Patenting living organisms has been permitted since the Supreme Court’s decision in Diamond v. Chakrabarty in 1980. Whether this precedent will apply to gene patents remains to be seen. To date, the most controversial dispute in this arena involves gene patents related to breast and ovarian cancer.
In May, the ACLU and others filed suit against Myriad Genetics, Inc., The University of Utah Research Foundation, and the United States Patent & Trademark Office challenging the validity of various patents for the two human genes BRCA1 and BRCA2. The complaint lists patients and researchers who have been restricted or prevented access to these genes for disease diagnosis, research, or other clinical applications. The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., filed in the United States District Court for the Southern District of New York, alleges certain claims of eight patents exclusively licensed to Myriad Genetics are (1) invalid under Article I, Section 8 of the U.S. Constitution and 35 U.S.C. § 101 for patenting “products of nature, laws of nature and/or natural phenomena,” and (2) unconstitutional under the First and Fourteenth Amendments of the U.S. Constitution for being “patents on abstract ideas or basic human knowledge and/or thought.”  Given the many issues raised by this case and the effect it could have on gene patenting, we will be following this case closely. (Click here to follow the progress of the case).