Law School Case Brief
Ass'n for Molecular Pathology v. Myriad Genetics, Inc. - 569 U.S. 576, 133 S. Ct. 2107 (2013)
The rule against patents on naturally occurring things is not without limits, for all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas, and too broad an interpretation of this exclusionary principle could eviscerate patent law. Patent protection strikes a delicate balance between creating incentives that lead to creation, invention, and discovery and impeding the flow of information that might permit, indeed spur, invention.
Each human gene is encoded as deoxyribonucleic acid (DNA), which takes the shape of a “double helix.” Each “cross-bar” in that helix consists of two chemically joined nucleotides. Sequences of DNA nucleotides contain the information necessary to create strings of amino acids used to build proteins in the body. The nucleotides that code for amino acids are “exons,” and those that do not are “introns.” Scientists can extract DNA from cells to isolate specific segments for study. They can also synthetically create exons-only strands of nucleotides known as complementary DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening introns.
Respondent Myriad Genetics, Inc. (Myriad), obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of *** and ovarian cancer. This knowledge allowed Myriad to determine the genes' typical nucleotide sequence, which, in turn, enabled it to develop medical tests useful for detecting mutations in these genes in a particular patient to assess the patient's cancer risk. 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. Petitioners filed suit, seeking a declaration that Myriad's patents are invalid under 35 U. S. C. §101. As relevant here, the District Court granted summary judgment to petitioners, concluding that Myriad's claims were invalid because they covered products of nature. The Federal Circuit initially reversed, but on remand in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U. S. 66, 132 S. Ct. 1289, 182 L. Ed. 2d 321, the Circuit found both isolated DNA and cDNA patent eligible.
Under 35 U.S.C.S. § 101, was a naturally occurring DNA segment patent eligible?
The U.S. Supreme Court unanimously held that a naturally occurring DNA segment was a product of nature and not patent eligible under 35 U.S.C.S. § 101 merely because it was isolated, but cDNA was patent eligible because it was not naturally occurring. In isolating the genes, the laboratory found important and useful genes but did not create or alter either the genetic information encoded in the genes or the genetic structure of the DNA, and the location and order of the genetic sequences existed in nature before the laboratory isolated them. However, cDNA which removed codes for anything other than amino acids was not a product of nature and was patent eligible since the removal of the unwanted codes unquestionably created something new.
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