Legal: No Exception? - Pharmaceutical Executive


Legal: No Exception?
An important legal loophole has made patented tools available for research. Today, though, it appears to be closing.

Pharmaceutical Executive

Research tool registry One beneficial long-term solution would be establishing a central registry of biomedical research tools, similar to the Orange Book, which identifies therapeutically equivalent drugs approved by the FDA. This proposed patents registry would be overseen by a government agency such as the US Patent and Trademark Office. Often researchers have to mount a time-consuming and costly search in order to determine if infringement is an issue. A central database would put researchers on notice and allow users to approach patent owners for licenses more efficiently. By listing the patent, the owner would agree to negotiate reasonably and forego the right to control disposition of developments by the licensee. If a user failed to obtain a license or lost an invalidity challenge, he could be fined substantially and possibly held to treble damages for willful infringement. If the patent owner failed to list his patent, he would forfeit all claims of infringement and resulting damages.

While this solution is only a proposal, the idea of underscoring the collaborative nature of the scientific community with a universally searchable registry is a step in the right direction, assuring that patent user and owner are on a more equal footing. Other working solutions would be consortia, clearing houses and patent pools, which have been used successfully in other fields.

In fact, the prospects of biotech research may be brighter than they look. Recent changes in experimental use defenses will have an insignificant effect on the climate surrounding biomedical R&D. As the research community continues to create working solutions, they, not the courts, should be the ones responsible for the fair use of research tools in our traditional systems of open science and patent exclusivity.

Margaret Buck is an associate in the intellectual property department of Cozen O'Connor. She can be reached at (215) 665-4183.


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