• U.S. District Court of Delaware
  • D66271
  • Apr 15 2014 (Date Decided)

U.S. DISTRICT COURT OF DELAWARE

Edwards Lifesciences AG v. CoreValve Inc., DeFAX Case No. D66271 (D. Del. April 15, 2014) Sleet, J. (24 pages).

Adjudicated patent infringer was enjoined from selling its infringing product, but an exception was made for high risk patients who could not safely use plaintiff's product. Motion for preliminary injunction granted in part, denied in part.

Both Edwards and Medtronic were in the business of making and selling transcatheter heart valves. Edwards made the SAPIEN line of valves and Medtronic manufactured the CoreValve system. Medtronic was Edwards' only competitor in the U.S.

In 2008, Edwards filed suit against CoreValve and Medtronic for patent infringement. Following trial in 2010, a jury found in favor of Edwards and awarded it over $72 million in lost profits for infringement, plus more than $1.2 million on royalties.

Edwards brought a motion for preliminary injunction in November 2013, seeking to enjoin Medtronic from continuing to infringe on its patent by selling its CoreValve Generation 3 as soon as Medtronic obtained FDA approval. Edwards' patent expired on May 2, 2012. The U.S. patent office subsequently granted two one-year extensions, and Edwards anticipated the patent office would ultimately extend the term of the patent to March 22, 2016.

Despite the 2010 verdict in which the jury found Medtronic was a literal and willful infringer, Medtronic continued to make the CoreValve Generation 3, and there was evidence Medtronic was stockpiling infringing devices as part of a greater plan to overtake Edwards in the heart valve market. Medtronic was able to make its valve available to extreme risk patients through an FDA-sanctioned continued access clinical trial. The FDA subsequently approved the CoreValve Generation 3, but the continued access program ended, and Medtronic argued that the only way extreme risk patients would be able to access its valve was if Medtronic made it commercially available as soon as possible.

Edwards argued it was entitled to a preliminary injunction because it had already succeeded on the merits and obtained a jury verdict in its favor. Medtronic responded that Edwards' rights were limited to copies of the SAPIEN and did not apply to any devices, such as the CoreValve 3, which were not copies of the SAPIEN. The concluded Edwards was correct, because the rights secured by the extension of the patent were limited by the approved use of the SAPIEN, not just copies of the SAPIEN.

Irreparable harm was likely to occur if Edwards was not granted a preliminary injunction. The court found Edwards was likely to lose sales, market share and revenue if Medtronic was allowed to launch the CoreValve 3 in the U.S. Medtronic was Edwards' only competitor in the U.S. and would compete directly against Edwards for the same patients. Medtronic had a history of undercutting Edwards' prices in Europe. The court was convinced that Medtronic would not only seek to convert to its own uses the hospitals in which Edwards had invested, but would succeed to a degree that a later injunction could not fully address.

The balance of hardships also favored granting a preliminary injunction. Without an injunction, Edwards' right to exclude based on its patent would be rendered meaningless. Any harm to Medtronic as the result of its willful infringement and deliberate flouting of the jury verdict against it was not counted in its favor by the court.

Medtronic argued that an injunction would leave patients at risk of inferior care or no care at all. Some extreme risk patients had blood vessels too small to allow safe implantation of the SAPIEN. However, the SAPIEN XT was expected to be on the market soon which was able to be implanted in patients with smaller blood vessels. Medronic asserted that patients with large annulus sizes could not use either the SAPIEN or the SAPIEN XT, and that those patients would be denied life-saving implants if all sales of the CoreValve 3 were enjoined. Edwards proposed a carve-out in the injunction to address this group of extreme risk patients. The court concluded the public interest required some accommodation that would grant patients with large annulus sizes access to the CoreValve 3.

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