October 16, 2012 | By Julie Samuels

Myriad's Dangerous Patents and their Negative Impact on Women's Health

Today is Ada Lovelace Day, when EFF and technology users around the Internet celebrate women in science, technology, engineering, and math. What better excuse to revisit how some issues core to EFF's mission particularly impact women?

We often talk about just how dangerous the flawed U.S. patent system is for innovation. Our primary gripes surround software patents, but many misguided patent laws in other subject matter areas negatively affect our society, too. Case in point: ongoing litigation surrounding patents covering naturally occurring human genes that, when present, signal an increased likelihood of developing breast cancer.

The case, Association for Molecular Pathology v. Myriad, has been bouncing through the courts for some time now. The ACLU and the Public Patent Foundation filed the lawsuit in May 2009, representing 150,000 geneticists, pathologists, laboratory professionals, and individual breast cancer patients. The plaintiffs argued that the patents covered nothing more than laws of nature and asked that they be invalidated. The district court agreed, but the Federal Circuit reversed, holding that the isolated genes contained molecules that were "markedly different" than those that occur in nature. The parties challenging the patents asked the Supreme Court to review the case. While their petition was pending, the Supreme Court issued its ruling in Mayo v. Prometheus. Mayo invalidated a patent covering diagnostic testing and stated unequivocally that laws of nature could not somehow become patentable merely because an applicant included "well-understood, routine, conventional activity previously engaged in by researchers in [the] field."

This background is important. After the Supreme Court issued its unanimous opinion, it also sent the Myriad case back to the Federal Circuit, asking the judges to reconsider their ruling in light of Mayo. In August 2012, the Federal Circuit issued another opinion, again upholding Myriad's patents covering the "breast cancer genes" and claiming that the ruling in Mayo shouldn't apply because of the types of claims at issue. (The Federal Circuit has recently had some internal disagreement about just how to apply Mayo—we think it's easy: simply apply the rule to all § 101 inquiries. Period.)

It's safe to say that this case is not going away anytime soon. The patents' challengers will likely ask the Supreme Court to weigh in, and if the justices believe the Federal Circuit failed to property apply the Mayo ruling (as we do), there is a decent chance the Supremes could take the case.

The ACLU and the Public Patent Foundation have brought an important fight, one that highlights some of the most pernicious effects of improvidently granted patents. 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 patent system is supposed to incentivize and spread innovation, not cut people—women, men, or children—off from its benefits.


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