Two months ago, we discussed the Stanford v. Roche decision and its relevance to the research administration community. Not content to rest on their laurels, the Supremes recently revisited the arena of intellectual property in Mayo v. Prometheus, which addressed the patentability of methods or processes that are borne from “laws of nature.”
Prometheus Laboratories, a pharmaceutical company, was issued two patents directed to the treatment of autoimmune diseases and whether a related drug was working as it should. Specifically, the patents described an “administering” step (whereby the doctor is instructed to administer the drug), a “determining” step (whereby the doctor is instructed to measure levels of a certain antimetabolites in a patient’s blood after administration), and finally a “wherein” step (whereby the doctor is instructed on how to read the levels and determine whether the dosage is effective). Originally, both Prometheus and Mayo Collaborative Services/Mayo Clinic used diagnostic kits based on the above patents. However, Mayo eventually decided that it would produce and sell a kit that was slightly different than that created by Prometheus, and Prometheus subsequently filed suit claiming that the Mayo kits infringed on its two patents.
Patent law affords wide latitude with respect to potentially patentable subject matter, but one explicit restriction is on the protection of laws of nature, physical phenomena, and abstract ideas. Unless some additional feature is added to these “technologies,” they will not be afforded protection, and thus anyone will be able to use them however they see fit. Prometheus’ processes were, by and large, predicated on a naturally-occurring phenomenon (i.e. the increase or decrease of a blood marker following the introduction of a drug). However, the case hinged on whether Prometheus, by providing the levels that represented the administration of a proper dose, had in fact created an additional, original step that made their patented processes novel.
Ultimately, in a unanimous decision, the Supreme Court struck down Prometheus’ patents, holding that “[t]he three additional steps in the claimed processes here are not themselves natural laws but neither are they sufficient to transform the nature of the claims.” Because the instructions merely guide a doctor to perform tasks that are well-known in their field, without anything novel being added, they were insufficient to “transform an unpatentable law of nature into a patent-eligible application of such a law.”
While it might not be apparent, the Prometheus case does and will have a direct impact on the field, especially at our School of Public Health. Much of the work performed by our investigators occurs in locales that use non-traditional methods to treat diseases. These can range from basic homeopathic remedies to town-centric herbal combinations and similar processes, but all have relatively high levels of efficacy when used to combat a particular affliction. As a result, our PIs frequently come back from the field with ideas as to how to turn these treatments into kits similar to those designed by Prometheus, and the discussion then becomes whether they fall under the IP clause of their related funding agreement. However, without any above-considered ‘additional step,’ these processes generally remain open (however minimally) for the public to use, and, as a result, the school will not seek patent protection.