Update: Proposed Second Opinion Safe Harbor for Genetic Diagnostic Testing Withdrawn

We reported yesterday on a proposed Patent Act amendment that, if successful, would create a safe harbor for second opinion genetic diagnostic testing. While conceptually simple, the proposed amendment would have left genetic testing developers and providers, patent holders and courts with considerable uncertainty about the safe harbor’s appropriate interpretation and application.

Initially offered by Representative Debbie Wasserman Schultz (D-FL) in April, the amendment surfaced again this past week in the Manager’s Amendment to H.R. 1249 (pdf), the House’s attempt at patent reform legislation.

As news of the proposed amendment spread, it generated a flurry of activity on Capitol Hill. The American Civil Liberties Union (ACLU), the group largely responsible for coordinating the plaintiffs in the Myriad gene patent litigation, spearheaded the charge. An ACLU-led coalition wrote in opposition to the proposed amendment (pdf), arguing that the proposed second opinion safe harbor “would fail to block all patent holder objections to [second opinion] testing, fails to address the many other limitations on scientific research arising out of the issuance of [gene patents], and risks allowing gene patent holders to argue that Congress implicitly endorses the validity of such patents.” The group was joined in its efforts by the American Medical Association, the Association for Molecular Pathology (the first named plaintiff in Myriad) and others, who collectively lobbied Rep. Wasserman Schultz and her colleagues to avoid creating “unintended harms to patients, medical professionals and genetic researchers.”

Rep. Wasserman Schultz evidently agreed with the concerns raised by the ACLU and others, submitting a new amendment to H.R. 1249 (pdf) this afternoon that eliminates the second opinion safe harbor in its entirety. Without Rep. Wasserman Schultz’s support, the original second opinion safe harbor proposal should be quickly removed from the patent reform legislation, allowing the ACLU and others who opposed the amendment to breathe a sigh of relief.

Reexamining the Role of Second Opinion Testing. In the safe harbor’s place is a charge to the Director of the U.S. Patent and Trademark Office (PTO) to “conduct a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist.”

The study would include an examination of (1) the impact a lack of second opinion testing has on patient care, (2) the effect that the availability of second opinion testing would have on existing rights-holders, (3) the impact current exclusive licensing practices have on the practice of medicine and (4) the effect of cost and insurance coverage on access to genetic diagnostic tests. The report would be due to the Judiciary Committees of both the House and Senate within 9 months from the legislation’s enactment and would include recommendations for establishing the availability of appropriate second opinion genetic diagnostic testing.

While there is no guarantee that Rep. Wasserman Schultz’s revised amendment will be passed by the House, or even that Congress will succeed in passing patent reform legislation in any form, if the new amendment does pass there will be plenty for the PTO to investigate. Although the issue of second opinion testing was discussed last year by the now-defunct Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) as part of its controversial report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests (pdf), many questions would benefit from a second, closer look.

Key questions meriting further investigation include:

  • how frequently confirmatory genetic diagnostic testing currently occurs in areas where a lack of patents and/or non-exclusive licensing permits multiple test providers;
  • what manner of safe harbor provision would encourage providers to actually offer second opinion testing in areas where patents and/or exclusive licensing present patients with only a single (or limited) testing option; and
  • the effect of a safe harbor provision for second opinion testing on the ongoing gene patent debate (as embodied in Myriad), as well as the larger conversation concerning the proper role of intellectual property in personalized medicine innovation.

Most importantly, if further study does indicate that a safe harbor or other similar mechanism to enable second opinion diagnostic testing would be beneficial, the PTO and Congress will need to spend more time carefully crafting a legislative solution that eliminates—or at least dramatically reduces—the uncertainty attached to the most recent safe harbor proposal. Otherwise, despite its best intentions, Congress could inadvertently muddle the personalized medicine patent landscape in a way that restricts—rather than enhances—patient access to genetic tests.