Edwards Lifesciences (NYSE:EW) scored a win on 1 front of the long-running war with Medtronic (NYSE:MDT) over their entries into the transcatheter aortic valve implant market today when a federal appeals court upheld a ruling that effectively invalidates a Medtronic patent.
Back in November 2012 the U.S. District Court for Central California ruled that the priority date for Medtronic’s so-called ‘281 patent, "Prosthetic valve for transluminal delivery," was April 10, 2003, finding its claims invalid as anticipated, according to court documents. Medtronic appealed to the U.S. Court of Appeals for the Federal Circuit, which today upheld the Edwards win.
The appeals court, citing requirements that the chain of priority be clearly specified in each successive patent filing, agreed with the lower court that Medtronic failed to adequately document its priority chain, according to court documents.
"We agree with the district court that because intermediate U.S. Applications 6 and 8 failed to specifically reference the earlier filed applications in the priority chain, the ‘281 patent is not entitled to claim the priority date," according to the documents. "
That, in turn, means the patent is invalid because the prior reference cited could be anticipated by a person skilled in the art, the appeals court found.
"We have considered Medtronic’s remaining arguments and do not find them persuasive. Summary judgment of invalidity in this case was predicated on the determination of the priority date of the ‘281 patent. Because Medtronic failed to specifically reference each earlier filed application in the intervening applications in the chain of priority for the ‘281 patent, the district court was correct to limit the priority date of the patent to no earlier than April 10, 2003 and thereafter find the asserted claims invalid as anticipated. For the foregoing reasons, the judgment of the district court is affirmed," according to the documents.
"We are very pleased that today the U.S. Court of Appeals for the Federal Circuit ruled in favor of Edwards, reaffirming the November 2012 opinion of the California district court that Medtronic’s Seguin transcatheter heart valve patent is invalid. We have always believed that the patent was invalid and the suit was without merit, which the courts have now confirmed. While Medtronic may try to appeal to the U.S. Supreme Court, Edwards does not believe this appeal would be successful. We are proud to be an innovator in treatments for heart valve disease, and we will continue to vigorously defend our intellectual property as we develop new therapies to address the needs of patients.," an Edwards spokeswoman told MassDevice.com via email today.
Medtronic did not immediately respond to a request for comment.
It’s the 2nd win in as many weeks for Edwards, which landed a $393 million award when a Delaware jury ruled that Medtronic’s CoreValve device infringes a patent covering Edwards’ Sapien device. That amount could be trebled because the jury found that the infringement was willful; Medtronic has said it will appeal the verdict.
But Edwards lost some of its edge last week after the FDA approved CoreValve for the U.S. market, ending the hegemony Edwards had enjoyed since the FDA OK’d Sapien in October 2012.
The 2 companies have been battling over TAVI technology for a long time. In July 2013, a German court ruled that Medtronic’s CoreValve TAVI infringes an Edwards Lifesciences patent, forcing Medtronic to cede the German market to Edwards and its Sapien valve. The next month the European Patent Office issued a preliminary, non-binding ruling that the Edwards patent at the center of the dispute in Germany is invalid. Medtronic resumed its German CoreValve sales in November.
Across the pond, the U.S. Supreme Court denied Medtronic’s appeal of a $74 million win scored by Edwards; Mussallem this week said a lower appeals court is poised to close the books on that front of the war.