The US Supreme Court (highest court in the United States) has closed the door on the previously common US practice of patenting human genes or gene sequences with its decision of June 13, 2013 in re ASSOCIATION FOR MOLECULAR PATHOLOGY ET AL. v. MYRIAD GENETICS, INC., ET AL. (cf. http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf).
Not influenced by the decision are gene sequences which as such do not occur in nature, for example synthetic DNA derived from natural genes that is missing the introns existing in the natural genes („cDNA“) or sequences for which the original natural sequence was changed.
The claims underlying the decision were related to
1.) an isolated DNA coding for the BRCA-1 peptide with a respective sequence as well as
2.) its cDNA sequence
The Supreme Court turned down the first claim with the argument that it is a „product of nature“ for which the step of isolation alone does not suffice to make it patentable and explained „…Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.“ Undisputed, it was established in this context that the claimed DNA according to number 1 above corresponded to the human one in the BRCA1 gene, thus corresponding to the “product of nature”.
The second patent claim directed to the cDNA was however considered patentable subject-matter since it did not claim a „product of nature“ but cDNA not occuring in humans.
The statement of the Supreme Court „Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particluar section of DNA” already shows that a minimal structural change in the natural DNA after its isolation from the genome appears to be sufficient to jump the newly errected patent hurdle. This will have to be considered when drafting US patent claims in the future, in particular also for European companies for which it is still possible in Europe to get protection for DNA sequences isolated from nature. This holds true at least as long as Article 5(2) of the biotechnology directive 98/44/EC cited below is not sacrificed in light of the increasingly critical discussion (keyword: „No patent on life“) and the US Supreme Court case law referenced here.
“An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.“