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Skinny-Labeling in Hatch-Waxman Litigations: The Law in Flux?


Level: Intermediate
Runtime: 59 minutes
Recorded Date: March 31, 2023
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Agenda

  • The Law of Infringement by Inducement Generally
  • Inducement in the Context of Hatch-Waxman Cases – Pre-Glaxo v. Teva
  • Glaxo v. Teva at the District Court Case
  • Glaxo v. Teva at the Federal Circuit
  • Supreme Court Petition for Certiorari
  • Perspectives – Discussion

For NY - Difficulty Level: For both newly admitted & experienced attorneys.
For NY - Difficulty Level: Both newly admitted and experienced attorneys

Description

A “skinny label” is a label on a generic pharmaceutical product that “carves out” (eliminates) the listing of an indication or disease for which the reference drug has been approved. Generic manufacturers use skinny labels to try to avoid “inducing” infringement of branded patents that claim the treatment of the carved-out diseases. But sometimes infringement can still be found. In what many see as a pivotal case – Glaxo v. Teva – the Federal Circuit found infringement despite a skinny label.

The panelists will discuss the law of induced infringement before and after Glaxo v. Teva; what that case portends for the future; and what the U.S. Supreme Court may or may not do with the case.

This program was recorded on March 31, 2023.

Provided By

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Panelists

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Pablo Hendler

Partner
Potomac Law Group, PLLC

Pablo Hendler has counseled clients for nearly 30 years on intellectual property matters.  Pablo’s focus has been on life science patent litigation, including Hatch-Waxman, biologic, and medical device cases.  His clients have consistently praised him as an “excellent lawyer” and a “sharpshooting” litigator, particularly for his “sterling” work in ANDA litigations. They are comforted by his “seen-and-done-it-all experience. Pablo is also actively involved in pro bono immigration work.

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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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