Are Human Genes Patentable?
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| Copy Kat, the first kitten clone |
The Supreme Court had to decide on two issues: (1) Are DNA sequences eligible for patent protection? (2) If not, what about complementary DNA sequences (cDNA)?
In an unanimous ruling, the nine Justices came to the conclusion that DNA sequences are products of nature; isolating them from their natural environment does not create anything with markedly different characteristics. Isolated human genes are therefore not considered patentable. However, cDNA is deemed patent eligible, because its chemical composition is different from that of naturally occurring DNA.
With regard to genomic DNA, the Supreme Court notes:
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 […]. The question is whether this renders the genes patentable. […]
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. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry. […]. Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes "new . . . composition[s] of matter," § 101, that are patent eligible. […]
Many of Myriad's patent descriptions simply detail the "iterative process" of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought. Myriad seeks to import these extensive research efforts into the § 101 patent-eligibility inquiry. But extensive effort alone is insufficient to satisfy the demands of § 101.With regard to cDNA, the Court explains:
cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. […]. Creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring. […] The lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a "product of nature" and is patent eligible under § 101.Finally, the Supreme Court points out that the case 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.
Since the IPKat is a native European [the UK is still a Member of the EU, right?], it cannot hurt to draw a brief comparison with the situation in Europe. As far as genomic DNA sequences are concerned, the protection available in EU Member States is partly broader und partly narrower than in the US. It is broader because, according to Articles 3 and 5 of the Biotechnology Directive, genomic DNA can be subject to a composition claim even though it is identical to natural DNA. At the same time, protection is narrower because both genomic DNA and cDNA are only subject to purpose-bound protection. According to the interpretation of Article 9 of the Biotechnology Directive adopted by the CJEU in the Monsanto case (Monsanto Tchnology v. Cefetra et al.), the protection conferred by a patent for a gene sequence is limited to the (technical) function of that sequence, as indicated in the patent application.
This Kat will not dare to speak out on the practical implications of the Myriad ruling. But other Kats and readers are very welcome to put in their two cents.
Posted by: Matthias Lamping & Roberto Romandini
Image source: ScienceMag
