Assoc. for Molecular Path. et al. v. Myriad Genetics, Inc., No. 12-398 (U.S., June 13, 2013).
The Supreme Court decided today that “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated” under 35 U.S.C. Section 101. Therefore, naturally occurring DNA sequences containing both intron and exon sequences are no longer patentable, even if isolated. The Court, however, also decided that synthetically-generated strands of DNA, called cDNA, are eligible for patent protection. This decision was in accordance with the one advocated by the Obama administration.
The Court did note that “insofar as very short series of DNA may have no intervening introns to remove when creating cDNA,” under such circumstance, “a short strand of cDNA may be indistinguishable from natural DNA.” Therefore there it would appear that isolated primer sequences per se which are indistinguishable from natural DNA are also no longer patentable subject matter. Also, it is noteworthy that prokaryotic DNA does not contain introns, and therefore, cDNA derived from prokaryotic organisms also appears to no longer be patentable subject matter as well.
The Court said that it was “merely hold[ing] that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material,”, and the Court noted explicitly that their decision did not reach new methods claims based on naturally occurring DNA, methods of manipulating naturally occuring DNA, or new applications of knowledge basd on genes. Therefore, patentability of methods based on knowledge of new genes should remain intact.
Open questions remain after this decision. There are several classes of compounds which are useful for biotechnology which were not addressed by this opinion, such as amino acid sequences (proteins) and RNA (mRNA, siRNA, and the like), that are identical to those found in nature. It remains to be seen if the Myriad decision is extended by other courts to polypeptides and RNA that are identical to those found in nature. Commentary from other sources indicate that many are hopeful that this decision will be limited to DNA sequences that are identical to human genes and not extended to other molecules such as polypeptides and RNA.