Account

Sign in to access your account and subscription

Evolution of the Patent Infringement Safe Harbor

Since its enactment in 1984, the scope of the "safe harbor" provision of the patent code has been in flux. The provision is intended to exempt from infringement certain acts related to the development of drugs and medical devices that are subject to FDA regulatory approval, to enable competitors to immediately enter the market upon patent expiration. However, the contours and boundaries of the safe harbor have been a consistent source of controversy in the courts.

24 minute readSeptember 02, 2014 at 12:00 AM
By
Sarah A. Bennington
Anthony M. Insogna
Evolution of the Patent Infringement Safe Harbor

Since its enactment in 1984, the scope of the “safe harbor” provision of the patent code, codified at 35 U.S.C. '271(e)(1), has been in flux.

This premium content is locked for The Intellectual Property Strategist subscribers only

ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN The Intellectual Property Strategist

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

Already have an account? Sign In Now

For enterprise-wide or corporate access, please contact Customer Service at [email protected] or call 1-877-256-2473.

NOT FOR REPRINT

© 2026 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.

Continue Reading

The volume and sophistication of work hitting law firm marketing departments is accelerating. That moves the burden from responding to being ready: ready with differentiated positioning, ready with competitive intelligence, ready to get a compelling pitch to the right client before a formal process even begins. That requires more sophisticated output, produced faster, by teams that are already stretched past capacity.

April 01, 2026

The annals of copyright decisions could provide a reasonably representative catalog of what our culture has been up to over the past 200 years. A Feb. 3 decision from the Southern District of New York is a case in point. It involves a sex-trafficking conspiracy, Tweets attacking a troubled crypto firm, and a claimed transfer of copyright ownership through a restitution order in a criminal case, all over an undercurrent of competing First Amendment and victim-privacy concerns.

April 01, 2026

Matthew McConaughey secured eight federal trademark registrations covering his voice and iconic catchphrases in a novel legal strategy aimed at combating AI’s unauthorized use of his voice and likeness. The move signals an important evolution in the power dynamics between talent/brands and the companies providing generative AI tools.

April 01, 2026