Diagnostic patents at the Supreme Court.

• Author: Rai, Arti K.

Introduction I. Innovation, Access, and Validity II. Innovation and the Court's Recent Subject Matter Decisions III. Beyond Diagnostics Conclusion Introduction

In June 2013, the United States Supreme Court handed down a highly anticipated decision on DNA patenting, Association for Molecular Pathology v. Myriad Genetics, Inc. (1) Overturning the determination reached by the U.S. Court of Appeals for the Federal Circuit, but in line with the position of the U.S. solicitor general, the Court distinguished between DNA that has merely been isolated (genomic DNA, or "gDNA") and DNA that has non-protein-coding regions excised (complementary DNA, or "cDNA"). (2) The Court held that, while gDNA is a patent-ineligible "product of nature," cDNA is patent-eligible. (3) The upshot of the Court's decision is that certain patents generally associated with diagnostic medicine (gDNA) are invalid, but patents typically associated with therapeutics (cDNA) are valid.

The Court's decision in Myriad came on the heels of its unanimous decision a year earlier in Mayo Collaborative Services v. Prometheus Laboratories, Inc (4) In Mayo, the Court similarly overturned the Federal Circuit's approach to deciding whether subject matter associated with diagnostic medical practice should be eligible for patenting. (5) There the Court struck down method claims on measuring a thiopurine drug metabolite to adjust doses of a thiopurine drug, stating that the claims in question merely added routine activity to the law of nature that individuals metabolize thiopurine drugs differently. (6)

The Court's recent interest in diagnostic patents comes after years of heated public controversy over whether such patents pose an impediment to patient access and control of medical decision making. This controversy encompasses, but is also broader than, the controversy over DNA patenting.

Some critics of the Myriad and Mayo decisions fear that the Court was improperly swayed by concerns over access and patient control. In this view, conventional among patent lawyers, validity doctrine exists to promote innovation--and only innovation. The Myriad case, involving patents on BRCA1 and BRCA2 genes associated with breast cancer, (7) is particularly troubling, as the momentum behind the case was clearly driven in part by concerns unrelated to innovation.

At least some critics of the decisions might concede that patents were not essential for innovation in the specific factual scenarios raised by those cases. Even so, they would argue that the Court's decisions are likely to have unintended consequences in areas where patents are more necessary. These include not only therapeutics but also diagnostic research that is more complex, or less enmeshed in federal funding, than the research in Myriad and Mayo.

In line with the conventional frame, this essay agrees that interpretation of patentable subject matter and other validity doctrines should be guided by innovation goals. Although innovation and access cannot be entirely separated in the case of physician-researchers who also provide clinical care, the conceptual emphasis should be on innovation. Promoting access should rely not on validity doctrine but rather on the carefully calibrated tools of infringement exemptions that borrow from antitrust principles, from agency use of background government rights to persuade those who receive federal funding to engage in appropriate licensing practices, and from insurer bargaining over price.

Myriad and Mayo need not, however, be interpreted in a manner that is antithetical to innovation. This essay lays out a path forward from these cases that is compatible with innovation goals.

1. INNOVATION, ACCESS, AND VALIDITY

   As a historical matter, U.S. patent validity doctrine has focused on innovation. The Constitution's intellectual property provision, which discusses patents as promoting the "Progress of ... useful Arts," puts the spotlight squarely on innovation. (8) Moreover, although the Supreme Court has given Congress broad leeway to interpret this constitutional provision, (9) U.S. patent legislation, unlike legislation in other jurisdictions (e.g., Europe), (10) rarely imposes nonutilitarian limits on patent eligibility.

   This historical focus is reinforced by functional considerations. As a functional matter, patent validity is a blunt and over-inclusive mechanism for policing concerns about access. In many cases where access concerns are raised, problems could be alleviated by the patent owner's being forced to adopt a different enforcement strategy. In the Myriad case, for example, one very significant complaint was Myriad's alleged use of its patent to deny women the option of a second opinion after having received Myriad's test. (11) In that situation, principles of patent exhaustion drawing upon antitrust law suggest that patients who have already given Myriad a monopoly profit by using its services should have the option of using another provider to get a second opinion. Conversely, providers who offer those second opinions shouldn't be liable for patent infringement. Efforts to create a safe harbor from infringement liability for...