Patent Case Brief – Association of Molecular Pathology v. Myriad Genetics, Inc.

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Citation – 133 S. Ct. 2107 (June 13, 2013)

Facts:  Myriad Laboratories discovered the existence of genes BRCA 1 and BRCA 2 on the Human Chromosomes, the mutations of which can cause breast cancer, amongst approximately 15 million genes in the human genome. In addition, it synthesized a gene called the BRCA cDNA, which is a synthetic product that mirrors the coding sections of the BRCA genes, and “primers” used in diagnostics gene and applied for a composition patent on it. Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes) by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome. The patents would also give Myriad the exclusive right to synthetically create BRCA cDNA. In Myriad’s view, manipulating BRCA DNA in either of these fashions triggers its “right to exclude others from making” its patented composition of matter under the Patent Act.

Issues:
1) Whether Myriad’s claimed invention BRCA 1 and BRCA 2 and BRCA cDNA, the sequence of certain human genes in both isolated and purified forms, falls within the scope of inventions for which a patent may be granted.
2) Whether the product patents obtained by Myriad Laboratories on the discovery of genes, BRCA 1 and BRCA 2 and BRCA cDNA, on the human genome valid under the provisions of 35 U. S. C. §101 and in consonance with the relevant jurisprudence on the matter.

Rule:
35 U. S. C. §101: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

Analysis:  
The Supreme Court considered the argument made by both the sides and held that, “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring”. So, the discovery by Myriad Laboratories, of the position of BRCA 1 and BRCA 2 genes was not patent eligible under the provisions of 35 U. S. C. §101. Although the section makes patents eligible for a new composition of matter, but “laws of nature, natural phenomena, and abstract ideas” ‘are basic tools of scientific and technological work’ ” that lie beyond the domain of patent protection, and hence these naturally occurring genes were not patent eligible under the provision of the law.
Myriads discoveries falls within the law of nature exception. The primary work of the plaintiff was to discover the already existing location of the genes BRCA 1 and BRCA 2. Mere discoveries cannot be made patent eligible even though there are ground breaking discoveries.  Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible “new . . . composition[s] of matter,” §101. Myriad’s patent descriptions highlight the problem with its claims: They detail the extensive process of discovery, but extensive effort alone is insufficient to satisfy §101’s demands.
However, the court agreed to grant patent to the composition of cDNA because, it was clear that this was not a “product of nature”, in the sense that it did not exist in nature, Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, Human intellect and skill had to involved to produce this matter in the laboratory. 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 differentiated this case from the Diamond. The case in diamond was that the plaintiff had created a living organism by changing the strains in it through a laboratory process and hence, it was not naturally occurring and patent eligible. Whereas in the present, with the exception of cDNA, the others were naturally occurring and the plaintiff did not have to put in any work, intellectual and skill, in the production of the DNA.

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