Therasense V. Becton Dickinson: A First Impression

Article excerpt

TABLE OF CONTENTS  INTRODUCTION I.   BACKGROUND      A. The Case      B. The En Banc Opinion II.  LAW AND POLICY ISSUES RAISED BY THERASENSE      A. A Patent Handout      B. Implications for Patent Quality      C. Implications for Patent Litigation      D. Implications for Patent Practitioners         1. Will Therasense Really Change Case Outcomes?         2. Will Therasense solve the Problem of Applicant            Overdisclosure?      E. What Does It All Mean? III. A Glimpse of the New Federal Circuit?      1. An Ex Post, not an Ex Ante Patent System      2. A More Political Federal Circuit?      3. A Pro-Patentee Federal Circuit? CONCLUSION 

INTRODUCTION

The purpose of this Article is to provide an early analysis of some of the most substantial law and policy concerns raised by the very recent en banc decision of the united states Court of Appeals for the Federal Circuit in the now-famous Therasense v. Becton Dickinson case. (1) The doctrinal issue central to the case is inequitable conduct, a judicially created doctrine developed to punish patent applicants who behave inappropriately during patent prosecution, the ex parte process of patent creation.

The core thesis of this Article is that Therasense could have a much more significant, complex, and nuanced impact on the legal infrastructure of American innovation than the opinion for the court appears to appreciate. In view of these complexities, the court may be too sanguine in its expectations for the instrumental effect of its decision. More specifically, there are few reasons to be confident that the new doctrinal regime imposed by Therasense is well crafted to remedy any putative problems encouraged by the old law. Moreover, there is much reason to believe that the new doctrine could aggravate existing problems with the patent system and establish new ones. In sum, this is a decision that holds the potential to erode the legal infrastructure of American innovation.

To enhance understanding of the concerns developed in the analysis, the first Part of this Article provides a background that explains the innovation context and history of the case and describes the relevant legal dispute. The second Part of this Article is devoted to an early analysis of substantial innovation law and policy concerns raised by the decision of the court. We finish with a brief third Part, in which we consider what the Therasense case might reveal about the "new" Federal Circuit.

I. BACKGROUND

United States Patent No. 5,820,551, the patent at the heart of Therasense v. Becton Dickinson, had its origins in a United Kingdom laboratory in the early 1980s. (2) There, a team of pioneering scientists came together to develop a groundbreaking way for diabetes patients to monitor their blood glucose levels--a crucial advance in the treatment of diabetes, a disease whose growth rate over the past few decades has reached epidemic proportions. To give a sense of the magnitude of the epidemic, government statistics show that in 1980, 5.6 million Americans were diagnosed with the difficult-to-manage and potentially debilitating disease; (3) by 2010, that number had climbed to a startling 18.8 million Americans (with another 7.0 million believed to be undiagnosed). (4)

The device developed by these scientists was simple and elegant. it began with the creation of an improved sensor coated with biochemical compounds that produced a tiny flow of electricity in the presence of glucose, an invention that led to patent number 4,545,382 in the United states and patent number EP 0 078 636 in Europe. The scientists next placed the new sensor on a test strip that could be inserted into a meter to produce a digital readout of the blood glucose level and then thrown out. (5) This innovation made it possible for anyone to test their blood glucose at any time, leading to a revolution in diabetes patient care. (6)

As with the sensor invention, the scientists sought a patent for the disposable test strip. …