1.1- Motive of the Research
The framers of the U.S. Constitution created incentives for technological invention by drafting Intellectual Property Clause.1 One of major goals of the patent law is to disclose the newest scientific discoveries information to the public and to enlighten the public as to how these discoveries can benefit society.2 However, since the first gene patent issued to Regents of the University of California in 1982
regarding a bacteria containing plasmid that expresses a chronic somatomammotropin gene3, the debate over the protection of human gene sequence has sparked a long debate whether human genes should be treated as a patentable subject matter. One of the major concerns is the limited access to testing and diagnosis where patients are unable to confirm or verify the accuracy of the diagnostic test with another diagnostic facility when the patentee is the sole provider of the gene test.4 Another concern relates to the potential of impeding the future researches which contradict with the original purpose of setting patent system and that is to stimulate innovation.5
Since the instigation of human gene research, the outcomes of the various researches have played pivotal roles in treating and preventing genetically inherited diseases. Starting in late 1970s, scientific researchers began to view genetic material as a means of developing treatment options for a variety of human diseases.6 As the gene researches become prevalent, there is an increase trend of seeking for patent protection. Human gene sequences are now widely used in different clinical and research areas such as gene therapy, diagnostic genetic testing, and purified protein production. With the advancement of pharmaceutical industry, the relationship
1 The Constitution gives Congress the power to “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” U.S. Const. art. I, § 8, cl. 8.
2 Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 151 (1989).
3 Gene Patents and Global Competition Issues, available at http://
www.genengnews.com/articles/chitem.aspx?aid=1163&chid=0 (last visited April. 15, 2012).
4 David H. Ledbetter, Gene patenting and licensing: the role of academic researchers and advocacy groups, 10GENETICS IN MED.314,314(2008).
5 Kate Murashige, Patents and Research--An Uneasy Alliance, 77ACAD.MED. 1329(2002) (evaluating the claim that patents such as gene patents inhibit scientific progress).
6 MARTIN J.ADELMAN, ET AL.,CASES AND MATERIALS ON PATENT LAW 59 (3d ed. 2009).
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between drugs and gene product has become closer compared to a few decades ago.7 For example, the completion of the Human Genome Project in 2003, identifying nearly 25,000 genes and 3 billion base pairs in the human body that setup a complete human gene database.8 One of the aims of this technology is to transfer the
information to private sectors, thereby facilitating diagnoses of disease and
pharmaceutical development.9 This caused a drastic increase in the number of patent applications for human genes over past few decades.10 The number of applications increased more than double from approximately 16,000 applications in 1990 to 33,000 applications in 2000.11 Today, close to two thirds of new drugs that reach the market have been influenced by genetic research,12 and genetic material has been linked to more than 850 human diseases.13 The average life expectancy of U.S.
citizens has elongated and quality of life have greatly enhanced over the past century, and this largely due to the improvement of pharmaceutical and genetic innovations.14 Nearly twenty percent of human genes are patented under United States law15 and a
7 GREGORY J.HIGBY, FROM COMPOUNDING TO CARING:AN ABRIDGED HISTORY OF AMERICAN
PHARMACY IN PHARMACEUTICAL CARE 19,36-37 (Knowlton H. Calvin & Richard P. Penna eds., 2d ed.
2003).
8 Battelle Technology Partnership Practice, Economic Impact of the Human Genome Project (2011), http://battelle.org/docs/default-document-library/economic_impact_of_the_human_genome_project.pd f?sfvrsn=2.
9 Id.
10 Richard Willing, Gene Patent Gets Tougher, USATODAY, Nov. 15, 2000, at 14A.
11 Id.
12 Andrew Pollack, The Genome at 10: Awaiting the Genome Payoff, N.Y.TIMES, June 15, 2010, at B1, available at http://www.nytimes.com/2010/06/15/business/15genome.html (indicating that the Research and Development President at Bristol-Myers Squibb and the Research Executive Vice President at Roche have both proclaimed that two-thirds of newly developed drugs have been influenced by genetic research).
13 Nicholas Wade, A Decade Later, Gene Map Yields Few New Cures,N.Y.TIMES, June 13, 2010, at A1, available at
http://www.nytimes.com/2010/06/13/health/research/13genome.html?pagewanted=1&ref=business.
14 LAURA B.SHRESTHA,CONG.RESEARCH SERV.,RL32792,LIFE EXPECTANCY IN THE UNITED STATES
2-5 (2006) available at http://aging.senate.gov/crs/aging1.pdf (showing that the average American life expectancy has increased by nearly thirty years in the past century and citing medical advances as a reason for these decreased mortality rates); see also Kaiser Public Opinion Spotlight: Views on Prescription Drugs and the Pharmaceutical Industry 1, THE HENRY J.KAISER FAMILY FOUND. (Apr.
2008), http://www.kff.org/spotlight/rxdrugs/upload/Rx_Drugs.pdf (indicating that most American adults take prescription drugs and that a vast majority of Americans believe that prescription drugs improve quality of life).
15 Kyle Jensen & Fiona Murray, Intellectual Property Landscape of the Human Genome, 310SCI.239, 239(2005).
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large portion of those patents related to human health especially cancer related.16 With the increase importance in pharmaceutical development, the recent landmark case on patentability of cancer detecting gene sequence, Association for Molecular Pathology, et al. v. United State Patent and Trademark Office, et al. (the Myriad case)17, has bought greater attention from the public and biotechnology industry on the issue of patentability of human gene sequence.
The patentable subject matter is set forth in 35 U.S.C §101. As the law stated
“whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”18 Attached with this rule are three major exceptions: natural phenomenon, law of nature, and abstract ideas. Those exceptions are excluded from patentable subject matter and all needed to be examined before the Court goes on to reach a conclusion as to the issue of patentable subject matter. Despite numerous preceding court decisions on this issue, prospective inventors are still left with uncertainty the standards used in determining the patentable subject matter. The recent case Association for Molecular Pathology, et al. v. United State Patent and Trademark Office, et al., may help to determine the most recent view of the U.S. Courts.
In this law suit, numerous non-profit organizations, research organizations and patients sued defendant Myriad and United States Patent and Trade Office (USPTO) based on the invalidity of breast cancer detecting gene patents, BRCA1 and BRCA2.
The defendants’ patents, which encompass composition of matter claims and process claims, were invalidated by the United States District Court, S.D. New York. However, when the case is appealed to the U.S. Court of Appeals for the Federal Circuit, district court’s judgment was partly reversed because the Federal Circuit still holds the same view as expressed in the long practice of USPTO and another leading case, Diamond v.
Chakrabarty, which supports a broad protection of bio-organisms thus "anything
16 Id. at 240.
17 Ass’n of Molecular Pathology v. USPTO, 702 F. Supp. 2d 181 (S.D.N.Y. 2010); Ass’n for Molecular Pathology v. USPTO, 653 F.3d 1329 (Fed. Cir. 2011); Ass’n for Molecular Pathology v.
USPTO, 132 S.Ct. 1794 (2012); Ass’n for Molecular Pathology v. USPTO, 689 F.3d 1303 (Fed. Cir.
2012).
18 35 U.S.C § 101 (2006).
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under the sun that is made by man" is patentable.19 The case was appealed to the U.S.
Supreme Court and certiorari was granted. The case was then vacated and remanded by the Supreme Court to the Federal Court and was given an instruction to reconsider in light of Mayo Collaborative Services v. Prometheus, Inc. case.20 However, in the recent verdict on remand dated Aug 16, 201221, the Federal Circuit still reaffirmed their previous decisions.22 As mentioned above, this judgment by the Federal Circuit may have tremendous impact for the probability that it could bring clarity to the patentability issue regarding human gene sequences. Therefore, this case should be closely analyzed.
1.3 - Research scope, Method, and Structure of the Thesis
1.2.1 Purpose and Scope of the Research
The foundation for the U.S. patent system is based on the Article I, Section 8, Clause 8 of the U.S. Constitution which allowed the Congress to promote the progress of the science and useful arts.23 But, the reality is showing signs that patents are not only assisting but rather partly impeding the progress of science. Since the massive patenting of ESTs (Expressed Sequence Tags) without knowing the actual function of these genes, the issue of patenting genes has become a greater issue because some scientists have argued the difficulty of developing the multiplex gene diagnostic test as it may require hundreds of genes. As more people are reliant on the biotechnology development, this issue must be resolved in order to promote greater progress of science. Via the analysis of the most recent case, Association for Molecular Pathology, et al. v. United State Patent and Trademark Office, on patentability of gene sequence, in hoping to determine the patentability of human gene sequence and the standards used to determine the patentable subject matter. Also, examining from a broader view, how will these recent standards set by the Federal Court may affect the future research, patient access and incentive for investment? At last, some possible solutions in
19 Ass’n for Molecular Pathology v. USPTO, 653 F.3d 1329, 1358 (Fed. Cir. 2011).
20 Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 1295 (2012).
21 Ass’n for Molecular Pathology v. USPTO, 132 S.Ct. 1794, 1794 (2012).
22 Ass’n for Molecular Pathology v. USPTO, 689 F.3d 1303, 39 (Fed. Cir. 2012).
23 U.S. Const. art. I, §8 , cl. 8.
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solving the future problems that can be caused by the numberless of previous granted patents.
1.2.2 Research Method and Structure of the Thesis
The Myriad24 case has brought the attention the issue of patentability of human gene sequence. In patent law, patentable subject matter is one vital requirement for receiving a patent protection. Thus, one of the main goals of this thesis is to evaluate the standards used in precedents in determining a patentable subject matter. Standards will be categorized and analyzed via precedent cases that relate to the topic of
patentable subject matter. Confirmed and disputable standards will all be discussed.
These standards will be evaluated again in the new Myriad25 case and compared if there are any changes to these standards.
The first chapter will introduce the motive, purpose of the research, and the research method. Chapter two includes the fundamental background knowledge on human gene sequences. A brief introduction on patent and related terms is also introduced. Chapter three focuses on the U.S judicial decision on the subject matter requirement of gene patents and why this is still an issue today. Different cases related to patentable subject matter are described and further divided into two major
categories: 1) natural product in general and 2) gene in specific. Chapter four provides a detailed follow up on the Association for Molecular Pathology v. U.S. Patent and Trade Office26 case. Chapter five is the issue assessment of the case and the impact that the holdings might have on people. Chapter six presents some possible solutions to the problem of gene patents and the conclusion in Chapter seven.