In a much awaited decision, on June 13, 2013 the United States Supreme Court issued a unanimous opinion in Association for Molecular Pathology v. Myriad Genetics, Inc., in which it found that naturally occurring “isolated” DNA is not patent eligible subject matter under 35 U.S.C. §101. The Court found that isolated DNA falls within the law of nature exception. cDNA, on the other hand, was held to be patent eligible subject matter because it is not naturally occurring, and results from human intervention.
The Myriad patents in question relate to the BRCA1 and BRCA2 genes, in which mutations are strongly implicated in breast and ovarian cancer. The patents include claims to “isolated” DNA, as well as methods for analyzing and comparing DNA sequences. The company uses their invention in tests commonly used for assessing the genetic risks for breast and ovarian cancer. Opponents argue that Myriad’s enforcement of its patents to restrict the use of the genes by others has led to an increased price of the test and lack of alternate screening options.
The Myriad case was initially brought by the American Civil Liberties Union, joining individual patients and medical organizations as plaintiffs, in the Southern District of New York. The United States Patent and Trademark Office (USPTO) and the University of Utah were also named as defendants in the suit. On March 29, 2010, the District Court judge penned an opinion finding the patents in the suit to be invalid. With respect to claims to isolated DNA, the District Court found that the subject matter falls under the category of laws of nature, and thus are not patent-eligible subject matter. On appeal, the Federal Circuit reversed the decision, finding that “isolated” genes are patent-eligible subject matter.
The practice of claiming “isolated” DNA is a time-honored strategy used by patent practitioners and specifically endorsed by the USPTO. One theory behind this practice is that DNA does not exist in nature in an isolated form and, as previously stated by Congress and reiterated by the Supreme Court, patentable subject matter includes “anything under the sun that is made by man.”
Nonetheless, the Supreme Court granted certiorari to answer: (1) Whether a naturally occurring segment of DNA is patent eligible subject matter under 35 U.S.C. § 101 by virtue of its isolation; and (2) Whether synthetically created DNA, known as cDNA, is patent eligible subject matter.
With respect to the statutory provisions of 35 U.S.C. 101, the Court restated that it has “long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable.” While, the Court acknowledged that the restrictions against patents on naturally occurring things are not without limits, because all inventions are in some way based on laws of nature, natural phenomena, or abstract ideas, it found that the limits are not applicable in this case. The Court determined that Myriad did not create, nor alter, any of the genetic information in the BRCA1 and BRCA2 genes or the genetic structure of the DNA. Its principal discovery was the exact locations and sequences of the genes within the chromosomes. And, while Myriad found “an important and useful gene,” separating the gene from its surroundings “is not an act of invention.”
With respect to synthetically created complementary DNA (cDNA), Petitioners argued that cDNA is not patent eligible because the lab technician still did not control the nucleotide sequence, but the Court disagreed, stating that the technician creates something new in cDNA, which is distinct from the naturally occurring DNA. Therefore, cDNA is patent eligible under § 101.
The Court noted that the holding applies only to isolated DNA and not claims involving methods, new applications of knowledge regarding genetic sequences, or DNA in which the order of the naturally occurring nucleotide sequences has been altered.
The impact the decision will have on the biotechnology industry is not yet clear. Although the decision is limited to gene patents, the test applied by the Court could potentially render patents to diagnostics, proteins and peptides, and other potentially life-saving biotechnology inventions that rely on naturally occurring biomolecules and their sequences, invalid as well. Patent claims drawn to biomolecules that are chemically distinct from their naturally occurring counterparts (for example, recombinant polynucleotides, labeled polynucleotides, vectors, transfected host cells, non-naturally occurring or chemically modified proteins and peptides etc.) will most likely survive the patent eligibility question resolved in Myriad. Similarly, claims incorporating the chemical changes that result from the production and/or isolation of a particular biomolecule that distinguish it from the naturally occurring counterpart or its sequence will likely pass muster under the Myriad patent eligibility test.