Greenberg Traurig is one of the largest law practices in the United States, with 2,100 attorneys serving clients in 41 offices in the U.S., Europe, Latin America, the Middle East and Asia.
Medical Design & Outsourcing recently sought insights from some of the top lawyers at GT who are involved in medical device products liability and intellectual property: Ginger Pigott, Michael R. Goodman and patent attorney Roman Fayerberg.
MDO: Medtech companies are increasingly packaging sensors, software and other digital features into their devices. How is going digital shifting the way device companies protect their intellectual property? What kind of new liability challenges is it creating?
Pigott/Goodman: The inclusion of software, digital features, data sharing and remote access are all at the forefront of medical device technology and associated therapies. They also introduce new liabilities. For example, is there a possibility that the software will depart from its intended use? Can an implanted sensor-transmitter withstand the body’s own defenses? Are these products secure from evolving outside threats and to what extent might the software developer or device manufacturer be liable?
We are also seeing non-traditional companies competing in this space with devices that blend the practical with the medical. More and more apps and fitness devices incorporate health data or tracking. And, with the advent of 3D printing, tech companies are entering into the medical device space. But if there is a software error when designing a product from a 3D printer, for determining liability, it is unclear whether the software is also the product or just the medical device. It may simply depend on whether the state considers a product “tangible.” These are a few examples that may challenge some of the traditional legal defenses that have protected prescription medical devices.
Fayerberg: With respect to the intellectual property protection, medtech companies will need to be more strategic in the way they protect their intellectual property. Protection of the digital features introduces additional considerations that do not arise when protecting more traditional medical devices. In particular, some digital features, mobile apps or software may not be eligible for patent protection. Accordingly, medtech companies will need to carefully consider which digital features of their devices can be protected with patents, and which other options are available to them to protect their intellectual property, including trade secrets. Medtech companies will also need to ensure that their patent counsel are experienced in both traditional medical devices and software patents.