In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for...more
4/26/2024
/ Abbreviated New Drug Application (ANDA) ,
Applications ,
Carve Out Provisions ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Injunctions ,
Orange Book ,
Patent Applications ,
Patent Infringement ,
Patents ,
Prior Art
On February 8, 2022, U.S. District Court Judge Maryellen Noreika of the United States District Court for the District of Delaware granted the plaintiff’s motion to exclude defendant’s expert testimony for being “based on an...more
On November 5, 2021, the U.S. Court of Appeals for the Federal Circuit in Celgene Corp. v. Mylan Pharmaceuticals Inc., Case No. 21-1154, affirmed a decision from the District Court of New Jersey dismissing a suit brought by...more
On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district courts over what constitutes...more
11/13/2020
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
FRCP 12(b)(3) ,
Generic Drugs ,
Hatch-Waxman ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Principal Place of Business ,
Venue
On April 6, 2020, the U.S. District Court for the District of New Jersey, in Celgene Corp. v. Sun Pharma Global FZE, No. 19-cv-10099, denied Sun’s motion to dismiss Celgene’s claims that Sun’s generic Revlimid® (lenalidomide)...more
In a precedential opinion on October 4, 2019, the United States Court of Appeals for the Federal Circuit, in OSI Pharmaceuticals v. Apotex, No. 2018-1925, reversed the Board’s Final Written Decision in an inter partes review...more
10/16/2019
/ Final Written Decisions ,
Form 10-K ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Likelihood of Success ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Precedential Opinion ,
Prior Art ,
Reasonable Expectations Test ,
Reversal ,
Treatment Method Patents
On August 13, 2019, the United States District Court for the District of New Jersey, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 18-cv-14305, held that venue was not proper in New Jersey over...more
8/24/2019
/ Abbreviated New Drug Application (ANDA) ,
Bristol-Myers Squibb ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Venue
On October 18, 2018, the United States District Court for the District of Delaware, in Bristol-Myers Squibb v. Mylan Pharmaceuticals Inc., No. 17-00379, held that venue was not proper in Delaware over Mylan Pharmaceuticals...more
On March 12, the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District of Texas as the first courts to consider a generic drug manufacturer’s motion to dismiss...more
3/18/2015
/ Abbreviated New Drug Application (ANDA) ,
DaimlerChrysler v Bauman ,
Forum ,
Generic Drugs ,
Hatch-Waxman ,
Minimum Contacts ,
Motion to Dismiss ,
Patent Infringement ,
Patents ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
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