Patents related to Regeneron’s EYLEA (aflibercept) were recently added to the Purple Book. Under the Biological Product Patent Transparency Act, signed into law December 27, 2020 and codified at 42 U.S.C. § 262(k)(9), patents must be submitted to the FDA for listing in the Purple Book during the “Patent Dance” under the BPCIA. Specifically,
On March 14, 2022, Regeneron Pharmaceuticals Inc. (“Regeneron”) filed a statutory disclaimer under 37 CFR § 1.321 disclaiming all claims of U.S. Patent No. 10,857,231 B2 (the “’231 patent”) in response to a petition for a post-grant review submitted by Celltrion Inc. (“Celltrion”). On September 7, 2021, Celltrion submitted a petition for post-grant review of
The U.S. Patent and Trademark Office (USPTO) recently instituted two of Mylan’s petitions seeking Inter Partes Review of Regeneron’s U.S. Patent No. 9,669,069 B2 (the “’069 Patent,” subject of IPR2021-00880) and U.S. 9,254,338 B2 (the “’338 Patent,” subject of IPR2021-00881), finding that Mylan (now part of Viatris) established a reasonable likelihood in prevailing in showing
On October 26, 2021, the Patent Trial and Appeal Board (PTAB) granted Regeneron’s petition to institute an inter partes review (IPR) of Novartis’s patent U.S. Pat. No. 9,220,631 (“the ’631 patent”), which covers a pre-filled glass syringe for injecting a VEGF-antagonist into the eye. This is the second time the PTAB reviewed Regeneron’s petition to
Mark your calendars – on December 9th, the Federal Circuit is slated to hear oral arguments as to whether two Amgen patents claiming a genus of antibodies meet the enablement requirement of 35 U.S.C. § 112. The court’s decision may have a considerable impact on antibody-based drug development and the scope of patent
Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for treatment of high cholesterol.[1] The case reached an important milestone recently as a jury entered a verdict largely upholding the validity of Amgen’s asserted patents, to the disappointment of Sanofi and Regeneron. A similar
Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. recently scored a victory in their ongoing dispute over a patent that Immunex Corporation claims covers Dupixent®, Sanofi and Regeneron’s anti-IL-4 antibody marketed for treatment of moderate-to-severe eczema. In February, the Patent Trial and Appeal Board (“the Board”) instituted two petitions for inter partes
On December 20, 2017, Bristol Myers Squibb Company, Bavarian Nordic, and Enzo Biochem, Inc. filed an amicus brief in support of Amgen’s petition for rehearing en banc. We reported previously that on November 6, 2017, Amgen filed a petition for rehearing en banc of a Federal Circuit panel’s decision vacating a permanent injunction against
On January 3, 2018, Momenta and Mylan announced their development plan for a proposed biosimilar to Regeneron’s Eylea® whose active ingredient is aflibercept, a recombinant fusion protein. Eylea® was first approved as an intravitreal injection indicted for the treatment of patients with neovascular (wet) age-related macular degeneration. Eylea® is now also indicated for macular edema
In October, a Federal Circuit panel vacated a permanent injunction against Sanofi and Regeneron’s Praluent® and remanded the proceeding to the district court for a new trial on the defendants’ written description and enablement defenses.[i] The panel had held that the district court erred by (i) excluding the defendants’ evidence of written description and