By Andrew D. Thibedeau

In the early evening of March 29, 2010, the Honorable Judge Robert W. Sweet handed down his much anticipated ruling in Association for Molecular Pathology v. United States Patent & Trademark Office.[1] In his detailed opinion, Judge Sweet confronted the legal issue whether "isolated human genes and the comparison of their sequences [are] patentable."[2]  The more significant question the decision wrestles with, however, is whether the law ought to treat the human genome as a species of property.  The biomedical sector has long regarded DNA as "intellectual property," to be bought, sold, and controlled like any other form of capital.  For this reason, most observers have predicted that the outcome of Association for Molecular Pathology "will have far-reaching implications, not only for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of biomedical research."[3]  "This action is unique," Judge Sweet himself remarked in an earlier opinion in the case, "in the identity of the parties, the scope and significance of the issues presented, and the consequences of the remedy sought." [4]

For nearly three decades, it has been the policy of the U.S. Patent & Trademark Office (PTO) to issue patents covering human DNA that have been "isolated and purified."  By one accounting, as much as 20% of the human genome has already been patented.  The PTO's practice "is premised on the view that DNA should be treated no differently from any other chemical compound, and that its purification from the body . . . renders it patentable by transforming it into something distinctly different in character."[5]  "Like other chemical compounds," the PTO states in a 2001 policy paper, "DNA molecules are eligible for patents when isolated from their natural state and purified."[6]  Pursuant to this policy, between 1997 and 2000 Myriad Genetics (Myriad), a for-profit corporation based in Utah, obtained seven patents covering two human genese-BRCA1 and BRCA2-both linked to an increased risk of ovarian and breast cancer.

Women possessing mutations in their BRCA1 or BRCA2 genes stand up to an 85% cumulative risk of developing breast cancer in their lifetime, and a 50% cumulative risk of developing ovarian cancer.  The outcome of these genetic tests can therefore dramatically affect the choices women face-from hormone therapy, chemotherapy, or in some cases radical prophylactic surgery.  As a result of the breadth of their patents, however, Myriad has the right to control all genetic testing related to breast and ovarian cancer associated with BRCA1 or BRCA2.  Although Myriad offers a number of their own genetic tests, they have not permitted other laboratories or clinics to undertake research or testing involving BRCA1 or BRCA2.  This has left many women without the ability to obtain a second opinion after undergoing a Myriad test.  What's worse, Myriad's steep pricing and unwillingness to work with many insurance carriers has left women unable to obtain testing at all.

Thus, in May of 2009, a coalition of concerned individuals and public interest organizations lead by the American Civil Liberties Union (Plaintiffs) filed a lawsuit against Myriad and the PTO (Defendants) in an effort to end Myriad's monopoly on BRCA1 and BRCA2 testing as well as halting the PTO's practice of granting patents on human genes.  The suit alleges that the PTO's policy of issuing patents covering human DNA-and Myriad's gene patents obtained thereunder-run afoul of Federal Constitutional and statutory law.  Plaintiffs therefore have asked the Court to declare Myriad's genetic patents invalid and to enjoin the PTO from granting further such patents.  In common cause, the Council for Responsible Genetics soon added their voice to Plaintiffs' by filing an amicus curiae (or "friend of the court") brief, arguing for the invalidation of Myriad's BRCA1 and BRCA2 patents.

To understand how Judge Sweet, writing as the Court, addressed the important questions implicated in Association for Molecular Pathology, however, it is necessary to understand a few basic points about the law of patents.  The American system of patents and trademarks is governed by the so-called "copyright clause" of the U.S Constitution.[7]  Unlike other provisions of the Constitution that secure fundamental rights and liberties, the copyright clause embodies a compromise between public good and private profit.  To achieve this balance, the patent system offers an incentive to innovators to invest in the development of new technology, which can then be marketed under patent protection, in exchange for which the inventor must reveal the secrets of her invention which the public may freely use when the patent expires.  In 1952, Congress passed the Patent Act, which states that "[w]hoever 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."[8]  In the years since its enactment, courts have interpreted this provision to require two things for a patent to be granted: a claimed invention must be "useful" in some way, and must be a "process, machine, manufacture, or composition of matter."

Following this second requirement, the Supreme Court has recognized "that scientific principles and laws of nature, even when for the first time discovered, have existed throughout time, define the relationship of man to his environment, and, as a consequence, ought not to be the subject of exclusive rights to any one person."[9]  In other words, one can't patent products of nature, or materials isolated from products of nature, if those materials behave in the same way they would in nature.  For example, the U.S. Court of Appeals held that artificially purified tungsten is not patentable, despite possessing superior strength over its natural counterpart.  The court reasoned that it was nature, not the patent applicant, who gave pure tungsten its superior qualities.[10]  On the other hand, the Supreme Court has allowed a patent for a genetically-engineered microorganism capable of metabolizing crude oil and designed for use in oil spills.  There, the Court concluded that the patent application covered a novel biochemical organism whose properties derived from its inventor, not from nature.[11]

In view of this well-established principle, the Court in Association for Molecular Pathology ruled in favor of Plaintiffs, invalidating all seven of Myriad's patents.  The Court's analysis turns on the unique character of the DNA molecule as a carrier of information.  More than a chemical compound, "the information encoded by DNA reflects its primary biological function."  It is this informational aspect of DNA that marks it as unique.  Central to the Court's reasoning is the fact that the purification of native DNA does not alter this essential characteristic, which is determined by nature and is central to both its biological function within the cell and its utility as a research tool in the lab.  "The preservation of this defining characteristic of DNA in its native and isolated forms" the court ultimately holds, "mandates the conclusion that the challenged [patents] are directed to unpatentable products of nature."[12]  Put differently, the fundamental features of DNA-all of which are the products of nature-are the same whether inside a human cell or "isolated and purified" in a laboratory.  As products of nature irrespective of form, human genes thus cannot meet the Patent Act's requirement that a patentable invention be a "new and useful process, machine, manufacture, or composition of matter."

Although the Court's ruling in Association for Molecular Pathology is a dramatic win for Plaintiffs, the story is far from over.  First, the Court based its ruling solely on the Patent Act, and did not reach Plaintiffs' Constitutional claims.  This leaves open the possibility that the law could be changed through the legislative process, in essence reversing the Court's ruling.  Second, the Court did not invalidate outright the PTO's policy of issuing patents that cover DNA, nor did it rule on the validity of patents covering DNA generally-its holding was limited to the seven Myriad patents.  This leaves significant ambiguity as to the status of other genetic patents held by other biotech firms.  Finally, the case will now begin the appeals process, where the Court's decision will be reviewed first by the Court of Appeals and then, possibly, by the Supreme Court.  Nevertheless, these reasons for uncertainty must not diminish the significant victory achieved by Plaintiffs-a victory not limited to the triumphant parties to this case, but shared by women everywhere who stand to benefit from increased access to BRCA1 and BRCA2 testing.


[1] No. 09 Civ. 4515 (S.D.N.Y. Mar. 29, 2010) (hereinafter "Association for Molecular Pathology II").

[2]Association for Molecular Pathology II, slip op. at 2.

[3] Association for Molecular Pathology I, at 370.

[4]Association for Molecular Pathology v. United States Patent & Trademark Office, 669 F. Supp. 2d 365, 370 (S.D.N.Y. 2009) (hereinafter "Association for Molecular Pathology I").

[5] Association for Molecular Pathology II, slip op at 7.

[6] Utility Examination Guidelines, 66 Fed. Reg. 1092, 1093 (2001).

[7] U.S. Const. art. I, § 8, cl. 8.

[8] Patent Act, 35 U.S.C. § 101 (LexisNexis 2010).

[9] In re Meyer, 688 F.2d 789, 795 (C.C.P.A. 1982).

[10] Gen. Elec. Co. v. De Forest Radio Co., 28 F.2d 641, 642 (3d Cir. 1928).

[11] Diamond v. Chakrabarty, 447 U.S. 303, 309-10 (1980).

[12] Association for Molecular Pathology II, slip op. at 125.

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