Association for Molecular Pathology v. Myriad Genetics, Inc., Supreme Court, No. 12-398 (June 13, 2013)

http://www.law.cornell.edu/supremecourt/text/12-398

On June 13, 2013, the Supreme Court held unanimously that isolated human DNA is not patentable because it is a “product of nature.” The act of isolating the material—no matter the time, technology, or ingenuity involved in doing so—does not make it patentable. The Court also ruled that synthetically created complementary DNA (cDNA) is “patent eligible.”

The underlying suit, filed in 2009 against Myriad Genetics, Inc. (Myriad), was brought in the US District Court SDNY by a group of plaintiffs, including researchers, doctors, and breast cancer patients, and was supported by the ACLU and the Public Patent Foundation. The plaintiffs asserted that Myriad’s patents on gene mutations in two human genes linked to breast, ovarian, and other cancers, BRCA1 and BRCA2, were invalid. District Court Judge Robert Sweet agreed, and struck down the patents, finding isolated DNA, fragments thereof, and corresponding cDNA’s to be patent ineligible “products of nature.”

On appeal to the Court of Appeals for the Federal Circuit, a 2-judge majority reversed in part, finding Myriad’s claims to isolated BRCA1 and BRAC2 genes, including fragments thereof, were patent eligible subject matter, although the two judges in the majority did not agree on a rationale for this conclusion. All three panel judges agreed that cDNA’s were patent eligible as clearly formed by the hand of man.

The Supreme Court considered nine DNA composition claims from the three challenged patents. A first group of claims covered isolated BRCA1 and BRCA2 genes defined by the genes’ nucleotide sequences, and a second group, fragments of the genes containing at least 15 nucleotides of the claimed genes. Both the gene and gene-fragment claims were found to be patent ineligible as products of nature, in line with the district court and Fed Circuit minority decisions. Central to the Court’s reasoning was its earlier Chakrabarty decision, where a modified bacterium was found patent eligible as “a nonnaturally occurring manufacture or composition of matter—a product of human ingenuity ‘having a distinctive name, character and use.’” In the eyes of the Court, simply cleaving and isolating a gene from its natural environment did not produce a new molecule having a distinctive name, character, and use. Rather, the claimed DNA’s (which are sequence dependent) focus on the genetic information encoded by the BRCA1 and BRCA 2 genes, and this information is identical to that of the gene in its native form. Regardless of the ingenuity required to identify a claimed gene sequence, the claimed gene and its fragments remain “product[s] of nature.”

A third group of claims considered by the Court are cDNA’s formed by reverse transcription of mRNA. Here the Court concurred with the majority and minority Fed Circuit opinions that cDNA is not a product of nature and so is patentable under §101. Although the nucleotide sequence of cDNA is dictated by nature, “its creation results in an exons-only molecule which is not naturally occurring.” The Court did add an important and logical caveat, however—cDNA is patent eligible “except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.” In other words, an isolated DNA derived from a single exon or portion thereof would fall under the “product of nature” prohibition regardless of how it is produced, whether by isolation, enzymatic transcription, or chemical synthesis.

Beyond that, there is less clarity from the Court on the types of DNA compositions that would be patent eligible. Perhaps a useful clue to this question can be found in Judge Bryson’s dissent in the Fed Circuit Myriad decision, since this dissent closely parallels the Supreme Court’s conclusions and reasoning in Myriad. Judge Bryson points to two types of DNA inventions, other than cDNA’s, that would fall outside the “product-of-nature” prohibition. The first is isolated DNA attached to tags or probes, and the second, sets of DNA fragments that function as primers, as long as the fragment sets are limited to species with markedly different characteristics from any found in nature. More definitive guidance on the implications of the Myriad decision should be forthcoming from the USPTO in the form of examination guidelines.

Finally, what does the Supreme Court’s Myriad decision portend for the patentability of isolated proteins? Probably not too much, for the simple reason that an isolated protein will typically have distinctive uses and characteristics, e.g., therapeutic uses, not shared by the protein in unpurified form. Whereas DNA is predominantly an information carrier, and that function is preserved whether it is in native or purified form, proteins have complex three-dimensional structures and properties that may depend on the environment the protein is in, including in some cases, the presence of other proteins.