On October 12, 2011, the American Civil Liberties Union and the Patent Protection Foundation announced their decision to petition the Supreme Court for certiorari after its Federal Circuit rehearing petition for Association for Molecular Pathology v. U.S. Patent and Trademark Office (Myriad) was denied. This petition comes after the Court of Appeals for the Federal Circuit held in Myriad that isolated DNA was patentable material, which reversed a District Court decision written by Judge Sweet that found isolated DNA ineligible to receive a patent.
The subject of this case is two isolated genes associated with an increased risk of breast cancer. Myriad Genetics, Inc. isolated the BRCA1 and BRCA2 genes and filed a patent covering the isolated portion of DNA that codes for those genes. These two genes are important because the presence of one of them in a person increases the risk of breast cancer from 12-13% in the general population to 80%.
In a split opinion, the Federal Circuit found isolated DNA, including the BRCA1 and BRCA2 genes, to be eligible for a patent under section 101 of the Patent Act. Section 101 allows a patent to be given to “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter.” Despite this broad language, the Supreme Court has limited the subject matter of patents to exclude “laws of nature, natural phenomena, and abstract ideas.” Citing both Funk Brothers Seed Co. v. Kalo Inoculant Co. and Diamond v. Chakrabarty, the Federal Circuit found isolated DNA to be “markedly different” than DNA found in nature, which meant it was not excluded from patent eligibility.
"These two genes are important because the presence of one of them in a person increases the risk of breast cancer from 12-13% in the general population to 80%."
The key contention in Myriad was whether isolated DNA was different enough from natural DNA to be eligible for a patent. In the opinion of the court, Judge Lourie found that isolated DNA had a different chemical identity, because it was a detached segment of DNA that was severed from a naturally occurring molecule of DNA. Judge Moore, the other judge finding isolated DNA patentable, hinged her opinion on isolated DNA having a different and valuable use. While these two opinions did not agree on the exact test to be used in determining the patentability of isolated DNA, they did agree that the longstanding practice of the United States Patent and Trademark Office in granting these patents deserved judicial deference, because a decision changing a long followed practice should come from Congress and not from the courts.
As the lone dissenter, Judge Bryson reached the opposite conclusion and affirmed the District Court. Judge Bryson found that the differences between isolated DNA and natural DNA are only those inherently created by the isolation process. Furthermore, he declared that the use of isolated DNA is the same use as natural DNA—it codes for a certain gene.
The nature of the split opinion and the importance of the issue to the biotechnology industry give the ACLU a decent chance that the Supreme Court will accept the case when the petition for certiorari is filed. Some people even go so far as to rank Myriad as one of the top cases in realm of patent law this coming year. The only thing that is certain for now is that the case is not over until the Supreme Court weighs in, either by denying certiorari or accepting the case.
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