Recent Developments In Medical Device Patent And FDA Law

Patent litigation in the medical device area continues. Along with pharmaceutical patent litigation, medical device patent litigation continues to provide important rulings and case law precedent. Because of the large-scale investment needed to bring medical devices to the market, device sponsors need certainty about the law and its application to ensure a return on the investment. Unlike pharmaceuticals in which the patent portfolio may include claims to the bare-naked compound/molecule and to formulations using that compound, medical device patent claims are usually related to the mechanical aspects of the invention. That is, most medical device claims are to parts and pieces put together into a patent claim. For example, an implantable pacemaker may include claims to wires, power supply, leads, attachments, etc. These tend to be medical grade but off the shelf parts or pieces. Medical device patents can also be claimed as method steps.