Summer Reading

EDITOR'S PAGE

This summer, medical device executives have more than the usual number of good reasons to be watching the U.S. Congress very closely.

In April, for instance, the bipartisan Patent Reform Act of 2007 was introduced in the Senate and the House (S. 1145; H.R. 1908). Similar to legislation proposed last year, the 2007 version would establish a first-to-file patent system and limit the situations in which damages may be trebled for willful infringement.

However, medtech companies aren't exactly lining up to support the bills. According to a press release from the California Healthcare Institute (La Jolla, CA), provisions of concern to life sciences innovators include the apportionment of damages for patent infringements, creating a new administrative mechanism for challenging patents throughout the life of a patent, and expanding the rulemaking authority of the U.S. Patent and Trademark Office to enact restrictions on continuation applications and the number of claims in patent applications.

Also in April, FDA announced its recommendations for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II). Those proposals have now been incorporated into bills that are moving rapidly through the Senate and the House, toward early reconciliation and final voting.

Although industry associations were heavily involved in revising the device user-fee program, other elements of the proposed legislation haven't had the benefit of such input. In this issue, John F. Kamp, executive director of the Coalition for Healthcare Communication (New York City), discusses provisions related to the regulation of drug marketing, some of which could bring about unexpected results if applied to medical devices.

Medtech executives should get a jump on these and other issues now under consideration if they hope to influence the shape of legislation that will be passed later this year.

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