Getting Along: Human Gene Patents

Episode: 
76

You may remember a phrase that entered our popular language, courtesy of Rodney King: “Can’t we all just get along?” Getting along would be helpful in the world of bioethics, medical research, health, and patent law. There is a significant case on its way up to the United States Supreme Court that illustrates how these diverse interests can work together, or can collide.[1] It involves the patenting of the human genes for breast cancer.

In 1990, Mary Claire King at Berkeley discovered the linkage between one breast cancer gene and the chromosome where it appears. Within three years, a group of researchers patented that gene. Myriad Genetics ended up owning the patent for two breast cancer genes, giving it exclusive control over research and diagnostics.

Myriad has vigorously resisted efforts by other researchers to develop new tests. They also prohibited university researchers from revealing results to women who were tested, in part because the researchers offered the tests for far less than Myriad’s $3200 price tag.

The ACLU and others have sued to have Myriad’s patents invalidated. They claim that the patents are violating the intent of patent law.

Patents are explicitly protected by the US Constitution, as necessary for encouraging scientific research and innovation. Research and development is expensive, with no guaranteed returns. A patent gives the inventor exclusive rights to the invention for a period of time, enabling them to recoup their costs. In exchange, the inventor must disclose the details of the invention. Other innovators may be inspired to improve the product, or even design it differently. This quid pro quo benefits everyone, by protecting investment, expanding innovation, and eventually reducing costs. For example, a company in the United Kingdom has developed a more accurate breast cancer test that costs only $950.[2]

Patents on the human genome have not encouraged innovation. Patent holders may charge fees that are too expensive for university researchers. A biologics company may be reluctant to invest millions of dollars to develop a therapy that turns out to be a bust. It’s also complicated: one commentator observed that there is such a thicket of patents that it is hard to figure out how many different patent holders would have to be paid to do work on one specific gene segment.

What we need is a better balancing of the interests of patent holders, researchers, pharma and biologics companies, and patients. That is one challenge the Supreme Court will face, if they agree to review the Myriad Genetics case. The other question is even more foundational: whether the human gene should be patented at all.

Keep your eyes on the news. We just might find out if the Supreme Court will require all parties who are interested in health to “just get along.”



[1] Association for Molecular Pathology, et al. v. United States Patent and Trademark Office

[2] Barbara Puffer, “Critics in Connecticut, elsewhere challenge patent on breast cancer genes.” The Middletown Press. Feb. 17, 2012. Available at http://middletownpress.com/articles/2012/02/17/news/doc4f3ed7047d967131627053.txt?viewmode=fullstory.

 

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