You can’t patent a piece of the human genome, the Supreme Court declared in a unanimous decision in June. So why, in the weeks after, did Myriad Genetics — the company whose patents were voided — sue a competitor for patent infringement for testing for the very gene declared unpatentable by the Court?
Some background: In the case, the Association for Molecular Pathology brought suit against Myriad because it thought it one company shouldn’t have the sole rights to a segment of the human genome — especially when that segment indicates a person’s breast-cancer risk. The organization argued that Myriad’s monopoly of testing for the malignant variants of the BRCA1 and BRCA2 genes plugged up innovation in the science and drove up costs for patients. Those with a certain variant of these genes have a 60 percent likelihood of developing breast cancer. If you recall, the actress Angelina Jolie discovered she was a carrier for the gene, which prompted her to undergo a double mastectomy to void the risk.
The Supreme Court largely agreed with the Association for Molecular Pathology, declaring slices of the naturally occurring human genome unfit for patents. And right after the decision, two companies — Ambry Genetics and Gene By Gene — saw an opening to start offering the breast-cancer screening tests that Myriad had been performing. And then Myriad sued … for patent infringement.
The short answer to how Myriad could justify its move is this: Science is so very complicated, and the Court ruled narrowly.
In its decision, the Supreme Court maintained that man-made copies of human DNA were still patentable. These pieces are called cDNA, which are slightly altered copies of the naturally occurring genes. They are useful tools for genetic testing, since they can be used to relay a person’s genetic information in a stable form. This bit of the ruling, in effect, allows Myriad to still lay claim to much of the breast-cancer testing.
Writing in Scientific American, Megan Krench, a geneticist, provides a more detailed answer (Reader’s Digest version: While the Court took away Myriad’s castle, they left them the moat):
Why do Myriad’s patent rights to cDNA matter? There are several reasons. First, cDNA is an important research tool. For example, the edited cDNA sequence, not the longer DNA sequence, is often used to create animal models of diseases. Those models are essential for researching new treatments and cures. Without the licensing to BRCA1/2 cDNA, certain cancer research may be restricted to Myriad. Next, cDNA is critical for developing new diagnostic tests for genetic disorders. Since the BRCA1/2 genes themselves are not patented, it may be possible for other companies to develop new genetic tests — but the patented cDNA will make this process much more difficult.
In all, after the Court’s decision, Myriad argues in the documents filed against Ambry, it has retained 515 of 520 patent claims regarding the test.
This issue is going to get another go-around in the courts, as Ambry has countersued, citing antitrust violations. A lot of money is at stake here for Myriad and its competitors. According to Ars Technica, Myriad hauled in $57 million from the tests that can cost $3,000 or more. And the introduction of competitors, however brief, pushed the market price way down: Ambry started to sell the tests for $2,280; Gene by Gene offered a relative steal at $995. The genetic-testing industry is on the verge of booming, as I reported in June. By 2021, the national costs for genetic testing could rise to $25 billion. Right now, they are around $5 billion.
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