Myriad Mocks Supreme Court's Ruling On Gene Patents; Sues New Competitors Doing Breast Cancer Tests

from the chutzpah dept

As of the morning of June 13, 2013, Plaintiffs collectively had 24 patents containing 520 claims concerning two genes (BRCA1 and BRCA2), and methods of use and synthetic compositions of matter related thereto. On June 13, the Supreme Court of the United States ruled that five patent claims covering isolated naturally occurring DNA were not patent-eligible, thereby reducing the overall patent estate to 24 patents and 515 patent claims. This case involves none of those five rejected claims.

The patent claims the Supreme Court invalidated last month were “composition of matter” claims, covering the chemical structure of the BRCA genes. But Myriad’s patents also have “method” claims covering processes for diagnosing breast cancer. And while these patents use different language than the composition-of-matter patents the high court invalidated, their practical effect on the genetic testing market could be very similar.



Consider Patent 6,951,721, one of the patents cited by Myriad in its lawsuit against competitor Ambry Genetics. It claims the concept of diagnosing breast cancer by “determining the nucleotide sequence of the BRCA1 gene” from a “female individual” and then checking for mutations at specific points on the gene. The patent isn’t limited to any particular technology for isolating or sequencing the patient’s BRCA1 gene. So while it’s not technically a patent on the BRCA1 gene, it might as well be.

PubPat director Dan Ravicher, e-mailing Ars from Beijing, described Myriad's new suits as a way to save face with Wall Street. He said the Supreme Court decision was a "total loss" for Myriad, and the synthetic cDNA they are focused on now is not needed for genetic testing. "I am confident they will lose these cases, too, so long as the defendants have the financial resources and institutional desire to fight," said Ravicher.

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Remember how, just a month ago, the Supreme Court had struck down gene patents in the Myriad case? If you don't recall, Myriad claimed, effectively, to have patented the isolated BRCA1 and BRCA2 genes, which are indicators of a likelihood for developing breast cancer. As such, they blocked anyone else from doing tests to find those two genes, and charged a whopping $4,000 or so for anyone who wanted the test. The Supreme Court, thankfully, tossed out those claims, noting that Myriad "did not create or alter any of the genetic information" in those genes, and that if found valid, it would "give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes." That's obviously crazy, so it was good that the Supreme Court rejected those claims.Immediately after that, a few competitors jumped into the space, offering BRCA1 and BRCA2 testing -- for significantly lower prices. And, Myriad wasted very little time in suing them all for patent infringement . Huh? The short version is that Myriad claims that the Supreme Court merely removed five total claims out of its patents, and it still has 515 remaining claims across 24 patents -- and these tests violate those:The filing goes on to suggest that the Supreme Court ruling really didn't mean very much at all. In many ways, this really does appear to be Myriad giving the middle finger to the Supreme Court. As Tim Lee notes, if Myriad's interpretation of the Supreme Court ruling is correct, then the Court's ruling is effectively meaningless, because Myriad (and anyone else) can effectively write patents for genes by just changing how they structure the patents:Of course, as you look over the details, it seems like Myriad is still going to be in trouble. Effectively, the claims it's relying on may appear to be more similar to a patent on the diagnostic process itself. But, that's a problem for Myriad, because in the big Prometheus Labs case, which the Supreme Court decided a year ago, and which it relied on in the Myriad case itself, medical diagnostics aren't patentable either It seems like Myriad is just trying to squeeze some more money out of these patents before it gets smacked down again. Of course, not everyone agrees. Dennis Crouch seems to think they have a "very strong case," while PubPat's outspoken Dan Ravicher feels otherwise Of course, it's that last bit that's the challenge. Any such case will take years and millions of dollars. And, during that time some may just choose to settle, and if lower courts side with Myriad and issue injunctions it can be a big risk for the competitors in the space. The end result may work in Myriad's favor even if these cases are completely bogus: it's likely to scare away competitors, and keep the prices of its breast cancer gene tests very high, making it much more likely people will die. I do wonder how Myriad's execs look at themselves in the mirror. There is no reason for doing what they're doing other than to enrich themselves, while ensuring that more women will die from undetected breast cancer. Sickening.While the FTC has claimed that it's going to go after patent trolls , this seems like another situation where they, along with the DOJ,also look into Myriad. While it may not be a traditional "troll," there's certainly a strong argument to be made that the company is abusing patents in a manner this is likely to lead to much higher prices for consumers, especially following the Supreme Court rejecting the very premise that they're now relying on in these new lawsuits -- that no one but Myriad can offer tests for BRCA1 and BRCA2. One hopes that the FTC decides to expand its "investigations" into companies like Myriad.

Filed Under: brca1, brca2, breast cancer, cancer, gene patents, lawsuits, patents

Companies: myriad genetics