The U.S. Department of Health & Human Services is looking for input on a report looking at the effects of gene patents on patient access to genetic tests.  The Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comments on a draft report to the Secretary of Health and Human Services, “Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.”

The review was limited to those genetic tests, whether used for diagnostic, predictive, or other clinical purposes, that rely on analysis of nucleic acid molecules to determine human genotype. As such, the kinds of patent claims evaluated were nucleic acid-related patent claims associated with genetic tests for human genotype. The report does not address protein-based genetic tests or protein-related patent claims associated with tests designed to infer genotype.

Now, the Committee is looking for public input on several issues, including whether changes are needed in patenting and licensing practices that affect genetic testing, and the appropriateness, feasibility, and implications of the report’s policy options.

The report showed:

Based on its review of the literature, case studies, and review of international policies regarding gene patents, SACGHS found little in the way of broad or consistent evidence that indicates either positive or negative effects of gene patents on patient access to diagnostic tests.

Although it is difficult to document measurable and systematic impacts, either positive or negative, of gene patents on patient access to tests, SACGHS did identify several issues of concern that, if not addressed, might result in future barriers to patient access as the number and complexity of gene tests increases.

Finally, in the case of patents, perceptions can have important impacts on behavior and can affect the willingness of researchers to investigate a particular problem, the willingness of companies to operate in a particular region, the willingness of academic laboratories to develop a given test, and the actions of clinicians who order and utilize genetic tests.

SACGHS identified key findings for the following issues:

Did the prospect of a patent encourage researchers to search for gene-disease associations that could be developed into a genetic test? 

In general, the prospect of receiving a patent was not the major force motivating scientists to search for gene-disease associations that could be used to develop a genetic test. However, it also appears that the prospect of a patent for a therapeutic attracted investment …

Based on the above, it seems to reasonable to conclude that if patent protection for genetic tests did not exist, scientists likely would continue to pursue research into gene-disease associations with equal fervor, motivated by various factors, including the desire to advance the understanding of a disease, earn the esteem of their colleagues and advance their individual careers. Whether companies would continue to pursue this research if patents did not exist is unclear and would be a difficult hypothesis to test.

What role did patents play in the commercialization of the genetic tests? 

The case studies suggest that for those who secured a patent on a gene-disease association, there was an incentive to commercially develop a genetic test. [A] patent apparently is not uniformly a necessary incentive to develop or commercialize a genetic test. Patents, however, may be necessary to stimulate commercial development of genetic tests for rare alleles.

How did patents and licensing practices affect price? 

The case studies attempted to evaluate how patents and licensing practices affected the price of genetic tests, but could not always reach definite conclusions because of difficulties in obtaining relevant data and challenges in determining the relative contribution of various factors, including overhead costs, to price.

Thus, there is at least the risk that a patent-protected genetic test will have an inflated price; this inflated price, in turn, may reduce how many patients use the test. Licensing many providers may mitigate price inflation. However, various factors other than patenting and licensing affect the price of genetic tests, including ordinary market forces, such as demand and market size (where there is a large market and high demand, the company stands to make considerable revenue even at a lower price). Many of these factors exert a downward pressure on price.

How did patents and licensing practices affect availability? 

The case studies generally found that for patented tests that were licensed to many providers, there was no evidence of any limitations on availability. Where there is a sole provider, due to the patent holder practicing the patent exclusively or licensing exclusively to a single entity, the effects on availability can be positive or negative.

What is the potential that the patent may cause some future harm? 

The case studies note that patents relating to genetic tests could hinder the anticipated increase in multiplex genetic testing and the foreseeable clinical use of whole genome analysis/sequencing.

Preliminary Conclusions

Patents and Pricing — Evidence from the case studies did not reveal widespread overpricing for genetic diagnostic tests that were patented and exclusively licensed relative to tests that were either unpatented or non-exclusively licensed. In addition, SACGHS did not find quantitative information in the general literature on this issue nor has it been addressed in international policies.

Effects of Patents on Access — Thus far, patents covering genetic tests and related licensing practices do not appear to be causing wide or lasting barriers to patient or clinical access.

Effects of Patents on Innovation and Development — Two principal ways patents are supposed to promote science is through stimulating research and inventive activity and through stimulating investment to commercially develop promising inventions. While there is a longstanding consensus that patents function this way in many arenas, the findings from the Committee’s work thus far suggest that they do not serve as powerful incentives for either genetics research in the diagnostic arena or development of genetic tests.

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Members of the public are invited to provide any additional information and data regarding the positive or negative effects gene patenting or licensing practices have had, are having, or may have on patient and clinical access to genetic tests.

To submit comments to SACGHS, please e-mail them to Darren Greninger, at greningerd@od.nih.gov, by May 15, 2009. Alternatively, comments can be mailed to Mr. Greninger at the National Institutes of Health (NIH) Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 700, Bethesda, MD 20892 (20817 for non-U.S. Postal Service mail), or faxed to 301-496-9839.

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