Isolated Genes are Patent-Ineligible, Apparently
The Supreme Court issued its long-awaited decision in Association for Molecular Pathology v. Myriad Genetics today. Justice Thomas writing for the Court, with Justice Scalia concurring in part and concurring in the judgment, held that the composition of matter patent for the isolated DNA sequence of BRCA1 and BRCA2 from the human genome was patent ineligible under section 101 of the Patent Act. The cDNA, that is the chemically manufactured sequence for both BRCA1 and BRCA2 genes, was found to be patent eligible.
Section 101 of the Patent Act of 1952 has long been found to contain an implicit exception to patent eligibility in that “[l]aws of nature, natural phenomena, and abstract ideas are not patentable,” and this is fundamental to the patent system’s policy of promoting invention. The Court held that Myriad’s efforts in locating the DNA sequence for both breast cancer related genes from the human genome and isolating it were simply efforts relating to what exists already in nature. Myriad did not, in any way, create or alter the genes and simply isolating the sequences did not create a new and useful invention eligible for patent protection. Gene isolation methods have long been known by scientists, and the isolated DNA sequence was not considered a new molecule. Myriad’s claims were not in relation to the chemical composition of the isolated gene nor in relation to any new chemical properties that isolating the gene may create. The Court also rejected the reliance argument made by Myriad, and found in Judge Moore’s concurrence in the Federal Circuit’s decision, that the USPTO has been granting isolated DNA patents for years now.
In contrast, the Court found that the creation of the cDNA sequence for BRCA1 and BRCA2 was patent eligible, because cDNA is completely chemically manufactured and therefore is not a naturally-occuring composition of matter. The Court also noted that this decision did not pertain to any method or process claims relating to Myriad’s invention for testing for the BRCA1 and BRCA2 genes, as only the composition of matter claims relating to the DNA and cDNA sequences were before them.
The Court, therefore, affirmed in part and reversed in part the Federal Circuit’s decision in the case. Justice Scalia, concurring in part and concurring in the judgment, made the point that he could not affirm the parts of the opinion discussing the details of molecular biology, regarding DNA and cDNA sequences and gene isolation practices, as he does not have the requisite knowledge. He simply comes to the same judgment as the rest of the Court from reading the lower court opinions and expert reports in the case.
While this decision marks a huge change in previous practice of upholding gene patents both at the USPTO and at the Federal Circuit , it does not come as a surprise in light of the Court’s decision last year in Mayo v. Prometheus. It will be interesting to see how the USPTO’s practice will change and how the genetic industry will be affected by this variation in the status quo of patent-eligibility.