The recent discovery of teixobactin, part of a new class of antibiotics, offers substantial promise to combat the serious problem of antibiotic-resistant bacteria. This seems like exactly the sort of innovation that the patent system is intended to encourage. Surely that means teixobactin is patentable?
In Europe, Australia, and New Zealand the answer is yes. As a novel and inventive compound, teixobactin is patentable subject matter. But in America, the inventors are struggling to secure a monopoly for their breakthrough. This approach to natural product antibiotics places America in the company of countries usually considered hostile to pharmaceutical patents. Why then is the US, usually the most ardent champion of IP rights, refusing protection for a new antibiotic?
The patent application claiming teixobactin was rejected by the United States Patent and Trademark Office (USPTO) last year on the basis that the antibiotic compound is not patent-eligible subject matter. Specifically, both the compound and methods of treatment involving that compound were not considered 'significantly different' from a naturally-occurring product. The lack of patent protection for something as desirable as a new antibiotic highlights the far-reaching effects of the USPTO's interpretation of the decisions in Myriad and Mayo.
The USPTO's approach to new pharmaceuticals derived from natural products is particularly perplexing when viewed in light of President Obama's recent Executive Order setting out a National Strategy to combat the rise of antibiotic-resistant bacteria. As part of this National Strategy, government agencies are directed to enhance domestic and international capacity to develop next-generation antibiotics. But the continued rejection of patents for 'natural products' will have implications for the development of new drugs. Nearly 80% of our current antibiotics were originally derived from natural sources which continue to be the focus of current research efforts. Scientists are looking at the natural toxins that bacteria and fungi produce to fight off their microbial competitors, the same microbes that cause diseases in humans. If the pharmaceutical companies with the resources to fund the necessary research have no way of obtaining a return on that investment, they will turn their attention to other matters. It will also deter new commercial parties from pursuing this area of research.
Fortunately for the industry, in December 2014 the USPTO issued revised guidelines, which set out a more lenient eligibility test. The new guidelines include an expanded list of criteria for how a substance can be 'significantly different' from a natural product. An isolated natural product can be eligible matter if it possesses a difference based on function, chemical, physical, and/or biological properties. The examples given in the guideline suggest that 'significantly different' will be assessed more leniently in the future. For instance, in an example related to a method of treatment, 'applying' a natural product to treat a disease is sufficient for patentability without the need to recite specific dosages. It follows that at least the method of using teixobactin to treat infections should be patentable.
The pharmaceutical community will be watching carefully to see how these revised guidelines will be applied in practice.