By Mark Rawls.
Prometheus, the unrepentant Titan who gave fire to mankind, suffered severely for that crime. Mayo Collaborative Services v. Prometheus Laboratories, Inc., in what may be a Titan of a case, among Supreme Court cases on patentability, has similarly – if in somewhat less dramatic fashion – come down against Prometheus. And although the Nine lack thunderbolts to hurl, the decision has, notwithstanding, shocked many in the patent community. Prometheus Laboratories, for its part, would like you to think it has brought fire to mankind. This post will look at what is at issue in the case, and what the possible consequences are of the Court’s unanimous opinion, in particular with respect to the Myriad Genetics case recently remanded.
This decision has been much commented on. See the SCOTUSBlog coverage, for instance, which provides both the briefs filed in the case and commentary. Or Dennis Crouch at Patnetly O (also explaining the USPTO’s preliminary internal memo on the case). The decision has sparked some sharp criticism: a series of guest posts at Patently O by attorney Robert R. Sachs (1, 2, 3, and 4), goes on at length about what he calls the “logical and legal errors in the Court’s decision.” At IPWatchdog, attorney Gene Quinn begins with “The Sky is Falling!” and calls the Court’s opinion “terrible,” and even “pathetic, [and] narrow-minded” (hoping that Congress acts to affirmatively reverse the Court). In a post by Michael Risch, co-author of Life after Bilski, a paper cited by the Court’s opinion, Risch, for his part, thinks the decision is “hardly earth shattering.” And over at Groklaw, there is predictable glee about the outcome. Rob Tiller, VP and assistant general counsel at Red Had, has a brief post on the case, looking at it from the perspective of software patents. (On software patents more generally, see my previous post.) The Washington Post has also commented on the case.
So what is this case about? Prometheus Laboratories obtained a patent on a medical process, which it claimed Mayo infringed. Risch summarizes: “In short, the patent covered the following: administer a drug, measure the residual effects of the drug, decide whether more or less of the drug should be administered based on the findings.” The drug in question, a thiopurine drug, has been known for over fifty years and used for various medical purposes. But it is toxic at certain levels, and there is apparently some difference among individuals about the right level to use. As the Court’s opinion states, at the time of the patent, the medical community knew that the level of certain metabolites in a patient’s blood were correlated with the likelihood that a particular dosage would either be harmful or effective. What Prometheus Laboratories did was to identify this correlation with some precision. Thus they created a process where doctors could give a certain dosage of the drug, measure the blood level, and decide whether a further dosage was required. Prometheus marketed this test, Mayo bought and used the test for some time, but eventually decided that it would begin using and selling its own test, with somewhat altered thresholds.
Prometheus, then, contributed the knowledge of particular threshold values in monitoring certain metabolites in the blood. The drugs, their medical use, and the vague knowledge of the metabolites correlating to the effectiveness of the drugs, were all known. The Court ultimately held that these threshold values are laws of nature or natural phenomenon, and that Prometheus did not add anything inventive to those natural facts to be patentable. The Court elaborates:
A patent, for example, could not simply recite a law of nature and then add the instruction “apply the law.” Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa). Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float.
This is, essentially, the reasoning of the Court. It is a long-standing doctrine that laws of nature are not patentable; Prometheus, supposedly, has only identified an existing natural condition (granted, with some specificity not before known), but all the processes it attached to that natural condition were well known and practiced before its patent application. (For a critique of this law of nature or natural phenomenon reasoning, see in particular Sach’s first post in his series at Patently O; for a critique of the argument that not “enough” is added to the thresholds, see his third post.)
In light of this decision, the court vacated and remanded the case Ass’n for Molecular Pathology v. Myriad Genetics. (See Dennis Crouch at Patently O or Groklaw about the remand.) This case concerns the question, as presented in the petition for certiorari, “Are human genes patentable.” The Federal Circuit had reached the conclusion that human genes were patentable under certain circumstances. In particular, Myriad had isolated the gene (using well known techniques), and the court reasoned that while the DNA molecules exist in a certain form naturally in the human body, they do not exist in an isolated form and so the isolated form is a distinct chemical entity. The court relied on precedent where, for instance, scientists had engineered certain microorganisms with beneficial properties, where such organisms existed in nature but not with the unique characteristics given to them. The Supreme Court had previously upheld such patents. (See Diamond v. Chakrabarty.) The losing party, for its part, argued that the DNA sequence, which is what controls the gene, is the same as that found in nature. To be sure, the Court’s remanding this case doesn’t say one way or another what it believes the outcome should be, but Dennis Crouch has speculated that one possible interpretation of Prometheus is that the gene in Myriad is unpatentable. This is a big issue because of the progress of medical biology. As the Federal Circuit’s opinion in Myriad states, while the average risk in women of breast cancer is around 12%, this climbs to 50-80% when certain gene mutations are present. On the one hand, patents may be necessary to fuel this research; on the other, the public might not be served by having critical medical testing controlled by a state enforced monopoly. This is too close a question to resolve in the confines of a blog post, especially one by a first year law student who has yet to take patents. But rest assured that in the wake of the Prometheus decision, this is a topic of active discussion in the patent community.