Post-Merck KGaA v. Integra, A Negative Impact On “Research Tools”?
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Bradley J Olson
Bradley J. Olson is a patent attorney in the intellectual property group in Washington, DC offices of the law firm of Dickstein Shapiro LLP. Mr. Olson's practice includes representing biotechnology and bio-medical device companies in the United States and Europe.
Abstract
In the approximately two and a half years since the United States Supreme Court issued its opinion in Merck KGaA v. Integra Lifesciences I, Ltd. (“Merck KGaA”), the U.S. Court of Appeals for the Federal Circuit has issued an opinion on remand, and several decisions have issued from various federal district courts that ruled expressly or by implication that patented biotechnology “research tools” are exempt from infringement under 35 U.S.C. § 271(e)(1) under the “safe harbor” provision that was expanded in Merck KGaA. Thus, “research tools” should be accorded the same sheltering from infringement that more typical products and processes are given if they are reasonably related to a new drug approval application (“NDA”) that is potentially or actually submitted to the FDA. A brief overview of the Merck KGaA opinion is provided, how the Federal Circuit followed the Merck KGaA instructions on remand, and particularly, how federal district courts have applied the Merck KGaA doctrine since it issued in mid-2005.
About the author
Bradley J. Olson is a patent attorney in the intellectual property group in Washington, DC offices of the law firm of Dickstein Shapiro LLP. Mr. Olson's practice includes representing biotechnology and bio-medical device companies in the United States and Europe.
© Walter de Gruyter
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Artikel in diesem Heft
- Editorial
- TRIPs, TRIPs-PLUS, Developing Countries and Public Health: The Case of Egypt
- Are You a Man or a Mouse?
- Take three cases: A reflection on the mission of applying law to human frailty
- Post-Merck KGaA v. Integra, A Negative Impact On “Research Tools”?
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- Australian Developments With Regard To Regulation of Embryonic Stem Cell Research and Therapeutic Human Cloning
