Originally Published MX March/April 2005

GOVERNMENTAL & LEGAL AFFAIRS

Owners of device patents now may obtain extended terms based on the first use of any approved device covered by a patent.

Marc S. Gross and Chandra Garry

Photo courtesy Edwards Lifesciences

Patents directed to drugs or medical devices for which regulatory review is required prior to marketing may be extended for periods having reference to delays in the regulatory process. However, a recent court decision is likely to increase the length of time for which owners of medical device patents specifically, as distinct from drug patent holders, can extend (or restore) their patent terms.¹ That is because, under the court's interpretation, owners of device patents may now choose to cite any previously approved device covered by a patent when seeking a patent term extension (PTE).