In a 104-page ruling, U.S. District Judge Mark L. Wolf granted summary judgment in favor of Celltrion and Hospira, finding that a doctrine of equivalents claim made by Janssen Biotech (“Janssen”) with respect to a Remicide®-related patent would ensnare the prior art.

Janssen makes Remicade®, a biologic drug whose active ingredient is the monoclonal

On August 10, 2018, AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively “AbbVie”) sued Sandoz Inc., Sandoz GMBH, and Sandoz International GMBH (collectively “Sandoz”) in the district of New Jersey alleging infringement of two patents related to Humira®:  U.S. Patent 9,187,559 (“the ʼ559 patent”) and U.S. Patent No. 9,750,808 (“the ʼ808 patent”).

According to the complaint

On July 2, 2018, Genentech filed suit against Eli Lilly and Company (“Lilly”) in the Southern District of California alleging Lilly’s Taltz® infringes newly issued U.S. Patent 10,011,654 (“the ʼ654 patent”).  According to the complaint, the ʼ654 patent issued at 12:00 am Eastern time on July 3, 2018, and the complaint was filed immediately thereafter.

As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a host of patents covering Rituxan® and Herceptin® were non-infringed, invalid, and/or unenforceable.  Genentech responded by moving to dismiss, arguing that Celltrion’s claims were statutorily barred by the BPCIA.  As we reported here, the Court agreed with Genentech and

The Patent Trial and Appeal Board (“PTAB”) recently denied Sandoz’s petition for inter partes review (“IPR”) of claims 1-30 of AbbVie’s patent, U.S. Patent No. 9,187,559 (“the ’559 patent”). The ’559 patent is directed towards a multiple-variable dose regimen for treating idiopathic inflammatory bowel disease. The patent discloses administering a high dose of a TNFα

Last week, Eli Lilly and Company (“Lilly”) announced that galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headaches. Lilly previously announced that galcanezumab met its primary endpoints in three different Phase 3 studies evaluating its effectiveness in preventing episodic and chronic migraine.

The episodic cluster headache study was

Earlier this month, Celltrion, Inc. (“Celltrion”) filed a copycat IPR petition directed against U.S. Patent No. 7,976,838 (“the ʼ838 patent”) that is essentially identical to a petition filed by Pfizer, Inc. (“Pfizer”).  The PTAB recently instituted review of the ʼ838 patent based on Pfizer’s petition in IPR2017-01923.  Celltrion’s copycat petition was accompanied by a motion

Earlier this month, the Patent Trial and Appeal Board (“PTAB” or “the Board”) denied institution of Sandoz’s petition for inter partes review of Abbvie’s patent, U.S. Patent No. 9,512,216 (“the ’216 patent”), directed to methods for treating moderate to severe chronic plaque psoriasis with a human anti-tumor necrosis factor α (TNFα) antibody.[1] The petition,

Today, the FDA announced that it approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen® for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.  The FDA also approved Retacrit for use before and after surgery to reduce the chance that red blood cell transfusions