Patients, Researchers File Suit to Invalidate Patents on Breast Cancer Genes

The ACLU filed suit Tuesday in the Southern District of New York seeking to invalidate patents on the BRCA1 and BRCA2 genes.

The complaint alleges violation of Article I, section 8, clause 8 of the Constitution (the “patent” clause), the First Amendment, the Fourteenth Amendment, and 35 U.S.C. section 101 (patent subject matter eligibility).

The complaint can be accessed at

With recent decisions from the Federal Circuit limiting the types of inventions that are eligible for patent protection, the time may seem ripe for this test.  The question, however, is whether challenging patents like these will ultimately advance innovation.  Perhaps limiting the enforceability of such patents might better address some of the more troubling aspects they raise.

–Brenda Simon

2 Responses to Patients, Researchers File Suit to Invalidate Patents on Breast Cancer Genes
  1. This is an interesting law suit. Myriad has had the BRCA 1 patent since 1997 and shortly thereafter obtained patents on BRCA 2. The first American BRCA 1 patent should expire in about five years. It has certainly taken a long time for someone to challenge it. Myriad has, from the beginning, taken an aggressive and widely criticized approach to these patents, generally refusing to out-license their use for clinical purposes, charging high fees (which have not declined with the impressive decline in sequencing costs), and playing hard ball with research labs.

    So why this suit now? It may be a function of ACLU interests/funding/politics, but I suspect it may also have something to do with the sense that a significant group of Supreme Court justices, led by Justice Breyer, are concerned about “this kind” of patent. And that this Supreme Court concern may be evoking a mirrored reflection from the Federal Circuit, at least in some areas, such as business patents.

    Whether this leads to a victory for the plaintiffs, at any level, remains to be seen. Some of the ACLU claims (First Amendment violation?) seem a stretch (or two). Even if the plaintiffs win, a decision that knocked out, say, composition of matter patents but did not affect patents on using the sequence for discovered purposes (like predicting breast and ovarian cancer risk) might not ultimately be much of a victory. And all of this is against a backdrop of the limited lifetime of human wild-type sequence patents, some of which have already expired and more of which will be expiring with each passing year.

    I’m not a patent scholar, but I have had to learn something about gene patents. I’d be interested in people’s thoughts about this suit.


  2. Pingback: More on the ACLU Suit to Invalidate Myriad’s Patents on Breast Cancer Genes « Stanford Center for Law & the Biosciences Blog

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