Association for Molecular Pathology v. Myriad Genetics, Inc.

Patent:  DNA: 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 breast 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. Held: 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.

This case, it is important to note, does 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 has been altered (U.S.S.Ct., 13.06.2013, Association for Molecular Pathology v. Myriad Genetics, Inc., J. Thomas).

Brevet : code génétique : les scientifiques sont capables d’extraire l’ADN des cellules pour en isoler certains segments à des fins d’étude. Un segment d’ADN est un produit de la nature et ne saurait faire l’objet d’un brevet, même s’il a pu être isolé par la communauté scientifique. Par ailleurs, les scientifiques savent créer des fractions d’ADN en y retirant les introns, ne laissant subsister que les exons. Cette création porte le nom d’ADN complémentaire (cDNA) et elle peut être brevetée, car elle n’apparaît pas ainsi dans la nature. La présente espèce ne concerne pas la protection de méthodes, ni la protection de nouvelle application de connaissances génétiques, pas plus que la protection d’ADN dont la structure a été modifiée.