Medtech giant Abbott (NYSE:ABT) is looking to extend patent protection for its Xience Prime L1 drug-eluting stent, hoping to get back some of the time that the device spent in clinical trials and review under the FDA.
Abbott is asking for a patent extension of 630 days, or about 1.7 years, although by the FDA’s calculations the company may be eligible for up to 890 days, or about 2.4 years.
The extension timing represents following investigational device exemption and preceding premarket approval for the device, during which Abbott’s Xience Prime L1 was undergoing regulatory trials and assessment for market approval. Under applicable law, medical devices, drugs and other products under the FDA’s purview are eligible for up to 5 years of patent extension to account for time spent under review.
The Xience Prime L1 device won IDE approval in May 2009, the PMA was submitted in April 2011 and the application was approved in November 2011, according to the FDA notice.
The U.S. Patent & Trade Office is not required to take the FDA’s calculations at face value, as other statutory limitations may apply in determining the actual length of the patent extension, the FDA noted.