The Supreme Court’s ruling in Mayo v. Prometheus, is, by several accounts, a horrible precedent for patent law and research-driven industries. Some background for non-patent-lawyers: Mayo addresses the validity of a patent held by Prometheus Labs, Inc., which claimed a “method of optimizing therapeutic efficacy” that essentially works by increasing or decreasing the administered dose of a compound (6-thioguanine, here) based on measured levels of the compound in a person after an initial dose. The Court invalidated Prometheus’ patents, following this reasoning:
[T]he claim simply tells doctors to: (1) measure (somehow) the current level of the relevant metabolite, (2) use particular (unpatentable) laws of nature (which the claim sets forth) to calculate the current toxicity/inefficacy limits, and (3) reconsider the drug dosage in light of the law. These instructions add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field. (page 13 of the opinion)
For more information about the decision, Dennis Crouch has posted an excellent and thorough analysis of the opinion at PatentlyO. On its face, the decision is a clear rejection of broad patent eligibility for claims that apply laws of nature, with particular attention paid to fields associated with medicine. Going deeper, Gene Quinn, of IPWatchdog, has posted a detailed criticism of the decision that argues, in effect, that SCOTUS has applied a false reading of patent law, and in so doing, has “nullified §§102, 103, and 112 [of the Patent Act].” The Mayo ruling may also have implications for the Myriad gene patent litigation – Mr. Crouch at PatentlyO speculates that Myriad (where the Federal Circuit previously ruled that DNA sequences can be patentable subject matter) may be vacated and remanded. Courtenay Brinckerhoff, of Foley & Lardner LLP, notes that “[m]any may view the Court’s decision as upsetting the status quo of patent-eligibility….”
Implicit in the ongoing criticism of the Mayo opinion is the assumption that patents are necessary to the continued vitality of American research industries. This is, at least, arguable – Mark Lemley, in his paper Ignoring Patents, argues that companies in patent-intensive field simply ignore patents. Heidi Williams of MIT, in an excellent working paper, noted that intellectual property (within the empirical context of gene patents) tends to decrease, rather than promote, downstream innovation by researchers.
Many advocates of patent reform point to the “patent thicket” and the inability of companies to efficiently and effectively determine who they may owe royalties to. As a policy issue, health advocates oppose the ability of companies to prevent medical practitioners from using patented treatment methods, or at least charge a premium for their use. The Mayo decision may significantly alter the patent landscape by significantly shrinking the universe of protectable subject matter and imposing stricter review of claims based on natural laws. If it in fact does so, it would be well for reform advocates to keep a close, data-gathering eye on the biotech industry. With fewer patents to rely on, genuine market competition will become a larger factor in the success of the industry, and empirical evidence of growth would help contribute to a more informed public debate on the necessity of IP laws in general.