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Can They Patent Your Genes?

kevles_2-030713.jpg
National Cancer Institute/National Institutes of Health
Malignant breast cancer cells metastasized to the liver

Christopher Hansen, one of the ACLU’s co-counsels, has said that the plaintiff’s lawyers approached the suit as though it were a civil rights case, reaching beyond the technicalities of patent law to emphasize that the patents, as well as the 2001 “Guidelines” on which they rested, enabled Myriad to infringe the rights of biomedical scientists, physicians, and patients.

Myriad’s patents are sweeping, covering both the corrupted and normal versions of each isolated form of BRCA DNA and all mutations and rearrangements within them, including—by implication for the BRCA1 gene and explicitly for the BRCA2 gene—those as yet unknown. They also encompass every conceivable use of the three types of DNA, including diagnostics, therapies, drug development, and the identification of other cancers involving either of the genes.

The patents gave Myriad a virtual lock on research and diagnostics on the workings of the BRCA1 and BRCA2 genes because, for the most part, such research and diagnostics required analysis and manipulation of the DNA in isolated form. Myriad, exercising the power of exclusivity inherent in its patents, reserved to itself the performance of all diagnostic analyses of a patient’s DNA that might be disclosed to her. According to the complaints of the plaintiffs, Myriad’s policy enabled it to charge prices for the tests that put them beyond the reach of some women. It also prevented patients from obtaining a second diagnostic opinion from an independent laboratory. And it forced clinical researchers who scrutinized a woman’s DNA to violate the ethical norms of medical practice because they were prohibited from telling her what they found. Myriad’s policy hampered such research because women at risk were disinclined to participate if the outcomes had to be kept from them.

The company blocked several biomedical scientists from conducting clinical research on the BRCA DNA, except under severe restrictions. It could, if it wished, prevent scientists from exploring the meaning of mutations of unknown significance that the tests might reveal. Myriad also kept for itself the right to incorporate the discovery of the new alterations in the BRCA genes, even those made by others, into the diagnostic tests. It thus retarded the development of the most comprehensive tests possible for women at risk. Except as the company allowed, no other laboratory could assess the reliability of its tests or improve upon their speed or cost.

Myriad’s control over BRCA DNA differed little from that established by a patent on any other molecule, but the plaintiffs emphasized that DNA was not just another chemical. Even in isolated form, it embodies the gene’s natural repository of genetic information and its ability to express laws of nature. Moreover, genes are not only special natural products; each is also unique in its composition and function. No one can invent another BRCA1 or BRCA2 any more than someone can devise a different hydrogen or oxygen. Finding another gene that predisposes a woman to breast or ovarian cancer will not help identify whether she is at risk for either BRCA1- or BRCA2-induced illnesses.

Breaking new ground in a patent case, the plaintiffs contended that Myriad’s patents—and by clear implication the policy that enabled them, notably the 2001 “Guidelines”—violated the US Constitution, particularly the Progress Clause and the First Amendment. By empowering Myriad to control all research and uses of a unique part of nature, the patents impeded the progress of science and the useful arts. By restricting access to and use of the genetic information that the DNA embodied, they gave Myriad control over all “thought, knowledge, and ideas” concerning the genes, a monopoly that the First Amendment, in accord with judicial holdings, prohibited the PTO from granting.

Opponents of human gene patenting had raised similar substantive warnings when the PTO was devising its 2001 “Guidelines.” The PTO had then summarily dismissed these objections, citing Section 101, Learned Hand’s dicta, and Diamond v. Chakrabarty. Myriad’s lawyers now flatly rejected the constitutional challenges to its patents, deriding them as “frivolous atmospherics” and calling “false” the charge that its patents “directly limit thought and knowledge.” They declared that the company “freely” allowed academic research on both genes and that more than eight thousand papers about the genes had been published around the world.

They neglected to say that the scientists involved had to avoid violating Myriad’s restrictions on the uses of the DNA covered by its BRCA patents. Both Myriad and the PTO sidestepped the impossibility of inventing alternatives to the BRCA genes, resorting to the irrelevance that patents like Myriad’s would stimulate competitors to identify predispositions to cancer through “research on other genes.” Myriad asserted that the company publicly disseminated the results of its own investigations of the two genes. In fact, it had ceased contributing its data to an international breast cancer consortium in 2008.10 Myriad said that there was no need for women to seek a second, independent diagnostic opinion because its tests were recognized, according to the company’s then president, Gregory C. Critchfield, as “the gold standard” in the field.

In March 2010, Judge Sweet struck down Myriad’s patents on the isolated BRCA DNA and the diagnostic methods that Myriad used to determine whether a patient possesses the genes herself. Accepting a number of the plaintiffs’ main arguments, he repudiated Hand’s dicta as questionable at the time and “certainly no longer good law in light of subsequent Supreme Court cases.” He held, moreover, that the isolation of the BRCA DNA, in whichever form, did not alter its “essential characteristic”—the sequence of base pairs that made it a carrier of genetic information. Myriad’s BRCA DNA was thus not eligible for a patent as a new composition of matter.11

Myriad appealed the decision to the Court of Appeals for the Federal Circuit, in Washington, which hears all appeals in patent cases. The appeals court found reasons to deny standing to all but one of the plaintiffs—he was Harry Ostrer, a biomedical scientist then at NYU—but one sufficed for the suit to remain active. On July 29, 2011, in a split decision, a three-judge panel of the court partially reversed Judge Sweet by upholding Myriad’s claim that the BRCA DNA is eligible to be patented. In December, the ACLU and the PPF petitioned the Supreme Court for a review of the case.

On March 26, 2012, the Supreme Court vacated the finding of the Court of Appeals, instructing it to reconsider that ruling in light of a decision the Court had announced a week before in Mayo Collaborative Services v. Prometheus Laboratories. In that case, the justices unanimously struck down a patent that covered the relationship between the size of a drug dose and the level of certain metabolites in the blood. Speaking for the Court, Justice Stephen Breyer held that the relationship was unpatentable because it constituted a law of nature. Breyer noted the Court’s repeated emphasis that a patent required an “inventive concept” and “that patent law not inhibit future discovery” or “impede innovation more than it would tend to promote it” by granting monopolies over use of laws of nature, natural phenomena, manifestations of nature, and abstract ideas.12

When the Court of Appeals reconsidered the case, a friend-of-the-court brief on the relevance of Mayo on behalf of neither party was filed by the Department of Justice. In an extraordinary move the year before, the department had filed a friend-of-the-court brief with the Court of Appeals in opposition to the Obama administration’s PTO. Aware of the broad stakes in the case, the Justice Department lawyers had pointed out then that DNA extracted from the body was no more patent-eligible than any of the natural elements in the periodic table—lithium, for example—that had to be separated chemically from the compounds in which they occur in the earth. Now, along with the plaintiffs and several other friends of the court, it found “indirect guidance” in the Mayo ruling for the disposition of the Myriad case, contending that a patent

that effectively prevents the public from studying and making use of a product of nature is just as objectionable, and for the same underlying reason, as [one on] a method…that effectively prevents the public from studying and exploiting a law of nature.

On August 16, 2012, a Court of Appeals panel, composed of the same three judges who had dealt with the case the year before, unanimously affirmed Judge Sweet’s ruling against the patentability of Myriad’s diagnostic methods, finding them tantamount to a law of nature, but otherwise overturned his decision once again. The panel held unanimously that cDNA itself is patent-eligible because it is markedly different from the DNA in the body, and, most important, it ruled 2–1 that the other forms of isolated BRCA DNA, whether the fragments or the whole of the gene, are also eligible to be patented.

The principal in the court majority was Judge Alan Lourie, who had been an organic chemist before turning to the law. He insisted that in patent law, unlike in biology, BRCA DNA was not information but was solely a chemical compound. Having been chemically modified at its ends upon extraction from its neighboring DNA, it differed sufficiently from the native version to be patent-eligible. He dismissed the Mayo ruling as irrelevant to the case, embracing arguments made by Myriad’s lawyers that the justices’ ruling in that case concerned a biomedical process while the Myriad case concerned DNA, a composition of matter.

Judge Kimberly A. Moore, an electrical engineer by original training, concurred with Lourie’s opinion, but reached her conclusion by a different route. Mayo meant to her, in contrast to Myriad’s lawyers, that products of nature were no more patentable than laws of nature, and in her view, contrary to Lourie’s, the extraction of the BRCA DNA from its natural habitat did not make it adequately different from the native version to warrant a patent. But she held that the fragments of isolated BRCA DNA were made patent-eligible by the combination of their difference from BRCA DNA, however small, and their usefulness as diagnostic probes.

The complete DNA of the BRCA genes presented Moore with “a more difficult issue” because such isolated DNA did not differ markedly from its native counterpart and was not yet useful. Moore held that if the case had come before her prior to the development of the biotechnology industry, she might have decided differently on the merits. But she was mindful of the huge accumulated investment that rested on patents that the PTO had been issuing on isolated DNA for thirty years. Moore held the isolated DNA of the entire BRCA gene patent-eligible on grounds that not to do so would violate the industry’s “settled expectations and extensive property rights.”

The reasoning of Judges Lourie and Moore provoked an acid dissent from Judge William Bryson, who had come to the bench via a career in the Department of Justice rather than the patent bar. To his mind, the isolated BRCA DNA was fundamentally the same in structure and function as the DNA in the body. It was no more a human invention because it had been isolated from the chromosome than was a kidney taken from the body, a limb removed from the tree, or a mineral or plant extracted from the earth.

The Court of Appeals’s several opinions made explicit that the case pitted the property rights of innovators and investors in gene-based biotechnology against the rights of free access to and use of human DNA by researchers, physicians, and patients. In effect, the absolute control inherent in DNA patents protects—and thus privileges—this sector of the biomedical complex against all others who have reasons to make use of human DNA. The instrument of the privilege is the current strict interpretation of patent law that is guided beyond legal logic by concerns for incentives to innovation and investment.

The PTO had adhered to this approach when it dismissed the arguments of the dissenters from human gene patents in the course of devising the 2001 “Guidelines.” Judge Lourie followed suit, noting explicitly in his opinion that the case was not about, for example, a patient’s right to a second diagnostic opinion or whether it was “desirable for one company to hold a patent or license covering a test that may save people’s lives.”

Judge Moore did acknowledge that Myriad’s patents “raise substantial moral and ethical issues” about the allowance of property rights in “human DNA—the very thing that makes us humans, and not chimpanzees,” and she allowed that BRCA DNA “might well deserve to be excluded from the patent system.” But she considered such a “dramatic” destruction of property rights properly the province of Congress, not the courts.

Against this strict view of patent law stands an expansive version of it, consistent with the Progress Clause, that recognizes the adverse consequences in the clinic and the laboratory of monopoly control over human DNA, a scientifically and medically essential substance for which there is no substitute. The plaintiffs advanced the expansive version of the law, and so did Judge Bryson. He found good reasons in the Mayo ruling to reject Myriad’s patents, noting that they lacked an inventive concept and that they would interfere with future research and innovation.

On September 25, 2012, the plaintiffs asked the Supreme Court to review the Court of Appeals’s August decision and on November 30 the Court accepted the case, confining its review solely to the fundamental question of whether genes are patentable.13 Its decision will determine whether the narrow or expansive interpretation of the law will apply to human DNA. In effect, to borrow from Madison’s assurance that patent monopolies posed no danger in the American democracy, it will declare whether the rights of the many—scientists, physicians, and patients—will be given standing in what has long been the province of the biotechnological few.

  1. 10

    By halting its contributions to public data bases, Myriad aimed to protect as trade secrets its accumulating knowledge about additional alterations in the two genes and thus to maintain a strong hold on fully comprehensive testing for corrupted versions of them even after its patents expire. Andrew Pollack, “Despite Gene Patent Victory, Myriad Genetics Faces Challenges,” The New York Times, August 24, 2011. 

  2. 11

    Judge Sweet, having decided the case on statutory grounds, followed standard judicial practice by declining to address the constitutional issues, which mooted the plaintiffs’ challenge against the PTO

  3. 12

    U.S. S.Ct., Court Orders, Case 11-725, available at www.supremecourt.gov; Mayo Collaborative Services v. Prometheus Laboratories, 566 U.S., “Syllabus,” p. 3; Decision, p. 2 (2012); Adam Liptak, “Justices Back Mayo Clinic Argument on Patent,” The New York Times, March 20, 2012. 

  4. 13

    Adam Liptak, “Supreme Court to Look at a Gene Issue,” The New York Times, November 30, 2012. 

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