Just 18 months after a controversial patent ruling in the US, global pharmaceutical companies and manufacturers of diagnostic methods are working hard to overcome some of the nonsensical exclusions that now apply when seeking commercial protection there.
The US Supreme Court’s ruling in Mayo Collaborative Services v Prometheus Laboratories Inc on 20th March 2012 rocked the global pharma and biotech industries. The decision rejected claims that technology developed by Prometheus for the purpose of calibrating the optimum dosage of thiopurine drugs to treat autoimmune diseases is eligible for patent protection. In essence, the court decided that methods used to optimise the therapeutic efficacy of certain drugs were ineligible for patent protection because they are nothing more than ‘laws of nature’.
At the time of the ruling, there was considerable concern that it could undermine valuable research in the growing area of personalised medicine as scientists link gene sequences and other biomarkers to various diseases and disorders. It was felt that the uncertainty surrounding the decision could limit the development of new diagnostic tests, including those used for early diagnosis of conditions like cancer, for example. This is a particular concern to research being undertaken with respect to personalised medicine, which tests an individual to determine their suitability for a particular treatment. This area of research is providing substantial benefit to individuals who may now receive a tailored and effective treatment..
As predicted, over the past 18 months, there has been a noticeable increase in patent application rejections from the US Patent and Trademark Office (USPTO) based on the Prometheus decision. In response, patent attorneys around the world have been exploring ways to avoid a claimed invention being considered excluded subject matter. Although it is not yet clear which specific wording will satisfy the USPTO, US patent applications for new diagnostic methods typically include the widest variety of optional features possible in an attempt to distinguish the technology from anything that might be described as a ‘law of nature’. In particular, US patent applications are now being drafted so that any diagnostic method can include the additional step of treating the patient and, if possible, steps defining the processing of the sample.
The Prometheus decision has confounded all involved in pharma and biotech innovation and left these industries scrabbling to find a premise that will allow it to continue its research and help bring new life-saving drugs and products to market in the US. But how could the US Supreme Court arrive at such a decision, which is entirely contrary to the established law in the other major markets, including Europe and Japan?
The fact is that while it is the highest court in the land, the US Supreme Court is also a generalist court, in which Judges lack an everyday working knowledge of US Patent Law. The Judges’ decision in this case may also have been influenced by anti-patent sentiment in the US in relation to biotech and pharma research. Of course, the industries affected by this decision know that the view that patents act as a barrier, effectively blocking new drugs from getting to market, is a misguided one. They know that without patent protection in this expensive area of research and development, it would become impossible to secure investment. And without the investment, the research wouldn’t happen in the first place.
Recognising that the Prometheus decision could ultimately prove to be harmful to the US public because it could restrict the number of medicines and potentially life-saving diagnostic kits coming to market there, some US lawyers are attempting to overturn it by seeking a legislative amendment. While it is not yet clear whether this is achievable, the global biotech and pharma industry is banking on this outcome.
In the meantime, we will have to wait and see if this ‘laws of nature’ ruling starts to impact on investment in this important area of medicine. Perhaps then the USPTO will recognise what it’s done.