Cristin Cowles , Ph.D., is a patent attorney at McCarter and English, LLP, with over eleven years of experience prosecuting biotechnology and pharmaceutical patents.
In a somewhat unexpected turn of events, in March 2010 a judge from the U.S. District Court from the Southern District of New York ruled that human genes are not patentable in a lawsuit brought by the Association for Molecular Pathology (AMP) against Myriad Genetics.
At issue were a number of patents owned by Myriad directed to isolated DNA encoding the BRCA1 and BRCA2 genes used in cancer testing in patients. AMP successfully argued that Myriad’s patents were invalid because they cover human genes which are a “product of nature” and, therefore, not patentable. Interestingly, AMP was represented by the American Civil Liberties Union (ACLU).
In the pharmaceutical and biotechnology industries, the 152 page lower court decision brought concern. Did the lower court not realize that thousands of “gene patents” have been issued by the U.S. Patent and Trademark Office over the last thirty years? Indeed, it is estimated that there are over 40,000 patents related to DNA.
Fast forward through legal appeals, and on April 15, 2013 the U.S. Supreme Court heard oral arguments in this highly anticipated gene patent case. The simple question asked by the Court was: Are human genes patentable? Numerous amicus briefs were filed in the case, including notable briefs by Eric Lander and James Watson.
In the oral hearings, the justices seemed comfortable with the concept of synthetically made DNA, e.g., cDNA, as being patentable, but struggled to understand how an isolated gene is different than a gene in a human body. The justices also seemed concerned with the impact that their decision could have on innovation and the biotechnology industry, should genes be labeled as unpatentable subject matter. The Court’s decision is expected in late June, and will likely have a significant impact in the pharmaceutical and biotechnology industries.
Do you think that human genes can and should be patented?