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FDA’S Clarification of 180-Day Exclusivity Rules
  • Cozen O'Connor
  • USA
  • August 23 2018

On July 13, 2018, the FDA issued a letter to ANDA applicants for buprenorphine and naloxone sublingual film that has application beyond that drug

Proposed Legislation: The Hatch-Waxman Integrity Act
  • Knobbe Martens
  • USA
  • July 23 2018

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

Hatch Bill: Restore Hatch-Waxman Balance; Limit Generics’ Access to PTAB
  • Jones Day
  • USA
  • July 1 2018

Senator Orrin Hatch (R-Utah), the namesake and coauthor of the Hatch-Waxman Act, proposed (but has not yet introduced) an amendment titled the

Choose Your Weapon: Senate Amendment Pits ANDABPCIA Pathway Against Post-Grant Proceedings
  • Seyfarth Shaw LLP
  • USA
  • June 26 2018

Per Senator Orrin Hatch, the America Invents Act has disrupted the “careful balance” he struck with Senator Waxman in the development of the

FTC Says Hatch-Waxman Suits Not Immune from Antitrust Scrutiny
  • Vinson & Elkins LLP
  • USA
  • June 26 2018

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

Personalized Medicine Gets a Boost from Federal Circuit’s Vanda Pharma Decision - PART II: Enforcement
  • Mintz
  • USA
  • April 30 2018

The Federal Circuit’s decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2707, 2016-2708 April 13, 2018) provided some good news on

A U.S. Perspective on Global Strategy
  • Sterne Kessler Goldstein & Fox PLLC
  • USA, Taiwan
  • April 13 2018

In December 2017, the Taiwan Pharmaceutical Affairs Act has been amended to harmonize generic approval process with prevailing international norms

Orange Book-Listed Patents Challenged in AIA Trial Proceedings
  • Buchanan Ingersoll & Rooney PC
  • USA
  • March 22 2018

The USPTO recently issued a study concerning AIA trial proceedings challenging Orange Book-Listed patents.1 The study was presented by the PTAB in a

Innovation in Hatch-Waxman and ANDA Litigation
  • Seyfarth Shaw LLP
  • USA
  • March 12 2018

The Hatch-Waxman Act was enacted in 1984 to address two main congressional goals: (1) to encourage innovation in pharmaceutical research and

District Courts Split over Proper Patent Venue for Hatch-Waxman Act Litigation
  • Morgan Lewis
  • USA
  • December 7 2017

There have been two interpretations of the "acts of infringement" language in the patent venue statute regarding ANDA submissions in Hatch-Waxman