Myriad Genetics, Inc. (Myriad), obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes. Mutations of these genes dramatically increase the risk of breast and ovarian cancer. This knowledge allowed Myriad to determine the genes' typical nucleotide sequence, which allowed it to develop medical tests useful for detecting mutations in these genes in a particular patient to assess the patient's cancer risk. Scientists can extract DNA from cells to isolate specific segments for study. They can also synthetically create exons-only strands of nucleotides known as composite DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening introns. If valid, Myriad's patents would give it the exclusive right to isolate an individual's BRCA1 and BRCA2 genes, and would give Myriad the exclusive right to synthetically create BRCA cDNA.
Medical organizations, researchers, genetic counselors, and patients sued Myriad and the Patent and Trademark Office (PTO), seeking a declaration that Myriad's patents were invalid under 35 U.S.C.A. § 101. Section 101 of the Patent Act states, “Whoever invents or discovers any new and useful ... composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”
The plaintiffs and Myriad cross-moved for summary judgment, and the PTO moved for judgment on the pleadings. The United States District Court for the Southern District of New York granted the PTO's motion, granted the plaintiffs' motion in part, and denied Myriad's motion, concluding that Myriad's claims were invalid because they covered products of nature. Myriad appealed. The United States Court of Appeals for the Federal Circuit initially reversed, but on remand in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (March 20, 2012), the Circuit found both isolated DNA and cDNA patent eligible.
The Supreme Court affirmed in part and reversed in part. The court held that isolated DNA involved a naturally occurring segment of DNA, precluding patent eligibility, but synthetically created DNA known as cDNA was not naturally occurring, as would preclude patent eligibility.
The Court held that isolated DNA cannot be patented because it involves a naturally occurring segment of DNA. The Court reasoned that the Patent Act contains an important implicit exception, under which laws of nature, natural phenomena, and abstract ideas are not patentable because they are the basic tools of scientific and technological work that lie beyond the domain of patent protection. Without the exception, there would be considerable danger that the grant of patents would tie up the use of basic tools of scientific and technological work and thereby inhibit future innovation premised upon them, which would be at odds with the very point of patents, which exist to promote creation.
The Court found that Myriad's isolated DNA patent claim fell within the law of nature exception. Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent an eligible “new ... composition of matter,” as required by section 101.
Isolated DNA separated from the rest of the human genome, involved a naturally occurring segment of DNA, and thus, the isolated DNA was not patent eligible. The location and order of nucleotides existed in nature before Myriad found them. Myriad did not create or alter the genetic structure of DNA. Instead, Myriad's principal contribution was uncovering the precise location and genetic sequence of the genes within two chromosomes.
Conversely, the Court held that cDNA is not a “product of nature,” so it is patent eligible under § 101. cDNA which contained the same protein-coding information found in a segment of natural DNA, but omitted portions within the DNA segment that did not code for proteins, was not naturally occurring. cDNA differed from natural DNA in that the non-coding regions had been removed. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.
The Court expressly limited the scope of its holding. The Court noted that the case did not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides had been altered.
See: Association for Molecular Pathology v. Myriad Genetics, Inc., 2013 WL 2631062 (U.S., June 13, 2013) (not designated for publication).