Abstract
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The focus of this article is on “abstract ideas” under Mayo and what might be done about it from a patent standpoint. What constitutes “products of nature” under Myriad is beyond the scope of this article.
Although the article concludes with some criticisms of the Mayo decision, the purpose is not to re-litigate the decision, which is law for the foreseeable future. Instead, the purpose is to analyze both the Mayo patent and the Mayo decision with a view toward identifying alternative means to protect inventions that otherwise might be denied patent eligibility.
As might have been expected, post-Mayo, there has been scholarly pessimism regarding patent protection for inventions related to personalized diagnostics. 3 Such pessimism is common following patent-related Supreme Court decisions. In 2007, for example, there was much concern 4 about the ability to overcome charges of obviousness following a Supreme Court decision 5 that promoted “an expansive and flexible approach” to make obviousness easier to find, yet since 2007, the number of patents issued annually in the U.S. has nearly doubled, and 2014 saw a record high number of patents issue. 6
The patents 7 to which Prometheus Laboratories had acquired rights that were at issue in Mayo were directed to diagnosing inflammatory bowel disease (IBD). It had been known in the art to administer thiopurine drugs to treat autoimmune diseases such as IBD, and that doctors had found it difficult to determine whether a particular patient's dose is too high (risking harmful side effects) or too low (and so likely ineffective). The Prometheus patents sought to broadly cover the discovery of the lower level of thiopurine metabolite in the blood below which efficacy became questionable, and the numerical higher level, above which toxicity could become a concern. Both of the two patents at issue in Mayo, as well as additional descendant patents, have only method claims. Claim 1 of the original patent reads:
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
The Court held that the above claim consisted of reciting something that was not eligible for patenting, namely, the “law of nature” of “relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” The Court also held that the “relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.”
The above analysis may be referred to as Mayo step one 8 in a two-step analysis. The second step is determining whether the remaining steps (apart from the patent-ineligible law of nature) of “administering” and “determining,” along with the “wherein” clauses, added something significant as a whole apart from their parts taken separately which was more than well-understood, routine, conventional activity already engaged in by the scientific community. The Prometheus patents failed this second step.
The method claims in the Prometheus patent are entirely understandable as being perhaps the broadest way to cover the invention—in this case, the discovery of the salient upper and lower levels of thiopurine metabolite in the blood for the treatment of IBD. The problem is that this way of disclosing and claiming the invention resulted in a complete loss of patent rights, at least as to the first two Prometheus patents that were under litigation.
A difficulty with the Prometheus patents is that their technical specification was indeed written with a view to the broadest possible coverage, and omitted what may have been an important implementation detail discussed further below. The first four columns of the original Prometheus patent essentially repeat, in various forms, the summaries above. The succeeding description broadens the definition of what can be considered metabolites and what diseases can be considered to fall under “IBD,” including in some cases descriptions of the pathologies of specific diseases. The patent also describes a multiplicity of ways in which the metabolites can be assayed, and concludes with three examples of test protocols that were used to assay samples from treatment groups of IBD patients. The patent is a well-written one that closely resembles in form a scientific paper divulging a newly discovered scientific principle.
Up to this point, and after carefully reading the Prometheus patent, the reader has no idea why Mayo sued Prometheus to obtain what it got: namely, a declaratory judgment of patent invalidity.
The reason has to do with test kits, which is how Prometheus made money: it sold test kits and returned test reports. Mayo had been purchasing these products from Prometheus, but decided it would make its own test and sell it. 9 The Prometheus patents, however, never discuss how the discovery might be used to commercialize the invention.
It would be interesting to know what happened between Prometheus and Mayo after the Supreme Court decision, because it appears that Mayo still sells Prometheus tests, as advertised on a website with a 2015 copyright date. 10 Of relevance to this article is that the website indicates the products include test tubes with sample blood that a doctor's office refrigerates and sends to Prometheus to assay, with a report being returned indicating the test results along with the discovered numerical upper and lower bounds and a qualitative comment about where the assay falls. 11
None of this is discussed in the Prometheus patents. Neither the way in which the report is generated and provided (presumably over the Internet) nor the contents of the report, much less the inputs, outputs, and processing of the assay facility computers, are touched on in the patent. Yet this is the way that money is made using the core concept.
This leads to the following observations. In drafting biotechnology patents, by all means discuss the science, particularly if it is important to teaching one of skill in the art how to make and use the invention. But by all means also inquire as to how, precisely, the invention might plausibly be commercialized. Of course, it is true that one cannot merely claim an otherwise ineligible abstract idea or natural law and then say “apply it,” 12 nor can post-solution activity that is merely conventional or obvious transform an unpatentable principle into a patentable process. 13 Moreover, dropping an abstract idea into machine format, without more, will not save it from patent-ineligibility. 14 None of this, however, is what is being suggested. By exploring implementation details, including the details necessary to commercialization, such as the (inevitable) computer programming needed to support commercialization or the seemingly trivial details of an actual test kit, which if claimed properly becomes much more than a principle in the abstract, the possibility is open to obtaining eligible, enforceable claims. While such claims might not be as broad as the type of method claim sought by Prometheus, the value of such claims may surprise.
This is because seemingly “routine” implementation of an idea typically is anything but. Technology has grown too complex to dismiss what may appear to be inconsequential implementation and commercialization details as being unimportant. Sometimes, an implementation detail may seem trivial, but may be one that every purveyor of competitive products or services may need to employ. That detail, when combined with the remaining elements of the claim may indeed (when taken as a whole, apart from their parts taken separately) be more than well-understood, routine, conventional activity already engaged in by the scientific community.
Someone has to program a computer to accept certain inputs and provide certain outputs. Someone has to format those outputs into a salable format and then provide that format to the customer. Hidden within these mundane activities can be patent gold. But it cannot be claimed if it is not disclosed.
I do not presume to second guess anyone about a technology I know little about, or about business models I know even less about, but as an academic exercise to illustrate these points, consider the following hypothetical claim. I do not represent that it would be bulletproof from either an eligibility or obviousness viewpoint—only that it might have had a better chance of survival than the claims that were invalidated, while still covering competitive commercialized products. It is well to consider these drafting steps from the outset, as the Patent Office has published guidance for its examiners to undertake the Mayo two-step analysis discussed above. 15
A computer comprising:
a processor; and
a computer memory that is not a transitory signal and that comprises instructions executable by the processor to:
receive at an input port a signal representing a level of 6-thioguanine in a patient having an immune-mediated gastrointestinal disorder,
compare the level of 6-thioguanine to upper and lower bounds,
based on the compare, output in human-readable format the level of 6-thioguanine along with numerical indicia of the upper and lower bounds and a qualitative indicator of the level of the 6-thioguanine in relation to the upper and lower bounds.
Note that this claim did not require an actual program to have been written (although such a program, if in existence, would certainly help) or an actual sample report to have been designed (although several examples of such a report would also help). Note further the probable difficulty in showing that the combination of computerized steps above was obvious, already in use, or purely conventional, as the steps are integrated to produce an output that is an application of a novel discovery and thus, arguably, does not seek to preempt all uses of the discovery, therefore meriting patent-eligibility under Supreme Court precedent. 16 While not covering all uses of the Prometheus discovery, consider whether the hypothetical claim may cover, with potentially effective breadth, commercialized products—which is the whole point of patenting.
Other claims can be hypothesized, but the point is that describing not just the underlying scientific principle, but also various ways that might be envisioned for implementing and commercializing the invention, may be an effective way to address the barrier erected by Mayo.
I will end by noting that the Mayo decision itself is plagued by logical infirmities. The principal concern of the Court in banning the judicial exceptions to patent-eligibility purportedly is the concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature. 17 But this concern ignores the fact that nothing ever is “tied up” beyond the limited period of the patent grant; and, moreover, that the Prometheus patents decidedly did not “inhibit further discovery” because—as the Court itself noted—Mayo was motivated by the Prometheus discovery to develop a new and presumably more accurate assay limit. 18
The Court also “intuited” that which is counter-intuitive in dismissing the Government's proposed “novelty” approach in allowing broad rein to patent-eligibility while policing overly broad patents using the novelty and obviousness requirements of the patent law: “[i]ntuitively, one would suppose that a newly discovered law of nature is novel.” 19 Quite the opposite, however, is true: a law of nature does not acquire novelty based on human perception. Gravity, for example, has been a law of nature for many billions of years, only the last sliver of which has witnessed the rise of humans, yet our late appearance (and even later “discovery” of gravity) did not make this fundamental natural law novel.
Perhaps most egregiously, the Court continues to ignore that its judicial exceptions were first enunciated prior to the 1952 Patent Act, 20 yet Congress declined to adopt any of those exceptions in its definition of what is patent-eligible: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 21
Nonetheless, the Court proceeds as though its own policy-driven law survives the decision of Congress not to incorporate its judge-made exceptions into the definition, declaring that the Court's policy balancing expressed at the end of the Mayo decision must not be changed unless Congress “craft[s] more finely tailored rules.” 22 This ignores the fact that Congress already has crafted a definition of patent-eligibility that does not adopt the Court's prior policy-driven judicial exceptions to patent-eligibility.