HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program. They are: Eliquis (apixaban, Bristol Myers Squibb) Jardiance (empagliflozin, Boehringer Ingelheim) Xarelto (rivaroxaban, Janssen Pharms) Januvia (sitagliptin phosphate, Merck Sharp Dohme) Farxiga (dapagliflozin, AstraZeneca AB) Entresto (sacubitril;…
The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021. As we previously reported, the litigation pertains to ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL. The case had been administratively stayed since January 2020. Judgment…
As previously reported, in February 2019, the Patent Trial and Appeal Board issued final written decisions in two IPR proceedings initiated by Sanofi challenging the U.S. Patent No. 8,679,487 (the ’487 patent) owned by Immunex. In IPR2017-01884, the Board held that the challenged claims of the ‘487 patent were unpatentable…
We previously reported on the decision by the District of New Jersey (Cecchi, J.) to uphold the validity of U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product ENBREL” and U.S. Patent No. 8,163,522, related to ENBREL’s method of manufacture. As we reported…
We previously reported on the bevacizumab preliminary injunction appeal in Genentech v. Immunex Rhode Island Corp., Fed. Cir. Case No. 19-2155. The notice of oral argument was posted today and is scheduled for June 3, 2020.
This week, in the Immunex v. Samsung Bioepis BPCIA litigation regarding ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL, the New Jersey district court entered a Consent Injunction Order that prohibits Samsung Bioepis from using, importing, offering to sell, or selling any etanercept product in the United States, except as allowed…
Today, in the Immunex v. Sandoz BPCIA litigation, a District of New Jersey judge held that U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product Enbrel®” and U.S. Patent No. 8,163,522, related to Enbrel®’s method of manufacture, are not invalid. As we previously reported,…
Yesterday, the PTAB issued final written decisions in two IPR proceedings (IPR2017-01884 and IPR2017-01879) it instituted on February 15, 2018 against U.S. Patent No. 8,679,487 (the ’487 patent), held by Immunex. The ’487 patent is directed to isolated human antibodies that compete with a reference antibody for binding to human interleukin-4 (IL-4) receptor. …
On September 25, 2018, the 10-day bench trial came to an end in the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar. As we previously reported, prior to the start of trial, the Court had entered a stipulation of infringement of certain asserted claims of U.S. Patent No. 8,063,182 (“the ‘182 patent”)…
As we have previously reported, the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar is scheduled to begin trial today before New Jersey District Judge Claire C. Cecchi. Yesterday, prior to the start of trial, the Court entered a stipulation wherein Sandoz stipulated to infringement of…