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Critical Issues in Hatch-Waxman Litigation


Level: Advanced
Runtime: 86 minutes
Recorded Date: December 18, 2023
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Agenda

Key topics include:
  • Hatch-Waxman Act: Latest Issues and Challenges
  • Examining the Pharmaceutical Labeling Carve-Out Regulations
  • Analyzing The implications of the Teva v. GSK ruling
  • Other Skinny-Labeling-Related Cases
  • Practical Tips and Compliance Strategies
  • What Lies Ahead

For NY - Difficulty Level: Experienced attorneys only (non-transitional)

Description

The pharmaceutical labeling carve-out regulations remain a source of complexity in several cases. The Hatch-Waxman Act created a way for the Food and Drug Administration (FDA) to approve generic drugs even if they omit information about protected use to encourage competition among generic products. However, following the Teva v. GSK ruling, businesses must exercise caution and recognize the intricate relationship between Orange Book listed use patents, reference listed drug’s prescribing information, and promotional labeling and other related activities.

Furthermore, as other skinny-labeling-related cases continue to emerge which emphasize the need for legal professionals, businesses and other practitioners to remain up to date with recent developments to successfully navigate this area of law.

Join distinguished experts Jason A. Lief (Windels Marx) and Ha Kung Wong (Venable LLP) for an in-depth discussion on the latest developments impacting Hatch-Waxman litigation. The speakers will share valuable insights, including practical advice and strategies, to help navigate the dynamic legal landscape in this field.

Provided By

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Panelists

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Ha Kung Wong

Partner
Venable LLP

Ha Kung Wong practices general intellectual property (IP) law with an emphasis on complex patent and trade secret litigation, as well as IP transactions and contract negotiations for mergers, acquisitions, vendor agreements, and collaborations in pharmaceuticals, biologics, chemistry, medical devices, digital health, and artificial intelligence.

Cases Ha Kung has litigated include those related to proton pump inhibitors, anti-epileptic drugs, anti-tussives, ADHD medications, injectable microspheres, RNAi products, antibiotics, and other pharmaceuticals. Ha Kung also has extensive experience with inter partes review, post-grant review, IP counseling, pre-suit investigations, licensing, and due diligence, including patent strength and freedom-to-operate analyses.

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Jason A. Lief

Partner
Windels Marx

Jason Lief is a premier patent trial lawyer with 25 years of experience. He has litigated and tried dozens of major patent and other intellectual property cases on behalf of some of the world’s most innovative and dynamic companies, often involving billion-dollar products. Applying his legal and scientific training, Jason has established a reputation for winning outcomes and courtroom excellence.

Jason’s cases include major Hatch-Waxman pharmaceutical litigations (Zantac?, Wellbutrin?, Wellbutrin SR?, Wellbutrin XL?, Ceftin?, Intuniv?, Vyvanse?, Oxtellar XR?, Angiomax?, and Lialda?), as well as biotech, chemical, and consumer product patent cases. Jason has also litigated trade secrets, trademark, copyright, and IP contract disputes. He has argued before the U.S. Court of Appeals for the Federal Circuit and appeared in foreign courts pursuant to the Hague Convention. Jason has also successfully litigated in the inter-partes review (IPR) arena.

Beyond litigation, Jason also counsels clients on various intellectual property issues.

Jason’s approach is to partner with clients to comprehensively understand the scientific, legal and business concerns they face. Listening to clients and asking the right questions is the key to winning. As Jason often says, “Litigation is the art of the question.”

Jason’s matters have spanned a range of technologies and industries, including pharmaceutics, pharmaceutical formulation, sustained-release formulations, pharmacokinetics, biotechnology, organic chemistry, polymers, antibodies, combinatorial chemistry, RNAi, DNA-sequencing technology, antibiotics, anti-depressants, anti-epileptic drugs, anti-retroviral AIDS drugs, ADHD medicines, gastrointestinal and anti-ulcer medicines, asthma medications, nanotechnology, injectables, peptide drug formulation, drug stabilization, advanced battery systems, detergents, dental rinses, deodorants, financial trade secrets and jewelry design.


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