Regulatory compliance is often treated as completely independent from development or enforcement of patent rights. This situation is not helped by the absence of coordination between the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO). Still, companies must understand and appreciate the impact regulatory submissions may have on their patent portfolio.
The FDA provides significant barriers to market entry because foods, drugs, biologics and medical devices must be proven safe and effective before they are approved. Navigating the FDA regulatory approval process can be daunting for both established and startup medical device companies.
The Federal Food, Drug, and Cosmetic Act (FDCA) defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article which is intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease or intended to affect the structure of any function of the body and which does not achieve its primary intended purpose through chemical or metabolic action. The FDA classifies medical devices as low risk (e.g., stethoscope), medium risk (e.g., blood pressure cuff) and high risk (e.g., artificial heart). Although some devices must obtain premarket approval (PMA), the majority of medical devices are cleared by showing that the new device is “substantially equivalent” in terms of safety and effectiveness to an existing, legally marketed device. This 510(k) process is relatively fast, inexpensive and increasingly popular.
Seeking patent protection via the USPTO is a common method to promote innovation and allow device manufacturers to recover research and development costs. Medical devices must be new, useful and non-obvious to obtain the legal monopoly rights conferred by a patent.
Statements made during regulatory submissions may negatively affect patent validity or enforceability and information related to clinical efficacy or competing devices may later be viewed to have been material to patentability, for example. Some additional areas of tension between FDA and patent law include:
- the impact of lengthy regulatory delays on the effective term of a patent;
- if a device manufacturer may seek FDA clearance under the guise of substantial equivalence to an existing product yet claim novelty in a patent application;
- if a manufacturer admits infringement when claiming equivalence to a device covered by a patent;
- if equivalency for purposes of medical device approval amounts to equivalency for purposes of the doctrine of equivalents under patent law;
- the difficulties of dealing with two separate government agencies that may create an inequitable conduct defense in patent litigation; and
- the overall effect of medical device regulation on innovation when the process for bringing devices to market is easy and inexpensive for recognized devices and complex and expensive and for unfamiliar devices.
Medical device regulation, particularly 510(k) submissions, is a tradeoff between permitting the quick introduction of new devices and maintaining FDCA protection of public health. These goals are often conflicted. The complexities of patent law are very important to the medical device industry and to people who benefit from these devices. This complex intersection between the FDA and USPTO requires attention to avoid pitfalls.