A medical device is defined as an instrument, application, or implant that is used in the diagnosis or treatment of a disease or other medical condition. Medical device patents differ from patents on biologics or pharmaceutical products in that there is less need to establish the efficacy of the device, actually build a prototype, or provide supporting data. In many cases, once the inventor has thought of the idea and how it would be implemented, a patent application for a medical device can be pursued.
When a new medical device is disclosed to the Office of Technology Transfer, our case managers analyze the potential market for the product, what development still needs to occur for the product to be commercially viable, and perform a preliminary prior art search. Subsequently, if the market and initial patent analyses suggest that the idea is commercially feasible, the Emory Patent Group will get involved to develop a patent strategy, perform additional prior art searches, and draft a patent application.
From an intellectual property (IP) standpoint, there are different options to protect a medical device when compared to a biologic or small molecule therapeutic. For any of these products, a utility patent application that covers the composition and function of the product can be filed. In the case of a device, a ‘design’ patent that specifically covers the appearance of the product may also be pursued in addition to the utility patent. Design patents are based solely on the look rather than the function of a product and can provide additional value.
Utility patents often cover only a particular aspect of a product. For example, Emory owns a series of patent applications focused on an idea for repairing leaking heart valves where the invention seats existing valve replacements in a unique frame that allows them to fit easily into any person. This type of product is most readily protected by a utility patent, as the structure of the device is critical to its function. The Emory Patent Group has also obtained several design patents in recent years, although typically on products that are not readily protected by utility patents. For example, we have obtained a design patent on the graphical user interface of a new software system that allows more detailed identification of chemical compounds during an SAR study, a patent on the form of a mounting device that allows more effective attachment of cameras to an operating room retractor system, and a series of patents on eye chart symbols designed to help non-verbal and non-English speakers test eye sight.
Patents on medical devices often present fewer enablement challenges for researchers than do patents on biologics or pharmaceutical agents. By the same token, the scope of protection in any individual patent is often more limited and we have to use multiple strategies to obtain commercially relevant IP. Those strategies include filing multiple utility patents focused on specific functional aspects of a device as well as design patents on its appearance, and sometimes even using trademark and copyright law to supplement these defenses. We work closely with our researchers to develop appropriate protections and to ensure that our IP strategy continues to align with their work as they develop prototypes and clinically apply their ideas.