During the past 30 years, companies routinely obtained patents on isolated genes. Many biotech firms built their businesses by exploiting these patents, the validity of which was regularly upheld by U.S. district courts and the Federal Circuit. All that was swept aside on June 13 when the Supreme Court ruled that isolated human genes are products of nature and thus not patent-eligible. The unanimous decision in Association For Molecular Pathology v. Myriad Genetics, Inc. upset many in the biotech sector.
Myriad, which lost its patents on genes related to breast and ovarian cancer, saw its stock drop 5.6 percent on the day of the decision.
Why is such cDNA patentable, while isolated DNA isn’t? Both are man-made molecules not found in nature. Both contain the same genetic information as naturally occurring DNA and are chemically different from the naturally occurring version. (Because isolated DNA is separated from the chromosome, the ends of the isolated molecule have different chemical structures than chromosomal DNA.)
So why isn’t isolated DNA patent-eligible? The court doesn’t provide an answer. “[Myriad] leaves open the question of what distinguishes patent-eligible cDNA from patent-ineligible isolated DNA,” says Professor Rebecca Eisenberg of University of Michigan Law School.