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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.

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
Lief Parke LLP

Jason Lief is a leading patent and intellectual property trial lawyer with over 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.
After decades in some of the world’s most prestigious law firms, Jason Lief has now branched out to co-found the firm of Lief Parke LLP, which is committed to providing the highest caliber of intellectual property litigation and counseling services in the most efficient manner possible. More information can be found at www.liefparke.com.


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