Software as a Medical Device (SaMD) requires novel approaches for both offensive and defensive intellectual property strategy.
Offensive strategies (i.e., protection) with which the audience may be familiar, tend to rely on patent, copyright, trademark, and trade secrets. Within the context of SaMD, it can be useful to employ overlapping parallel protection strategies, as these areas of the law have different origins and are used for different purposes. Moreover, these strategies also operate on different timelines and can provide different types of remedies. For example, copyright protection should be leveraged early, prior to the possibility of a copying event to preserve the innovator's access to statutory damages under copyright law, to protect against actual events of copying. Patents, while considerably more expensive and more difficult to obtain, provide broader protections against entities that do not copy, but still intrude on the innovator's commercial space. And, if the innovator's ultimate objective is to secure an exit, this is difficult to do without meaningful patent coverage.
Defensive strategies can be overlooked by even experienced innovators. But, what happens when a coder hired by a company copies another company's copyright protected material? How should a company manage its use of open source software? What of the 800 pound gorilla with patents in the innovator's space? And importantly, how should a SaMD company minimize its risk related to cybersecurity concerns, as is increasingly mandated by the FDA. Our panel will delve into these issues to caution innovators to avoid pitfalls that can make the difference between a successful exit, and bankruptcy.