Patients V. Patents? Policy Implications of Recent Patent Legislation

Article excerpt

INTRODUCTION

Ancient Greek philosophers, such as those depicted in Aristotle's The Politics, advocated recognition, awards, and honors for the achievements of discoverers.1 At the same time, the Hippocratic Oath commands physicians to care for their patients ethically and selflessly.2 These Hellenic ideas flourished and were widely embraced by civilizations around the globe and throughout the ages.3 Yet recently, the western legal system has witnessed a collision between these ancient principles.

Patents for industrial and consumer innovation are common and are welcomed in our society.4 Yet the widespread pursuit of patents for medical innovations has aroused strong opinions and has elicited powerful emotional reactions from the public, as if a reminder of one's own mortality.5 Whether a society should recognize, or, further, even protect a medical discovery implicates a host of questions from the fields of science, law, economics, and ethics.6 This issue also implicates the proper roles of the federal government, the states, and the medical and legal professions in fostering the progress of science, medicine, and the public health.7

The United States Congress is vested with broad authority to enact statutes and to shape public policy. The historic 104th Congress tackled a long legislative agenda, including passing significant legislation to ensure patient access to health care, as part of the ongoing debate over a national health care policy.8 Numerous intellectual property bills were also introduced to address the interests of patent, copyright, and trademark holders.

Legal worlds collided when a conflict arose between health care and patent law. Litigation over patents for medical procedures became a subject of political debate. In response, a restriction on medical procedure patent infringement remedies was introduced in the Congress and signed into law by the President. The outcome of this legislative activity reveals much about the perceptions of the medical and patent law professions, as well as the fundamental underpinnings of the United States patent system.

This Article explores whether the patent code can be changed in a way that enhances innovation and economic activity, especially in the biomedical arena. Consideration is given to aspects of the legal, economic, scientific, and ethical dimensions of the intersection of medicine and patent law. In light of recent litigation and legislation, this Article reviews the background and history of medical patents and discusses alternatives to the newly enacted change in the patent code. The next section of this Article advocates prior user rights as a narrowly tailored alternative course to solve some of the patent system's current flaws, both with biotechnology and generally. Finally, this Article examines these policies in the context of economic theory and legal principles.

I. MEDICAL PATENT LEGISLATION

"The reason for the patent system is to encourage innovation and its fruits: new jobs and new industries, new consumer goods and trade benefits."9

Recent medical patent litigation spurred a legislative chain reaction. In Pallin v. Singer,10 eye surgeon Dr. Samuel Pallin sued several of his peers, including fellow eye surgeon, Dr. Jack Singer, for the infringement of a medical procedure patent covering a new cataract surgery technique.11 Neither civil suits against doctors nor patent infringement litigation are uncommon on their own merits,12 yet this suit is considered remarkable. It is a rare instance of one physician suing another over an invention such as a medical procedure patent.13

The invention at stake is patent number 5,080,111, a technique for making a chevron shaped incision into the white wall of the eye14 in such a fashion to be "substantially self sealing" and sutureless.15 The Pallin patent reportedly results in a "savings of $17 per operation."16 Despite these savings, the defendants objected to paying either the patent royalty fee of $5 per operation17 or a flat fee for a clinic of $2,500 to $10,000 per year. …