By Kevin E. Noonan —

Biotech has met its Benson in the Court's Prometheus decision.  Before considering what can be done, it is prudent to consider the implications of this decision (and the previous decade of Supreme Court decisions on patent law).

It is now clear that the only patent law that matters is Supreme Court law.  In decision after decision, the Court has chosen to ignore thirty years of Federal Circuit precedent in favor of its decisions from thirty, sixty, or over a hundred years ago.  Despite sentiments (dicta, to be accurate) from Bilski v. Kappos regarding the dangers of imposing horse-and-buggy thinking about technology to the 21st Century, the Court seems happy to do so.

This creates problems for American innovation because of the increased complexity of modern technology compared to those halcyon days of plows and cotton gins.  Those devices needed patent protection because they were easily reverse-engineered and thus could be freely copied without the ability to stop the copyist without a patent.  Today's inventions, particularly in the biotechnology sphere, are often the opposite — harder to reverse engineer, and capable, with a modicum of effort, of being made more so.

The reason that, by and large, the efforts necessary to rely less on patent protection have not been made are many-fold, but relate in large part to the fruitful cooperation between academic science and biotech startups that for a generation has transferred technology created in universities into useful (and profitable) products.  These have included true "wonder drugs" such as human growth hormone, interferon, and insulin, as well as a wealth of research tools that have made it possible to perform screening of small molecule drugs much more easily, cheaply, and humanely.  And in the process, the money American taxpayers have contributed to university research has been recompensed by licensing fees (and commercially available drugs), rather than providing no return on that investment following the disclosure of such research in scientific publications that academic scientists rightly still believe are their principle stock in trade.

But the current spate of Supreme Court decisions has threatened this balance, because in almost every case the Court has seen fit either to make continued viability of various categories and types of patents uncertain (reversing a generation of efforts by the Federal Circuit to increase certainty in patent law, pursuant to Congressional mandate) or to "upset the settled expectations" of patent holders.  Under these circumstances, investors can be expected to be less ready to choose already risky biotechnology inventions, where return on investment of even a successful product may be vitiated by the next decision of the Court.

The current trend is also bad for the Federal Circuit, whose jurisprudence is threatened to be relevant only at the margins.  The Federal Circuit did yeoman's work in harmonizing U.S. patent law from the patchwork of regional circuit differences into a (relatively) cohesive whole, with increasing business certainty the explicit goal.  As a consequence, the first 15 years of the CAFC's existence saw a large increase in technology-driven companies in America, from Genentech, Amgen, Genzyme, and Biogen in biotechnology to Cisco, Intel, Microsoft, and Apple in the electronics arena.  While these different industries relied to different extents on patent protection, the availability of patents to protect innovation had a beneficial effect on technological innovation in this country unmatched in the centuries before.

Another entity with diminished effects on patent policy is the Administration (or, perhaps, just this Administration), where for the second time in less than a year, the Supreme Court expressly disregarded the views of the Solicitor General in rendering its decision.  While the earlier instance, in Stanford v. Roche, may have been credited to the subject matter (statutory interpretation of the Bayh-Dole Act) and the involvement of the government in being the presumptive assignee of Federally funded research (and thus less of a disinterested party), here the Court expressly rejected the considered views of the Executive, presumably informed by the experience of the U.S. Patent and Trademark Office.  While it is easy to appreciate why the government would prefer to utilize other sections of the patent statute to assess claims like the ones in Prometheus, the Court's decision has made it more difficult to administer the patent laws fairly and even-handedly, in view of the "we know what's patentable when we see it" nature of this and several other of the Court's decisions.

It is also clear that the Court has little time for the specifics of patent law generally, not surprising from a Court who characterized obviousness law as "gobbledygook" not so many years ago.  The problem with this approach, and the "totality of the circumstances" approach in general, is that it makes patent law even more uncertain in all respects:  from the increased likelihood of the variable application of patentability standards during patent prosecution to the likelihood that a judge or jury will be able to impose their own subjective beliefs on whether something should or should not be protected by patent.

In an interesting departure from its recent denigration of the efforts of the legal academy, the Court also signaled its willingness to credit their theories of what drives and sustains innovation against the arguments, based on actual experience, from groups and individuals who have created companies and been involved in innovation in the biotechnology industry.  And the Court seems equally ready to be influenced by the consumers of innovation, such as amicus the American Medical Association, who understandably wish to have the maximum freedom to have their patients benefit from new technology (and the minimum interference from patent holders who would reduce their opportunities to profit therefrom).

Finally, the true villians of the decision are clearly patent drafters, whose efforts the Court expressly held out for disdain if not contempt; its precedent "warn[s] us against interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art' without reference to the 'principles underlying the prohibition against patents for [natural laws].'"  This analytical principle is in direct conflict with the patent statute, of course, which requires claims that set forth the "metes and bounds" of the invention and indeed are the legal description of the patent grant.  Not to be bothered with these niceties, the Court is more than happy to impose its own (and by extension, any judge, jury or patent examiner's) subjective understanding of the underlying "principles" at stake in assessing whether a technology should be patented.  But the reality is that claims will (by statute and practical necessity) define whatever scope of patent protection may remain available, and suggests that only by accepting the Court's challenge can patent claim drafters minimize the negative impact of this and other decisions of the Court.  Suggestions on how that may be done will be in another post.

By Kevin E. Noonan —

In a decision he has waited six years to write (having dissented from the Court's decision not to decide similar issues in Laboratory Corp. v. Metabolite Labs., Inc. in 2006), Justice Breyer (and a unanimous Court) overturned the Federal Circuit's decision that diagnostic method claims are eligible for patenting under 35 U.S.C. § 101.  Before discussing the reasons for the Court's decision and its possible impact, it is best to attempt to discern the reason why the Court believes its judgment on patent-eligibility is superior to the court specifically created by Congress to make patent law its particular area of expertise.

As a reminder, the case involves claims directed to methods for determining whether an effective amount of a drug is being administered to a patient.  The claims of the patents-in-suit (U.S. Patent Nos. 6,355,623 and 6,680,302) were held invalid by the District Court as being outside the scope of patent-eligible subject matter under 35 U.S.C. § 101, based on its application of the "machine or transformation" test enunciated in In re Bilski.  These claims included claims that affirmatively recited an "administrative" step, exemplified by Claim 1 of the '623 patent:

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.

And claims that did not recite such a step, exemplified by Claim 46 of the '302 patent:

46.  A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:

    (a)  determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, 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 or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8×10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The Federal Circuit reversed, finding that the claims recited sufficiently transformative steps that they satisfied the Bilski "machine or transformation" test.  The Federal Circuit interpreted the entirety of Supreme Court precedent on patent eligibility to construe patent-eligibility broadly, limiting eligibility to exclude only laws of nature, physical phenomena, and abstract idea (based, the panel suggested, on historical precedent extending back to the 19th century; Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174-75 (1853), continuing in the Court's most recent opinion on this issue (Bilski v. Kappos).  In the appellate court's opinion, the Prometheus claims are merely a particular application of a natural phenomon, alá Diehr, rather than an attempt to preempt a natural phenomenon, alá Benson and Flook.

The Supreme Court disagreed.  Beginning with its decision in Diamond v. Diehr, the Court's opinion set out the terms of the debate:  to pass Constitutional muster, 35 U.S.C. § 101 must contain an "implicit exception":  laws of nature, natural phenomena, and abstract ideas.  Citations of the Court's prior precedent (bolstered by citation of English law, curiously post-independence) are followed in the opinion by the overriding policy assumption behind the Court's decision:  that "monopolization of [the basic tools of scientific and technological work] through the grant of a patent might tend to impede innovation more than it would tend to promote it."  In this context, of course, the Court recognizes the uncertainty of the policy conundrum, and suggests that evidence that "monopolization" would not impede innovation should be important in deciding that such claims would or would not transgress the Court's policy imperatives.

Fortunately, the Court also recognizes that there must be a balance, since "too broad an interpretation of this exclusionary principle could eviscerate patent law [because] all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas."  That balance is appropriately struck, accordingly, by determining whether a claim embodies an application of a natural phenomenon or a law of nature; however, the Court warns that transforming a law of nature into a "patent-eligible application of such a law [requires that] one . . . do more than simply state the law of nature while adding the words 'apply it.'"

This case, the Court says, is at the "intersection of these basic principles."  How the Court frames the issue goes a long way towards understanding their decision:  according to the opinion, the case is about "claims covering processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high," illustrating another issue central to Justice Breyer's concerns:  interference by patents with the practice of medicine.  The Court then announces the fundamental reason it decided that the Prometheus claims are not patent-eligible:  the "claimed processes have [not] transformed these unpatentable natural laws into patent-­eligible applications of those laws."

Citing Parker v. Flook, the Court immediately takes its decision outside Judge Rich's adage about how to interpret patent law:  while that eminent jurist realized that "the name of the game is the claim," the Court here states that its precedent "warn us against interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art' without reference to the 'principles underlying the prohibition against patents for [natural laws].'"  Doing so requires that claims to "a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself."  In this the Court continues its historical tendency to conflate patent-eligibility under § 101 with patentability under, inter alia, § 103.  (Because this is a tendency apparently incapable of correction, it is perhaps best to accept it.)  This does lead to another quirk of the Court's interpretation of patent law:  rather than consider the claims as a whole (which, after all, is mandated by § 103), the Court then arrives at its decision by considering that "the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field" (albeit not applied to this method), and that "at the same time, upholding the patents would risk dis­proportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries" (seemingly ignoring the portion of the patent statute that limits patent term to 20 years from the earliest effective filing date).

Having set forth the grounds for its decision, the Court then directed its attention to the claims at issue.  In its opinion, "scientists already understood that the levels in a patient's blood of certain metabolites, including, in particular, 6-thioguanine and its nucleotides (6–TG) and 6-methyl-mercaptopurine (6–MMP), were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective" (taking this understanding from the '623 patent specification).  The opinion acknowledges that the patentees determined the "precise correlations between metabolite levels and likely harm or ineffectiveness."  But the Court also noted (in agreement with the Federal Circuit) that "the claim's language, 'indicates a need to decrease' (or 'to increase'), as not limited to instances in which the doctor actually de­creases (or increases) the dosage level where the test results suggest that such an adjustment is advisable."

The Court disagreed with the Federal Circuit, however, that the recited steps of the claim involved a transformation sufficient to render the claims patent-eligible.  The Court starts with its interpretation that the Prometheus claims "set forth laws of nature," and then determines that the claims do not "so significantly more that simply describe these natural relations."  Specifically, the Court says that the patent claims do not do "enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws."

The Court next explicates why it comes to this conclusion.  The opinion returns to its concerns over the efforts of the artful claim drafter seeking to "monopolize the law of nature itself."  The Court illustrates situations where such efforts should be unavailing (interestingly, taking its examples from the physical rather than the chemical or biological/medical arts):

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.

For the Court, the Prometheus claims provide no more than in these hypothetical situations.  The claims "administering" steps "simply refer[] to the relevant audience, namely doctors who treat patients" with thiopurine drugs.  But this audience is "preexisting" since these drugs have been used to treat certain diseases (and impliedly to be subject to the same limitations on ascertaining the proper dose of a drug for a particular patient) before the patented invention.  The "determining" step is indeterminate:  no particular method for making the determination is specified, and thus the entirety of prior art methods for making the determination is encompassed by the claim, in the Court's opinion.  This is the basis for the Court's opinion that the step embodies "well-understood, routine, conventional activity previously engaged in by scientists who work in the field."  Hieing back to Flook, the Court states that such "pre-solution activity" is "not enough to transform an unpatentable law of nature into a patent-eligible application of such a law."  And the Court does not believe that these claims embody the "exception to the exception" recognized in Diehr that "a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made" because "[a]nyone who wants to make use of these laws must first administer a thiopurine drug and measure the resulting metabolite concentrations."

For the Court, "[t]he upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations," merely "inform[ing] a relevent audience of certain laws of nature."

The Court also states that the cases "most directly on point" to their decision are Flook and Diehr; this choice suggests philosophical as well as practical possibilities that will be discussed elsewhere.  In the opinion, the Court found the "way the additional steps of the process [recited in Diehr] integrated the equation into the process as a whole" rendered those claims patent-eligible, while in Flook all that was provided by the claim was the patent-ineligible algorithm to calculate alarm limits in pre-existing processes.  (While this portion of the opinion also [re]introduces language concerning whether these additional steps, in both Flook and Diehr, were "obvious, already in use or purely conventional," this conflation is an invariant part of any § 101 analysis by the Court.)  Applying this precedent, the Court finds that the Prometheus claims present a case for patent-eligibility that is "weaker than the (patent-eligible) claim in Diehr and no stronger than the (patent-ineligible) claim in Flook."

The Court then takes a brief excursion beyond the boundaries of its own precedent, considering a 19th Century English case regarding blast furnaces (which the Court must have considered the closest other precedent raising "a legal problem very similar to the problem now before [the Court])" and to its own Bilski and Benson opinions before arriving at a concern raised in Benson:  that "patent law not inhibit further discovery by improperly tying up the future use of laws of nature" (citing Benson, Flook, Bilski, and O'Reilly v. Morse).  Curiously, in view of the Chief Justice's recent statements on the general lack of usefulness provided by the legal academy, the opinion cites law review articles by Mark Lemley, Bohannan & Hovencamp, and Rebecca Eisenberg (whose "tragedy of the anticommons" is still anticipated 14 years after its possibility was perceived).  The Court recognizes that the laws of nature encompassed by the Prometheus claims are "narrow laws," but their transgression is that they "tie up the doctor's subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations" as well as "threaten to inhibit the development of more refined treatment recommendations (like that embodied in Mayo's test), that combine Prometheus' correlations with later discovered features of metabolites, human physiology or individual patient characteristics."  While these concerns seem to implicate claim scope as much as subject-matter eligibility, the Court seems content with making its decision on § 101 grounds.

The opinion does leave some room for hope (or for more artful patent claim drafting), stating that the Justices do not "now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them."  The "basic underlying concern" is that "these patents tie up too much future use of laws of nature."

Finally, the opinion considers and rejects the views of the Federal Circuit, Prometheus, the U.S. government, and relevant (and informed) amici such as the Biotechnology Industry Organization.  Regarding the Federal Circuit, any transformation associated with the "administering" step is "irrelevant" according to the opinion, since this step merely selects the group of patients "who are likely interested in applying the law of nature."  The Court also finds no transformation in the determining step, because such a step "could be satisfied without transforming the blood, should science develop a totally different system for determining metabolite levels that did not involve such a transformation."  In rejecting Prometheus' argument that the narrowness of the laws of nature encompassed by the claims argues in favor of patent-eligibility, the opinion states that "[c]ourts and judges are not institutionally well suited to making the kinds of judgments needed to distinguish among different laws of nature, . . . the cases have endorsed a bright-line prohibition" against patenting such laws per se.

The government's position is rejected by the Court because relying on the other sections of the patent statute to invalidate claims such as the Prometheus claim would turn § 101 into a "dead letter" and is inconsistent with the Court's prior precedent (which perhaps the government was trying to modify).  The Court also explicates its reasons why the other sections are not up to the task of policing the patent-eligibility question regarding laws of nature.

The last group of advocates whose views are rejected by the Court, amici with relevant experience, are counterbalanced by other amici, like the AMA and other medical groups, who advocate little or no patent protection to avoid "a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care."  In doing so, the Court finds more persuasive the opinions of consumers of this technology rather than its providers.  The Court also sees these differences of opinion as reflecting the "double-edged sword" of patent protection, reiterating Justice Breyer's long-standing opinion that too much patent protection is as bad as too little.

In the end, the Court suggests that those who disagree with their decision have recourse elsewhere:

[W]e must recognize the role of Congress in crafting more finely tailored rules where necessary.  Cf. 35 U.S.C. §§161–164 (special rules for plant patents).  We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.

Clearly suggesting little chance of a change of heart from the Court.

By Donald Zuhn —

Following the Supreme Court's unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., issued earlier today, in which the Court reversed the Federal Circuit and found Prometheus' claims to be invalid for "effectively claim[ing] underlying laws of nature," few organizations have thus far decided to issue public statements regarding the decision.  In fact, Patent Docs has received only two statements from organizations, each representing a different side of the issue.

In a statement by Dr. Robert Wah, Board Chair for the American Medical Association (AMA), the group welcomed the Supreme Court's decision invalidating Prometheus' patents.  Asserting that the Court had "prevented irreparable harm to patient care with today's unanimous decision to invalidate two patents that gave Prometheus Laboratories exclusive rights over the body's natural responses to illness and medical treatment," the AMA declared that the decision was "a clear legal victory that ensures critical scientific data remain widely available for sound patient care and innovative medical research."

Had the Court found the patents to be valid, the AMA argued that "physicians would have encountered a vast thicket of exclusive rights that would prevent them from considering all relevant scientific information when reviewing diagnostic test results."  The group also suggested that a finding of validity would have "inhibit[ed] future discoveries."

The AMA, together with the American College of Medical Genetics, the American Hospital Association, the American Society of Human Genetics, the Association of American Medical Colleges, the Association for Molecular Pathology, the Association of Professors of Human and medical Genetics, the College of American Pathologists, the Florida Hospital Association, the Minnesota Hospital Association, and the Minnesota Medical Association, submitted an amici curiae brief in support of Petitioners Mayo Collaborative Services and May Clinic Rochester.

The Biotechnology Industry Organization (BIO) viewed the Court's decision in a decidedly different light.  In a statement that the group distributed this afternoon, but had not yet posted to its website, Dr. Hans Sauer, BIO Deputy General Counsel for Intellectual Property, noted that BIO was "surprised and disappointed in the Court's decision, which disregarded the considered judgment of the Executive Branch experts and numerous amici such as BIO, who warned about the unintended consequences of attempting to use patent eligibility as a basis to strike down these patents for biomarker-based diagnostic methods."

While the group indicated that it was still analyzing the Court's opinion, BIO expressed "concern[] that it introduces new and confusing concepts into the traditional body of patent law, which patent examiners and lower courts will struggle to consistently and rationally implement."  In addition, BIO noted that "[w]hile the opinion's lack of guidance may limit its practical impact, we are troubled that the Court's opinion fails to appropriately recognize the importance of personalized medicine, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases."  The group ended its response to the decision by offering to "work with the Administration and the U.S. Patent and Trademark Office to ensure that the future application of this opinion does not irrationally restrict the ability of innovators to protect inventions that lead to cures, medical breakthroughs, and other technologies that make our lives and our environment cleaner, safer and healthier."

BIO submitted an amicus curiae brief in support of Respondent Prometheus Laboratories.

By Kwame Mensah —

In an opinion published earlier today, the Supreme Court unanimously held that claims directed to the relationship between the concentrations of blood metabolites and response to a therapeutic drug in two patents owned by Prometheus Laboratories, Inc. were unpatentable, stating that they "effectively claim the underlying laws of nature themselves."  This is a reversal of the Federal Circuit's decision, which held that the claims did indeed encompass patentable subject matter.

Prometheus Laboratories, Inc. (Prometheus) is the sole licensee of two patents (U.S. Patent Nos. 6,355,623 and 6,680,302) claiming methods for determining optimal dosages of thiopurine drugs used to treat gastrointestinal and non-gastrointestinal autoimmune diseases.  The patents generally claim methods reciting the steps of:  (a) administering a thiopurine drug to a subject, and (b) determining the levels of the drug or the drug's metabolites in red blood cells in the subject.  The measured metabolite levels are then compared to pre-determined metabolite levels, wherein measured metabolite levels in the patient that are outside the pre-determined range indicate a need to increase or decrease the level of drug to be administered so as to minimize toxicity and maximize treatment efficacy.

The Court sought to determine whether the claims did more than merely describe laws of nature.  It asked specifically, "do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?"  The Court generally focused its analysis on two specific cases:  Diamond v. Diehr, 450 U.S. 175 (1981) (granting claims which encompassed natural phenomena) and Parker v. Flook, 437 U.S. 854 (1978) (invalidating claims encompassing natural phenomena).  In analogizing the Prometheus claims to those in Flook, the Court stated that the steps recited in the claimed method “add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field" and thus, the claims encompassed non-patentable subject matter.

The general message conveyed by the Court seems to be two-fold.  First, if "the steps in claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field," such claims likely encompass non-patentable subject matter.  And second, the Court demonstrated general concern that "upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries."  How this message affects the thousands of existing patents in the field of personal medicine remains to be seen.  However, going forward, patent practitioners would be wise to revisit this ruling when drafting claims to medical diagnostic methods.

Patent Docs will provide a more detailed analysis of this decision in a subsequent post.

Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012)
Opinion by Justice Breyer