Getting Our Genes Back

The argument that we often hear from companies regarding the “benefits” of intellectual property regimes is that they help provide incentives for innovation by providing temporary monopoly to reap the benefits of the innovation. This was what Myriad Genetics, a company based in Salt Lake City, UTAH, argues about the patents it owns for BRCA1 and BRCA2 genetic sequences, which are linked to higher hereditary risk of Breast and Ovarian cancer.  Everyone has these two genes. They are believed to work as tumor suppressors (a good thing, because they suppress cancer cells) when they function normally. However, women with certain types of mutations are at a heightened risk of contracting ovarian and breast cancer (National Cancer Institute, 2009).

Myriad Genetics holds the patents for these two genes and hence is the only company that makes tests to detect these genes. According to Myriad Genetics, without proper patent protections, they would not have found the investors to support Myriad to identify the associations between mutations that are linked to increased risk of breast or ovarian cancer.

The problem is these mutations are naturally existing phenomena. And knowing about these mutations does not really have the “new or distinctive form, quality or property” that makes it eligible for patent protection. Rather, Myriad Genetics, and many other companies that hold a patent over a great number of genes, are patenting knowledge and information (not actually patentable). Very crudely put, this is like patenting an arm or a leg, or patenting the law of gravity.

The implications for innovation are highly severe. The Electronic Frontier Foundation (2011) argues:

Because Myriad owned the patents, testing on these two genes could only take place in Myriad’s own labs – meaning that others could not develop tests on those genes, depriving women from alternative (and cheaper) tests.

The Myriad Genes also prevent other researchers from developing treatment methods without Myriad’s permission (probably in exchange for hefty fees, something not all creative geniuses can afford to pay)

In 2009, a union of breast cancer and women’s health groups, breast cancer patients, approximately 150,000 researchers filed a lawsuit against Myriad Genetics’ patents over BRCA1 and BRCA2 gene mutations (Ray, 2009):

The lawsuit claims that patenting genetic sequences hinders the free flow of information and therefore infringes the First Amendment protecting free speech. “Genes are informational. [By] allowing a company to have a patent on the actual sequence you are restricting the free flow of information,” Tania Simoncelli, ACLU’s science advisor, told Pharmacogenomics Reporter this week.

In March 2010, the U.S. District Court found in the plaintiffs’ favor and invalidated the patents:

“It is concluded that DNA’s existence in an ‘isolated’ form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter.”

Of course, it did not take long before Myriad filed an appeal in 2010.

Last week, the U.S. Federal Circuit Court of Appeals in Washington D.C. heard the oral arguments. The good news is that The U.S. Department of Justice is also supporting the decision by the U.S. District Court to invalidate the patents.

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