Yesterday the U.S. Supreme Court ruled that human genes cannot be patented. Writing for the unanimous court in Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., Justice Clarence Thomas laid out their reasoning.
The Patent Act permits patents to be issued to “[w]hoever invents or discovers any new and useful . . . composition of matter,” 35 U.S.C. §101, 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.
Being obviously careful not to demean the research done at Myriad, the court stated Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Myriad did not create nor alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy [a] §101 inquiry.” Locating the BRCA1 and BRCA2 genes did not render the genes patent eligible as “new compositions of matter.”
The court also addressed cDNA, or complementary DNA, artificial DNA molecules that alter or recombine raw genetic materials in new ways. cDNA is not a “product of nature,” so it is patent eligible under §101.
For analysts with biotechnology clients, essentially the court followed the reasoning laid out in the amicus curiae brief submitted by the United States. You can read that here, off the American Bar Association site.