The United States Supreme Court recently heard oral argument in Association for Molecular Pathology v. Myriad Genetics, Inc.. In that case, the Association sued Myriad Genetics and the US Patent and Trademark Office (USPTO) challenging the validity of Myriad's patent on the BRCA-1 and BRCA-2 genes and certain mutations thereof. Doctors can used those genes, along with certain methods that are subject to patents also challenged by the Association, to detect a high risk of breast and ovarian cancers in humans.
Myriad's patents give it exclusive reign over the lucrative testing and diagnostic procedures that require use of the BRCA genes. Angelina Jolie was recently in the news for her decision to have a preventative double mastectomy after a BRCA-1 test, administered to her by Myriad, revealed she had an 87 percent risk of developing breast cancer.
In the Supreme Court, Myriad argued that the genes at issue were detected and isolated by inventors, and patentable "compositions of matter" under § 101 of the Patent Act. The Association argued the genes are "products of nature" and therefore unpatentable under the court's long-standing doctrine.
Greg Castanias, counsel for Myriad, compared the "invention" of the patented BRCA genes to the invention of a baseball bat. Just as a baseball bat consists entirely of naturally-occurring wood, the invention lies in the decision on how to carve it from the tree. The BRCA-1 and BRCA-2 genes, although naturally-occurring, are inventions in that they were cut out from the gene sequence to a precise "shape," if you will.
I think this analogy doesn't work because, whereas you can cut a bat from any part of a tree and achieve the same end product, the genes at issue here already exist in their final form within the gene sequence--Myriad simply recognized their shape and cut along the dotted line.
The shape of a bat is the product of human ingenuity. Decisions were made as to the length, width and pitch of the bat. But the shapes of the BRCA-1 and BRCA-2 genes are predetermined by nature. Myriad merely ascertained the shape of the genes, or more specifically, the nucleotide sequence of the genes, and snipped them out of the overall sequence. The "carving" was done according to instructions provided by nature.
It's hard to feel confident talking about this case from a legal perspective because it's such a scientifically fact-intensive issue. I might be missing something. Greg Castanias has done an incredible job arguing this case in the Court of Appeals for the Federal Circuit and the Supreme Court. I had the honor of eating dinner with Greg (he wouldn't let me call him Mr. Castanias) at Maurer Law School when he came to judge the moot court competition that I was involved in.
Greg is a wicked smart guy and a depressingly good lawyer. He won the case for Myriad in the Court of Appeals, but I just don't know if his case has got the legs to win over the Supremes. The only question accepted on certiorari is, "Are human genes patentable?" That's a big question, and the implications of an answer in the affirmative might be too far-reaching for the court to stomach at this time. We'll find out when the decision arrives.