The U.S. Supreme Court is going to have the last word on whether human genes can be patented. That’s going to make civil libertarians happy and the personalized medicine industry queasy.
The high court granted certiorari Friday in Association for Molecular Pathology v. Myriad Genetics, on the specific question, “Are human genes patentable?” Given the court had already asked the U.S. Court of Appeals for the Federal Circuit to reconsider the question, and the Federal Circuit had stuck with its original answer of “yes,” IP lawyers could see some handwriting on the wall.
A contrary decision could call into question thousands of patents and disrupt license agreements worth hundreds of millions of dollars, said Fenwick & West partner Robert Sachs, who represented amicus curiae Advanced Biological Laboratories at the Federal Circuit. “Will they think through the consequences?” he asked. “It’s not going to go over lightly. This is not a minor change.” The IP laws of every other industrialized country recognizes patented genes, said his Fenwick partner, Michael Shuster.
The case concerns Myriad Genetics Inc.’s claims involving isolated human “BRCA” genes, whose mutations are associated with a predisposition to breast and ovarian cancers. Myriad mapped the genes and patented them in the 1990s, then sought to block medical facilities that hadn’t obtained licenses from commercially testing patients.
The Federal Circuit upheld the patents in 2011, but the U.S. Supreme Court sent the case back, asking the Federal Circuit to consider its own recent decision in Mayo Collaborative Services v. Prometheus, which said patented processes must do significantly more than “simply state the law of nature.”
Even in light of Mayo, a divided Federal Circuit ruled in August, Myriad’s claims remained valid. “The isolated DNA molecules before us are not found in nature,” Judge Alan Lourie wrote. “They are obtained in the laboratory and are man-made, the product of human ingenuity.”
Judge Kimberly Moore concurred separately, saying that while she might rule differently on a “blank canvas,” Congress and the U.S. Patent and Trademark Office have long embraced similar patents. “I will not strip an entire industry of the property rights it has invested in, earned and owned for decades unchallenged under the facts of this case,” she wrote.
Judge William Bryson dissented, saying the argument that the isolated BRCA gene is part of a much larger structure “is no more persuasive than arguing that although an atom may not be patentable, a subatomic particle is patentable because it was previously part of a larger structure.”
Lawyers from the ACLU in New York and the Public Patent Foundation at Benjamin Cardozo School of Law petitioned for cert on behalf of medical practitioners who they say can’t examine the BRCA genes. “Myriad’s patents have allowed it to dictate the cost of genetic testing, stopped other laboratories from creating and offering new and improved testing procedures, and made it impossible to obtain second opinions that could better inform patients of their cancer risk,” states the petition, signed by the ACLU’s Christopher Hansen.
Ropes & Gray partner James DeGraw, who’s not involved in the case, said a lot of IP lawyers were anticipating the court taking up the case . That’s partly because the Justice Department had distanced itself from the PTO’s position and tried to stake out a middle ground where man-made DNA molecules are patent-eligible but isolated, unmodified genes are not.
“The policy interests on all sides of this equation are pretty strong,” DeGraw said. “The fact that there’s been so much industry built around [personalized medicine], it will help to have clarity.”
