For over 30 years, it was believed that an isolated and purified DNA sequence possessing the same sequence as a naturally occurring gene was eligible for patent protection. On June 13, the U.S. Supreme Court held patent claims covering isolated naturally occurring DNA were not patent eligible. Since the court’s decision, debate continues about what constitutes patentable subject matter.
Prelude
In 1998, Myriad Genetics was granted a patent that covered mutations to the BRCA1 and BRCA2 genes (breast cancer genes). The patent also covered methods for: (i) using these mutations for diagnosis and prognosis for breast and ovarian cancer; (ii) screening for cancer predisposition; and (iii) developing therapeutic cancer treatments.
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