In a recent decision, The Federal Court of Australia held that a method of using gene sequence analysis to identify beneficial traits in cattle was patentable (Meat & Livestock Australia Limited v. Cargill, Inc. ( FCA 51)(“MLA”)). The MLA case highlights increasingly divergent approaches to the issue of patentable subject matter between Australia and the U.S. when it comes to certain life sciences inventions.
Over the past 5 years, the highest courts in both the U.S. and Australia have reviewed patents owned by Myriad Genetics with claims to isolated naturally occurring DNA sequences (Association for Molecular Pathology v. Myriad Genetics, (U.S. Myriad”); D'Arcy v Myriad Genetics Inc. ( (“Australian Myriad”). In both cases, the Courts held that naturally occurring nucleic acid molecules that have merely been isolated from surrounding genetic material are not patentable.
However, the Courts differed in how they reached their decisions. The High Court of Australia focused more on comparing the information embodied by the claimed DNA and the naturally occurring DNA. In contrast, the U.S. Supreme Court focused more on comparing the physical molecules of the claimed DNA and the naturally occurring DNA (i.e., the specific nucleic acid sequences of the two DNA molecules).
This difference in analysis led to a discrepancy in how each Court dealt with complementary DNA (“cDNA”). cDNA is synthetically created and leaves out portions of the naturally occurring sequence that do not code for proteins. The U.S. Supreme Court held that cDNA is eligible for patenting because it has a different nucleic acid sequence than the naturally occurring gene. Conversely, the High Court of Australia held that cDNA is not eligible for patenting because the genetic information encoded by both molecules is the same.
The U.S. Patent & Trademark Office has extended the U.S. Supreme Court’s decision to consider naturally occurring proteins and microorganisms that have only been isolated from their natural environments as unpatentable. Subsequent cases in the U.S. have also held that diagnostic methods based on the correlation of a disease or condition with naturally occurring biomarkers such as genes or proteins are unpatentable without “something more” (Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo”); Ariosa Diagnostics Inc. v. Sequenom, Inc. (Fed Cir. 2015)(“U.S. Sequenom”). The “something more” can be, e.g., the inclusion of a novel apparatus, a novel non-naturally occurring reagent, or a novel treatment.
In Australia, isolated naturally occurring proteins and microorganisms remain patentable. The MLA case indicates that, in general, claims directed to the practical application of gene sequences, including methods of genetic screening, are also patentable. MLA also potentially foreshadows how the Federal Court of Australia will decide the Australian counterpart to the U.S. Sequenom case, which has currently been set down before the Court for August 2018.
So what does this mean for U.S. life sciences companies pursuing global patent portfolios? The divergence in the law between Australia and the U.S. serves as a reminder that case law and patent office policies vary from country to country. For U.S. patent applicants it is important to remember that broader protection may be available outside of the U.S. and it is wise to include claims of varying scope in your patent applications. This provides the flexibility to pursue broader claims where they are available while allowing for the presentation of claims in the U.S. that include additional elements as described above. It is also important to work closely with patent counsel to monitor the shifting sands in this legal area and adjust global patent strategies accordingly.