The biotech community has been chattering ever since the Mayo Collaborative Services v. Prometheus Laboratories (“Prometheus”) ruling was issued by the U.S. Supreme Court March 20, 2012. Biotech folks, unaccustomed to the flurry of appellate activity surrounding some recent biotech cases, including the July 2011 Federal Circuit decision, Assoc. for Molecular Pathology et al. v. U.S.P.T.O. and Myriad Genetics, 2010-1406 (2011), are understandably nervous and have been engaged in a parlor game of guessing the effects of the decision on the biotech industry. The dinner discussions in my own household have centered on the subject (my kids think their parents are total nerds). Several posts and the many comments on this august blog and on other blogs are indicators that the biotech patent bar has found itself thrust into the legal limelight in a series of decisions which many fear may seriously harm the biotechnology industry, still struggling in a slow economy. In fact, the stock prices of several prominent biotech companies fell at the news of the Prometheus ruling, including Myriad’s stocks, which had fallen 9% at one point. As many of my esteemed colleagues have and will continue to dissect the case, I will instead focus on the effect of the decision on the future of biotech patents.
Unlike many in the biotech community I do not think the Prometheus decision will break the biotech industry or even seriously affect it . Much like the car mechanic in a small Caribbean island told me when my engine light came on in my rental car, “no worries, no problem!” (our car, in fact, never broke down, even on a mountain road with no shoulders). I believe the holding in Prometheus prevents what could be a future legal quagmire, where overly-broad patents could serve to block entire fields of practice and create an enforcement nightmare in which ghosts of legal uncertainty and licensing ambiguities would haunt hospital hallways, R&D labs, boardrooms, and investment entities throughout the country. If the Prometheus decision would have gone the other way, it would not have been status quo, but rather been fairly harmful to future innovation.
The technology involved is a therapeutic method involving thiopurine treatment of persons with intestinal tract autoimmune disease. Thiopurines are a class of pharmaceuticals called nucleoside analogs, which mimic naturally-occurring nucleosides, the subunits making up DNA or RNA – genetic material. Nucleoside analogs include the well-known cancer drugs fluorouracil and ara-C, as well as HIV drug AZT (Retrovir) and the shingles drug, famcylcovir (Famvir), among many others. A good review by Dr. William Plunkett’s group (MD Anderson Cancer Center at the University of Texas) is found here.. There are many patents which cover the products and methods of using these compounds and those patents will still be safely in place, with proper claims drafting.
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The difference in Prometheus, in my humble opinion, is in the claim language itself and is a drafting problem, rather than a subject matter issue. The claim(s) at issue include:
“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: a) administering a drug providing 6-thiopurine to a subject…, b) determining the level of 6-thioguanone in said subject…, and wherein the level of 6-thioguanine less than about… indicates a need to increase the amount of drug…”.
The “wherein” clause is considered by the Court as a separate method step. The administering step was dismissed by the Court as merely identifying the artisan who would practice the invention. The key step in the claim then, is the “determining” step. This claim wording, with all due respect to the claim drafter, is so wrong on so many levels that it is hard to key in on any one aspect. When I was an Examiner, I would have rejected this claim as merely stating an inherent property of the drug metabolism – a rejection under 35 U.S.C. 101, as being non-statutory subject matter. The drug is administered, which is an active step, but there really is nothing else in the claim. The “determining” limitation is a mental step, and the “wherein” clause is even worse – because the limitation just indicates a need to increase the drug. None of these steps do anything except describe a natural product whereby the body itself metabolizes a drug to a certain level. In other words, an “administering” step does not rescue a method claim when the other steps consist of a mental step (“determining”) and a stated need to do something.
While I don’t disagree with the Court’s conclusions, the danger I think they created in this decision was that lower courts may start to hold all drug therapy claims invalid, because of course, all therapeutics are metabolized by the body without human intervention. I would have liked to see more clarity from the court on the extent to which a claim might pass muster.
It is clear that the Court zeroed in on their core concern – of tipping the balance from the exclusivity of a patent grant on one hand and the flow of information needed for future innovation on the other. Whenever the Court mentions a “balance,” the patent bar should get nervous because invariably, “balancing tests” will soon find their way into future lower court decisions that bear little semblance to what (we think) the Court intended in the decision.
Since the Prometheus claims included two non-statutory components: a mental process, the “determining” step, and an inherent characteristic (metabolism by the body), if the Court would have issued a ruling with the opposite holding, I can envision a scenario where lower courts would start finding claims based on either mental processes or inherent characteristics as being patentable subject matter. The problems are obvious – think thought police barging into a patient’s hospital room as her physician contemplates the correct dosing (“determining the level of…”) after reading the results of the serum drug level testing. The scope of these future claims could bar whole areas of R&D, where the scope of the claims would so broad that normal medical decisions could be blocked by a patent.
The Court, in essence states as a question, that there is nothing more to the issue than a “drafting effort designed to monopolize the law of nature itself,” but sort of held on other grounds, namely a grounds based more on public policy (citing the Benson case): there is a “concern that patent law not inhibit further discovery by improperly tying up the future laws of nature.” In the first respect, my position is similar to that of the Court: Prometheus highlights more of a drafting problem – not a subject matter problem. The exclusivity vs. innovation debate has always been the center of the patent system, so the Court broke no new grounds in public policy. The claims at the center of the decision needed no intervention on the part of the Supreme Court to be rejected, but needed to be invalidated nonetheless. However, the fact that the Court chose to hear the case means that they determined that there were issues beyond drafting errors for which they felt needed to be addressed. The efforts of the Court to force the biotech industry to tighten up their claim language to not include products of nature are needed, as evidenced by the issuance of the two Prometheus patents considered by the Court.
The decision in Prometheus centered on the particular claim language, not on biotech patents in general, as addressed by Justice Breyer: “The laws of nature at issue here are narrow laws that may have limited applications, but the patent claims that embody them nonetheless implicate this concern. They tell a treating doctor to measure metabolite levels and to consider the resulting measurements in light of the statistical relationships they describe.” (Emphasis added). Justice Breyer then states, “[t]he “determining” step too is set forth in highly general language covering all processes that make use of the correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways.” Thus, the folks that are giddy about the possible Supreme Court overturn of all biotech patents based on the narrow confines of this decision are likely to be disappointed.
(Note: during the drafting of this post, the Supreme Court granted Cert. in the Myriad case and remanded the case back to the Federal Circuit to reconsider the case based upon the Prometheus decision. 566 U.S. __, 11-725, March 26, 2012)