Dr Penelope Farbey, Associate
Wrays Perth
The Australian biotech sector has made headlines throughout 2012 with several mergers and acquisitions, regulatory approvals, and multimillion dollar deals recently announced.
However, there have been storms on the horizon. In particular, legal developments in the US this year have made several global market-minded Australian biotechs think twice about the patentability of their inventions. In this article, we take a look at the recent US Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012), and how it may affect your biotech business.
Why is this US decision important? The reason is simple: it has the potential to radically change patentability requirements in the US. This particularly affects Australian biotech companies who are trying to obtain valid patent rights in the US in order to protect their US markets. While it doesn’t change the law in Australia, this US decision may be potentially devastating for biotech companies developing assays and diagnostics, specifically for personalised medicine, and who are trying to protect their business in the US.
The US Supreme Court’s controversial decision in Prometheus
The parties in this case argued over whether patent claims directed to methods for optimizing the therapeutic efficacy of a drug treatment for a specific disorder in a patient should be allowed. The method claims were worded in a particular way, claiming: (a) administering a specific drug to the patient; and (b) determining the level of a metabolite of the drug in the patient, wherein the dosage of the drug should be increased or decreased if the level of the drug is outside of a specified range.
In March 2012, the US Supreme Court found that the diagnostic method claims were unpatentable. The court found that, even though there were additional steps and limitations in the claims (such as administration of a drug not naturally occurring in the body, measuring levels of a metabolite that would not have been in the blood save for administration, specific values for the high/low ranges), these were insufficient to make the claimed invention patentable.
Ramifications for biotech inventors
As a result of the Prometheus decision it may now be more difficult for biotech companies to obtain patent claims to predictive diagnostic processes or methods, such as checking whether a patient has a higher propensity to develop a disease like cancer based on their genetic or biochemical make-up.
At the heart of every diagnostic test is a natural correlation between a biomarker and a pathology. Personalised medicine treatments include diagnostics that tell a physician if a particular drug is likely to be effective in a given patient before treatment begins, or alternatively if adverse effects may be likely. Previously, biotech companies could patent their inventions relating to simple correlations between biomarkers and pathologies as long as they showed the additional steps of, for example, administration of the drug and measurement of the metabolites. Before Prometheus, this would have been sufficient to transform the subject matter of a mere correlation to a process or method requiring human intervention, and thus to a patentable invention.
Simply discovering and claiming a correlation between something happening in the body, and a disease has never been patentable. Now, the US Supreme court has made the position in the US clear: whilst such correlations are still not patentable even if additional steps of administration, testing etc are included, if these steps are considered routine to the technology. Without an extra ‘something’ that adds some further degree of intervention or transformation, the claims are still regarded as an unallowable attempt to claim and monopolize a law of nature or natural phenomenon despite the additional steps. However, the Court gives no guidance as to what that extra ‘something’ should be, saying only that it should “transfor[m] the process into an inventive application of the formula”.
How this decision affects Australian biotech companies?
The uncertain situation in the US has raised many questions that the Court did not answer. In anticipation of many of these questions, the United States Patent and Trademark Office (USPTO) immediately issued a short memorandum post-Prometheus (http://www.uspto.gov/patents/law/exam/mayo_prelim_guidance.pdf) saying that, for now at least, the situation is ‘business as usual.’
The USPTO will therefore be examining applications as they have been for the last few years. The full implications and applications of the decisions will take some time to become apparent in the US. The law in the US may also change yet again. For these reasons, we recommend continuing to file patent applications in the US for biotech inventions such as: diagnostic tests, medical treatments, isolated gene sequences and other related technologies. It may be necessary to carefully draft patent claims in light of the Prometheus decision. It may also be worthwhile including additional steps in method claims that are unique to your invention.
If you have a biotech invention that you would like to obtain patent protection for in the US, or if you are concerned as to whether you can still obtain valid as protection for an invention in the field of personalised medicine as a result of the Prometheus decision, we would be happy to discuss this with you.
For further information, please contact Dr Penny Farbey at penny.farbey@wrays.com.au