Keith Barritt (DC) was quoted in BNA’s Medical Devices Law & Industry Report.
Two advisory board members, Andrew E. Rawlins of Foley & Lardner LLP in Washington, and Keith Barritt, of Fish & Richardson PC in Washington, raised intellectual property-related issues device company attorneys should be watching in the coming year.
Barritt, who practices trademark law as well as medical device law, noted that “2010 saw a flurry of lawsuits alleging false advertising of various products regulated by FDA,” including medical devices. For example, he said, there was Photomedex v. Irwin, 601 F.3d 919 (9th Cir. 2010), in which a competitor in the market for eye laser surgery devices accused the device maker of falsely stating that its product was “FDA approved” or “FDA authorized,” when FDA had not officially cleared or approved the modified device.
“The Ninth Circuit affirmed a summary judgment for the device maker after finding that the claim came within FDA’s exclusive jurisdiction,” Barritt explained. However, the court also said a Lanham Act false advertising claim could have been pursued if the company had falsely claimed that FDA authorization had been obtained for the device, when no such authorization had been issued for any version, and FDA had taken no enforcement action to stop the marketing of the modified device, he said.
More recently, the U.S. Court of Appeals for the Federal Circuit held that the color blue, used in a surgical device, was not entitled to trademark protection, ERBE Elektromedizin GmbH v. Canady Technology LLC, Fed. Cir., No. 2008-1425, 12/9/10. The maker of the device was unable to overcome a showing that the color was functional, as the color was used to allow surgeons to distinguish the device from body tissue.
“The interest of plaintiffs seeking to restrain competitors by alleging violations of the Federal Food, Drug and Cosmetic Act will likely continue, despite the hurdles such claims face,” Barritt said.
Mobile Devices, Other Issues
Barritt said “FDA anticipates releasing a final guidance document in 2011,” and that the draft guidance, released in 2007, “contains a reference to a myriad of issues that manufacturers are supposed to consider that are so numerous as to be nearly overwhelming.”
“In order to encourage manufacturers to embrace wireless technologies, with all of the potential for efficiency and improved care that they offer, the FDA will need to provide more comprehensible, actionable guidance,” Barritt said. A memorandum of understanding FDA reached with the Federal Communications Commission might help streamline the regulatory process for wireless medical devices, he said. But, in the meantime, “some manufacturers are moving forward with wireless devices, including devices that are clearly exempt from the 510(k) program,” he said.
Reproduced with permission from Medical Devices Law & Industry Report, 5 MELR 64, 01/26/2011. Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com/