By Dennis Crouch
[Update - In an order released only hours after Medtronic's emergency motion, the Federal Circuit has asked for immediate briefing on whether to grant a stay of preliminary relief - a decision is expected by the expiry of the district court's seven business day temporary reprieve.]
Edwards Life Science v. CoreValve and Medtronic (Fed. Cir. 2014)
In an emergency motion, Medtronic has asked the Federal Circuit to stay a preliminary injunction blocking sale of the Medtronic’s CoreValve aortic heart valve replacement system. Delaware district court Chief Judge Gregory Sleet ordered the preliminary injunction and would enforce the injunction pending outcome of the appeal did grant a seven–business-day stay to allow for an emergency appeal.
A stay should be entered and this appeal expedited because, if the injunction were permitted to go into effect, treatable patients may unnecessarily die in the name of already expired patent rights. Put simply, the calamity to public health that would result from the injunction is premised on a legally improper extension of patent rights. The injunction bans the sale of Medronic’s life-saving CoreValve system (“MCS”) and precludes the training of additional hospitals and other medical care facilities to use MCS. MCS is a unique and revolutionary minimally invasive aortic heart valve replacement system that is fundamentally different than the only similar product in the U.S. market, which is the Sapien product line of Plaintiffs-Appellees Edwards Lifesciences AG and Edwards Lifesciences LLC’s (collectively, “Edwards”). The MCS replaces diseased aortic heart valves in dying patients who may not survive traditional surgery.
There are basically two arguments here: (1) that the public interest weighs in favor of denying injunctive relief and (2) that the patent is not enforceable because it has expired (infringement has already been determined).
The district court agreed that some lives may be lost and attempted to mitigate that damage by ordering the parties to find some resolution so that “patients who cannot be helped by Edwards’ devices” can receive the CoreValve system since it is “a safer device and … patients in whom it is implanted have better outcomes with a lower risk of death.” Medtronic argues that the order is not enough to save lives.
Wall-street analysts are not known for their humanity, but in their note on the case, even the JP Morgan Analysts questioned: “How does a judge take a product off the market that has shown an ability to reduce mortality?” Of course, Medtronic has not been giving these away but instead sells the valves for $30,000 each.
The enforceability question is interesting the patent expired in May 2012, but the FDA has granted an interim extension of patent rights under 35 U.S.C. § 156 (for delays in FDA approval). One limitation of a patent term extension is that ordinarily, the extension does extend the term of the entire patent, but instead is “limited to any use approved for the product.” In Merck v. Kessler (Fed. Cir. 1996), the court interpreted this as extending only to “the product on which the extension was based.” Here, Medtronic argues that its product – although perhaps covered by the original patent – is different from Edwards approved product (Sapien) and therefore is not covered by the term extension.
The district court considered these issues and decided that the clear language of Section 156(b) was limited approved uses not approved products. And, since the accused infringing product has the same use (valve transplant), then the patent covers it as well.
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The case highlights an important strategic concern for injunctive relief, although district court judges have the power to stay injunctive relief pending appeal, there is no right to such a stay and courts regularly refuse to grant stays pending appeal.
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