Originally Published MX May/June 2005

GOVERNMENTAL & LEGAL AFFAIRS

Full disclosure is the best way to be sure of enduring patent validity.

Margaret M. Buck and Paul K. Legaard

It is every medical technology company's worst nightmare: After the long and costly process of taking the idea from research and development into production, a medical device's potential to invigorate the company's bottom line is shattered at the eleventh hour.

One instance in which this can happen is when, because material information is determined to have been withheld from the United States Patent and Trademark Office (PTO), a granted patent is later declared invalid. Such an eventuality means that the company has effectively wasted large sums of money developing the device. Without a valid patent, the company's market is exposed; anybody can jump in with a competitive product and divert previously established market share.

One case affirmed in January by the appellate court that hears patent cases, the United States Court of Appeals for the Federal Circuit, tells a cautionary tale.

How to Lose a Patent