Finding the Right Tool for the Job: Adequate Protection for Research Tool Patents in a Global Market? (2005)

I. PATENT LAWS IN THE UNITED STATES II. PROCESS PATENTS AMENDMENT ACT--HISTORICAL PERSPECTIVE III. BIOPHARMACEUTICALS: THE SCIENCE AND THE INDUSTRY A. Biotech 101-A Basic Primer on the Relevant Science B. The Focus of Biotechnology in the Post-Genomic Era C. What is a Research Tool? D. The Marriage of the Biotech and Pharmaceutical Sectors E. Challenges Facing the Industry IV. CONFLICTING ENFORCEMENT POLICIES OF RESEARCH TOOL PATENTS A. Bayer AG v. Housey Pharmaceuticals, Inc B. Madey v. Duke University 1. Wrongful Assignment of the Burden of Proof. 2. Reinforcement of the Experimental Use Standard C. Integra Lifesciences I, Ltd. v. Merck KGaA V. ALTERNATIVE PROTECTION FOR RESEARCH TOOLS UNDER U.S. LAW A. Patent Protection under Section 337 of the Tariff Act of 1930 B. Process Patents and the ITC--In re Certain Abrasive Products VI. THE DIFFICULTIES OF INTERNATIONAL PATENT PROTECTION A. The History of International Patent Laws B. Application and Enforcement of Foreign Patents VII. CONCLUSION This comment discusses the remedies available for enforcement of tool patents used in the biotechnology and pharmaceutical industries. Part I describes the general function of U.S. patent laws and addresses a loophole allowing infringement of patents. As discussed in Part II, recognition of this loophole prompted Congress to add section 271(g) to the Patent Act. Part III introduces the scientific principles that govern modern drug discovery, describes what is meant by the term research tool, and presents current business and trends in the biotech and pharmaceutical industries. Part IV analyzes recent decisions from the Court of Appeals for the Federal Circuit (CAFC) regarding infringement exceptions. Part V describes a limited, alternative remedy available to U.S. patent holders when the Patent Act provides inadequate protection. Finally, Part VI highlights the challenges encountered by small businesses seeking adequate international protection for tool patents. In large part, these challenges are due to impracticalities in the application for and enforcement of foreign patents. The author concludes that the decisions collectively promote willful infringement of tool patents in international forums that will harm primarily small biotech entities and stifle innovation and suggests expanded coverage for tool patents under the Patent Act. I. PATENT LAWS IN THE UNITED STATES Globalization of the world economy has created an ever-increasing need for consistent and reliable protection of intellectual property (IP) rights. (1) In the United States, the protection afforded by constitutional (2) and legislative (3) mandate provides a dependable means for securing exclusive rights to the fruits of an inventor's creative labor. Patents serve as the main source of domestic protection for new ideas and may issue for one of three types of claimed inventions: products, methods of manufacture, or methods of use (the last two are also called process inventions). (4) The scope of protection afforded to U.S. patent holders against acts of domestic infringement is definitive. (5) The exclusionary rights granted by a patent are crucial where commercial ventures rally around a central technology-based product or idea. (6) In developed nations, this security is universally assumed. (7) While the protections granted by U.S. patents are explicit, (8) the protection has limited effect beyond the U.S. borders. (9) Inventors relying solely on United States patents for protection were once completely powerless to enforce their rights against infringers who chose to make, use, offer to sell, or sell patented subject matter in foreign countries. (10) This possibility created an obvious loophole around the protection extended to valuable patents. …