| A Primer on Federal and Legal Protections for Clinical Inventions
by Janet Brown
The increasingly entrepreneurial nature of medical practice has been reflected in our own professions by the marketing of products and techniques that have a commercial as well as clinical impact.
Commercial products or techniques that are patented or advertise approval by the U.S. Food and Drug Administration (FDA) add another layer to the clinician's task in evaluating programs, products, or procedures. ASHA provides guidance in the evaluation process through a series of questions. In addition to examining the available research evidence, clinicians may need to understand the FDA patents that are held.
The following article serves as a primer for speech-language pathologists and audiologists to learn about legal protections for clinical inventions. Here, David Denton describes the purpose and process of obtaining patents and introduces the complex issue of patents for medical procedures. In an upcoming issue, the second part of this series will provide an inside view of the process of FDA approval for medical devices.
Janet Brown is director of health care services in speech-language pathology. Contact her at jbrown@asha.org.
|
by David Denton
A patent is a major type of intellectual property law that allows you to control and secure the fruits of your innovation and creativity. Consider the following scenario: You invent a new widget. Your research confirms the invention's usefulness and consumer demand. As a consequence, you invest in the widget's production and marketing and anticipate that the product will be well received and financially rewarding. However, as soon as your widget hits the stores someone starts producing copies and competes with you in the marketplace. Under the circumstances, without a patent, you may have few rights or a legal remedy against the infringer.
Patent law is applicable to speech, language, and hearing devices. Examples of patented items include hearing aids, hearing aid technology, artificial electronic larynges, and other speech and hearing assistive devices.
What Is a Patent and What Protection Does It Provide?
When you hear that someone "owns a patent" it does not mean that person owns the invention in the traditional sense. The United States Patent and Trademark Office defines a patent as a property right that affords the patent holder the right to exclude others from making, using, offering for sale, or selling the invention in the U.S., or from importing the invention into the United States. Unless renewed, a patent is granted for 20 years (or 14 years for a design patent) from the date the patent application was filed. A U.S. patent is not effective outside of the United States and its territories and possessions. When the patent expires, the invention enters the public domain. Until that time, the U.S. grants the patent holder the exclusive right to the invention and no one else can make, use, or sell the invention unless the owner of the patent transfers that right to another party.
How Do I Obtain a Patent?
Application for a patent is made with the United States Patent and Trademark Office (USPTO). Subject to interpretation by federal courts, Congress has authorized the USPTO to grant a patent to "whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." The application process is arduous and exacting, and the invention must meet strict patentability requirements of novelty, creativity, non-obviousness, or originality. You can also apply for a patent on a design, or on a process to reproduce a distinct and new variety of plant.
Is a Patent the Best Way to Protect an Invention?
Not always. You may be able to protect your invention well beyond the 20-year life of a patent by employing trade secret law. However, not all inventions lend themselves to trade secret protection, and even when they are, maintaining the confidentiality of a trade secret is fraught with problems. It may be better to err on the side of caution and obtain a patent for a more secure 20-year period of protection.
Will the USPTO Sanction Individuals Who Infringe on a Patent?
No. However, the owner of patent can pursue a legal course of action against the infringer, and any other parties that contribute to the patent infringement. In addition, trying to make a small or trivial change to a patented item in an attempt to avoid infringement will not shield the infringer from liability. If a court determines an infringement has occurred, remedies include injunction, money damages, attorney's fees, and costs.
When I Think of a Patent, I Think of a Product or Device. However, the Definition of a Patent Includes "Any New and Useful Process." What are Examples of a Patentable Process?
This is an emerging area of patent and intellectual property law, especially regarding methods and procedures. For example, it is not generally well known that you can patent many business methods. Until recently, business methods and procedures were protected simply by keeping them secret. However, with the advent of the Internet, companies doing business online found that as soon as they invented a new and successful Internet business method it was copied by a competitor and they lost their market advantage. In 1998 a federal circuit court held that business methods can be patented.
You can also patent some new innovative medical procedures, but the practice has been controversial. The American Medical Association's position is that seeking, securing, or enforcing a patent on medical procedures limits the availability of new procedures to patients and is unethical. As a result of these concerns, Congress has changed the law so that, depending on the circumstances, a medical practitioner cannot be held liable for infringement with respect to medical activity. Therefore, although an individual can obtain a patent on a medical procedure, the patent holder may not be able to enforce the patent against a medical practitioner. That part of patent law is often referred to as the "physicians' immunity statute" but, because there are exceptions, the immunity should not be sought without the advice of a patent attorney.
David R. Denton is ASHA's director of ethics. Contact him at ddenton@asha.org.
|