Judge Invalidates Human Gene Patent

A federal judge in Manhattan has stirred up the Intellectual Property community and specifically the biotech industry with a decision invalidating two patents on human genes relating to breast and ovarian cancer. This decision has the potential for far-reaching effects on thousands of gene based patents, since approximately 20% of the human genes have been patented. United States District Court Judge Robert W. Sweet found the patents to be invalid because the genes are found in nature and cannot be patented.

“The resolution of these motions is based upon long recognized principles of molecular biology and genetics: DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA’s existence in an “isolated” form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to “isolated DNA” containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 USC 101.”

What effect this ruling may have on the incentives for companies to conduct gene research is unknown for now, but it is likely that this decision will be appealed.

The case is Association for Molecular Pathology v. U.S. Patent and Trademark Office, 09cv4515, U.S. District Court for the District of New York. Download the Opinion Here