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12:00 AM
Sep 08, 2003
 |  BioCentury  |  Regulation

Narrowing the value of tool patents

Holders of research tool patents have received mixed news from U.S. courts in recent months. On one hand, they have been encouraged by a decision that sharply limits the ability of pharmaceutical companies to claim a research use exemption to justify infringement. At the same time, the courts have suggested that holders of research tool patents have no recourse against the use of a technology that occurs off America's shores, even if the resulting product is sold in the U.S.

In June, the U.S. Court of Appeals for the Federal Circuit (CAFC), which has special jurisdiction over intellectual property cases, ruled on the ability of companies to use the Hatch-Waxman Act as a safe harbor against infringement claims. Hatch-Waxman provides a research exemption allowing companies to begin developing generic versions of a patented product prior to the expiration of the innovator's patents.

In its ruling, the CAFC determined that the Hatch-Waxman exemption applies only narrowly to clinical research done to support a marketing application to the FDA for a generic version of a marketed drug (see BioCentury, June 16).

The decision, involving an infringement suit brought by Integra LifeSciences Corp. (IART, Plainsboro, N.J.) and the Burnham Institute (La Jolla, Calif.) against Merck KGaA (FSE:MRK, Darmstadt, Germany) and the Scripps Research Institute (La Jolla, Calif.) illuminated an area of law that was "totally gray," according to Kathleen Williams, a partner at Palmer & Dodge in Boston. Prior to Integra, no...

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