BRCA Gene Patent

Merry Christmas

I’ve decided what I want for Christmas this year.  I want the court rulings from 2009-2010 on the Myriad Genetics company’s BRCA gene patent for BRCA gene testing to be upheld and to become law.  Those of you who are new to DrPullen.com you may not know that my wife has a BRCA2 gene mutation and is living with cancer of the ovary, currently on treatment in a clinical trial including a PARP inhibitor.  She was diagnosed with this mutation by use of the genetic testing licensed by Myriad Genetics and the University of Utah.  I was essentially unaware of the whole controversy over licensing of the human genome prior to Kay’s diagnosis, but have been much more passionate about how wrong is and how badly this can affect patients, their families, and adversely affect medical research since then.

The BRCA gene was isolated and cloned at the University of Utah in 1994.  The same year Myriad Genetics was formed, a patent filed for the BRCA 1 and subsequently BRCA 2 genes was filed.  The first patents were granted in 1997 and 1998.  Currently Myriad provides the only available testing for BRCA 1 and BRCA 2 gene mutation testing.  The patents for this testing and for the patent on the BRCA 1 and 2 genes held by Myriad have been challenged in court with lawsuits supported by patients, physicians, medical associations and the ACLU.

In a somewhat surprising set of court rulings in the case of Association for Mollecular Pathology et. al. v. United States Patent and Trademark Office a motion to dismiss the case was denied on Nov. 1, 2009.  Subsequently on March 29, 2010 Justice Robert W Sweet ruled in US District Court in NY that the patents on the BRCA 1 and 2 genes are invalid.  Of course this has been appealed by Myriad to the US Court of appeals.  This will be a very interesting case to follow, as its outcome may go a long ways towards setting a direction for the whole field of genetic patents.

Currently 20% of the human genome is patented.  The impetus to overrule the Myriad BRCA gene patents has been energized by the arrogance with which Myriad has defended their monopoly on testing for this gene’s mutations.  The fact that they charge $2975 for this testing adds to the anger by patients and physicians.  Myriad has refused to allow use of their testing to assess the accuracy of the test itself.  The cost keeps thousands of patients from access to a test that could potentially save their lives or allay their anxiety.

According to the ACLU website article on the case, “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.”

So this year for Christmas I am asking for more great work by the ACLU attorneys on this case, and for the court rulings to continue against Myriad and the holders of this patent.  The testing for our immediate family is already done, but it’s just wrong for a company to hold thousands of people hostage for testing of what belongs to these patients as much or more than it belongs to a corporation just does not pass the sniff test.  It just stinks.

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