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 read September 02, 2014 at 12:00 AM
By
Sarah A. Bennington And 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

Agentic AI introduces risks that are novel and complex, but the most effective response is a familiar one. Zero Trust answers the problem of when an AI agent misfires on its own by constraining what an agent can do rather than betting on how it will behave.

July 31, 2026

The outsourcing of office and administrative services is expected to grow 50%-60% in the next five years. Contrary to what decision-makers think, and what the service providers hope you think, the biggest risk in outsourcing isn't choosing the wrong provider. It's outsourcing the wrong process, under the wrong model, with the wrong performance measures and contract terms.

July 31, 2026