Association for Molecular Pathology v. U.S. Patent and Trademark Office is a lawsuit challenging the legality of gene patents in the United States, specifically challenging patents over breast cancer genes BRCA1/2 held by Myriad Genetics and the University of Utah. The ACLU and Public Patent Foundation represent the plaintiffs, and Jones Day represents Myriad. The case was heard in the Southern District of New York.
The declaratory judgment suit was originally filed against the Myriad, the Trustees of the University of Utah, and the U.S. Patent and Trademark Office (PTO), but the PTO was severed from the case by the district court.
On March 29, 2010, Judge Robert W. Sweet issued a 156-page decision, which declared the patents invalid.[1] Newsweek declared it a "surprise ruling".[2] Sweet's decision stated: "DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable under 35 U.S.C. ยง101." The decision also found that comparisons of DNA sequences involved in these patents are abstract mental processes, therefore also unpatentable.[3] The decision was appealed.[4][5]
About 2000 human genes have been patented in the United States before this ruling.[4]
Myriad appealed, challenging the court's jurisdiction and its decision. Myriad argued that it had not accused the plaintiffs of infringement, so they lacked standing to file a declaratory judgment suit. Myriad also raised two arguments in favor of patent eligibility. Briefing for the appeal to the Court of Appeals for the Federal Circuit (CAFC) was completed as of February 2011. Oral arguments before the CAFC took place on April 4, 2011.[6]
Myriad, the defendant-appellant, was supported by at least 15 amicus (friend of the court) briefs.[7]
The plaintiff-appellees' position received support from 12 amicus briefs, including a joint brief on behalf of the American Medical Association, the American Society of Human Genetics, the American College of Obstetricians and Gynecologists, the American College of Embryology, and the Medical Society of the State of New York.[8]
On October 29, 2010, the Department of Justice provided a surprising and unsolicited brief that supports the appellees in part and appeared to contradict the PTO's own position.[9][10] The DOJ brief suggests that claims covering isolated naturally-occurring human genetic sequences are not properly patentable.
On July 29, 2011 the Federal Circuit overturned the District court in part, and upheld the decision in part.[11] The Federal Circuit overturned the District Court's finding that the claims covering isolated gene sequences are invalid and also overturned the invalidity of some of the diagnostic claims; the Federal Circuit upheld the finding that the claims for the diagnostic methods that only compare or analyze sequences - that have no transformative step - are invalid. [12][13] Further appeals are likely; on October 12, 2011 the ACLU and the Public Patent Foundation said they intended to petition the Supreme Court to overturn the decision. [14]
On December 7, 2011, the ACLU filed a petition for a writ of certiorari to the U.S. Supreme Court.[15]