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SERVICES

Hatch-Waxman Litigation

Overview

Haug Partners has appeared as lead trial counsel in about two hundred Hatch-Waxman litigations in its twenty-three year history, involving more than sixty different pharmaceutical products. Our team includes more than thirty-five attorneys with technical degrees who have extensive experience litigating Hatch-Waxman cases. We have prosecuted over 16,000 issued patents, and over 70% of our partners are registered to practice before the U.S. Patent Office. Haug Partners effectively combines its scientific expertise with its broad trial experience to achieve favorable results for our life science clients.

The Haug Partners team has practiced Hatch-Waxman litigation since the earliest days of the Hatch-Waxman Act. Our attorneys have extensive experience representing both innovator and generic pharmaceutical companies and are able to counsel our clients from both perspectives. Haug Partners’ unique cross-functional biotechnology and biopharmaceutical litigation, patent litigation, and FDA practices also enable our Hatch-Waxman Litigation team to provide seamless, interdisciplinary counseling and representation across all phases of a litigation, from pre-suit strategy and patent analysis to appeals before the Court of Appeals for the Federal Circuit. Haug Partners regularly appears before the country’s most active Hatch-Waxman Litigation districts – including the District of Delaware and the District of New Jersey – as well as the Federal Circuit.

The Hatch-Waxman litigation team’s achievements include successfully representing or obtaining favorable settlements on behalf of global biopharmaceutical companies in Paragraph IV challenges against the following drug products:

  • Mydayis® (mixed salts of a single-entity amphetamine product)
  • Firazyr® (icatibant injection)
  • Gattex® (teduglutide)
  • Trokendi XR® (topiramate)
  • Cardene® (nicardipine hydrochloride)
  • Adderall XR® (mixed salts of a single-entity amphetamine product)
  • Vyvanse® (lisdexamfetamine dimesylate)
  • Oxtellar XR® (oxcarbazepine)
  • Lialda® (mesalamine)

What We Do

  • Hatch-Waxman litigation
  • Federal Circuit appeals
  • Inter Partes Review proceedings
  • Intellectual property procurement & strategy
  • FDA compliance & counseling

Services

  • Anti-Counterfeiting
  • Antitrust Counseling
  • Antitrust Government Investigation
  • Antitrust Litigation
  • Appellate Litigation
  • Automotive Litigation
  • Biotechnology Litigation
  • Class Action Litigation
  • Commercial Litigation
  • Consumer Products Litigation
  • Copyright
  • Due Diligence
    & Investigations
  • FDA
  • Intellectual Property Litigation
  • ITC Litigation
  • Latin America Practice
  • Licensing
    & Transactions
  • Life Sciences Litigation
  • Patent Prosecution
  • PTAB Post-Issuance Proceedings
  • Trade Secret Litigation
  • Trademarks
    & Unfair Competition

Haug Partners LLP
+1.212.588.0800
haugpartners.com
©2020 Haug Partners

Hatch-Waxman Litigation

Overview

Haug Partners has appeared as lead trial counsel in about two hundred Hatch-Waxman litigations in its twenty-three year history, involving more than sixty different pharmaceutical products. Our team includes more than thirty-five attorneys with technical degrees who have extensive experience litigating Hatch-Waxman cases. We have prosecuted over 16,000 issued patents, and over 70% of our partners are registered to practice before the U.S. Patent Office. Haug Partners effectively combines its scientific expertise with its broad trial experience to achieve favorable results for our life science clients.

The Haug Partners team has practiced Hatch-Waxman litigation since the earliest days of the Hatch-Waxman Act. Our attorneys have extensive experience representing both innovator and generic pharmaceutical companies and are able to counsel our clients from both perspectives. Haug Partners’ unique cross-functional biotechnology and biopharmaceutical litigation, patent litigation, and FDA practices also enable our Hatch-Waxman Litigation team to provide seamless, interdisciplinary counseling and representation across all phases of a litigation, from pre-suit strategy and patent analysis to appeals before the Court of Appeals for the Federal Circuit. Haug Partners regularly appears before the country’s most active Hatch-Waxman Litigation districts – including the District of Delaware and the District of New Jersey – as well as the Federal Circuit.

The Hatch-Waxman litigation team’s achievements include successfully representing or obtaining favorable settlements on behalf of global biopharmaceutical companies in Paragraph IV challenges against the following drug products:

  • Mydayis® (mixed salts of a single-entity amphetamine product)
  • Firazyr® (icatibant injection)
  • Gattex® (teduglutide)
  • Trokendi XR® (topiramate)
  • Cardene® (nicardipine hydrochloride)
  • Adderall XR® (mixed salts of a single-entity amphetamine product)
  • Vyvanse® (lisdexamfetamine dimesylate)
  • Oxtellar XR® (oxcarbazepine)
  • Lialda® (mesalamine)

What We Do

  • Hatch-Waxman litigation
  • Federal Circuit appeals
  • Inter Partes Review proceedings
  • Intellectual property procurement & strategy
  • FDA compliance & counseling