6/28/2005
Experimental Use Post-Merck in the Non-Pharma Industries, a Nanotechnology Law & Business Roundtable
Prior to the conference, the U.S. Supreme Court will have decided the very important Merck v. Integra case that draws new lines for “safe harbor” research under the 1984 Drug Price Competition Act for the use of competitors' patented technology where it relates to a drug in the federal regulatory pipeline at the U.S. Food and Drug Administration (FDA).Even after the Supreme Court's decision, questions will remain regarding the common law experimental use exemption. Emerging industries and universities have relied upon the experimental use exemption with relative safety until the notorious case of Madey v. Duke — denying universities a research exemption — and dicta following one judge's concurring opinion in Embrex, denying any experimental use exemption. Foley Intellectual Property Partner and Nanotechnology Law & Business Editor-In-Chief Stephen B. Maebius chairs the roundtable, which will consider the following: - Merck v. Integra holding (expected in early June) and how it relates to non-pharmaceutical research
- “Innocent” infringement without knowledge of the patent and
pre-notice avoidance of liability - Liability for sponsorship of state university research under § 271(b) under Syrrx v. Oculus
- Offshore research to avoid U.S. liability and the scope of Bayer v. Housey
- Possibilities for judicial review of the Embrex dicta
- Statutory reform of the experimental use doctrine
Results from the roundtable will be published in a future edition of Nanotechnology Law & Business.
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