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US Court upholds Myriad’s breast cancer gene patents

The biotechnology industry breathed a deep sign of relief today, as a US Appeals court upheld a company’s controversial patents on genes linked to breast cancer.

The US Federal Appeals Court in New York overturned a lower court’s ruling in a case pitting the genetics testing firm Myriad Genetics against a legion of plaintiffs concerned that the company’s patents on BRCA1 and BRCA2 are limiting the development of tests for breast and ovarian cancer and research into these conditions.

When the case got underway in April, Nature offered this bit of background:

The plaintiffs argue that claims in seven of Myriad’s 23 patents on the two human genes, which greatly increase the risks of inherited breast and ovarian cancer, are stifling diagnostic testing and research, and limiting women’s medical care options. They also contend the patents are illegal because the genes are naturally-occurring. A precedent-setting Supreme Court decision in 1980 determined that patent claims apply only to a thing that is non-naturally-occurring and “a product of human ingenuity.” The central question at the heart of the case is whether the disputed Myriad patents, which have allowed the company to develop an exclusive, $3,000 genetic test for mutations in the two breast cancer genes, fall within that category.

In a 105-page decision released today, the court determined that isolated DNA molecules are not products of nature and therefore are eligible for patent protection. “We reverse the district court’s decision that Myriad’s composition claims to ‘isolated’ DNA molecules cover patent-ineligible products of nature,” the decision reads.

“For Myriad, this is roughly the result that we expected,” said Daniel Vorhaus, editor of the Genomics Law Report and a life sciences attorney at Robinson, Bradshaw & Hinson. “But it’s also almost certainly an interim result. The Federal Circuit made it clear that they understand just how much is riding on this case, and that if someone is going to rock the biotechnology patent boat it will have to be either the Supreme Court or Congress.”

“With three separate opinions from three separate judges, including one partial dissent, this was not a unanimous decision by any stretch,” he adds. “There is ample fodder in here for both proponents and critics of the status quo in biotechnology patents, including gene patents.”

Some in the biotechnology industry have worried that if the lower court’s ruling were upheld it could spell disaster for gene patent holders. “If you deny those patents, you are potentially putting a lot of companies and their technologies at risk,” Junaid Husain, senior medical technology analyst at Soleil Securities, a New York–based investment advisory firm, told Nature after the lower court ruling.

The US Department of Justice, in October 2010, filed a brief to the court arguing against patent protection for unmodified genes. “Common sense would suggest that a product of nature is not transformed into a human-made invention merely by isolating it,” they wrote.

In 2008, after 7 years of legal wrangling, Myriad won a similar legal battle upholding their BRCA patents in Europe.


  1. Report this comment

    Robert Cook-Deegan said:

    Your headline is kind of true, but do note that while all three judges agreed that sometimes DNA can be patented, two of the three seemed to indicate that the broadest claims on DNA molecules are probably invalid if challenged. So not at all clear how this plays for diagnostics. That is, yes, DNA is the sort of thing that can be patented, and patentability of full-length cDNAs are a point of agreement among these three CAFC judges. They all agreed the broad method patents are invalid, however. They all agreed the assay claim is valid. But there is considerable disagreement among the three exactly when a DNA sequence found in nature is patentable, and how specific and concrete the claims need to be to pass muster. Given that all three had very different reasons, this is probably not the last round in this case.

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    Phil Goetz said:

    So, if we sequence the entire exome, instead of using PCR to isolate a gene, it will not violate the patent? That costs right around $3000.

    Or, if we isolate the BRCA1 mRNA, which IS a product of nature, and sequence that, it should also not violate the patent.

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    Daniel said:

    Micheal Crichton also wrote about this in an essay. Interesting to see his take on it since his MD is from Harvard Medical School.

    Also interesting is what is happening in the legal profession, in regards to not knowing much about science. This in turn leads to bad decision making. Below is the Professor’s name and his book.

    Professor Faigman – Legal Alchemy: The Use and Misuse of Science in the Law

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    Noah Berkowitz said:

    Thanks for sharing this valuable info!nice article!

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