2013] EXCLUSIVITY WITHOUT PATENTS 1401
In 1982, the United States Patent and Trademark Office (“USPTO”)
“issued the first gene patent to the Regents of the University of California for
work carried out” on a bacterium.1 Since then, genetic research, gene
isolation and purification, and genetic engineering have gained steam.2
Concomitantly, attempts to obtain patents on the results of these new
scientific endeavors have also skyrocketed.3 Applications on gene patents
have been filed in the United States, Canada, Japan, and the European
Patent Offices.4 The patents granted on these applications number in the
tens of thousands.5 With all patents, the decision whether or not to permit
patenting of a certain category of inventions generally rests with the national
patent authorities6 and is based on considerations of public policy7 and
whether patenting that category would be beneficial or detrimental to the
1. Edward Weck, Note, Exclusive Licensing of DNA Diagnostics: Is There a Negative Effect on
Quantity and Quality of Healthcare Delivery That Compels NIH Rulemaking?, 31 WM. MITCHELL L.
REV. 1057, 1062 (2005); see also U.S. Patent No. 4,363,877 (filed Apr. 19, 1978) (issued Dec.
2. See, e.g., Larry I. Palmer, Disease Management and Liability in the Human Genome Era, 47
VILL. L. REV. 1, 20 (2002); Andrew W. Torrance, Gene Concepts, Gene Talk, and Gene Patents, 11
MINN. J.L. SCI. & TECH. 157, 190–91 (2010); Cara Koss, Note, Oysters & Oligonucleotides: Concerns
and Proposals for Patenting Research Tools, 25 CARDOZO ARTS & ENT. L.J. 747, 754 (2007).
3. Omid E. Khalifeh, The Gene Wars: Science, the Law and the Human Genome, 9 LOY. L. &
TECH. ANN. 91, 102 (2010); Cydney A. Fowler, Comment, Ending Genetic Monopolies: How the
TRIPS Agreement’s Failure to Exclude Gene Patents Thwarts Innovation and Hurts Consumers
Worldwide, 25 AM. U. INT’L L. REV. 1073, 1084 (2010).
4. See generally Melissa Wetkowski, Note, Unfitting: Gene Patent Limitations Too Tight for
United States’ Biotechnology Innovation and Growth in Light of International Patenting Policies, 16 SW.
J. INT’L L. 181, 185–96 (2010) (discussing legal rules applicable to gene patents in the United
States, Europe, Japan, Canada, Australia, and China).
5. Dan L. Burk & Mark A. Lemley, Policy Levers in Patent Law, 89 VA. L. REV. 1575, 1625–
26 (2003) (“Patentees have acquired thousands of patents on DNA sequences that cover
specific genes or in some cases fragments of genes.”).
6. Gretchen Ann Bender, Clash of the Titans: The Territoriality of Patent Law vs. the European
Union, 40 IDEA 49, 51–52 (2000) (“A patent is a statutory right granted to an inventor or the
inventor’s assignee by a national government to exclude other people from practicing the
invention disclosed and claimed in the patent specification. . . . Patent law, like all intellectual
property law, has historically been based on the nation-state and the principle of territoriality.
National governments grant patents to inventors.” (footnote omitted)).
7. See Marsha J. Ferziger, Comment, Monopolies on Addiction: Should Recreational Drugs Be
Patentable?, 1994 U. CHI. LEGAL F. 471, 483 (“The debate over the ethical issues and public
policy concerns inherent in granting patents on living organisms has direct applicability to the
issue at hand. Commentators examining the patentability of biotechnological advances have
recognized that Congress has the authority to limit patent rights in order to advance the
general welfare.”); David S. Taylor, Note, The Sinking of the United States Electronics Industry Wit hin
Japanese Patent Pools, 26 GEO. WASH. J. INT’L L. & ECON. 181, 199–200 (1992) (“The grant of a
patent monopoly and the rights thereby conferred with it are permitted because of the benefits
derived from the full disclosure of the invention to the public.”).