Engineering and the Law; Part I: About Intellectual Property

Charles Walter device safer for the patient? Or should the engineer limit University of Houston Law Center safety considerations to his own professional knowledge and Program of Law and Technology judgment about hardware safety, and require the physician to University of Houston-University Park adapt to the device the engineer considers safe? In other Houston, Texas 77025 words, if airline pilots insisted that fewer gauges in the cockpit would be more convenient and are therefore safer for S an engineer personally liable for injuries resulting from passengers, should engineers build airplaines that way? Or, if Iservices or a device s/he helps to develop? anesthesiologists insisted that anesthesiology machines be The answer is "Yes" or (a) I wouldn't be writing this built without gauges to monitor potentially lethal outflow article, and (b) you wouldn't be reading it. gasses, should biomedical engineers build anesthesiology The basis of this liability is the engineer's duty to the public machines that way? to be professionally and socially responsible. One example of how this duty arises is from the ownership responsibilities of WHAT IS INTELLECTUAL PROPERTY? intellectual property rights. These responsibilities include As innovators, engineers create the technological knowlegal liability for harm to others. Part I of this series is about how that goes into the development of modern services and types of intellectual property important to engineers and products. The law calls this know-how "intellectual propengineering liability. erty." The importance of intellectual property rights was recognized by the framers of our Constitution in Article 1, THE ROLE OF BIOMEDICAL ENGINEERS, Section 8 which empowers Congress to promote the proPHYSICIANS AND OTHER PLAYERS gress of science and the useful arts by giving authors and Biomedical engineers design medical devices often used inventors exclusive rights to their writing and discoveries. under conditions which are inherently dangerous to third These intellectual property rights are very important to parties (patients). Since the users of medical devices are engineers. Although intellectual property is not tangible, physicians, design criteria, including safety features, are ownership of it nevertheless carries with it many of the rights substantially influenced by non-engineers who are supposed and obligations of ownership of tangible property. Examples to be expert in the use of the device. As a result, the safety of of intellectual property often owned by engineers include medical devices as well as their safe use is not entirely in the patents, trade secrets, and copyrights. hands of the engineers who create them. For these reasons, the relationship between the usefulness of a medical device WHAT IS A PATENT? and how safe it is to patients is legally very important to A patent gives an inventor the exclusive rights to an biomedical engineers. Should a biomedical engineer create a invention for 17 years. Patents are issued by the federal medical device that is more dangerous to the patient but more government through the U.S. Patent and Trademark Office convenient to the physician-user? Should the engineer accept (PTO). Basically, there are three steps to obtaining a patent: the word of the expert user that user convenience makes up First, the inventor submits an application disclosing the for the less safe design, and thereby actually makes the invention to the PTO. Second, the PTO reviews the application and sends the inventor one or more Office Actions, and the inventor prosecutes the application by responding to each Dr. Charles Walter is President of the law firm Office Action by amending the original application. Third, of Marsteller and Associates in Houston, after agreement is reached between the inventor and the Texas, where he practices law, and Director of patent examiner, the patent is issued by the PTO. the Program on Law and Technology at the To be eligible for a patent, an invention must meet strict University of Houston, University Park, where standards. Basically, the invention must be a new and useful he teaches courses in intellectual property law process, machine, manufacture or composition of matter, or and computer law. Dr. Walter was previously any new and useful improvement thereof. To be new, an Professor of Chemical Engineering at that invention must be novel to the engineering art to which it university, where he taught courses in chemipertains, and, additionally, it must be non-obvious to those cal and biomedical engineering. Before moving skilled in that art. To be useful, an invention must be to the University of Houston, University Park, beneficial to society. Dr. Walter was on the staff of the M. D. The relationship between the utility requirement for a Anderson Hospital and Tumor Institute, University of Texas System patent and the safety of an invention is an unexplored area of Cancer Center, where he did cancer research. He was also Associate law. While a completely unsafe invention may have no utility, Professor on the Biomedical Sciences Graduate Faculty of the complete safety is not required for an invention to be University of Texas, where he taught biomathematics and biochemispatentable. And while there are many examples of devices try. Prior to moving to Houston, Dr. Walter was Associate Professor which are legally defective for tort liability purposes either in the Colleges of Medicine, Dentistry, Nursing, and Pharmacy, and because they are likely to cause less good than harm, or the Graduate School of Basic Medical Sciences at the University of because they could be safer, I know of no case in which a Tennessee Medical Units in Memphis. Dr. Walter received his court has decided that such a device is not patentable postdoctoral training at the Cardiovascular Research Institute at the because it is defective. In fact, a patentable new and useful University of California Medical School in San Francisco; his Ph.D. improvement comprising a safer embodiment of a patented and M.Sc. from Florida State University; his J.D. from the University invention does not negate the patent in the unimproved of Houston; and his Sc.B. from the Georgia Institute of Technology. version. It seems likely, however, that failure to disclose