Access to the Safe Harbor: Bioterrorism, Influenza, and the Supreme Court's Interpretation of the Research Exemption From Patent Infringement

Journal of Intellectual Property Law Volume 13 | Issue 2 Article 4 April 2006 Access to the Safe Harbor: Bioterrorism, Influenza, and the Supreme Court's Interpretation of the Research Exemption From Patent Infringement Michael J. Brignati University of Georgia School of Law Follow this and additional works at: https://digitalcommons.law.uga.edu/jipl Recommended Citation Michael J. Brignati, Access to the Safe Harbor: Bioterrorism, Influenza, and the Supreme Court's Interpretation of the Research Exemption From Patent Infringement, 13 J. Intell. Prop. L. 375 (2006). Available at: https://digitalcommons.law.uga.edu/jipl/vol13/iss2/4 This Notes is brought to you for free and open access by Digital Commons @ Georgia Law. It has been accepted for inclusion in Journal of Intellectual Property Law by an authorized editor of Digital Commons @ Georgia Law. Please share how you have benefited from this access For more information, please contact . Brignati: Access to the Safe Harbor: Bioterrorism, Influenza, and the Supre NOTES ACCESS TO THE SAFE HARBOR: BIOTERRORISM, INFLUENZA, AND THE SUPREME COURT'S INTERPRETATION OF THE RESEARCH EXEMPTION FROM PATENT INFRINGEMENT TABLE OF CONTENTS I. INTRODUCTION II. BACKGROUND ........................................... 376 ............................................ 382 A. THE PATENT DOCTRINE AND THE EXPERIMENTAL USE EXEMPTION ........................................ B. THE HATCH-WAXMAN ACT AND ITS SAFE HARBOR ............. 382 386 C. JUDICIAL INTERPRETATION: THE SCOPE OF THE SAFE HARBOR .......................................... D. MERCK KGAA V. INTEGRA LIFESCIENCESI, LTD................ III. ANALYSIS ................................................. 388 391 395 A. IMPLICATIONS OF THE SAFE HARBOR ON GOVERNMENT-SPONSORED RESEARCH COLLABORATIONS ...... 1. A ccess to Technology .................................... 2. Impact on Licensing ..................................... 3. The Question of Research Tools ............................. 395 396 397 400 B. IMPLICATIONS OF THE SAFE HARBOR ON THE VALUATION OF PATENTS ................................. IV. CONCLUSION ............................................. Published by Digital Commons @ Georgia Law, 2006 401 404 1 Journal of Intellectual Property Law, Vol. 13, Iss. 2 [2006], Art. 4 J. INTELL PROP.LVl [Vol. 13:375 I. INTRODUCTION The global threats of infectious disease and bioterrorism are of great concern to the scientific community and the general public.' Although recent legislative and executive initiatives have attempted to address the risks posed by bioterrorism2 and the outbreak of an infectious disease, such as an influenza pandemic,3 the mere allocation of financial resources by the federal government represents only an initial step in promoting research endeavors directed at these formidable health issues. In fact, the exclusivity associated with patents and the underlying principles of intellectual property law present the greatest obstacles to innovative biomedical research.4 The Supreme Court's decision in Merck KGaA v. Integra LDfeSdences I, Ltd. represents the judiciary's most recent attempt to balance the property rights embodied in a patent against the availability of technology.' By providing legal access to technology, the Merck KGaA decision should encourage investment in research and development and thus expedite the discovery of novel drugs and therapeutics aimed at combating the threats of bioterrorism and the spread of infectious disease. Pharmaceutical and biotechnology patents exemplify the competing notions of intellectual property law: the social benefits of providing economic incentives for biomedical discovery opposed by the social costs of limiting the dissemination of scientific knowledge.6 The Patent Act provides pharmaceutical and biotechnology companies with the right to patent the fruits of their research and labor, which usually takes the form of innovative drugs.' Pharmaceutical patents grant a monopoly to the patent holder, preventing others from making, using, importing, or selling the patented invention in the United States.' Consequently, the patent provides its holder with exclusive access to the marketplace for a lifesaving drug, allowing for the recovery of costs related to drug discovery.9 Lawrence K. Altman, What is the Next Plague?,N.Y. TIMES, Nov. 11, 2003, at F8. 2 William H. Frist, M.D., U.S. Senate Majority Leader, Lecture at the Nantucket Atheneum: The Manhattan Project for the 21st Century (Aug. 3,2005), available athttp://frist.senate.gov/index. c fm?FuseAction=Speeches.Detail&Speech-id=261. ' President George W. Bush, Address at the William Natcher Center of the National Institutes of Health (Nov. 1, 2005), available at http://www.whitehouse.gov/news/releases/2005/11/ 20051101-1.html. 4 Norman G. Anderson & N. Leigh Anderson, A ManhattanProjectforBiotermrism,SCIENTIST, July 4, 2005, at 10. s Merck KGaA v. Integra LifeSciences I, Ltd., 125 S. Ct. 2372 (2005). 6 ROBERT P. MERGES ET AL., INTELLECTUAL PROPERTY IN THE NEW TECHNOLOGICAL AGE 13 (3d ed. 2003). 1 35 U.S.C. § 101 (2000). 8 See 35 U.S.C. § 154(a)(1) (2000). 9 CONGRESSIONAL BUDGET OFFICE, How INCREASED COMPETITION FROM GENERIC DRUGS https://digitalcommons.law.uga.edu/jipl/vol13/iss2/4 2 Brignati: Access to the Safe Harbor: Bioterrorism, Influenza, and the Supre 20061 SAFE HARBOR In an effort to encourage drug development and to expedite the introduction of pharmaceuticals into the marketplace, Congress amended the patent laws through enactment of the Hatch-Waxman Act. ° The Hatch-Waxman Act effectively insulated pharmaceutical research from patent infringement, providing that research utilizing a patented product is "solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs."" Section 202 of the Act, codified as 35 U.S.C. § 271(e)(1), 2 has become known as the safe harbor provision against patent infringement because it renders activities that would ordinarily constitute patent infringement non-infringing if performed for the purpose of gaining regulatory approval from the Food and Drug Administration (FDA) for a novel human or veterinary drug product, medical device, or food additive. 3 Courts have struggled to define the scope of the safe harbor provision. 4 Recently, a unanimous Supreme Court in Merck KGaA v. IntegraLifeSdences I, Ltd. broadly interpreted the safe harbor created by the research exemption of the Hatch-Waxman Act.'- The Supreme Court, in evaluating the phrase "solely for uses reasonably related to" overruled the interpretation adopted by the Court of Appeals for the Federal Circuit 6 and determined that § 271(e)(1)'s research exemption extended to all uses of patented inventions when the research was conducted in a manner reasonably related to the submission of any information HAS AFFECTED PRICES AND RETURNS (...truncated)