U.S. District Court Decides That Isolated Genes Cannot Be Patented

The District Court for the Southern District of New York has released an important decision holding that isolated genes cannot be patented under U.S. law. In a summary judgment ruling in Association for Molecular Pathology v. U.S. Patent and Trademark Office, the Court held that composition claims directed to DNA sequences are invalid because they violate the U.S. prohibition against patenting products of nature. The Court also found related process claims to be invalid because they were directed to mental processes that failed to include the machine or transformation steps required by the recent decision in In re Bilski.

Myriad Genetics, one of the defendants, has indicated that it will appeal the decision. Nonetheless, if it is affirmed, the decision could have far-reaching implications for U.S. patents claiming DNA-based inventions and for the biotechnology industry generally.