TABLE OF CONTENTS I. INTRODUCTION II. FDA's Medical DEVICE REGULATORY FRAMEWORK A. The Medical Device Amendments of 1976 B. Three Classes, Three Types of Oversight. C. The 510(k) Scheme 1. Overview 2. 510(k) Subject Matter and Predicate Devices 3. Substantial Equivalence D. Innovation in the Medical Device Industry III. A PRIMER ON PATENT LAW AND MEDICAL DEVICES A. The Foundations and Purpose of Patent Law B. Medical Device Patents C. The Novelty and Non-Obviousness Requirements IV. THE TENSIONS BETWEEN MEDICAL DEVICE REGULATION AND PATENT LAW A. Patent Terms and the Hatch-Waxman Act 1. [section] 156's Patent Term Extension 2. [section] 271(e)(1)'s Infringement Exception B. 510(k) as Prior Art C. 510(k) as an Admission of Infringement D. The Doctrine of Equivalents E. Inequitable Conduct F. Conceptual Areas of Tension and 510(k) 's Effect on Innovation Policy V. CONCLUSION
The medical device industry is tremendously important to health care in the United States. A steady stream of new or improved--but safe--medical devices, utilizing novel technological wizardry, is crucial to maintaining a state-of-the-art health care system. The legal structures regulating the introduction of medical devices must therefore strike a careful balance between promoting new and better devices and ensuring that devices on the market are safe and effective.
Medical devices are generally subject to review by the United States Food and Drug Administration ("FDA") before they may be marketed. Although some devices must receive premarket approval from FDA before going to market, the vast majority of new medical devices are instead cleared through a premarket notification process called "510(k)," which merely requires a showing that a new device is "substantially equivalent" in terms of safety and effectiveness to an existing, legally marketed device. 510(k) is rapid, inexpensive, and popular among device manufacturers.
Meanwhile, patent protection--the usual legal mechanism for promoting innovation--is crucial for device manufacturers because it allows them to recover the high upfront costs of their research and development ("R&D"). Inventions must be "novel" and "nonobvious" to merit the monopoly rights conferred by a patent.
These two areas of law regulating the introduction of medical devices occasionally come into tension and raise serious questions about the process by which new medical devices enter the market. This Note is a survey of these areas of friction and examines:
(1) the impact of lengthy regulatory delays on the effective term of a patent,
(2) whether a device manufacturer may seek FDA clearance under the guise of substantial equivalence to an existing product yet claim novelty in a patent application,
(3) whether a manufacturer admits infringement when claiming equivalence to a device covered by a patent,
(4) the difficulties of dealing with two separate government agencies that may create an "inequitable conduct" defense in patent litigation,
(5) whether equivalency for purposes of medical device approval amounts to equivalency for purposes of patent law's "doctrine of equivalents," and
(6) the overall effect of medical device regulation on innovation when the process for bringing devices to market is fast and straightforward for recognizable devices, but expensive and complex for unfamiliar devices.
This Note proceeds as follows: Part II examines the regulatory environment for premarket medical device review. Part III provides a brief survey of the most relevant aspects of patent law doctrine and policy as applied to medical devices. Part IV then explores the areas in which medical devices are caught in possible conflict between patent law and food and drug law, …