Last month the United States Supreme Court ruled that certain naturally occurring DNA sequences (the BRCA1 and BRCA2 genes, mutations in which are associated with a significantly increased risk of ovarian and breast cancer) were a product of nature that were not rendered patentable by virtue of being isolated from the rest of the genome. (For further details on the decision, see our previous post here.)
The Supreme Court’s decision received (and continues to receive) significant exposure in the legal, scientific and mainstream media. If you were to heed these stories you might think that the Supreme Court’s ruling endangers the survival of the biotech industry. Of course, the ruling that isolated genetic sequences are a product of nature is a significant decision and it will have an impact on companies and research organisations that currently hold patents which claim isolated genetic sequences. However, the parameters of what the Court actually decided should not be lost in all the hype and hyperbole.
There are also some important strategic lessons that can be taken away from the case and applied by patent holders who want to protect their inventions, whether gene-related or not. Most importantly, the Myriad case has so far demonstrated the importance of carefully drafting claims and maintaining a diverse patent portfolio, advice which is relevant to any company or research organisation that is reliant on patents to safeguard investment in research, development and innovation.
What was (not) found
In essence, the Supreme Court found that naturally-occurring DNA sequences, even if isolated, are not patentable. On the other hand, complementary DNA (cDNA) (DNA synthesised from an mRNA template that contains only the DNA coding sequences (exons)) was held to be patentable under US law (35 USC §101). For the biotech industry, it remains to be seen what degree of human interference or modification is required to render biological molecules other than DNA patentable. The Court was seemingly motivated by a concern to maintain the ‘delicate balance’ between ‘creating incentives that lead to creation, invention and discovery’ and still precluding an exclusive monopoly over genetic material in the exact form in which it exists in nature, and this rationale will no doubt inform the future judicial treatment of isolated biological molecules (including RNA, proteins and antibodies).
The Court also did not consider, and the decision does not affect, claims relating to methods of using genes and cDNA sequences (for example, techniques and processes for manipulating genes when testing for mutations). Such claims remain valid provided, of course, that they satisfy the other requirements for patentability.
As the Court emphasised in its decision:
It is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. …
Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. …
Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavours. We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.
The unscathed patentability of cDNA and methods based on knowledge of isolated naturally-occurring DNA (or cDNA sequences) forms the basis of several suits that Myriad has filed against its competitors since the Supreme Court’s decision. On 9 and 10 July Myriad filed suits against Ambry Genetics and Gene by Gene, claiming that the screening and testing processes which these two companies launched in the wake of the Supreme Court’s decision, infringe several of Myriad’s patents covering synthetic primers, probes and arrays, as well as methods of testing, related to the BRCA1 and BRCA2 genes.
Although the outcome of these suits will not be known for some time, Myriad has demonstrated one of the advantages of developing a diverse patent portfolio. The company has claimed that it still holds over twenty patents containing over 500 claims relevant to commercial exploitation of the two BRCA genes. Companies in a similar position to Myriad – who hold patents to isolated genetic material – should assess their own patent portfolios to ensure (where possible) that they hold adequate protection over the other patentable aspects of genetic inventions unaffected by the Supreme Court’s ruling.
Implications for isolated gene patents in Australia
The decision is, of course, also limited to the US and cannot be applied per se in other major markets such as Europe and the emerging markets in Asia. As matters currently stand in Australia, Justice Nicholas in the Federal Court recently found (Cancer Voices Australia v Myriad Genetics Inc  FCA 65) that the removal of material from its natural environment was sufficient to give rise to an ‘artificial state of affairs’, conferring patentability on the challenged claims of Myriad’s Australian patents. His Honour was seemingly motivated by rewarding the ‘immense research and intellectual effort’ involved, and not being persuaded that Parliament intended a contrary position. (For a more detailed summary of the progress of the Australian Cancer Voices litigation, see here.)
Justice Nicholas’ decision was appealed and the appeal has been heard. Although not binding, it will be interesting to see how the Full Federal Court regards the latest decision from the US. We expect the Full Court to hand down a decision on the appeal before Christmas. Be sure to read about the next step in the Australian litigation here on the IP Whiteboard.
James Ellsmore, Solicitor & Tom Zagami, Law Graduate