On June 13, 2013, the Supreme Court ruled on the AMP v. Myriad case and in a landmark decision, invalidated patents on the BRCA genes. BRCA1/2 genes are part of the human genome, and it is well known that certain deleterious variants confer increased risk for breast, ovarian and other cancers. The unanimous Supreme Court decision stated that “naturally occurring DNA segment is a product of nature and not patent-eligible merely because it has been isolated.” The argument brought before the Court was straightforward. The suit charged “that the gene patents violate the First Amendment and stifle diagnostic testing and research that could lead to cures and that they limit women’s options regarding their medical care.”
However, a recent draft proposal to amend Section 101 of the Patent Act would undo the Court’s decision by not allowing for such judicial exceptions related to laws of nature to determine patent eligibility. This legislation has the potential to not only undo AMP v. Myriad but also overturn other similar, important decisions. ASHG, the Association for Molecular Pathology (AMP) and over 200 prominent organizations have signed on to a letter with the American Civil Liberties Union (ACLU) expressing serious concerns with the draft proposal. According to Mary Steele Williams, Executive Director of AMP, “If naturally-occurring DNA sequences, segments or gene-disease associations become patent-eligible again, there would be serious consequences for research and clinical diagnostics.” Patient care costs could skyrocket, as each variant on a gene panel might incur licensing costs. Perhaps even more problematic, genetic testing could become severely restricted or even unavailable. Prior to AMP v. Myriad, patent owners could and did refuse to license. Implications for biomedical research are very serious. Under this proposed legislation, genetic and genomic tests could not be changed or improved upon. The professional organizations are making a strong plea for the sake of patient care and the advancement of science that the “boundaries between nature and technology” should not be blurred (again).
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