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…
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…
After another milestone year, here are our picks for the top-five biggest deals in the world of biosimilars in 2016: 1) As we reported in January 2016, Mylan N.V. and Momenta Pharmaceuticals, Inc. entered into an exclusive agreement to jointly develop, manufacture, and commercialize six of Momenta’s current biosimilar medications,…
On September 20, Teva Pharmaceutical Industries Ltd. and Regeneron Pharmaceuticals, Inc. announced an agreement to develop and commercialize fasinumab, an investigational NGF antibody currently under development by Regeneron as a treatment for osteoarthritis and chronic low back pain. The press release states Teva and Regeneron will collaborate globally, excluding Japan, Korea, and…
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…
IPR2016-00383 (U.S. Patent No. 6,331,415) (Genzyme) (Cabilly II patent) – Denying Institution of IPR The PTAB has denied IPR on U.S. Patent No. 6,331,415. On June 8, the PTAB instituted a separate Genzyme petition against this patent (IPR20016-00460), which was joined to an earlier Sanofi-Aventis and Regeneron IPR (IPR2015-01624) based on the same grounds.
On April 1, Sanofi and Regeneron announced positive results in two placebo-controlled Phase 3 studies of dupilumab, a monoclonal antibody under evaluation for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. According to Sanofi’s and Regeneron’s press release: “There are no approved systemic therapies in the U.S….
A jury trial starts Monday, March 7, in the patent case between plaintiff Amgen Inc. and defendants Sanofi and Regeneron over two biologic drugs, Amgen’s Repatha and Sanofi/Regeneron’s Praluent. The case is before Judge Sue Robinson in the District of Delaware. Both products, which are monoclonal antibodies used to treat…
IPR2015-01624 (U.S. Patent No. 6,331,415) (Sanofi-Aventis and Regeneron) (Cabilly patent) – Institution of IPR The PTAB has instituted IPR on U.S. Patent No. 6,331,415.
IPR2015-01624 (Sanofi-aventis and Regeneron) (U S Patent No 6,331,415) Petitioners: Sanofi-aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. Patent: U.S. Patent No. 6,331,415 Patent Title: Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein