Uncertainty over legal status of US gene patents

5 February 2009

In the US, a federal court is considering whether or not the nucleotide sequence of a gene is ‘obvious’ or not; if so, it cannot be patented. There are four key criteria by which patent applications are weighed: whether the invention described is novel, useful, non-obvious, and described in sufficient detail to allow another expert to reproduce or use it for the described purpose.

Prior to May 2007, finding the sequence of a gene encoding a protein that was already known to science was considered a patentable discovery in the US, and millions of gene sequence patents have been filed. However, a final ruling in the current case relating to a patent application filed by Kubin could be pivotal. The Kubin patent claims the nucleotide sequence encoding a protein at least 80% similar to the cell surface Natural Killer (NK) Cell Activation Inducing Ligand (NAIL) protein; however, the US Patent and Trademark Office (USPTO) rejected the application in early 2007 on the grounds that, since the protein had previously been isolated and the essential techniques used to determine the genetic sequence had previously been described, obtaining the nucleotide sequence required only routine biotechnological skills and was therefore an obvious step according to 35 U.S.C. § 103 [Kintisch E (2009) Science. 323(5913): 452-3].

Kubin appealed against the patent examiner’s decision to the Board of Patent Appeals and Interferences (BPAI), but the BPAI issued a precedential decision affirming the patent examiner’s rejection in May 2007. The current case is another appeal by Kubin to the Federal Circuit Court of Appeals; meanwhile, the legal status of gene sequence claims in the US remains uncertain (see PharmExec article). Depending on how this is eventually resolved, the way in which researchers seek to patent their work in order to allow commercial exploitation may have to change, especially for diagnostic applications.

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