Medical devices—encompassing everything from contact lenses to hemodialysis machines—are fundamental components of modern medicine. The regulatory bodies that govern these devices include FDA, which is charged with ensuring the safety and efficacy of the devices, and the Patent and Trademark Office (PTO), which seeks to encourage innovation by rewarding inventors with patents. While truly new devices must go through FDA's rigorous Premarket Approval (PMA) process, the majority of devices utilize the Agency's simplified Premarket Notification (PMN) process, more commonly known as the 510(k) process. To use the faster and cheaper 510(k) option, a device must be "substantially equivalent" to a previously approved "predicate device."
Proving substantial equivalence may create a conflict with patent law when a predicate device is covered by a patent. With a patented predicate device, manufacturers may find themselves advocating equivalence to FDA while also differentiating their product from the same device in a patent infringement suit.
Intuitively, it would seem that patent holders have a clear-cut path to exploit this contradiction in the courtroom by presenting the copying manufacturer's statements of equivalence as concrete proof of infringement. But because an FDA finding of equivalence and a court's finding of patent infringement require different inquiries, courts have been reluctant to admit 510(k) documents as direct evidence of infringement. While statements made to FDA may not provide patentees with the proverbial smoking gun, a number of contemporary cases, in combination with recently overhauled 510(k) guidance, demonstrate there are several ways 510(k) statements can be relevant in litigation.
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