Medical Device Trade Secret Not Publicly Disclosed via Patenting, Displaying, and Selling Covered Product, 7th Cir. Affirms
Can certain specific medical device details remain company know-how or protected trade secrets even if patents are pursued on the medical device? Consider the Seventh Circuit’s commentary in its August 9, 2021 decision upholding a preliminary injunction in the Life Spine, Inc. v. Aegis Spine, Inc. case. The preliminary injunction prohibits Aegis from selling or marketing its competing AccelFix product (shown below, right) until the case is resolved on the merits.
In 2019, Life Spine sued Aegis, a former distributor of Life Spine’s ProLift® expandable spacers (shown below, left) used in spinal surgeries, for, among other things, misusing its trade secrets.
Aegis argued in appealing the preliminary injunction that the district court erred in concluding that information about the ProLift device could remain a protected trade secret after Life Spine patented, displayed, and sold the device to hospitals and surgeons. However, the Seventh Circuit held that “Aegis does not come close to showing that [the district court’s] finding was clear error.” The Seventh Circuit stated that Aegis had not proven that Life Spine’s patent materials disclose the “exact dimensions and measurements of every ProLift component.” In addition, the Seventh Circuit stated that “those who attend ProLift displays do not have unfettered access to the device” and that “the only purchasers of the ProLift are hospitals and surgeons, who purchase the device for use in scheduled surgeries.”
Regarding the patent materials, a figure of which is shown below, the Seventh Circuit noted that “Life Spine’s patent did not disclose the precise specifications of the ProLift” devices. The Seventh Circuit recognized that such dimensions could only be learned by someone who has access to the device and sophisticated measurement technology. As for public displays, the Seventh Circuit noted that Life Spine representatives supervise those who attend ProLift displays as they handle the devices.
Regarding sales of the ProLift device, the Seventh Circuit noted that Life Spine or its distributors ship the ProLift in sealed boxes and that the surgeries are overseen by Life Spine representatives or distributors. The Seventh Circuit further noted that “it seems doubtful that the hospitals or surgeons purchasing the device . . . would secretly unpackage the device [and] measure all its components with specialized measurement technology” and that it “seems even more unlikely that a device would be removed from a patient’s body and then reverse engineered.”
Following this decision, the case will return to the United States District Court for the Northern District of Illinois to continue on the merits.
Edwards Secures Preliminary Injunction Against Medtronic
On April 11, 2014, according to a press release, the U.S. District Court for the District of Delaware issued a preliminary injunction barring Medtronic, Inc. from selling its CoreValve TAVI product to most new customers in the U.S. This ruling is the latest installment in a patent dispute between Medtronic and Edwards Lifesciences Corp. involving transcatheter heart valve technology. According to Bloomberg, this developing market is expected to reach $3 billion a year. In 2011, Edwards received FDA approval for its Sapien transcatheter aortic valve, which was the first approved transcatheter aortic valve in the U.S. until the CoreValve system was approved in January 2014.
In 2010, a jury found that the CoreValve device infringed Edwards’ U.S. Pat. No. 5,411,552 to Andersen et al. (the “Andersen patent”) and awarded Edwards $73 million in damages. The verdict was upheld on on appeal, and last October the U.S. Supreme Court declined to review that decision. In December 2011, Edwards filed an application for patent term extension on the Andersen patent. Edwards’ petition noted that the patent was due to expire on May 2, 2012, and requested an extension of 1,757 days based on the FDA regulatory review period of the Sapien valve, such that the new requested extended expiration date would be February 22, 2017. The USPTO has not yet made a final determination of the length of the patent term extension, but has granted multiple interim patent term extensions, the latest of which extends the Andersen patent’s term until May 2, 2015.
A NASDAQ article states that although the court believed that “CoreValve ‘is a safer device’ and produces ‘better outcomes with a lower risk of death,’” patients’ needs must be balanced against the public interest in enforcing patent rights. The article states, however, that Medtronic will still be allowed to sell the CoreValve for patients who are not candidates for Edwards devices. The injunction is scheduled to go into effect seven business days from the April 11th ruling. Medtronic has already filed a Notice of Appeal.
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