Copyright Protection of Software in an Off-Patent Medical Device: Is It Extending a Patent Monopoly?
Abstract20 Biotechnology Law Report 537 Number 4 (August 2001) Mary Ann Liebert, Inc. Copyright Protection of Software in an Off-Patent Medical Device: Is It Extending a Patent Monopoly? LARRY JOHNSON* INTRODUCTION Ironically, that may end up costing the insurance company more money for that particular patient, but their decision is based on patient statistics and the cost of using the machine. Supply and demand drives the market. If a âgenericâ device manufacturer enters the market, as with drugs, the price of the devices will drop along with their per-use charge. The results are better health care and cheaper insurance by allowing broader access for the insured to modern diagnostic equipment. What good is a device coming off patent if the manufacturer of that device, via copyright licensing and strict FDA regulations, creates an insurmountable economic barrier to competition? This document begins by explaining the origin of software regulation within the FDA and what the FDA requires from the device manufacturer prior to approval. Second, a brief overview is given of policy and function in the areas of patent and copyright law and how that law is applied to software. Lastly, this document proposes a solution already used in