On Nov. 30, 2012, the Supreme Court granted a writ of certiorari in the case of The Association for Molecular Pathology, et al v. Myriad Genetics Inc. In agreeing to hear the case, the court limited its review to the first of three questions the petitioner had requested, namely, “Are human genes patentable?” The answer, and how the decision is framed, could stir as much controversy as it quenches.
The case stems from Myriad’s patents on isolated DNA segments coding for BRCA1 and BRCA 2. Women who test positive using Myriad’s gene test—called BRACAnalysis—have an 82 percent higher risk of breast cancer and a 44 percent higher risk of ovarian cancer in their lifetimes. The test has proven to be valuable, and Myriad has used its patents to dominate the U.S. genetic testing market for these genes.
Myriad's patents on the isolated BRCA1 and BRCA2 genes were ruled invalid in 2010 by a U.S. District Court in New York. Myriad appealed to the Federal Circuit. The Federal Circuit decided in 2011 that the Myriad inventions were patent eligible. The case was appealed to the Supreme Court, which vacated the ruling and remanded the case back to the Federal Circuit in light of a recent Supreme Court decision. The Federal Circuit in August 2012 again ruled in favor of Myriad and that the isolated DNA inventions were patentable. The case was then appealed again to the Supreme Court, which has now agreed to hear the case.
The question raised by the cases is whether isolated DNA is a new chemical matter with important utilities that can only exist as the product of human invention. Judge Alan Lourie, writing for a majority in the Federal circuit ruling, said: “Everything and everyone comes from nature, following its laws. But the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.” The court further found that the “claims are drawn to patent eligible subject matter because the claims cover molecules that are markedly different—have a distinctive chemical structure and identity—from those found in nature.” The dissent viewed the discovery of the isolated DNA sequences as akin to no more than “snapping a leaf from a tree.”
The Myriad case could have significant commercial ramifications. The Patent and Trademark Office has long issued patents for isolated DNA sequences. A ruling against Myriad would likely be seen as a retrenchment from longstanding beliefs about what is patentable and what is not in the area of isolated DNA sequences, and it is possible that the ruling could have broader ramifications for biotechnology inventions. As is always the case, attorneys and legal scholars will scour the language of the opinion for both what is said and what is not said, for guidance as to how the opinion will shape future patent practice.
The Myriad case also has obvious ethical overtones—whether bits and pieces of even modified DNA that are derived from humans can be the subject of patents. Laws of nature, for example, are typically excluded from patent protection. Many object to judicial rulings in this area on the grounds that if such subject matter is to be excluded from patents, or included, it should be an act of Congress that decides the question and not the courts.
A decision is not expected until the end of the court’s spring term.