Some readers of your recent articles on a provision contained in the House patent reform bill may have been left with an inaccurate and misleading picture of the intent and effect of the legislation.
For years the Patent and Trademark Office and the Food and Drug Administration applied inconsistent interpretations of the same statutory language on patent term extension deadlines contained in the Hatch-Waxman Act. The House provision resolves this confusion by confirming the FDA’s interpretation and providing the certainty needed to incentivize costly investment in lifesaving medical research. Congress is right to address this issue.
The provision does not change existing law governing the filing of patent term extension applications. It merely confirms what the law has already been interpreted to mean. A federal court has already adopted the FDA’s interpretation, finding that the Medicines Co.’s patent term extension application was timely filed. The court concluded that it was the PTO — not the Medicines Co. or my firm — that had erred. The PTO decided not to appeal the court’s decision.
The provision is not an “earmark.” It is not even a spending provision. Rather, it amends the patent laws. Moreover, the provision does not provide a unique benefit to any entity. The provision is a law of general applicability that will apply to all patent term extension applications and to all cases. Multiple companies will benefit from the provision. According to one study, more than three-quarters of the applicants for patent term restoration from 2002 to 2007 miscalculated the date their applications were due. Indeed, one of those applicants just days ago sought reconsideration from the PTO on the basis of the interpretation that would be confirmed by this provision.
The House provision has long had broad bipartisan support. It was sponsored by three Democrats and four Republicans. Related provisions passed the House unanimously on two prior occasions as well as the Senate Judiciary Committee on a bipartisan basis. The House has again shown commonsense in passing this provision, which resolves confusion and stimulates innovation.
William J. Perlstein,
Co-Managing Partner, Wilmer Cutler Pickering Hale and Dorr