{"id":42822,"date":"2014-04-15T14:06:07","date_gmt":"2014-04-15T18:06:07","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&p=42822"},"modified":"2014-04-15T14:55:00","modified_gmt":"2014-04-15T18:55:00","slug":"corevalve-availability-in-us-threatened-by-court-decision","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2014\/04\/15\/corevalve-availability-in-us-threatened-by-court-decision\/","title":{"rendered":"CoreValve Availability In U.S. Threatened By Court Decision"},"content":{"rendered":"

A legal injunction may severely limit the availability in the United States of\u00a0Medtronic’s\u00a0CoreValve device, which only received\u00a0FDA approval earlier this year<\/a>. The device received abundant praise recently when\u00a0a large clinical trial<\/a>\u00a0demonstrated substantial advantages for CoreValve over traditional open-heart surgery.<\/p>\n

The injunction is the latest episode in an ongoing patent war in which\u00a0Edwards Lifesciences, which pioneered the field of transcatheter aortic valve replacement with its Sapien devices, has sought to hinder\u00a0Medtronic\u00a0from competing in the U.S. and international markets. This particular case was initiated in 2008. In 2010\u00a0a federal jury decided that\u00a0Medtronic\u00a0had infringed Edwards’\u00a0Andersen\u00a0transcatheter aortic valve replacement patent. The decision was affirmed by the Court of Appeals. The Supreme Court declined to review the case.<\/p>\n

Although the judge accepted\u00a0Medtronic’s\u00a0contention that CoreValve has important clinical benefits he ultimately sided with Edwards. Here is the key passage in the judge’s oral decision on Friday.<\/p>\n

Regarding the public interest factor, the Court\u00a0is persuaded that there are patients who cannot be served by\u00a0either the Sapien or Sapien XT and who need the CoreValve\u00a0Generation 3. The Court is also convinced that the\u00a0CoreValve Generation 3 is a safer device and that patients\u00a0in whom it is implanted have better outcomes with a lower\u00a0risk of death. At the same time, the Court cannot downplay\u00a0the strong public interest favoring enforcement of patent\u00a0rights. Thus, the Court finds that the public interest\u00a0weighs in favor of granting Edwards a preliminary\u00a0injunction, but that Medtronic must be allowed to sell its\u00a0devices to those patients who cannot be helped by Edwards’devices.<\/p><\/blockquote>\n

The judge ordered the two companies to negotiate an arrangement so that CoreValve could continue to be used in U.S. centers currently trained on CoreValve.\u00a0The judge also agreed to postpone implementation of the injunction for one week in order to allow Medtronic a chance to appeal the injunction.\u00a0(On Monday,\u00a0according to\u00a0Fierce Medical Devices<\/em><\/a>,\u00a0Medtronic filed its motion to postpone the injunction and appeal the ruling.)<\/p>\n

Wells Fargo\u00a0analyst Larry Biegelsen estimated that if the injunction is upheld CoreValve will be limited to about 15% of the U.S. market until patent expiration in March 2016.<\/p>\n

The\u00a0Wall Street Journal\u00a0<\/em><\/a>interviewed\u00a0<\/em>John Carroll, the director of interventional cardiology at the University of Colorado Hospital, which uses the Sapien valve but had planned to start training to use the CoreValve as well. Carroll told the\u00a0WSJ\u00a0<\/em>that Medtronic had put the training program on hold.\u00a0“It’s a shock because the device has been approved and is being used commercially,” said Carroll.<\/p>\n

I asked David Kandzari, the director of international cardiology at the Piedmont Heart Institute, for some additional perspective. He noted that there are additional patent cases that could threaten CoreValve. \u00a0“In short, the story is not over, even after this story is over,” he said.<\/p>\n

Referring to the historical precedent of drug-eluting stents, Kandzari suggested the two companies might ultimately reach a financial arrangement which would allow CoreValve a significant presence on the market. Edwards, he suggested, could damage itself by seeking extreme limitations on CoreValve availability:<\/p>\n

As much as this is unfavorable for Medtronic, it also represents a public relations dilemma for Edwards. In other words, do they appear to be suppressing a valuable technology for their own self-interest, or alternatively, do they show goodwill with some agreement for CoreValve to remain on the US market?<\/p><\/blockquote>\n

For additional perspective on recent TAVR studies, visit the following CardioExchange blogs:<\/p>\n

TAVR: Are You Impressed Now? <\/a><\/p>\n

Are We Equipped to Make a CHOICE Between TAVR Devices?<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

A legal injunction may severely limit the availability in the United States of\u00a0Medtronic’s\u00a0CoreValve device, which only received\u00a0FDA approval earlier this year. The device received abundant praise recently when\u00a0a large clinical trial\u00a0demonstrated substantial advantages for CoreValve over traditional open-heart surgery. The injunction is the latest episode in an ongoing patent war in which\u00a0Edwards Lifesciences, which pioneered […]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20,9],"tags":[710,1882,912,770],"class_list":["post-42822","post","type-post","status-publish","format-standard","hentry","category-cardiac-surgery","category-interventional-cardiology","tag-corevalve","tag-patents","tag-sapien","tag-tavr"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/42822","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=42822"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/42822\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=42822"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=42822"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=42822"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}