The patentability of genetic material has again come into the spotlight with the recent high court decision in Australia in the Myriad Genetics Inc. v D’Arcy case, where the High Court of Australia unanimously ruled that Myriad’s patent claims to an isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide was not patentable subject matter. The detection of mutations in the BRCA1 gene is able to be used as a diagnostic marker for the risk of a woman developing breast cancer. The high court decision was similar to the present position in the United States (US), where a number of US Supreme Court decisions have found that isolated genetic material is not patentable.
Myriad argued that nucleic acid is a chemical compound just like any other and should therefore be patentable if meeting the additional requirements of patentability including novelty and inventiveness. However, the high court agreed with the argument of Ms D’Arcy, the opposing party, that nucleic acid is more than merely a chemical compound and is, in fact, “genetic information” and that the genetic information stored in the isolated nucleic acids was the same information as that contained in the person from whom the nucleic acid was isolated and, hence, was not “artificially created”, which would be the requirement for patentability.
Applying the same logic, the high court further held that even cDNA (a synthetic form of DNA that is produced in the laboratory and that excludes naturally occurring intron sequences) was not patentable, in that cDNA also represented the naturally occurring genetic information that was present in the person from whom the nucleic acid was isolated. It appears from the high court decision that an important factor in its ruling was that the lower courts had attributed “misplaced significance” to the requirement that to be patentable it was sufficient for a product to result in an “artificially created state of affairs” leading to an “economically useful result”. The high court considered that it was important to take into consideration wider factors relating to policy and the public interest.
Of some consolation to innovators in the biotech field, is that the Australian High Court did not dispute the patentability of process or method of diagnosis claims as long as the additional requirements for patentability of novelty and inventiveness are met. This is in contradistinction to the present situation in the US where, following the decisions of May v Prometheus, Alice v CLS Bank and Association for Molecular Pathology v Myriad Genetics, the patentability of inventions relating to a method for the diagnosis of disease by determining the levels of a biomarker has been called into question.
Following the “Mayo framework”, it is required for the courts in the US, when considering patent eligibility of such a diagnostic method claim, to consider two steps:
- whether or not the claim recites a natural phenomenon, natural law or abstract idea (ie, a patent ineligible subject matter); and, if so,
- whether or not the claim recites enough additional elements that would make the claim refer to an application of the subject matter rather than to the subject matter per se.
For example, in the recent Ariosa Diagnostics v Sequenom case, the US Court of Appeal for the Federal Circuit held that a method for detecting a paternally inherited nucleic acid of foetal origin from a maternal blood sample by amplification of the nucleic acid from a sample followed by detection of the presence or absence of the nucleic acid was not patentable. The court considered the claims in terms of the Mayo framework and found that, firstly, the claims were directed to a product of nature (the nucleic acid of foetal origin) and that the additional elements or method steps applied were well known and conventional steps.
It seems that in order for diagnostic method claims for detection or assessment of products of nature to be patent eligible, it would be necessary to have a novel and inventive additional element to be present, such as a novel type of assay, detection method, apparatus or the like. Another possibility is to include treatment steps whereby the diagnostic method is coupled with a method of treatment of the subject.
It is not known, if tested by the courts in South Africa, whether the position of our courts would be similar to that in Europe, where as long as a known material or article has a newly discovered property that can be put to technical effect, the invention is patentable, or whether our courts would follow the Australian or US position.
It is important when considering patent claim construction for biological inventions, that there is flexibility provided for in the scope of the claims, so that depending on the jurisdiction in which applications are ultimately to be filed, claim amendments may be made to provide for at least some patent eligible claims.