A patent gives an inventor the exclusive rights to an invention for 17 years. Patents are issued by the federal government through the U.S. Patent and Trademark Office (PTO). Basically, there are three steps to obtaining a patent: First, the inventor submits an application disclosing 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 Office Action by amending the original application. Third, after agreement is reached between the inventor and the patent examiner, the patent is issued by the PRO.
To be eligible for a patent, an invention must meet strict standards. Basically, the invention must be a new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof. To be new, an invention must be novel to the engineering art to which it pertains, and, additionally, it must be non-obvious to those skilled in that art. To be useful, an invention must be beneficial to society.
The relationship between the utility requirement for a patent and the safety of an invention is an unexplored area of law. While a completely unsafe invention may have no utility, complete safety is not required for an invention to be patentable. And while there are many examples of devices which are legally defective for tort liability purposes either because they are likely to cause less good than harm, or because they could be safer, I know of know of no case in which a court has decided that such a device is not patentable because it is defective. In fact, a patentable new and useful improvement comprising a safer embodiment of a patented invention does not negate the patent in the unimproved version. It seems likely, however, that failure to disclose known information about substantial dangers inherent in an otherwise useful invention in a patent application could be used to challenge the ??? of the invention, and thus the ??? of the invention, and thus the validity of its patent.
A biomedical engineer (Smith) developed a new medical device for nerve stimulation and, together with a physician colleague, tested the device on a group of 50 patients. One patient, an individual suspected of having a demyelinating disease, experienced complications during the tests. Because it was a one-time event of questionable statistical significance, Smith omitted any reference to this observation in the patent application. Smith's patent attorney agreed with this omission because she felt the PTO examiner might have considered the invention less useful if the possibility that it might hurt someone were included in the application. Besides, the nerve stimulator helped the other 49 test subjects, and if the tests had been limited to those 49 individuals, no complications would have been observed. The patent issued, the device was approved by the FDA and became very successful, and Smith got rich. Five years later, while Smith was cruising the South Pacific on his yacht, Tantalus, a physician prescribed the nerve stimulation device for a patient (Jones), who it turns out, had multiple sclerosis. Jones experienced enormous pain and suffering and was injured as a result of using the device. Jones sued both physicians (however, their insurance had just been canceled) and Smith. The physicians settled and testified for Jones, and Smith was found to be liable for failure to reveal the test information. Subsequently, when Smith attempted to enforce his patent rights against a competitor, the patent was found to be invalid.
The enforcement of patent rights is not automatic: the government will not take action on behalf of the owner. The owner has to enforce his/her rights in court. Furthermore, the issuing of a patent offers no guarantee that the owner's exclusive rights in the patented invention will be upheld if challenged. Courts have held issued patents to be invalid because the applicant was not the inventor, because the invention was not useful, because the invention was not novel, because the invention was obvious, because there was fraud on the PTO during the prosecution, and for a variety of other reasons. A patent creates a presumption of validity of the owner's rights, so it is up to a challenger to prove it invalid, but it can be done. Generally, a strong challenge by an examiner in the Office Action and a comprehensive response by the examiner in the Office Action and a comprehensive response by the inventor creates a stronger patent, at least on the issue challenged.
A patented invention cannot be kept secret. A patent is a publication. Once it is issued, anyone can get copies. Thus, the constitutional mandate, "to promote the progress of science and the useful arts," coincides with the professional responsibility to scientists to share information. It is true that an inventor cannot delay applying for a patent for too long. Other publications by the invention cannot delay applying for a patent for too long. Other publication by the inventor about the invention do not bar an application for a U.S. patent, if it is made within one year of all such publications. However, if applications for certain foreign patents are to be made, they must be submitted prior to all other publications, even when the inventor is the author.
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