The High Court of Austrialia (October 7, 2015 order) has recently come down with a decision in the Myriad Genetics case which while having no precedent value for US court decisions, is nonetheless illustrative of the concerns about patenting DNA.
Claim 1 at issues reads:
“An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set for in SEQ. ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.”
Among the points of some of the judges which can serve as take home points for the general discussion in gene patenting invention are the following:
- Breadth of the claim: The claim is a product claim comprised of isolated nuleic acid having a particular characteristic which is the isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, where the sequence of the isolated nucleic acid contains one or more of the mutations or polymorphisms set forth in particular tables. The claim is very broad and if held valid, it will prevent isolation and testing of the BRCA1 gene even if a researcher is diagnostically testing for a purpose unrelated to detection of predisposition to one of the identified cancers. Not only that, Myriad would have an exclusive right to isolate the nucleic acid without having claimed the process of isolation. Granting such a monopoly has the potential to inhibit other researchers and medical practitioners from diagnostically testing the BRCA1 gene for an entirely different purpose. An anlogoy provided by one of the judges is the rule that a claim for a new use of an old product does not confer a monopoly over the old product (just the new use). Parity of reasoning dictates that application of a method of detecting the increased likelihood of certain kinds of cancer by isolating the BRCA1 gene and comparing it to the reference sequence does not conver a monopoly over the mutation BRCA1 gene itself. To state another way, it is one thing to say that a person who has invented a process which consists in isolating and examining a fragment comprising the BRCA1 gene for the presence of specified mutations and polymorphisms as an indicium of malignancy is entitled to a monopoly over the mutated BRCA1 gene istelf, which is used merely as an ingredient in that process.
- Arguing features not set forth in the claim: Counsel for Myriad stressed that claim 1 was for a discrete chemical molecule achieved by the breaking of chemical covalent bonds in the course of the extraction and amplification processes employed in deriving isolated nucleic acid from the source DNA, which significantly distinguished claim 1 from Myriad’s patent protetion in respect of the BRCA1 gene at issue in the US S. Ct. decision of Myriad Genetics. However, the judge points out that the plurality of the US S Ct. sates that Myraid’s calims are not saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. The 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 particular section of DNA.
- Discoveries versus Inventions: For a claimed invention to qualify as a manner of manufacture (a requirement in Australia), it must be something more than a mere discovery. The essence of invention inheres in its artificiality or distance from nature; and thus, whether a product amounts to an invention depends on the extent to which the product individualizes nature. In the instant case, claim 1 is the correlation between the incidence of cancer and the presence of the specified mutations and polymorphisms in the mutated BRCA1 gene. The subject matter of the claim does not make any contribution to the inclusion of the specified mutations and polymorphisms in the mutated BRCA1 gene. Their presence or absence in or from it is the result of the isolated BRCA1 gene being part of the naturally occurring DNA from which the sequence is isolated.
