On September 3, 2024, Eli Lilly filed a complaint against the FDA in the District Court for the Southern District of Indiana pursuing the latest challenge to the FDA’s application of its “biological product”...more
On January 30, 2023, the Court of Appeals for the Third Circuit issued a precedential decision rejecting a policy of the Department of Health and Human Services (HHS) in implementing the 340B Program. Under that policy, HHS...more
On April 23, 2021, President Biden signed into law the “Ensuring Innovation Act,” which modifies section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 355, by codifying the regulatory approach used by...more
On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect...more
The Federal Circuit Thursday issued a decision that narrows the venue options available to patent owners bringing suit against generic drug manufacturers under the Hatch-Waxman Act. In a unanimous decision, the court held...more
11/9/2020
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Principal Place of Business ,
Venue