On April 11, 2014, according to a press release, the U.S. District Court for the District of Delaware issued a preliminary injunction barring Medtronic, Inc. from selling its CoreValve TAVI product to most new customers in the U.S. This ruling is the latest installment in a patent dispute between Medtronic and Edwards Lifesciences Corp. involving transcatheter heart valve technology. According to Bloomberg, this developing market is expected to reach $3 billion a year. In 2011, Edwards received FDA approval for its Sapien transcatheter aortic valve, which was the first approved transcatheter aortic valve in the U.S. until the CoreValve system was approved in January 2014.
In 2010, a jury found that the CoreValve device infringed Edwards’ U.S. Pat. No. 5,411,552 to Andersen et al. (the “Andersen patent”) and awarded Edwards $73 million in damages. The verdict was upheld on on appeal, and last October the U.S. Supreme Court declined to review that decision. In December 2011, Edwards filed an application for patent term extension on the Andersen patent. Edwards’ petition noted that the patent was due to expire on May 2, 2012, and requested an extension of 1,757 days based on the FDA regulatory review period of the Sapien valve, such that the new requested extended expiration date would be February 22, 2017. The USPTO has not yet made a final determination of the length of the patent term extension, but has granted multiple interim patent term extensions, the latest of which extends the Andersen patent’s term until May 2, 2015.
A NASDAQ article states that although the court believed that “CoreValve ‘is a safer device’ and produces ‘better outcomes with a lower risk of death,’” patients’ needs must be balanced against the public interest in enforcing patent rights. The article states, however, that Medtronic will still be allowed to sell the CoreValve for patients who are not candidates for Edwards devices. The injunction is scheduled to go into effect seven business days from the April 11th ruling. Medtronic has already filed a Notice of Appeal.
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