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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Patent

Date & Time
  • event Date

    Thursday, November 30, 2023

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$347.00
CLE
ALL

This CLE webinar will guide patent counsel on the Hatch-Waxman safe harbor and the scope of its protection. The panel will discuss drug development and the implications of the safe harbor. The panel will offer best practices for leveraging the safe harbor.

Faculty

Mark J. Feldstein
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP

Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and trade secret issues, and post-grant trial proceedings at the USPTO, including inter partes review (IPR) and post grant review (PGR). He maintains an active patent prosecution practice, preparing and prosecuting U.S. patent applications on behalf of domestic and foreign clients. He also provides opinions and strategic guidance to clients on infringement, validity, enforceability, and clearance matters. His practice encompasses a range of technologies, including pharmaceuticals, biochemistry, polymers, small molecule chemistry, optics, and medical and analytic devices.

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Mark Stewart
Vice President - Intellectual Property Litigation
Merck Sharp & Dohme, Corp

Dr. Stewart is a Vice-President at Merck Sharp & Dohme and is the head of Merck’s global IP litigation group. He has more than 25 years of experience working as in-house counsel in the pharmaceutical industry. His experience has ranged from drafting and prosecuting patent applications, corporate transactions, due diligence work, and global patent litigation. He has a Ph.D. in Biochemistry from Colorado State University and did postdoctoral work both at the University of Michigan and Indiana University. He received his law degree and was an adjunct professor for a number of years at the Indiana University McKinney School of Law.

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Cora R. Holt
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP

Ms. Holt is an experienced patent litigator at both the appellate and trial levels. A former clerk at the U.S. Court of Appeals for the Federal Circuit, she represents clients in patent disputes before the Federal Circuit, the U.S. Supreme Court, and district courts across the country. She handles cases involving a variety of technologies, with an emphasis on the biotechnology, pharmaceutical, and life sciences industries. She also assists clients in portfolio counseling matters and proceedings before the U.S. Patent and Trademark Office (USPTO).

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Description

Companies developing products regulated by the FDA can rely on the Hatch-Waxman Act “safe harbor” to protect them from patent infringement during development. Specifically, importing, making, using and even selling “a patented invention . . . solely for uses reasonably related to the development and submission of information" to the FDA is statutorily excluded from patent infringement under 35 USC §271(e)(1). This can be important to many different companies and technologies, including generic small molecule, biosimilars, medical devices, and innovative products. However, the boundaries of the safe harbor are limited.

While the Supreme Court indicated in Merck I (2005) that the safe harbor provision provides a wide berth for patented drugs in the regulatory approval process, it is not all encompassing. There has been debate as to the definition of “patented invention” as used in the statute. Questions have also been raised concerning what falls within “reasonably related uses.” Further, whether “research tool” patents lie within the safe harbor has been a point of contention. It is important for companies—both those developing a product for submission to the FDA and patent owners—to understand the safe harbor and what falls within and outside of it when developing products that require FDA approval.

Listen as our authoritative panel of patent attorneys examines drug development and the role of the safe harbor. The panel will address the implications of the safe harbor and patent infringement in this context and offer best practices for leveraging the safe harbor.

Outline

  1. The safe harbor
    1. Common applications
    2. Related provisions of § 156 and § 271(e)(2)
    3. Merck I – ”wide berth" of protection
    4. Potentially Unprotected Activities
    5. Research tool patents
  2. Recent District Court Safe Harbor Decisions
  3. Best practices for using the safe harbor in developing FDA-approved products

Benefits

The panel will review these and other key questions:

  • How and when can the safe harbor be used?
  • What research tools fall within the Hatch-Waxman safe harbor?
  • What protection strategies should patent counsel employ in drug development?