Preliminary Injunction Bars Medtronic From Selling CoreValve

By Joseph Walker 

A federal court has issued a preliminary injunction that bars Medtronic Inc. from selling its recently approved CoreValve product to most new customers in the U.S., a setback for the medical-device maker in its heated battle with Edwards Lifesciences Corp. for sales in the growing market for minimally invasive heart valves.

The ruling was made as part of a patent dispute between the companies. Chief Judge Gregory M. Sleet, of the Federal District Court of Delaware, ruled Friday that Edwards Lifesciences had "more than demonstrated a likelihood of success" that it would prevail in its claims that its patents are infringed by Medtronic's CoreValve product.

The court ordered that the injunction go into effect in seven business days. Medtronic said it would appeal the ruling, and request the injunction be delayed until the appeals court decides whether the injunction was properly issued.

Judge Sleet ruled that Medtronic be permitted to continue selling the CoreValve to patients who cannot be implanted with Edwards Lifesciences' devices. Judge Sleet said he was convinced the CoreValve "is a safer device" and produces "better outcomes with a lower risk of death," but that patients' needs had to be balanced by the public interest in enforcing patent rights.

Medtronic's CoreValve, an artificial aortic heart valve that is implanted with a catheter instead of through open-heart surgery, was approved by the U.S. Food and Drug Administration in January. Medtronic is seeking to gain market share from Edwards Lifesciences, whose Sapien aortic valve was until recently the only FDA-approved catheter valve in the U.S. The Sapien was first cleared by regulators in 2011.

The valves are a growth area for medical-device companies, which have suffered from slower sales in core businesses including pacemakers and implanted defibrillators. Edwards Lifesciences has projected its Sapien valves will reach world-wide sales this year of $700 million to $820 million.

Judge Sleet said Friday Edwards Lifesciences was likely to prevail in the patent dispute since it had won an earlier patent case against Medtronic, and that Edwards would "suffer a loss of sales and market share" if Medtronic were permitted to continue selling CoreValve in the U.S.

Write to Joseph Walker at [e-mail]

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