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21 Health Law. 1 (2008-2009)

handle is hein.journals/healaw21 and id is 1 raw text is: THE ABA HEALTH LAW SECTION HEALTH H LAWYER IN THIS ISSUE A Patent Law Primer for Health Law Practitioners .......... 1 CMS Finalizes Major Stark Changes - New Physician-Self Referral Rules in the 2009 IPPS Final Rulemaking Will Require Restructuring of Many Common Healthcare Arrangements ..................... 14 The Role of PSQIA Privilege in Medical Error Reduction ..... 24 Medicare's Medical Necessity Criteria: A Mystery in the Making .............................. 30 What Are Never Events, and Why Do They Matter? ...... 34 Volume 21, Number 1 October 2008 A PATENT LAW PRIMER FOR HEALTH LAW PRACTITIONERS David B. Gornish, Esq. Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd. Philadelphia, PA Introduction Advancements in medical technology have changed the way medicine is prac- ticed. Modern medical technology has saved countless lives and improved quality of life for patients in ways that were not conceivable decades ago. Many advance- ments in medical technology were conceived and developed by physicians. Although inventing is not usually a part of a physician's job description (unless, perhaps, the physician is involved in research), the practice of medicine is fertile ground for creative problem solving, which often results in improved methods and products for diagnosing disease and/or treating patients. Thus, many physicians have become inventors in the course of practicing medicine. Hospitals that employ these inventive physicians often protect this valuable intellectual property (IP), usually with patents The trend of hospitals acting as patent-generating institutions is growing. Hospitals are recognizing that physicians make excellent inventors and that patent protection can provide a source of revenue. Consequently, a growing number of hospitals have issued clear and compre- hensive policies regarding IP conceived and developed by hospital-affiliated physi- cians. Some hospitals have internal IP or technology transfer offices that are focused exclusively on strategic protection and use of IP developed by hospital employees or otherwise acquired by the hospital.2 Accordingly, health lawyers who regu- larly counsel physicians and hospitals are likely to confront IP issues, including patent-related issues, during their careers. This article is a primer on patent law for the health lawyer. It introduces health lawyers to the practice of patent law by addressing patent law fundamentals as well as some particular patent-related issues germane to physicians and hospitals. What is a Patent? A patent is a temporary grant3 by the United States government giving its owner the legal right to stop others from making, using, selling, offering to sell, or importing an invention. All industrialized nations have their own patent systems. A nation's patents are enforceable only within its own territorial jurisdiction. For example, a United States patent can only be asserted against individ- uals or companies that engage in infringing activities in the United States and its terri- tories. For this reason, inventors may wish continued on page 3

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