In its long-awaited landmark decision in the case of Association for Molecular Pathology v. Myriad Genetics Inc., the U.S. Supreme Court has unanimously held that naturally occurring DNA sequences are products of nature and not patent eligible merely because they have been isolated. However, the Court also found that artificially created DNA sequences, such as cDNA, are eligible for patent protection because they do not occur naturally.
The Court’s decision can be found at the following link: http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf.
The decision represents a compromise position that was proposed during oral arguments in April 2013 by the Department of Justice Solicitor General, Donald Verrilli, Jr. and effectively takes the U.S. out of line with the current laws in relation to gene patents that currently exist in Europe and Australia.
The Court ruled that five of Myriad's claims covering isolated genomic DNA are invalid. In response to the ruling, Myriad remained optimistic by issuing a statement indicating that it holds more than "500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test." Investors appeared to be convinced by Myriad’s statement as, following the decision, Myriad shares were up by 10.3%.
In the decision, the Court noted "Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes." Although this was an important contribution, "Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA."
The Court also indicated that Myriad's claims were not "saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a non-naturally occurring molecule." Interestingly, the Court suggested that the relevant Myriad claims might have been deemed to be valid if they claimed the DNA in terms of chemical structure rather than in terms of the genetic sequence. This perhaps provides a hint as to how valid gene claims may be drafted in the future.
Predictably, parties opposed to gene patents were pleased with the decision. Breast Cancer Action, a non-profit advocacy group, described the decision as a "tremendous win for women's health — and for all our health!". Opinions such as these simply fail to consider and understand the financial investment that is required to bring life-saving diagnostic tests, such as the BRCA tests, to the market and for which patent protection plays a substantial role. This was clearly emphasized in one of the findings of a recent report into the economics of isolated human gene patents in Australia. Specifically, it was found that patents play a key role in promoting innovation and the public-private partnerships required to bring new gene-based medicines and diagnostics to market. For further information, refer to the article at the following link: http://www.shelstonip.com/news_story.asp?m=6&y=2013&nsid=284.
A potential ramification that was not considered in the Supreme Court decision is that any product of nature in an isolated form may no longer represent patentable subject matter in the U.S. This would include isolated proteins that may be found in nature and that have a commercial use, such as antibodies.
The Court did not rule on any method claims and a number of commentators have indicated that methods of using genes would likely still be held patentable. However, such “use claims” would have to meet the patentability requirements set down in the US Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012). In the Prometheus decision, it was controversially held by the Supreme Court that a “relationship” between the concentrations of blood metabolites and response to a therapeutic drug, claimed in patents owned by Prometheus Laboratories Inc., was not patentable because it represented a “principle of nature”. Such a “relationship” most likely would also encompass an invention involving the identification of a gene mutation(s) that renders an individual susceptible to developing a disease. If so, a claim directed to the use of a mutation in genomic DNA to determine the susceptibility of developing a disease may not be patentable.
At this early stage, the Myriad decision may not be the “game-changer” for the U.S. biotechnology sector that it could have been. However, it is clear that patents in the life sciences area will need to be drafted very carefully to ensure they meet the new U.S. patentability threshold requirements.