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Association for Molecular Pathology v. Myriad Genetics

Posted by: In: Uncategorized 06 May 2013 Comments: 0

Several Mondays ago, the Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, a case challenging the patentability of human genetic material. Myriad holds patents that claim isolated genetic material that can be used in diagnostic tests to determine a patient’s risk of breast cancer and ovarian cancer. The suit was brought by organizations seeking to invalidate Myriad’s patents, arguing that patenting genetic material will hinder research and increase the cost of these diagnostic tests for patients.

I caught a segment on Varney & Co. on Fox Business Network on Wednesday in which the attorney who argued for Myriad, Gregory Castanias of Jones Day, laid out his client’s case. The panel also included Dr. Marc Siegel of the Fox News Medical A-Team, who argued that genetic material should not be patent eligible.

Mr. Castanias explained that Myriad is not trying to patent a product of nature, but a man-made, isolated human gene. The genetic material is not naturally occurring and was defined and produced by humans in Myriad’s laboratories. Since the genetic material is not a product of nature, Myriad believes it is entitled to patent this innovation. Dr. Siegel, on the other hand, argued that Myriad’s discovery is still one step away from being an effective breast cancer and ovarian cancer treatment. He urged Myriad to continue their work and wait until they have reached that next step to patent their invention. Dr. Siegel worries that allowing Myriad to patent this genetic material will lead to a slippery slope where everything is patented.

For me, the most interesting fact presented during this debate is that Myriad has invested over $500 million in this genetic testing research. As Mr. Castanias noted, it is highly unlikely that university and publicly funded research institutions would have the resources to pursue these types of innovations. Only privately funded institutions have the means to continue this life-saving work. But, without being rewarded for their innovation through the patent system, private companies will not have the incentive to continue innovating using genetic materials. I worry that if biotech companies cannot patent genetic material that they have defined and produced, like Myriad has, they will abandon this type of research completely because the costs will outweigh the benefits – they will never recover their investment. This would severely lessen advancements in genetic diagnostic testing and treatment methods, which have the capacity to save thousands of lives.

The consensus of opinions I’ve read is that the Supreme Court seemed inclined to disagree with Myriad’s argument. When asked about this, Mr. Castanias responded that he thought the Court was simply “struggling to understand genetics.” This might be true, because the science behind the patent is very complex and the issues presented are equally difficult. But, according to Mr. Castanias, the Court was very receptive to Myriad’s argument that for over 30 years, the United States Patent & Trademark Office has recognized tens of thousands of patents on genetic material. It is always very difficult to read the minds of the Justices, so the Court really could rule either way.

– Suzy Fitzgerald

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