Eviscerating Patent-Eligibility of Drug Testing Methods: The Nonsensical Reasoning in the SCOTUS Prometheus Decision*

Well, Justice Breyer, the writer of the dissenting opinion in Laboratory Corp. v. Metabolite Laboratories, Inc., finally got his wish.  Writing the opinion for a unanimous Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., Breyer ruled that a claimed drug dosage calibration method based on previously unknown “precise correlations between metabolite levels [of administered thiopurine drugs] and likely harm or ineffectiveness” was patent-ineligible under 35 U.S.C. § 101 because it “adds nothing to the laws of nature that is not already present when the steps [of the claimed method] are considered separately.”  While I’m not surprised that Breyer ruled the claimed method patent-ineligible, his reasoning in Mayo Collaborative Services is, in my view, often nonsensical, and is fraught with unfortunate statements that could potentially eviscerate the patent-eligibility of drug testing methods (as well as related medical diagnostic methods) generally under 35 U.S.C. § 101.

Briefly, the claimed method in Mayo Collaborative Services determined (calibrated) the proper dosage of thiopurine drugs to treat both gastrointestinal and non-gastrointestinal autoimmune diseases.  What the claimed method sought to do was optimize therapeutic efficacy while minimizing toxic side effects.  The claimed method had essentially only two steps:  (1) administering a thiopurine drug to a patient; and (2) determining the level of metabolites of the drug in the patient after administration.  The claimed method also concluded with some “wherein clauses” that, if certain drug metabolites were below a certain level, that would indicate a need to increase the amount of the drug administered.  Conversely, if those drug metabolites were above a certain level, that would indicate a need to decrease the amount of the drug administered.  See CAFC: Method for Calibrating Drug Dosage Is Transformative.

The district court granted the alleged infringer’s (Mayo Collaborative Services’) motion for summary judgment of invalidity of this claimed drug dosage calibration method as being patent-ineligible under 35 U.S.C. § 101.  The Federal Circuit reversed the district court’s ruling twice, first before the Supreme Court’s decision in Bilski v. USPTO, then in a second decision after Bilski where the Supreme Court granted certiorari, vacated the first decision, and then remanded for reconsideration in view of the Supreme Court’s decision in Bilski.  The ruling by the Federal Circuit in the second decision essentially repeated the basis for the ruling in the first decision, namely that the claimed drug dosage calibration method was “transformative,” was therefore patent-eligible under 35 U.S.C. § 101, and further concluded that the Supreme Court’s decision in Bilski changed nothing in that respect.

In reversing the second decision by the Federal Circuit, Breyer’s opinion quotes the language of 35 U.S.C. § 101 for the first (and last time).  His opinion then proceeds to state the “implicit exception[s]” to this patent-eligibility provision, namely that “laws of nature, natural phenomena, and abstract ideas” are not patent-eligible.  He also states not much further on that “too broad an interpretation of this exclusionary principle could eviscerate patent law.”  So far, no disagreement with what Breyer’s opinion says.

But then Breyer’s opinion takes a decided turn for the worse.  Breyer refers to the claimed method as “purport[ing] to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects.”  Breyer then posed the patent-eligibility question for the claimed method thusly:  did the “claimed [methods] transform[] these unpatentable laws of nature into patent-eligible application of those laws.”  He concluded that “they have not done so and that therefore the [methods] are not patentable.”

In finding the claimed method to be patent-ineligible, Breyer’s first characterized the “administering step” as “simply refer[ring] to the relevant audience, namely doctors who treat patients with certain diseases with thiopurine drugs.”  Frankly, the “administering step” is more that as it determines what the metabolite will be for which the levels are being determined.  Second, Breyer characterizes the “wherein clauses” that identify what levels of the metabolite are too little or too much as “simply tell[ing] a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating his patient.”  Again, these “wherein clauses” are much more than “tell[ing] a doctor about the relevant natural laws,” and are at the crux of why the claimed method is unique.  Finally, Breyer characterizes the “determining step” as “tell[ing] the doctor to determine the level of the relevant metabolites in the blood, through whatever process the doctor or the laboratory wishes to use.”  True, but without determining what those metabolite levels are, the “wherein clauses” are meaningless.

Breyer summarizes this claimed method analysis by stating:

[T]he claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.  For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.

This statement is very problematical in at least a couple of respects.  First, the claimed method doesn’t simply “inform a relevant audience about certain laws of nature,” but instead tells that audience whether the levels of a specific metabolite found are too low or too high.  Second, that “any additional steps consist of well understood, routine, conventional activity” is likely true of most drug testing methods.  And while this statement might support the lack of patentability of the claimed method under 35 U.S.C. § 102 or 35 U.S.C. § 103 (as was urged by the U.S. Solicitor General), it is frankly inadequate, without more, to support patent-ineligibility under 35 U.S.C. § 101 of the claimed method as just covering a “law of nature.”

Breyer’s opinion then goes into a discussion of “controlling precedents [that] reinforces our conclusion” that the claimed method was patent-ineligible.  Dominating this discussion is the dichotomy created by the 1978 case of Parker v. Flook (method for adjusting alarm limits in catalytic conversion of hydrocarbons deemed patent-ineligible) on the one hand, and the 1981 case of Diamond v. Diehr (using the Arrhenius equation in claimed rubber molding method deemed patent-eligible) on the other.  Frankly, the discussion of this dichotomy by Breyer isn’t helpful in resolving the patent-eligibility of the claimed drug dosage calibration method.  Flook is based on the logically “flawed” view that a previously undiscovered “algorithm” is somehow part of the “prior art” (a view completely inconsistent with 35 U.S.C. § 103), as well as the nonsensical view that “post-solution activity” that is purely “conventional or obvious” cannot “transform an unpatentable principle into a patentable process” (which is also inconsistent with the concept of the invention “as a whole” expressed in 35 U.S.C. § 103).  By contrast, Diehr (in my opinion) is simply an effort by the Supreme Court to “minimize the damage” caused by the illogical reasoning in Flook that could have made the patenting of any process (or method) problematical under 35 U.S.C. § 101.  Going down the Flook–Diehr dichotomy road just makes the jurisprudential “quagmire” created by the Supreme Court on patent-eligibility issues worse.

Another beef I have with Breyer’s opinion is his overstated “concern that patent law  not inhibit further discovery by improperly tying up the future use of laws of nature.”  But the claimed drug dosage calibration method, which is specific to thiopurine drugs, in no way “[ties] up the future use of laws of nature.”  Indeed, his citation to O’Reilly v. Morse (where Samuel Morse discovered the electrical telegraph but then tried to claim any means for electrical communication) is “overkill” in the extreme with respect to this claimed drug dosage calibration method.
Even later in his opinion, Breyer raises a similar “horror story” by arguing that “the grant of patents that tie up [the use of discoveries, laws of nature, etc.] will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to ‘apply the natural law’, or otherwise forecloses more future invention than the underlying discovery could reasonably justify.”  But Breyer presents no data or evidence to support this supposed “horror story.”  Instead Breyer cites two law review articles, the first of which is authored by Lemley et al. and which supposedly “argues that [35 U.S.C.] § 101 reflects this kind of concern.”  So much for actual “facts” to support this supposed “horror story.”  This supposed “horror story” raised by Breyer is also pretty flimsy given that Mayo Collaborative Services didn’t “innovate” the claimed method in the first place (and contrary to what some amici disingenuously suggested, was a “for-profit” competitor of Prometheus, the patentee).

Far more troubling to me is the potential reaction by those researching, developing (and funding) such drug dosage calibration or other drug testing methods if the patent-eligibility bar is perceived as being raised too high by Mayo Collaborative Services.  Two potential reactions are possible, both of which would be a far greater impediment to innovation, as well as increasing the storehouse of scientific and technical knowledge for such drug testing methods.  One is that research, development (and funding) of drug testing methods will simply decrease if the investment in such testing cannot be protected (or is perceived to unprotectable) by patents.  (And without patents, there is no “disclosure to the public” of the drug testing methods being claimed.)  The other is that such research, development (and funding) of drug testing methods will continue to the extent that such methods can be viably protected as “trade secrets.”  And for universities engaged in researching such drug testing methods, and where “trade secrets” are not a viable option, making the patent-eligibility bar too high could be the “death knell” for such university research.

Running throughout Breyer’s opinion is another bothersome theme raised by several of the amici which is completely bogus:  the claimed method is trying to “patent thought.”  See, for example, Breyer’s assertion that the claimed method would “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.”  The trouble with this assertion is that it doesn’t reflect medical reality or what the claimed method actually covers.  The doctor is very unlikely to be the one determining the level of metabolites.  Instead, that doctor, after administering the drug, would most likely need a separate lab to determine the level of metabolites present in the blood sample supplied by that doctor.  And here’s the real kicker:  whatever the doctor does with (or thinks about) the metabolite levels determined by the lab doesn’t infringe the claimed method.  See also 35 U.S.C. §287(c) which immunizes a medical practitioner (and its related health care entity) from patent infringement for performance by the medical practitioner of a “medical activity.”

Another annoying spot in Breyer’s opinion is his response to the argument by the U.S. Solicitor General that the claimed drug dosage calibration method isn’t a patent-eligibility issue under 35 U.S.C. § 101, but is, instead, a patentability issue under either 35 U.S.C. § 102 or 35 U.S.C. § 103.  In fact, Breyer characterizes the U.S. Solicitor General’s argument as suggesting that 35 U.S.C. §§ 102, 103 & 112 should perform this initial “screening function” in place of 35 U.S.C. § 101.  (I frankly agree that it would be better approach, as do others, including Chief Judge Rader.)  But Breyer responds to this perceived approach by the U.S. Solicitor General as making “the ‘law of nature” exception to [35 U.S.C.] § 101 a dead letter.”  That’s simply not true.  For example, and using the Einstein E = mc² hypothetical posed by Breyer, a claim to this formula might satisfy 35 U.S.C. §§ 102, 103 & 112, yet still be “flunked” for patent-eligibility under 35 U.S.C. § 101 as covering merely a “law of nature.”

I’m particularly irked by Breyer’s snide remark early in his opinion that Supreme Court precedent “warns us against interpreting patent statutes in ways that make patent eligibility ‘depend simply on the draftman’s art’ without reference to the “principles underlying the prohibition against patents for [natural laws],” once more citing the logically flawed Flook case.  But that remark is a non-sequitur, given that 35 U.S.C. § 112, second paragraph, says that the invention is to be described (and defined) by “one or more claims” at the end of the patent specification.  If the “draftman’s art” cannot be used to turn a patent-ineligible “law of nature” into a patent-eligible application of that “law,” then what, pray tell, can be used?  Breyer’s further comment that such precedent “insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements” (which he says is sometimes referred as the “inventive concept”) is completely unhelpful.  After all, Breyer later in his opinion says “routine, conventional activity” won’t save a claimed process (or method) that otherwise is deemed to cover just a “law of nature.”

One thing I do agree with in Breyer’s opinion (and which is a major weakness is both Federal Circuit decisions) is that the “administering step” being “transformative” in terms of the drug being converted by the human body into the metabolites is essentially irrelevant to the patent-eligibility question under 35 U.S.C. § 101.  The claimed drug dosage calibration method is also problematical in relying upon a final “determining step” followed by “wherein clauses” that essentially provide the results of that “determining step,” as well as some “what ifs” about what those results mean.  After the Supreme Court’s ruling in Bilski, I was already concerned that such data-gathering “determining steps” might not push such drug testing methods, as well as other related diagnostic methods, into the “patent-eligible zone.”  In fact, in the companion case of Classen Immunotherapies, Inc. v. Biogen Idec, the claimed method which essentially calibrates an immunization schedule for a treatment group (relative to a control group) is now likely to be deemed patent-ineligible, especially in view of the Supreme Court’s ruling in Mayo Collaborative Services.

What Mayo Collaborative Services doesn’t address (at least not directly) is a claimed method that has the following additional step:  based on the metabolite levels in the “wherein clauses” showing either too much or too little thiopurine drug being administered, appropriately adjusting the dosage of thiopurine drug administered to patient.  Admittedly, such a claim might complicate the patent enforcement issue against a “for-profit” testing lab like Mayo Collaborative Services.  (An alternative additional step which indicates that the drug dosage should be appropriately adjusted might avoid this patent enforcement issue.)  But given Breyer’s unfortunate statements in his opinion that “routine, conventional activity” won’t save a claimed method that otherwise is deemed to cover just a “law of nature,” one must wonder whether even this additional “drug dosage adjusting step” would put the claimed method into the “patent-eligible zone.”

*© 2012 Eric W. Guttag.  Posted March 21, 2012 on IPWatchdog.com