Views on the AHA Policy Statement: Genetics and Cardiovascular Disease
Disclosure: Dr. Sung has nothing to disclose.
Pub Date: Tuesday, May 29, 2012
Author: Lawrence M. Sung, J.D., Ph.D.
Affiliation: University of Maryland Carey School of Law
Ashley EA, Hershberger RE, Caleshu C, Ellinor PT, Garcia JGN, Herrington DM, Ho CY, Johnson JA, Kittner SJ, MacRae CA, Mudd-Martin G, Rader DJ, Roden DM, Scholes D, Sellke FW, Towbin JA, Van Eyk J, Worrall BB; on behalf of the American Heart Association Advocacy Coordinating Committee. Genetics and cardiovascular disease: a policy statement from the American Heart Association. Circulation. 2012: published online before print May 29, 2012, 10.1161/CIR.0b013e31825b07f8.
The American Heart Association (AHA) Policy Statement entitled “Genetics and Cardiovascular Disease: A Policy Statement From the American Heart Association” addresses the significant societal issue of innovation in cardiovascular medical technology. In so doing, the authors, Ashley et al., consider particular legal and regulatory frameworks that govern research and development in the United States generally, and map these considerations onto specific genetic disease examples to arrive at discrete policy recommendations on behalf of the AHA Advocacy Coordinating Committee. In addition, the Policy Statement contemplates cardiovascular medical technology on the horizon and highlights the importance of education for health care providers.
The Policy Statement incorporates several themes, including the recognition that the effective delivery of innovative medical technology to the public depends on a balance of various factors each with its own set of priorities; that the transparency and sharing of reliable information is critical to the process; and that the robust discussion of the pertinent issues among various stakeholders offers the best approach to overall advancement. The legal and regulatory issues that the Policy Statement considers include gene patenting, genetic nondiscrimination, and genetic testing.
Regarding gene patenting, the Policy Statement sets forth the recommendation that more liberal licensing of gene patents should be encouraged and that future patents should not be granted to inventions essentially involving functionally unaltered human DNA. In arriving at these recommendations, the authors considered the recent public attention paid to lawsuit filed by the American Civil Liberties Union and the Public Patent Foundation on behalf of the Association of Molecular Pathology and certain health care providers against the U.S. Patent & Trademark Office, the University of Utah Research Foundation, and Myriad Genetics, Inc.1 The Myriad case is pending before the U.S. Court of Appeals for the Federal Circuit for oral arguments on July 20, 2012, following remand from the U.S. Supreme Court. The principal issue is the patent eligibility of claims to isolated DNA encoding a breast-ovarian cancer related (BRCA) polypeptide. The crux is whether a patent claim to “isolated” DNA sufficiently distinguishes that invention from naturally occurring DNA. This case is part of the greater attention being paid in recent days to what technological subject matter should (and should not) be eligible for patent rights.
This lead issue in the Policy Statement suggests the importance of the controversy to the AHA. But while the issue awaits judicial guidance, if not resolution, the AHA recommendation may be seen by some as less aggressive against gene patenting than that espoused by the plaintiffs in Myriad. Whereas the Myriad plaintiffs seek the invalidation of all gene patents, including those already granted, the Policy Statement recommendation against “further” patenting appears less encompassing. Indeed, because patent claims submitted today that are directed solely to human DNA sequences likely are not patentable anyway because they would not be novel or nonobvious in view of the prior art, the question of the eligibility of future patent claims to isolated DNA is arguably moot. Still, the Policy Statement is consistent with the public trend toward challenging the premise that patent exclusivity is an essential economic incentive to the research and development of innovative medical technology.
Regarding genetic nondiscrimination, the Policy Statement sets forth the recommendation for greater public awareness that the Genetic Information Nondiscrimination Act (GINA) still has shortcomings as a comprehensive safety net. Regarding genetic testing, the Policy Statement sets forth the recommendation for sound regulatory oversight of available and developing genetic tests to maximize the integrity of the diagnosis and treatment. In this regard, the Policy Statement emphasizes the ongoing need for funding and study efforts across the concerns relating to genetic testing, pharmacogenomics, and common variant genotyping, with the goal being to build reliable databases.
The Policy Statement concludes with a view toward the future of cardiovascular medical technology with a thoughtful perspective on the role that education of health professionals will play in the implementation of innovative diagnostic, therapeutic, and preventive care. In particular, the expansion of the public interface of health care provider services through pharmacists and genetic counselors beyond physicians and nurses, the multidisciplinary nature of forecasted patient care delivery, and the convergence of traditional classroom teaching and clinical training will continue to come to the fore as educational priorities.
In summary, the AHA Policy Statement provides an excellent information resource for those seeking a timely and comprehensive review of the issues that implicate the present and future of cardiovascular medical technology. Moreover, the recommendations offer specific and reasonable guidance, the attention to which can help establish a definite path forward.
- Ass’n of Molecular Pathology v. U.S. Patent & Trademark Office, No. 2010-1406 (Fed. Cir. 2012) (on remand in light of Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).