By Paul Billings
I have always opposed the concept that human genes and their DNA sequences could be patented. Not only did it appear to me that they were "a product of nature," but the idea that some entity might have ownership to a chemical residing in nearly every cell of my body seemed offensive and untenable. So it was apparently paradoxical and sadly ironic that I felt compelled to join the opposition to the SACGHS report on this topic that recommended various actions against gene patenting by the HHS Secretary. My opposition was distinct from that expressed by Mara Aspinall and Sheila Walcott, who cosigned the minority dissenting statement with me.

My objections were primarily based on three points:

1. The patent system has spurred innovation and rapid commercialization in the life sciences and medicine that has benefited many people worldwide. We should have a strong argument to disrupt a working "good." The report did not adequately reflect this fact, nor did it include any monitors or steps to preserve this effect, if it exists, in the field impacted by gene patenting.

2. The data demonstrating the harms caused by the current system of patenting that includes "gene patents" were scant and not convincing in its specificity. While some people surely have not had access to patented products, most have; and our system of health care provision and financing routinely discriminates against the poor (and many other needy groups) generally. The system needs change, but altering patenting will not do it.

3. Finally, the report called for a variety of Executive Branch actions (notably not helping the ACLU case against Myriad). I believe the courts need to clarify the current law on biotechnology patenting. Then, if we believe this legal regime as practiced by the PTO is inadequate or inappropriate, laws to alter it should be passed by the Congress. Executive action prior to this process seemed ad hoc to me and could cause harms while curtailing important deliberations.

I therefore opposed some of the recommendations and conclusions of this SACGHS Report. I do hope that this important issue will continue to be reviewed and litigated. A clear and widely acceptable result that promotes human integrity and non-commodification while providing the hope that active research and a fecund marketplace can bring to those in need would be my goal.      

Paul Billings, PhD, MD, is director and chief science officer of El Camino Hospital's Genomic Medicine Institute and a member of CRG's Board of Directors.

Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests

Report of the Secretary's Advisory Committee on Genetics, Health and Society

Statement of Dissent From Ms. Aspinall, Dr. Billings, and Ms. Walcoff


In our current health care system, patients routinely face unequal access to medical care, including diagnostic tests. Consequently, it is our position that statutorily modifying the gene patents system, including the creation of exemptions from liability for infringement upon such patents as defined in this report and proposed in the recommendations, would be more harmful than helpful to patient access and to the quality of innovative genetic diagnostics.

The basis of our position is recognition that there are a variety of financial and scientific decisions made by both government and private stakeholders throughout our health care system that impact patient access to genetic tests. We recognize the importance of supporting and encouraging discovery and, most importantly, translating those genetic discoveries into new tools to improve patient treatment and outcomes.

The patent system, although debatably imperfect, offers those who invest in developing discoveries a value for the investment. We believe that facts and findings cited in this report and in other reliable scientific literature support our view that the recommended change to the patent enforcement statute and the Bayh-Dole Act would have significant negative consequences. Many discoveries, in academic institutions or otherwise, may not be pursued or developed. Notably, the increasing complexity of development and clinical testing for genetic tests and higher evidentiary standards and regulatory hurdles such tests must meet require increasing levels of investment (measured in millions or tens of millions).

Notwithstanding our position that the recommendations regarding the statutory changes to the patent system would not ameliorate the patient access concerns this Committee has identified, we do acknowledge and appreciate the importance of patient access and quality standards with respect to provision of genetic testing. However, while we agree that licensing does play some role in universal access, public health plans such as Medicaid and Medicare, as well as private payers, continue to be free to refuse coverage and payment even if every laboratory in the country offers a test. Moreover, in addition to such reimbursement policy, other factors, including practice patterns and professional talent distribution, also impact what tests are conducted in what regions of the country. Therefore, we do not support the assertion that in most cases gene patents have had a direct and overarching negative impact on the ability of a patient to obtain a test.

In terms of clinical access on behalf of patients, our assessment of the data suggests that clinicians are often significantly limited by contractual and financial barriers placed on them by their organization/institution or cost containment restrictions imposed by public and private payers. The ability for every laboratory to offer every test, in our view, is a commercial objective more than a patient access issue since clinicians can and do order genetic tests for patients every day from laboratories both across the hall and across the county. 

Nevertheless, we agree that the inability of certain populations to afford genetic testing is an important and valid concern and should be addressed directly as an integrated component of systemic health care reform. It is important that good intentions do not give way to negative outcomes in other parts of the health system or economy. As such, we would strongly encourage the Department of Health and Human Services to critically evaluate the criteria and requirements of all public health programs, including Medicare and Medicaid, to ensure that every beneficiary of public health funding has reasonable and timely access to genetic tests regardless of income or geographic location. In addition, we strongly encourage HHS to evaluate relevant laws, regulations and policies, such as anti-kickback, health care fraud statutes, and government reimbursement policies, that are overly burdensome or result in practical barriers on diagnostic companies who would otherwise elect to offer tests at little or no cost based on financial need.

We also agree that testing, including quality standards, whether by a single laboratory or multiple laboratories, are an important factor to the public's health. Test quality has been and should continue to be appropriately addressed by the Food and Drug Administration and the Center for Medicare and Medicaid Services. Specifically, those agencies should continue to work together to keep pace with laboratory and diagnostic innovation and identify new ways to evaluate proficiency, reliability, and reproducibility of new and innovative genetic tests. We do not believe, nor has FDA or CMS ever suggested, that there is any credible evidence that the quality of testing performed in sole source laboratories is routinely or demonstrably subpar in any way to that which is done in multiple laboratories. Nor do we believe that data indicate that modifying the gene patent system and protections it offers through exclusive licensee agreements would result in multiple laboratories performing proprietary tests with better quality than generated by current and developing oversight of quality assurance undertaken by these agencies and the laboratories themselves.

Finally, we believe that the determination of patentable subject matter and the protections afforded to such patentable subject matter should remain the primary function of the US Patent and Trademark Office, Congress, and the US courts. The suspension of patent protections such as exemptions from liability for patent infringement for a restricted class of innovation (gene patents), unless they are determined to be non-patentable (for instance, a court determination that they are a "product of nature"), is unwarranted and a risky intrusion in to a process that has delivered many key innovations to needy Americans.

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