We previously reported on Judge Chesler’s claim construction order in Sanofi-Aventis v. Mylan et al. concerning Mylan’s proposed insulin glargine pen device, Vystra. This week, following a 5-day bench trial held on December 2-6, 2019, the U.S. District Court of New Jersey found U.S. Patent No 9,526,844, a pen-type injector…
As we previously reported, Revance Therapeutics and Mylan are collaborating in developing a biosimilar of Allergan’s BOTOX (onabotulinumtoxinA), and Mylan has an upcoming opportunity to opt in or out of the collaboration. Last week, Revance’s President and CEO, Mark Foley, announced on the company’s quarterly earnings call that “Mylan has…
On October 7, 2019, Mylan Pharmaceuticals filed 2 Petitions for Inter Partes Review (IPR2019-01657 and IPR2019-01658) of U.S. Patent RE47,614, which is assigned to Sanofi-Aventis. The ’614 patent claims a configuration for securely holding a cartridge within a drug delivery device, which can be used to deliver insulin. The petitions…
On September 17, 2019, the U.S. District Court for the Western District of Pennsylvania endorsed the parties’ stipulation and proposed order of non-infringement of U.S. Patent No. 9,643,997 in favor of Mylan, thereby resolving all pending disputes between the parties in Amgen v. Mylan, Civil Action No. 17-cv-1235, the BPCIA…
As we previously reported, in the Amgen v. Mylan litigation concerning Mylan’s FULPHILA (pegfilgrastim-jmdb), a biosimilar of NEULASTA, Amgen has asserted that Mylan infringes two protein purification process patents: U.S. Patent Nos. 8,273,707 and 9,643,997. Early this month, the district court requested the parties’ positions with regard to the ’707…
Mylan N.V. and Pfizer Inc. recently announced that Mylan and Upjohn, Pfizer’s off-patent branded and generic business, will combine to form a new company. According to the press release, each Mylan share would be converted into one share of the new company. Pfizer shareholders will own 57% of the combined new company,…
Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. According to…
As we reported here, on June 9, 2017, Mylan filed two IPR petitions challenging Sanofi-Aventis’s U.S. Patent No. 7,476,652 (IPR2017-01528) and U.S. Patent No. 7,713,930 (IPR2017-01526), related to Sanofi’s Lantus® (insulin glargine injection). Both petitions were instituted on December 13, 2017, as reported here. On September 10, 2018, Mylan filed ten additional…
Lupin Ltd. and Mylan N.V. both issued press releases today announcing a collaboration to commercialize a biosimilar to Amgen’s Enbrel® (etanercept). Mylan will commercialize Lupin’s proposed etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia. According to the press releases, Lupin successfully completed its…
Pegfilgrastim litigation We had previously covered Judge Stark’s grant of Coherus’s motion to dismiss Amgen’s complaint alleging infringement of the ‘707 patent in Amgen v. Coherus. Today, Judge Stark entered judgment against Amgen and dismissed the case. In the Amgen v. Mylan litigation earlier covered here, Mylan recently filed a…