Law360 has published an article by contributing editors here at Big Molecule Watch. The article, titled “IPR Estoppel Takes Shape,” looks at recent cases that discuss the scope of estoppel stemming from inter partes review proceedings. Click here for a link to the article.
As we previously reported, in November Mylan and Biocon submitted an aBLA to the FDA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Today, Mylan announced that the FDA has accepted its Mylan-Biocon’s aBLA. This is Mylan and Biocon’s first U.S. regulatory submission through the 351(k) pathway. The anticipated…
Goodwin announced today the release of its 2016 BPCIA Litigation Update and Thinking of Investing In a Biosimilars Product? The 2016 BPCIA Litigation Update recaps a busy year in the legal world of biosimilars, offering background, legal analysis and the status of the year’s most pivotal cases. Thinking of Investing…
We reported last week that a permanent injunction against the sale of Praluent® (alirocumab) was issued in Amgen v. Sanofi/Regeneron. The day after the court’s order, defendants filed a motion to stay the injunction while the decision is appealed to the Federal Circuit. Yesterday, Judge Robinson denied defendants’ motion to stay, noting that in the order…
In March 2016, a Federal Circuit panel issued a decision in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc. in which it held that Mylan was subject to specific personal jurisdiction in the District of Delaware because Mylan had submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval…
Law360 has published an article by three of our contributing editors here at Big Molecule Watch. As suggested by the title, “The Biosimilars Litigation Landscape for 2017,” the article provides an analysis of the expected BPCIA litigation activity, including potential new litigations, in 2017. Click here for a link to…
Japanese pharmaceutical company Takeda Pharmaceutical Company Limited announced via a press release today that it is acquiring Cambridge-based oncology company ARIAD Pharmaceuticals, Inc. in an all-cash deal worth over $5 billion. Takeda expects the deal to close by the end of February 2017, subject to required regulatory approvals and other customary…
In August 2016, we reported that CVS dropped Neupogen® (filgrastim) and Lantus® (insulin glargine) from its standard formulary and replaced them with biosimilar versions. Hikes in insulin drug prices have prompted pharmacies and insurers to change their formularies in favor of biosimilar alternatives, as reported this week by USA Today. In…
Goodwin and the Big Molecule Watch team are looking forward to participating in the 35th Annual J.P. Morgan Healthcare Conference, which brings together leaders from across the industry. If you will be in San Francisco for the conference, we hope you will join us next Wednesday, January 11, 2017, for…
For the past few years, Amgen has been asserting patents in a litigation against Sanofi and Regeneron Pharmaceuticals in the District of Delaware to prevent them from selling Praluent® (alirocumab), a biologic that competes with Amgen’s Repatha® (evolucumab). Both products are monoclonal antibodies that target PCSK9 to lower the levels…