Court Watchers know that there are approximately 8,000 petitions filed with the Supreme Court each year and an additional 1,200 applications of various kinds are filed per year that can be acted upon by a single Justice. There is simply not enough time to consider each case where Supreme Court review is sought, so the Court has historically been very selective in choosing cases, normally only issuing full opinions in roughly 85 cases each year. Notwithstanding, this Supreme Court has shown great interest in patent matters, particularly questions of fundamental importance such as what is patent eligible subject matter (See Bilski v. Kappos and Mayo v. Prometheus), what is considered obvious (See KSR v. Teleflex) and the appropriate level for the presumption of validity of an issued patent (See Microsoft v. i4i). The Roberts Court is no doubt placing its stamp on patent law, and it does not appear as if that will cease any time soon.
Notwithstanding, tomorrow is an anniversary of a peculiar Supreme Court event. Five years ago the United States Supreme Court decided not to issue a ruling in the case of Laboratory Corporation of America v. Metabolite Laboratories. This may not seem like an appropriate event to revisit, or even a noteworthy decision at all, but the issue in the case — what is patent eligible subject matter — has continued to be a question of great concern to the courts, including the Supreme Court. Indeed, with the Supreme Court recently granting cert. in Mayo v. Prometheus, it seems that it is only a matter of time before the issues in Lab Corp. make their way to a decision on the merits by the Supreme Court.
So what is the real story behind why a non-decision was noteworthy and remains worth revisiting? The real story behind Laboratory Corporation of America v. Metabolife Laboratories is that the Supreme Court did decide to hear this case as a part of the 2005 Term. The Term begins in October and runs through the following summer, usually ending at the end of June or the beginning of July. Notwithstanding the Court’s decision to hear the case, and notwithstanding the fact that it was fully briefed by both sides, on June 22, 2006, the Court, without explanation, issued an order explaining that no decision would be forthcoming because the appeal was improvidently granted.
So what does this mean? Well, this case would have likely required the Supreme Court to visit a topic that is becoming something of a thorny issue in patent law, namely what is patentable subject matter? While this may seem to be a trivial question, and indeed had been largely settled for many years until recently, the question of patent eligibility is back in the national spotlight (at least for patent aficionados) because of scientific advances, various rulings of the United States Court of Appeals for the Federal Circuit and a United States Patent Office that seems to grant patents on virtually anything. Of course, that is what is mandated by the Legislative History of the 1952 Patent Act, but those who would seek to erode patent rights are undeterred by such niceties as Legislative History, Supreme Court precedent, scientific reality or even common sense for that matter.
The patent in question In Lab Corp., U.S. Patent No. 4,940,658, claimed a method for detecting cobalamin or folate deficiency. Because these B vitamins assist in metabolizing the amino acid homocysteine, scientists directly assayed homocysteine to screen for cobalamin and folate deficiency. These direct homocysteine assays were unreliable. Then researchers at University Patents Inc. (UPI) discovered a relationship between elevated levels of total homocysteine and a deficiency in either cobalamin or folate. As a result, the UPI inventors ultimately received a patent on a process for determining cobalamin or folate deficiencies. The only claim at issue before the failed Supreme Court appeal was claim 13, which claimed: “A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.”
On appeal to the Supreme Court, Laboratory Corporation of America argued a method patent directing a party simply to ‘correlate’ test results could not be valid because it would violate the requirement that patents be issued to inventions displaying patentable subject matter. Specifically, they argued that if such patents are allowed the patentee would be granted exclusive rights over basic scientific facts. Whether this would be true or not, the fact is that Laboratory Corporation of America never raised the patentable subject matter argument before the district court, nor did they raise the argument at the Federal Circuit. This admittedly did not stop the Supreme Court from originally accepting the case, but well established appellate principles dictate that an argument not raised below is waived on appeal. It seems that the majority of the Supreme Court felt that Laboratory Corporation did not preserve the issue and the appeal should not have been granted in the first place.
Nevertheless, Justice Breyer issued a dissenting opinion, joined by Justices Stevens and Souter. These three Justices not only wanted to hear the case, but explained that there is no doubt in their mind that the claim in question, claim 13, was unpatentable because it merely recited a law of nature. In so voicing their opinion on the merits in a case where the key issues were not preserved for appeal, Just Breyer summarily dismissed the patent owners argument that the correlation is patentable because claim 13 packages it in the form of a “process” for detecting vitamin deficiency, with discrete testing and correlating steps. In so dismissing the patent owner’s argument, Justice Breyer merely explained that he did not accept their interpretation of prior case law. Justice Breyer did, however, acknowledge the Supreme Court’s previous rulings clearly indicating that a process is not unpatentable simply because it contains a law of nature, but did not address this point in a coherent manner.
Essentially, it seems that Justice Breyer was upset by the fact that such a broad claim could be allowed period. He acknowledged that the claim at issue does recite a series of steps, but was deeply troubled by the fact that any process can be reduced to a series of steps, which seems exceptionally curious given that in order to obtain method claims the overall process is required to be explained in a series of steps.
In truth, the dissent of Justice Breyer is extraordinarily short-sighted. As is the case with many inventions that are foundationally important, many judges seem extremely willing to find such pioneering inventions invalid for one reason or another. Indeed, Justice Breyer even glowingly referred to the Supreme Court’s decision in Gottschalk v. Benson, the Supreme Court case that originally prevented the patenting of software. Today, the ruling in Gottschalk universally believed to be wrong, yet to some it still seems to remain the seminal case showing that pioneering inventions should not be patented.
In Gottschalk the Supreme Court determined that an invention that manipulated decimal numbers into binary code could not be patented because its only use would be to enable digital computers to operate. This ruling has lead one leading American patent text to note: “With much of the world economy controlled by digital computers, it seems almost nonsensical to suggest that the invention has no substantial application except in connection with a digital computer.” Indeed, the Supreme Court got it wrong in Gottschalk v. Benson and pretending otherwise is nothing more than a charade. Fundamentally important inventions should be patentable, and it is indeed a sad state of affairs that such an obvious truth must be articulated.
Despite the desires of those who abhor patents, it is clear that patentable subject matter still allows for useful processes to be patented even if those processes incorporate scientific principles or discoveries. This has been the law since the beginning, it is engrained in well established case law from the Supreme Court and the Federal Circuit, and is actually explicitly authorized by 35 U.S.C. § 101. The Supreme Court did nothing to upset this well established law in Bilski v. Kappos, and perhaps took steps to make certain that methods, including at least some business methods, are patentable. But don’t think this is the last you will hear of this debate.
It seems with every new, fundamentally important invention there is a cry for a cut back in what is considered patentable subject matter. But, for now, we can rest easy given the dismissal of Laboratory Corporation of America v. Metabolife Laboratories. Rest, however, cannot be for very long. The issues raised in Lab. Corp. will be again on the Supreme Court docket during the October 2011 term.