On February 27, 2026, Genentech filed a complaint at the U.S. International Trade Commission (ITC) alleging that Biocon’s importation of its pertuzumab biosimilar, BMAB 1500/PERT-IJS (“BMAB 1500”), violates 19 U.S.C. § 1337 (“Section 337”). Biocon’s Biologics License Application (“BLA”) for BMAB 1500 references Genentech’s PERJETA (pertuzumab), a HER2-directed monoclonal antibody therapy used in treatment of
In our previous articles, we reported that the Federal Circuit affirmed the district court’s decision on December 20, 2024 ordering Teva Pharmaceuticals (“Teva”) to delist certain patents related to Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange Book, and that the Federal Circuit subsequently stayed that delisting order on January 22, 2025 following a
In our previous article, we reported that the Federal Circuit affirmed the district court’s decision requiring Teva to delist certain patents related to its Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange Book. Following a request from Teva for an en banc rehearing, the Federal Circuit stayed the delisting order on January 22
On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. The Federal Circuit affirmed the district court’s decision that Teva’s patents were improperly listed and must be
Last week, a federal court in Delaware unsealed an opinion supporting its grant of summary judgment that U.S. Patent No. 7,033,590 (“the ’590 Patent”) is invalid for lack of enablement.[1] The ’590 Patent is owned by Baxalta Inc. (“Baxalta”), a subsidiary of Takeda Pharmaceutical Co. Ltd (“Takeda”).
As we previously discussed,
Last week, Coherus BioSciences, Inc. (“Coherus”) announced that the United States Food and Drug Administration (“FDA”) approved YUSIMRY™, an adalimumab biosimilar. YUSIMRY™ is a tumor necrosis factor blocker approved as a subcutaneous formulation. It is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. This is