ABSTRACT

Defining the limits of biotechnology patents is one of the most Herculean tasks patent communities are faced with today. The topic was discussed by the Federal Trade Commission (FTC) and the National Academy of Sciences in their recent reports. Up to now, no coherent system has been developed that gives enough--but not too--much patent protection for DNA-related subject matter. This article analyzes the problem of patent breadth in the biotechnological field and outlines how to craft balanced patent protection for biotechnology inventions. Within the recommended system innovators would be rewarded adequately, but innovation would still be allowed without considerable delay and prohibitive costs. Based on a comparison of U.S. and European biotechnology patent law, the article first advocates for broad patent protection on DNA-related subject matter to create sufficient incentives for initial innovators to invest in costly biotechnological research. To simultaneously spur subsequent research, the article further proposes the introduction of a widespread compulsory licensing system on reasonable terms as a counterbalance. Thereby, the article opts for a compulsory licensing system that uses arbitration as an enforcement tool rather than traditional regulatory enforcement by the government. Arbitration is favored because it allows reconciliation of compulsory licensing with the principles of free trade. Moreover, arbitration makes compulsory licensing responsive to the peculiarities of the biotechnological area, which so strongly depends on patent protection.

TABLE OF CONTENTS

I. INTRODUCTION
II. PATENTS ON BIOTECHNOLOGY INVENTIONS--
    IMPORTANCE AND POLICY CONCERNS
  A. Biotechnology and Its Inventions
    1. Biotechnology and Its Usefulness
    2. What Are Biotechnology Inventions?
    3. Why Are Patents on Biotechnology Inventions So
       Contentiously Discussed?
  B. Importance of Strong Biotechnology Patents
  C. Concerns that Exist as to (Broad) Patents on
     Biotechnology Inventions
  D. Consensus: Broad Patents and Broad Access Rights
III. PATENTABILITY OF BIOTECHNOLOGY
     INVENTIONS IN U.S. AND EUROPEAN PATENT
     LAW
  A. Patentability of Biotechnology Inventions in the U.S.
    1. Utility, 35 U.S.C. [section] 102
    2. Nonobviousness, 35 U.S.C. [section] 103
    3. Enabling, 35 U.S.C. [section] 112
    4. Written Description, 35 U.S.C. [section] 112
    5. Possible Impacts of the U.S. Patentability Standards
  B. Patentability of Biotechnology Inventions in Europe
    1. The European Patent System
    2. Patentability Standards Pursuant to the Biotechnology
       Directive
      a. Utility
      b. Inventive Step = Nonobviousness
      c. Enabling Disclosure and Patent Scope
      d. Assessment of the European Patenting
         Standard
IV. GIVING ACCESS TO PATENTED INVENTIONS--
RESEARCH EXEMPTIONS AND COMPULSORY
LICENSES
  A. Access Rights to Patented Biotechnology Inventions in
     U.S. Law
  B. Access Rights to Patented Biotechnology Inventions in
     Europe--A System to Adopt?
    1. The Specific Access Rights in European Patent Law
      a. The Directive's Access Provisions
      b. Access Provisions in German Patent Law
      c. Access Provisions of the Proposal for a Regulation
         on the Community Patent
    2. Disadvantages of the European Experimental Use
       Provisions
    3. Disadvantages of the European Compulsory
       Licensing Models
      a. General Arguments Against Compulsory
         Licenses--Market Interventions
      b. Particular Drawbacks of the European Licensing
         Provisions
    4. Conclusion: Adopting Experimental Use Provisions
       and/or Compulsory Licensing to Ensure Access?
V. PROPOSAL FOR MODIFYING TRADITIONAL
   COMPULSORY LICENSING SCHEMES
  A. Substituting the Regulatory Nature of Compulsory
     Licensing
    1. Patent Pooling as a Market-Based Solution to Grant
       Access
    2. …