Today, the Supreme Court has handed down a major opinion regarding patentable subject matter in biotechnology, the first such opinion since Diamond v. Chakrabarty in 1980. Patentable subject matter asks whether a patent fits into the kinds of inventions that are eligible for patenting or whether it goes too far and extends into the impermissible categories of "abstract ideas, natural phenomena and laws of nature; " see here for background. Today's case is Prometheus v. Mayo; at issue was whether patent claims to a method of drug treatment which utilized a metabolic relationship to formulate drug dosage violated the long-standing prohibition against patenting laws of nature. In other words, did the patent effectively allow its owners to monopolize the scientific fact that the administration of a drug caused certain metabolites to be produced in the body, and those levels could indicate potentially toxic drug levels? If a doctor simply used the relationship between drug metabolites and drug toxicity to determine dosage, would that become patent infringement? If so, was this patent an undue extension of patent rights into the laws of nature? These were the issues at stake here. The court, in a unanimous opinion authored by Justice Breyer (who had previously shown great interest in these questions in the 2006 LabCorp v. Metabolite case) stated that the patent claims added no serious inventive work to the underlying law of nature: “To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately."
These patent claims illustrate a kind of patenting in biotechnology, where the use of a scientific relationship/law of nature forms the basis for a diagnostic or therapeutic treatment method patent claim. Where a patent does no more than simply dress up a law of nature for conversion into a patent method claim, it now stands vulnerable to invalidation under this line of reasoning from the Court. The Court referred to the possible anti-innovation effect of such patent claims, noting “the kind of risk that underlies the law of nature exception, namely the risk that a patent on the law would significantly impede future innovation.” In an accurate portrayal of how that can happen, the court noted “that very exclusivity can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing arrangements.” Finally, the Court reinforced the importance of the patentable subject matter doctrine in patent law, rejecting calls to subsume these difficult questions of line-drawing into other patent doctrines. So this case will have a tremendous impact on biotechnology patenting, cautioning against overly broad method claims that tie up the use of fundamental scientific observations. We are still waiting to hear whether the Supreme Court will take up the other outstanding issue in the patentable subject matter debates – gene/DNA patenting in AMP v. USPTO. The petition in that case has been filed; no decision yet. Over 30 years have passed since Chakrabarty was decided, in a case that made patent law receptive to the inventions produced from genetic engineering; currently, the patentable subject matter questions reflect decades of research into genes and genetic processes and how patent law can accommodate truly inventive efforts without putting basic scientific knowledge at risk of private control. Today, the Supreme Court struck a blow for the continuing validity of interrogating patent claims for adverse intrusion into the scientific public domain.