On April 30, 2024, the FTC issued a press release and warning letters to ten pharmaceutical companies notifying them that the FTC had “availed [themselves] of the FDA’s regulatory process and submitted patent listing dispute...more
FTC’s Challenge of Improperly Listed Patents On November 7, 2023, the Federal Trade Commission (FTC) officially challenged more than 100 patents that brand name drug manufacturers have listed in the Food and Drug...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is bringing sweeping changes to the cosmetics industry. One such change requires a “responsible person” to maintain and submit certain adverse event reports to...more
On April 27, 2021, the U.S. Tax Court issued its decision in Mylan, Inc. v. Comm’r of Internal Revenue regarding which legal fees that a generic-drug manufacturer incurs in connection with its Abbreviated New Drug Application...more
On April 23, 2021, President Biden signed into law The Ensuring Innovation Act (S. 415), which amends the requirements for New Chemical Entity (NCE) and Orphan Drug (ODE) exclusivities under the Federal Food, Drug, and...more
On November 5, 2020, the Federal Circuit issued a precedential opinion deciding a patent venue question concerning Hatch-Waxman cases left open after the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Grp. Brands...more
11/10/2020
/ Abbreviated New Drug Application (ANDA) ,
Corporate Counsel ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Venue