“Protecting Software Related To a Medical Device: A Case Law Review and Strategy Guide”

April 5, 2021
Intellectual Property Owners Association

In a report published by Intellectual Property Owners Association (IPO), Partner Ryan Phelan and other members of IPO’s Software-Related Inventions Committee and the AI & Other Emerging Technologies Committee discuss the developing space of legal treatment of medical devices and related software under U.S. patent law, including by the courts as well as at the USPTO.

Throughout the report, the authors examine decisions, both precedential and non-precedential, in guiding human actions, medical data processing, processing for output generation, medical device technology, and law of nature. The authors also give practitioners a better understanding of what to expect when advising their clients and working to protect medical device-related software innovations from both in-house and law firm perspectives.

“As more companies seek FDA approval of software as a medical device and are obligated to disclose software functionality as part of that process, such companies may seek patent protection since they can no longer keep such functionality as a trade secret. This increase may drive pressure to examine these cases differently, and it will certainly spur practitioners to be mindful of subject matter and other potential pitfalls when drafting, prosecuting, and litigating in this area,” the authors conclude.

Access “Protecting Software Related to a Medical Device: A Case Law Review & Strategy Guide” published with contributions from Ryan.