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587 results found

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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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Vinson & Elkins LLP | USA | 26 Jun 2018

FTC Says Hatch-Waxman Suits Not Immune from Antitrust Scrutiny

The Federal Trade Commission (“FTC”) has sought permission to file an amicus brief in a pharmaceutical patent case, urging a district court to reject…
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