Supreme Court Rules Against Patenting of BRCA1 and BRCA2 Genes in Landmark ACLU Case

On June 13, 2013, the U.S. Supreme Court delivered a landmark decision invalidating patents on two human genes, BRCA1 and BRCA2, which are associated with hereditary breast and ovarian cancer. This ruling came in response to a lawsuit filed by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) on May 12, 2009.

The lawsuit challenged the constitutionality and validity of patents granted on these genes, arguing that human genes are products of nature and therefore not eligible for patent protection. The plaintiffs represented a diverse group including researchers, genetic counselors, patients, breast cancer and women's health advocacy groups, as well as scientific associations representing approximately 150,000 geneticists, pathologists, and laboratory professionals.

The case gained significant attention when the Supreme Court agreed on November 30, 2012, to hear arguments regarding the patentability of human genes. The ACLU presented oral arguments before the Court on April 15, 2013, emphasizing that gene patents violate the First Amendment and hinder scientific research and diagnostic testing.

The plaintiffs contended that gene patents restrict access to genetic information by granting patent holders exclusive rights to prevent others from studying, testing, or even examining the patented genes. This exclusivity, they argued, delays and limits research and diagnostic options, ultimately restricting women's medical choices and impeding progress toward cures.

The U.S. Patent and Trademark Office (PTO) had previously granted thousands of patents on human genes, with estimates indicating that about 20 percent of human genes were patented. The lawsuit asserted that such patents are incompatible with patent law because genes are naturally occurring entities, not human-made inventions.

The Supreme Court's decision invalidated the patents on BRCA1 and BRCA2, reinforcing the principle that naturally occurring DNA sequences cannot be patented simply because they have been isolated. This ruling marked a significant shift in patent law as it applies to genetics and biotechnology.

The case was brought forward on behalf of a wide coalition, including researchers, genetic counselors, patients, cancer survivors, and medical professionals, highlighting the broad impact of gene patents on various stakeholders in healthcare and scientific research.

Prior to the Supreme Court ruling, the case had seen complex litigation, including a divided appeals court decision that upheld some gene patents while invalidating others related to comparisons of the genes.

The ACLU and PUBPAT's challenge to gene patenting has been accompanied by public education efforts, including features explaining the implications of gene patents and personal stories such as that of filmmaker Joanna Rudnick, who has lived with the “breast cancer gene.”

This ruling has set a precedent affecting ongoing and future patent claims on genetic material, emphasizing the balance between innovation incentives and public access to fundamental natural information.

The decision is widely regarded as a victory for patients, researchers, and advocates for open scientific inquiry, ensuring that genetic information remains accessible for diagnostic testing and research without the constraints of patent exclusivity.

The case, Association for Molecular Pathology v. Myriad Genetics, continues to be a reference point in discussions about the scope of patentable subject matter in biotechnology and the ethical considerations surrounding gene patenting.