Merck V. Integra: (Section) 271(e)(1) and the Common Law Research Exemption

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I. INTRODUCTION

II. BACKGROUND

  A. Common Law Research Exemption
  B. The Statutory Research Exemption
  C. Patent System Goals and Research Exemptions
  D. Merck v. Integra: Facts and History

III. ANALYSIS OF THE ARGUMENTS PRESENTED TO THE COURT

  A. Petitioner's Position
  B. Respondents' Position

IV. ANALYSIS OF THE SUPREME COURT'S OPINION

  A. Interpretation of the Federal Circuit's Decision
  B. Partial Rejection of this Construction
  C. The Supreme Court's Three Element Test

    1. The Regulatory Hook
    2. Subjective Intent
    3. Reasonable Basis

V. RECOMMENDATIONS--APPLYING MERCK V. INTEGRA

  A. The Target of the Supreme Court's Standard
  B. The Statutory and Common Law Research Exemptions

VI. CONCLUSION

I. INTRODUCTION

Protection from patent infringement liability for certain research-related activities has been a component of U.S. patent law from the early days of the patent system. These exemptions from infringement liability represent a limitation on patent exclusivity as well as an important mechanism for ensuring that patent exclusivity does not unduly hinder technological advancement. For these reasons, when the Supreme Court speaks regarding the scope of a research exemption, a close look at the scope of the exemption is warranted. In Merck v. Integra, (1) the Supreme Court issued an opinion explicitly interpreting a statutory research exemption. However, this opinion also provides guidance for how courts in the future should view the interaction between this statutory research exemption and the common law research exemption.

Part II of this Note provides background about the development of the common law research exemption, the statutory research exemption of 35 U.S.C. [section] 271(e)(1) (2000), the various policy considerations relevant to analyzing the scope of research exemptions, and the facts of Merck v. Integra. Part III analyzes the major arguments raised before the Supreme Court by the petitioner and the respondent in Merck v. Integra--a case involving Merck's research using an invention owned by Integra. Part IV provides analysis of the Supreme Court's opinion in Merck v. Integra and determines the standard for applying [section] 271(e)(1) in the future. Part V provides an evaluation of the relationship between the common law research exemption and the statutory research exemption of [section] 271(e)(1). This analysis leads to the conclusion that the statutory research exemption begins to provide immunity from patent infringement liability immediately after the common law research exemption's immunity ends.

II. BACKGROUND

First, this Part provides a brief synopsis of the development of the common law research exemption to patent infringement from its early common law roots to the modern Federal Circuit formulation. Second, this Part provides a look at the legislative intent and judicial interpretations of the statutory research exemption of 35 U.S.C. [section] 271(e)(1). Third, the various policy aspects of research exemptions are considered. Finally, this Part concludes with the factual and procedural setting of Merck v. Integra.

A. Common Law Research Exemption

The common law research exemption from patent infringement is widely recognized to trace its origins to two decisions from the early nineteenth century written by Justice Story. (2) These two cases, Whittenmore v. Cutter (3) and Sawin v. Guild, (4) stated that the use of a patented invention does not constitute patent infringement if the use is for the "mere purpose of philosophical experiment" (5) or to test the truth of the patent's specification. (6) This common law research exemption allowed for certain uses of patented inventions without the consent of the patentee as long as the use did not "divert to the accused infringer a portion of the profits" that rightfully belonged to the patentee. (7) In a more recent case, the Court of Claims (8) held that the United States could not utilize the common law research exemption when its use, testing to determine the capabilities of military helicopters built with patented technology, fell within the "legitimate business" of the United States military. …