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Baker McKenzie | USA | 3 Aug 2022
Patent linkage in the United States: key considerations for drug manufacturers
"Patent linkage" is generally understood to be the practice of linking the granting of marketing approval or any other regulatory approval for a generic or biosimilar medicinal product to the status of a patent for the originator reference product. The concept of patent linkage is a contentious issue in the healthcare industry as it concerns the involvement of drug authorities with patent......
Windels Marx Lane & Mittendorf LLP | USA | 15 May 2019
Hatch-Waxman Team Wins Appeal for Dr. Reddy's Laboratories in esomeprazole/naproxen (Vimovo®)
On Wednesday, May 15, a Windels Marx IP - Hatch-Waxman Act team achieved a significant victory on behalf of firm client Dr. Reddy’s Laboratories…
Jones Day | USA | 19 Apr 2019
Polymorph Patent Not Invalid as Obvious
The Federal Circuit upholds the validity of a patent covering a polymorphic form of a chemical compound…
Squire Patton Boggs | USA | 27 Jan 2019
A Private Sale is Still a Sale - SCOTUS Affirms the Federal Circuit for a Change
The Federal Circuit Court of Appeals has been a consistent punching bag for the Supreme Court over the past ten or so years. The high court has…
Troutman Pepper | USA | 21 Nov 2018
Why Biotech And Pharma Patents Survive IPR
When the America Invents Act of 2011 ushered in a number of new administrative procedures for challenging issued patents, the biotechnology and…
Dechert LLP | USA | 31 Oct 2018
Delaware Found to be Improper Venue for ANDA Suit
The District of Delaware dismissed a Hatch-Waxman Act ANDA lawsuit that Bristol-Myers Squibb had filed against Mylan Pharmaceuticals, finding that…
Cozen O'Connor | USA | 23 Aug 2018
FDA’S Clarification of 180-Day Exclusivity Rules
On July 13, 2018, the FDA issued a letter to ANDA applicants for buprenorphine and naloxone sublingual film that has application beyond that drug…
Knobbe Martens | USA | 23 Jul 2018
Proposed Legislation: The Hatch-Waxman Integrity Act
Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will…
Jones Day | USA | 1 Jul 2018
Hatch Bill: Restore Hatch-Waxman Balance; Limit Generics’ Access to PTAB
Senator Orrin Hatch (R-Utah), the namesake and coauthor of the Hatch-Waxman Act, proposed (but has not yet introduced) an amendment titled the…
Seyfarth Shaw LLP | USA | 26 Jun 2018
Choose Your Weapon: Senate Amendment Pits ANDA/BPCIA Pathway Against Post-Grant Proceedings
Per Senator Orrin Hatch, the America Invents Act has disrupted the “careful balance” he struck with Senator Waxman in the development of the…
