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Patent Infringement, Safe Harbor, and Drug Development: Navigating the Uncertain Boundaries, Recent Court Treatment

Recording of a 90-minute premium CLE video webinar with Q&A

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Conducted on Thursday, November 30, 2023

Recorded event now available

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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.


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.



  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


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?


Feldstein, Mark
Mark J. Feldstein, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and...  |  Read More

Holt, Cora
Cora R. Holt

Finnegan Henderson Farabow Garrett & Dunner

Ms. Holt is an experienced patent litigator at both the appellate and trial levels. A former clerk at the U.S. Court of...  |  Read More

Stewart, Mark
Dr. Mark Stewart

Vice President - Intellectual Property Litigation
Merck Sharp & Dohme

Dr. Stewart is a Vice-President at Merck Sharp & Dohme and is the head of Merck’s global IP litigation group....  |  Read More

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