The Supreme Court’s ruling this week in Prometheus vs Mayo that medical tests relying on correlations between drug dosages and treatment are non-patentable portends a dramatic and frightening reduction in patent protection for innovations in the life sciences and bio-technology industries – and beyond.
The Court held that San Diego-based Prometheus Laboratories’ patent claim for a method of diagnostic testing was not eligible for patent protection because it described nothing more than the “conventional” application of a law of nature. In this case, the Prometheus technology was based on its discovery of a statistical relationship between toxicity or efficacy of thiopurines (compounds used to treat Crohn’s disease) and the levels of their metabolites in the bloodstream.
The core of the Court’s analysis was that “the relation itself exists in principle apart from any human action. The relation is a consequence of the ways in which thiopurine is metabolized by the body -entirely natural process.” The Court held that a patent simply describing – without adding to – that natural process sets forth a “natural law” and hence is not eligible for patent protection. The Court reached this outcome by dissecting the patent claim into individual elements and then separately evaluating each element as whether it was a law of nature, or otherwise conventional.
This approach, however contravenes a long standing doctrine of evaluating a patent claim as whole.
The decision appears to impact mainly the life sciences and biotech industries. In many cases, these companies’ discoveries are of specific biologic, genetic, or chemical features of disorders and their relationship to specific treatments. Patents for these discoveries often claim the invention as a medical test-consistent with how these companies market their technology. These types of discoveries, like the one in Prometheus, inherently rest on what the Court would consider to be an un-patentable law of nature, the relationship between the biology and the consequent effect. In Prometheus’ case, their business focuses on analyzing and testing, and their patent claims match that model.
For life sciences and biotech companies then, the impact of Prometheus is immediate and severe. The Court’s approach directly attacks not just the technology here, but the very business model of companies like Prometheus. Many existing patents in these fields, especially those like Prometheus’ “assay and test” claim, can be argued to be invalid per se. Other patent claims are only an analogy away from defeat, as again many a patent claim can be said to be nothing more than instructions to one of skill in the art to understand a particular “natural correlation” and then “apply” it to a given patient, treatment, or event.
Prometheus will also have consequences well beyond the life sciences. If Prometheus’ patent claims are invalid, then so too are many hundreds of thousands of patents in a variety of scientific fields because they can be easily dissected into bits and pieces that can be easily (re)defined as either natural relations (thereby ineligible laws of nature) or conventional processes.
In Prometheus, the Court spliced together a legal virus that will undoubtedly be used to challenge and ultimately invalidate patents in a wide range of technologies. The most certain thing that can be said about this decision is that law of unintended consequences will be tested – and confirmed – once again.
