioscience, Inc. and Transposagen Biopharmaceuticals, Inc. have filed three petitions for IPR of Kyowa Hakko Kirin Co., Ltd.’s patents: IPR2017-01262 on U.S. Patent 7,425,446; IPR2017-01252 on U.S. Patent 6,946,292; and IPR2017-01254 on U.S. Patent 8,067,232. According to the petitions, the challenged claims are “directed to an isolated mammalian host…
On March 29, Senator Al Franken and fifteen co-sponsoring Senate Democrats introduced a bill called the “Improving Access to Affordable Prescription Drugs Act” (S. 771). A companion bill (H. 1776) with the same title was introduced the same day in the House by Representative Schakowsky and four co-sponsoring House Democrats….
On April 3, 2017, the Federal Circuit heard oral argument concerning the discovery dispute between Amgen and Hospira in their litigation concerning Hospira’s proposed biosimilar of Amgen’s product Epogen®/ Procrit® (epoetin alfa) (audio available here). In this dispute, Amgen is seeking to compel production of information concerning Hospira’s manufacturing process, including…
Lanka Business News is reporting that Celltrion and George Steuart Health have teamed up to launch Remsima (infliximab) in Sri Lanka. According to the article, this is the first biosimilar available in Sri Lanka. The article states that the launch took place at the Cinnamon Grand Colombo in Sri Lanka, and…
On April 5, Immunex (a wholly-owned subsidiary of Amgen) filed a complaint against Sanofi and Regeneron related to Sanofi and Regeneron’s Dupixent® (dupilumab) product, which received FDA approval last week. Immunex’s complaint was filed in the District Court for the Central District of California and asserts patent infringement and seeks a declaratory judgment of…
The PTAB issued a Final Written Decision in IPR2016-00258, wherein Petitioner Green Cross Corp. challenged claims 1-3, 16, and 17 of Shire Human Genetic Therapies, Inc.’s U.S. Patent No. 9,051,556. Green Cross, which is developing a biobetter of Shire’s Elaprase (idursulfase) for Hunter syndrome, had argued that the challenged claims were…
JHL Biotech announced today that China’s FDA has accepted its application for the use of JHL1101 in Phase 1 and Phase 3 clinical trials in non-Hodgkin’s lymphoma patients. JHL1101 is a rituximab biosimilar candidate that JHL is pursuing as part of its strategic biologics alliance with Sanofi. According to the press…