"Preliminary Injunction Bars Medtronic From Selling CoreValve,"
at 10:57 a.m EDT, misstated that Edwards Lifesciences had won an
earlier patent case against Medtronic in the second and last
paragraphs. Edwards actually won an earlier decision in the same
patent case.
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 the injunction was warranted
in part because a jury had previously ruled that Edwards
Lifesciences' patents were 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.
A trial court had already found that Medtronic violated Edwards
Lifesciences patents in an earlier round of the case, Judge Sleet
said in an oral opinion stating the reasoning behind the
injunction. He said 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 joseph.walker@wsj.com
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