Uncommon Genes, Unpatentable Subject Matter
| Publication year | 2011 |
"More than twenty years of pure policy arguments [against patents on human gene sequences] have gotten nowhere in the courts, and Congress has shown no inclination to put the lucrative biotechnology genie back into the bottle."(fn1)
I. Introduction
In a landmark decision on March 29, 2010, Judge Sweet of the Southern District of New York ruled on the first case challenging patents granted by the United States Patent and Trademark Office (USPTO) for gene sequences.(fn2) The plaintiffs(fn3) challenged the validity of Myriad Genetics'(fn4) patents on the BRCA1 and BRCA2 genes.(fn5) Myriad holds exclusive licenses for the patents claiming both the BRCA gene sequences and the mutations associated with those sequences.(fn6) These licenses grant Myriad the sole authority to test patients for BRCA mutations.(fn7) Because mutations in the BRCA genes correlate with a genetic predisposition to certain types of cancers,(fn8) the plaintiffs alleged that the grant of exclusionary rights to Myriad for the BRCA gene sequences inhibited patient access to medically relevant diagnostic tests and unnecessarily increased the cost associated with such tests.(fn9) Six different breast-cancer patients claimed they either received limited testing or could not afford tests due to Myriad's enforcement of its patent rights.(fn10) In this case, Judge Sweet sided with the plaintiffs, holding that, as a matter of law, Myriad's patents claiming the BRCA1/2 gene sequences are invalid.(fn11)
The Myriad litigation is just one example of the ongoing debate over patents on DNA sequences. The Myriad decision is currently before the Federal Circuit and may make its way to the United States Supreme Court, giving the judiciary an opportunity to weigh and clarify a questionable USPTO policy. The debate has taken several forms involving legal, ethical, and public-policy concerns.(fn12) Members of the biopharma-ceutical industry argue that patents are necessary to promote new genetic technologies.(fn13) In contrast, gene-patent opponents believe that human DNA patents are dubious patentable subject matter under both legal and ethical rationales.(fn14) The USPTO grants gene-sequence patents on the grounds that the isolated and purified gene, extracted from the cell, constitutes something different from DNA as it is found in nature.(fn15) Consequently, if "isolated" DNA is never found in nature, it should be amenable to patent protection. This construction is problematic, however, because there is no functional difference between a DNA sequence found in the cell and a DNA sequence isolated from the cell.(fn16) Judge Robert H. Sweet, persuaded that the patents claimed genetic information as it is found in nature, interpreted the BRCA gene sequences as products of nature.(fn17) Accordingly, he decided that gene sequences are a form of un-patentable subject matter and held that Myriad's gene patents were invalid.(fn18)
Human gene sequences are not only products of nature, but also products of cultural heritage. Although the USPTO fails to effectively balance the competing business and human interests associated with DNA sequence patents, the international community tries to weigh these interests appropriately.(fn19) To date, however, the ethics-based doctrine of Common Heritage has been largely ineffective in overriding competing business interests.(fn20) The basic tenet of Common Heritage supposes that certain resources are part of the common heritage of humanity, and that communal property rights, rather than individual rights, are appropriate for such resources.(fn21) Although the doctrine has been cited as an ethical bar to gene patents, as generally conceptualized, this application of the doctrine is suspect for at least two reasons. First, the idea of a common human genome is an abstraction; only identical twins share a common genome.(fn22) Second, a common genome is not the subject of patent claims over gene sequences.(fn23)
This Comment argues that although human gene sequences do not reflect a common human heritage, such sequences do reflect human cultural heritage. A patent that unfairly restricts access to basic genetic information generates wealth for the patent holder without regard to an individual's right to basic knowledge-knowledge that can be characterized and afforded legal protection as intangible cultural heritage. Much discussion is directed at the biological properties of DNA, but very little attention is given to the relationship between a human gene and its cultural derivation. While it is true that patent claims encompass only individual genes and gene fragments, these genetic regions and mutations result from human cultural and genetic evolution.(fn24) Genetic mutations distinguish individuals by virtue of different family genealogies.(fn25) Similarly, genetic mutations differentiate groups of people that share a common cultural heritage.(fn26) Any gene sequence is part of an individual's family history and group affiliation.
Human gene sequences can be conceptualized in three ways: as a molecular fragment, as genetic information, and as a product of cultural heritage.(fn27) This Comment uses the BRCA litigation as an organizing principle to discuss the importance of understanding human genes as something more than just biological material.(fn28) Part II addresses the background of the BRCA gene-patent case and the legal arguments against patenting gene sequences. Part III discusses the ethical objections to gene patents by focusing on common-heritage rationales. Further, Part III addresses the inadequacy of the Common Heritage Doctrine as applied to human gene sequences. Part IV highlights the international and domestic protections afforded to cultural heritage. Part V argues that because human genetic variation results from complex cultural and evolutionary processes, gene sequences should be protected from appropriation as intangible cultural heritage. Finally, Part VI offers some concluding thoughts.
II. Background
On March 29, 2010, Judge Sweet granted the plaintiffs' motion for summary judgment to declare invalid fifteen patent claims contained in seven of Myriad's BRCA patents.(fn29) The plaintiffs, represented by the American Civil Liberties Union (ACLU), included individuals from medical and advocacy organizations, as well as researchers, genetic counselors, and women either threatened by the risk of breast cancer or struggling to fight breast cancer.(fn30) The plaintiffs claimed that patents granted for the BRCA1 and BRCA2 gene sequences were unlawful under each of the following: (1) the Patent Act of 1952,(fn31) (2) Article I, Section 8, Clause 8, of the United States Constitution (the Patent and Copyright Clause), and (3) the First and Fourteenth Amendments of the United States Constitution.(fn32) In granting the plaintiffs' motion for summary judgment, Judge Sweet acknowledged the special significance of the claims before the court: "The resolution of the issues presented to this Court deeply concerns breast cancer patients, medical professionals, researchers, caregivers, advocacy groups, existing gene patent holders and their investors, and those seeking to advance public health."(fn33)
At trial, defense attorney Brian Poissant characterized the ACLU's position as an attack "on biotechnology patenting that warn[s] of the 'gruesome parade of horribles' that will happen if companies are given patents over biological phenomena."(fn34) Furthermore, he noted that "if a ruling were as broadly applied here as the ACLU [contends] then it could 'undermine the entire biotechnology sector.'"(fn35) Concerned, but not persuaded, Judge Sweet ruled for the plaintiffs, convinced that Myriad's patents claimed DNA as it is found in nature.(fn36) Judge Sweet concluded that natural products are "unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101."(fn37)
Judge Sweet's trepidations mirror the public's concerns about the gene-patent debate.(fn38) The plaintiffs' legal challenges to the BRCA patents raise a difficult legal and ethical dilemma: should information about an individual's personal genetic identity be protectable as intellectual property for the purpose of promoting scientific innovation? On the one hand, resolving this thorny question in favor of the plaintiffs could affect the future of biomedical research.(fn39) Conversely, a resolution favoring the defendants affects both personal healthcare and autonomy.(fn40)
The United States Constitution defines Congress's 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."(fn41) The exclusionary rights granted by the Constitution are thought to create incentives for invention and stimulate the public dissemination of scientific innovation.(fn42) Congress interprets exclusionary rights under the 1952 Patent Act (Patent Act) as encompassing "making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States"(fn43) for a current term of twenty years after the date of the...
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