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
On February 9, 2018, the Federal Circuit affirmed the District of Delaware’s holding that Merck Sharp & Dohme Corp. (“Merck”) failed to meet its burden of proving that Amneal Pharmaceuticals LLC’s (“Amneal”) ANDA product...more
On October 6, 2016, nearly thirteen years after passage of the Medicare Modernization Act (MMA), FDA published a final rule in the Federal Register implementing amendments and revisions to title 21 of the Code of Federal...more
On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...more
1/13/2016
/ Abbreviated New Drug Application (ANDA) ,
Eli Lilly ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Motion To Stay ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Patents ,
USPTO