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Lawsuit challenges patents on genes – it is about time

ACLU Challenges Patents on Breast Cancer Genes

On May 12, 2009, the ACLU and the Public Patent Foundation at Benjamin N. Cardozo School of Law (PUBPAT) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. The lawsuit was filed on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, breast cancer and women’s health groups, genetic counselors and individual women. Individuals with certain mutations along these two genes, known as BRCA1 and BRCA2, are at a significantly higher risk for developing hereditary breast and ovarian cancers.

The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes – in fact, about 20 percent of our genes are patented. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents.

As a result of the PTO granting patents on the BRCA genes to Myriad Genetics, Myriad’s lab is the only place in the country where diagnostic testing can be performed. Because only Myriad can test for the BRCA gene mutations, others are prevented from testing these genes or developing alternative tests. Myriad’s monopoly on the BRCA genes makes it impossible for women to access other tests or get a second opinion about their results, and allows Myriad to charge a high rate for their tests – over $3,000, which is too expensive for some women to afford.

The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed in the United States District Court for the Southern District of New York in Manhattan against the PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes.

http://www.aclu.org/freespeech/gen/39572prs20090512.html

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It should also be mentioned that the American Society for Clinical Pathology (ASCP) is joining the ACLU lawsuit against such patents.

From the ASCP website:
“ASCP joined this lawsuit because a fundamental tenet of ASCP is that patients come first,” said ASCP President Barbara J. McKenna, MD, FASCP. “Gene patents violate this principle by creating unjustifiable monopolies on human genetic information that is critical in the diagnosis of many diseases.”

http://bit.ly/4UbD (ascp.org)

I could not agree more with the need for such an action.

The College of American Pathologists has joined the suit against Myriad as well. From the CAP press release on the issue:
“As medical specialists in the diagnosis of disease, pathologists have a keen interest in ensuring that gene patents do not restrict the ability of physicians to provide quality diagnostic services to the patients they serve,” said CAP spokesperson, Dr. Jeffrey A., Kant MD PhD, immediate past Chair of CAP/ACMG Biochemical and Molecular Genetics Resource Committee and Professor of Pathology and Human Genetics at the University of Pittsburgh Medical Center.

http://bit.ly/13jcYC (cap.org)

Keith – A fascinating and complex topic. A few observations.

Observation #1: The plaintiffs and defendants are the opposite of what one might expect. When we hear about ‘gene patents’, we imagine a company like Myriad suing an academic medical center for performing a test on a gene on which that company has a specific patent claim. This is actually a very unusual event. To my knowledge there hasn’t been a single case that has gone to trial of the sort that I describe. I am aware of about six law suits; all were settled out of court.

Perhaps the academic community got tired of waiting for a case to go to court to set precedence on this topic. After all, we have been waiting for over a decade. Myriad was a good target because of some really poor PR decisions, but they are certainly not the only group that is vocal about their exclusive testing rights for a particular gene.

Observation #2: I have seen many violations of ‘gene patents’ by major industry and academic laboratories. – Partly this is because this is such a complex area that it can be difficult to know that you are in fringing on a patent. In my opinion it is also because of observation #1 – no patent holder was eager to push this to court and patents were being used more by marketing teams and less by legal teams.

Observation #3: Most of these genes and mutation discoveries were not funded by the companies that hold the patents. Not to pick on BRCA1, but I believe the first isolated and characterized DNA sequence that contained the gene BRCA-1 (although it wasn’t known to be BRCA-1 at the time) was published in nature genetics in 1994 by Albertsen et al. This work was funded by NIH grants R01-HG00367, R01-HG00339, and other private sources including the Howard Hughes Medical Institute. I can, of course, understand the utility of patents in protecting intellectual property. But, if the major part of a discover was with NIH money, there seems to be a conflict in granting private ownership of the gene, mutation, or disease association.