The Supreme Court has made a decision in Association for Molecular Pathology v. Myriad Genetics, Inc. today ruling that isolated BRCA1/2 DNA molecules for diagnosing breast and ovarian cancer risk are not eligible for patent protection under 35 U.S.C. §101, however cDNA sequences are patent eligible subject matter.
The Supreme Court reasoned that Myriad’s claims relating to isolated DNA are naturally occurring and thus do not constituted patent eligible subject matter under 35 U.S.C. §101. The Court noted that separating a gene or sequence of nucleotides from the rest of the chromosome, while useful and important, is not an inventive act. The Court also reasoned that Myriad’s claims are not expressed in terms of chemical composition or do not rely in any way on the chemical changes that result from isolation of a particular section of DNA but rather are concerned merely with the information contained in the genetic sequence.
The Supreme Court also held that cDNA sequences are not a “product of nature” and thus are eligible for patent protection. The Court reasoned that cDNA is distinct from the DNA from which it is derived since human manipulation is necessary to remove introns from the DNA sequence.
The Supreme Court also made sure to note that the decision does not have implications on innovative methods of manipulating genes; on new applications of knowledge using genes; or on scientific alterations of the genetic code.
The Supreme Court’s ruling in the Myriad case further clarified patentable subject matter in the biotech area. Claims that used to be written to “isolated DNA” now will have to be written as being drawn to “cDNA sequences”. Since the Court’s ruling did not address any method claims, methods of using the genes would likely still be held patentable.