You all may be suffering from Prometheus v. Mayo fatigue by now, but this remains the most important IP case before the Supreme Court, and may well alter the course of life sciences patenting for the foreseeable future. I know I am falling behind in posting on the appeal, but each party has now filed 59 page briefs. I recently finished Mayo’s brief (a copy provided at the end of this post along with Prometheus’ brief) and I wonder if they really want to clear the high legal fences they are “swinging for.”
The heart of their legal (vs. “This will hurt patients and inhibit research” policy) arguments are that Prometheus’ claims to administering to a patient having an immune-mediated g.i. disorder a drug providing 6-TG (the metabolite), measuring the levels of the metabolite wherein a level under x “indicates a need to increase” subsequent doses and a level over y “indicates a need to decrease” subsequent doses, improperly embed a law of nature or natural correlation with one or two information gathering steps that should be accorded no patentable weight. (I disagree with the testimony of Prometheus’ expert as summarized by Mayo at page 25, that the doctor who receives the results would infringe even if they were not read. This summary ignores the claim limitation “indicates a need,” which is recognized as functional by Mayo at page 22 of the brief: “[The patents] advise physicians to think about the need for dosage adjustments when metabolites reach certain levels….” For more about “thinking” as a claim element, see below.
Apart from vastly overstating the breadth of the claims, both in terms of potential infringers and their effect on stifling medical research, Mayo also argues that Prometheus has effectively preempted a natural phenomenon – namely the ability of the body to metabolize an immunosuppressive drug like AZA into a metabolite like 6-TG. Mayo’s brief makes no mention of the fact that this natural phenomenon would not occur at all if synthetic immunosuppressives had not been invented in the first place and found to be useful – within tightly controlled doses – when given to patients. And the brief is certainly not going to mention that a claim to a natural phenomenon should be easy to spot. As I have pointed out before, such a claim would read: “l. Human blood containing x mg/ml homocysteine and y mg/ml cobalamine,” or “2. Human blood containing x amount of PSA” (for us guys). Now those are claims that I will concede preempt any use of a natural phenomenon. They are equivalent to claims like “3. The Northern Lights,” “4. Calcite” or “5. Human genomic DNA.”
But the Mayo briefing team seems to want more than anything to tie these claims to the claim at issue in the “Labcorp dissent” (548 U.S. at 134, 136), in which Justice Breyer urged the Court to consider that all simple diagnostic tests that correlate a level of a chemical marker (like homocysteine) to a pathology (like a vitamin deficiency) were no more than an impermissible attempt to patent a natural phenomenon: “[T]he process is no more than an instruction to read some numbers in light of medical knowledge.” No matter that the medical knowledge originated with the patentee, as in the present case. Mayo writes: “Nor did [the process steps] limit the scope of the patent, which ‘any doctor’ would necessarily infring[e] merely by thinking about the relationship after looking at a test result.” Id. At 132. Pet. Brief at 31. Mayo forgot to add “that the doctor ordered be obtained.” That is what I meant by Mayo’s swinging for high legal fences – Mayo is apparently willing to live with a ruling that any diagnostic test that relies on correlating an in vivo marker with a patient condition or predisposition does not fall within the scope of section 101.
And since when is a step of thinking about a correlation barred from, or fatal to, a patent claim? Just by chance, I ran into an odd little group of older Board decisions that grapple with this issue in a completely unrelated art area, oil discovery. Ex parte Bond, 1961 WL 7999 (1961), the Board considered this claim: “16. A method for recovering oil from subsurface geological formations comprising analyzing soil-gas samples taken over a predetermined surface area to determine the ratio of [two carbon isotopes] therein, and drilling a well within the region of the maximum [ratio of the two isotopes].”
Now we are really getting back to Mother Earth! The claim recites taking samples, determining a natural phenomenon, the ratio, and (unlike Prometheus’ broad claims) taking action with a machine. Boy, were Bond’s attorneys ahead of their time. Bond conceded that none of his process steps was novel per se but that he had combined them to achieve an new, useful and unobvious result. The Board agreed then went straight on to conclude: “It follows from this conclusion that the rejection of the claims as directed to a mental process is also untenable. Since the claims are for a novel and unobvious combination, the examiner’s premise that the only novelty in the process is a mental operation is not correct….and in Ex parte Kahn et al. [124 USPQ 511] we pointed out that a method is not per se unpatentable merely because its practice requires that the operator thereof must think.” Ex parte Kahn held that “it is necessary to show, when a statutory method is claimed, that the distinction from the prior art resides solely in a mental step before [the claim in ineligible under 101].” Remember, the Prometheus claims both require the “old” step of measuring the 6-TG level and the novel step of comparing that level to two benchmark levels for “too high” or “too low” that were discovered by the inventors.
If you think Bond and Kahn were pulled from a musty closet, my next post will discuss how the Mayo brief uses an [in]famous 1862 decision to launch its argument that “[w]ell known, non-inventive steps cannot turn a natural phenomenon into patentable subject matter.”