On Monday, the United States Federal Circuit Court of Appeals heard oral argument in Association of Molecular Pathology v. U.S. Patent and Trademark Office. The court’s decision, expected in the coming months, could affect the validity of thousands of existing gene patents.
Under the U.S. Patent Act, “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent.” 35 U.S.C. § 101. The U.S. Supreme Court has held that patentable subject matter includes “anything under the sun that is made by man,” but excludes “laws of nature, physical phenomena, and abstract ideas.” Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
The primary question to be decided in the present case is whether a gene is no longer a product of nature when it is isolated from a human DNA strand. Myriad Genetics, the principal defendant, currently holds 7 patents on two genes linked to breast and ovarian cancer, known as BRCA 1 and BRCA 2. As a result, Myriad is the sole company that makes tests to detect these genes, and the plaintiffs, including the American Civil Liberties Union, have argued that this monopoly is detrimental to patients, who are unable to get second opinions on test results.
Last spring, Judge Robert Sweet of the U.S. District Court for the Southern District of New York invalidated Myriad’s patents, holding that they were barred by laws preventing the patentability of natural phenomena. Myriad appealed, and in oral argument before the Federal Circuit Court of Appeals on Monday, a three-judge panel questioned both sides for over an hour while several hundred spectators watched.
Many of the arguments made—by plaintiffs, defendants, and judges alike—were presented as simple analogies.
When Myriad’s attorney alleged that isolated DNA does not exist in nature and is the product of molecular biology, he said it was like making a baseball bat out of a tree. The ACLU countered by arguing that one cannot dissect a tree and find a baseball bat inside; rather, what Myriad has done is like a company patenting a kidney after removing it from a patient.
Others have questioned whether Myriad can explain the difference between patenting isolated DNA and patenting a leaf that has fallen off of a tree.
The U.S. Patent and Trademark Office has allowed gene patents over the last 35 years, so holding against Myriad could disturb thousands of existing patents, and, as Myriad argues, gene patents are essential to getting the funding necessary to exploit scientific research. But according to the ACLU, a ruling against Myriad would mean that scientists could freely examine genes for research and clinical purposes without worrying about patent infringement.
Regardless of the Federal Circuit Court’s ruling, the case is expected to eventually be heard by the U.S. Supreme Court. We will keep you updated as we receive new information.