The US Supreme Court has issued an important decision (SupremeCourtUSA-Myriad) in the field of patentability of the human genome.
The object of the legal action was a patent of Myriad, a company known for being the exclusive owner of the tests that diagnose the percentage of probability that a woman has to be subject to breast or ovarian cancer, a test undergone with great clamor by Angelina Jolie.
Myriad has had the merit of uncovering the precise location and genetic sequence known today as BRCA1 and BRCA2, from the examination of which the diagnose mentioned can be obtained. On this «discovery» it has obtained the patent that the Court has had to examine.
The Court has highlighted the contribution of Myriad, surely important from the scientific point of view, but it has also asked itself if this contribution was to be considered patentable:
«It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable.»
According to the Court, the answer to this question has to be negative. What already exists in nature and is simply uncovered without any particular intervention or manipulation cannot be patented.
It would have been different if Myriad had developed an innovative method or if it had created a synthetic genome :
«Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists.»
The Court expresses no opinion about synthetic genomes, explicitly asserting not to have examined this aspect, but it anyway leaves a door open :
«Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.»
Featured article
World IP Day 2024: innovation for a sustainable future
25 April 2024April 26th is World Intellectual Property Day, promoted by WIPO, the World Intellectual Property Organization. The theme...