Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials

Author:Gregory Dolin
Position:ssociate Professor of Law, Co-Director, Center for Medicine & Law, University of Baltimore School of Law
Pages:1399-1465
SUMMARY

Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists’ ability to continue and expand research into... (see full summary)

 
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1399
Exclusivity Without Patents: The New
Frontier of FDA Regulation for
Genetic Materials
Gregory Dolin, M.D.
ABSTRACT: Over the last twenty years, the legal and scientific academic
communities have been embroiled in a debate about the patent eligibility of
genetic materials. The stakes for both sides could not be higher. On one
hand are the potential multi-billion dollar profits on the fruits of research
(from newly discovered genes), and on the other is scientists’ ability to
continue and expand research into the human genome to improve patients’
access to affordable diagnostic and therapeutic modalities. This debate is
currently pending before the Supreme Court, which is considering a petition
for certiorari in Ass’n for Molecular Pathology v. U.S. Patent &
Trademark Office.
Both sides have legitimate concerns. Given the unique nature of DNA,
patents that broadly cover genetic materials and prevent their use (except by
the license of the patentee) create insurmountable roadblocks for future
research. However, denying exclusive rights to the fruits of laborious and
costly research will remove the necessary incentives for investment in these
endeavors, thus delaying scientific and medical discoveries.
To remedy these problems, this Article proposes a non-patent exclusivity
system administered by the Food and Drug Administration. Under such a
Associate Professor of Law, Co-Director, Center for Medicine & Law, University of
Baltimore School of Law; Adjunct Associate Professor of Emergency Medicine, The Johns
Hopkins University School of Medicine. B.A., The Johns Hopkins University; J.D., Georgetown
University Law Center; M.D., State University of New York at Stony Brook.
I would like to thank my friends and colleagues who have helped me throughout this
process, especially those of them who braved the scientific jarg on to read an exceedingly long
Article. They are William Hubbard, David Jaros, Colin Starger, Irina Manta, Herbert
Hovenkamp, F. Scott Kieff, Lisa Bernstein, Robin Effron, and Erin Sheley. A special thanks goes
out to my dear friends Sergei Khrapunov, Julia Kots, and Lina Tilman, who agreed to read and
comment on this Article, despite the absence of any possibility of me ever returning the favor.
Finally, none of this would be possible without the help of the most wonderful research
assistant, Erika Wevodau, who not only helped me footnote and Bluebook this Article, but also
corrected my often incomprehensible grammar.
1400 IOWA LAW REVIEW [Vol. 98:1399
system, the innovators who bring new therapeutic or diagnostic products to
market would receive exclusive rights to market their products for a limited
time. This regime would provide sufficient market-based incentives to
continue with the research and investment in this area. At the same time,
because genetic sequences would no longer be broadly protected by patents,
the public would be able to access these basic research tools without fear of
infringement litigation. This approach addresses the concerns of both sides
to the debate and leads to a cheaper, more predictable, and easier to
administer system of exclusive rights.
I. INTRODUCTION .................................................................................... 1401
II. THE SCIENCE AND USES OF GENE ISOLATION AND SEQUENCING ......... 1407
A. DNA IN THE NATIVE STATE ............................................................ 1408
B. FROM DNA TO RNA AND TO PROTEINS ........................................... 1412
C. DISCOVERING AND USING GENES ..................................................... 1413
D. SUMMARY ...................................................................................... 1416
III. THE PRINCIPLES, PRECEDENTS, AND PURPOSES OF PATENT LAW ......... 1417
A. THE BASIC DICHOTOMY BETWEEN DISCOVERY AND INVENTION IN
AMERICAN PATENT LAW ................................................................. 1417
B. TRADITIONAL JUSTIFICATIONS FOR PATENT PROTECTION ................. 1420
C. RECONCILING THE BROAD LANGUAGE OF THE PATENT ACT AND
THE NATURAL LAW EXCEPTION ...................................................... 1426
D. BEYOND PATENT ELIGIBILITY—THE NOVELTY REQUIREMENT ......... 1432
IV. PATENT ELIGIBILITY OF GENETIC MATERIALS ...................................... 1434
A. NATIVE IN SITU DNA .................................................................... 1434
B. ISOLATED AND PURIFIED DNA ......................................................... 1435
C. THE CDNA .................................................................................... 1441
D. ASSOCIATIONS BETWEEN DNA SEQUENCES AND CONDITIONS OF
INTEREST ....................................................................................... 1442
V. PATENTABILTY OF GENETIC MATERIALS .............................................. 1444
VI. FDA-ADMINISTERED EXCLUSIVITY REGIMES FOR PHARMACEUTICALS
AND BIOLOGICS .................................................................................... 1448
A. NEW CHEMICAL ENTITIES UNDER THE HATCH-WAXMAN ACT .......... 1450
B. BIOLOGICS UNDER THE AFFORDABLE CARE ACT ............................... 1452
C. APPLYING THE CURRENT MARKET EXCLUSIVITY PROVISIONS TO
PHARMACEUTICALS ........................................................................ 1453
VII. FDA-ADMINISTERED EXCLUSIVITY REGIME FOR GENETIC MATERIALS . 1454
A. THE SYSTEM DESIGN ...................................................................... 1454
B. THE JUSTIFICATION AND BENEFITS OF THE PROPOSED SYSTEM .......... 1462
VIII. CONCLUSION ....................................................................................... 1465
2013] EXCLUSIVITY WITHOUT PATENTS 1401
I. INTRODUCTION
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.
14, 1982).
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. INTL 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. INTL 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. INTL 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.”).

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