By Kevin E. Noonan —

The Federal Circuit majority decision in Classen Immunotherapies, Inc. v. Biogen IDEC engendered a strong dissent from Judge Moore on almost every aspect of that decision.  Judge Moore disagreed with the majority's opinion that the claims were patent-eligible, that the issue of inherent anticipation was not properly before the Court, and that certain activities by defendant GlaxoSmithKline fell within the "safe harbor" provisions of 35 U.S.C. § 271(e)(1).  While all of her arguments warrant consideration, the importance of the question of patent-eligibility (particularly in view of Judge Moore's role in Association for Molecular Pathology v. U.S. Patent & Trademark Office, aka the Myriad case) compels this part of her dissenting opinion be discussed first.

Judge Moore contends in her dissent that the claims in all of the patents-in-suit are ineligible because they are directed to a "fundamental scientific principle" and are "so basic and abstract" as to provide "a monopoly over the scientific method itself."  The dissenting opinion begins by comparing the claims at issue here with the claims in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, agreeing with the majority that the Prometheus claims were "inapt"; the opinion disagrees with the majority's conclusion because, in Prometheus the Court provided a detailed analysis that distinguished the Prometheus claims from the principles enunciated in the earlier In re Grams case, and requires the conclusion that the transforming step (administering 6-thiopurine) was not a mere data gathering or insignificant post-solution activity, concluding that the administration step in the Prometheus claims "not preempt broadly the use of [the] natural correlation, but rather recited specific treatment steps with specific drugs."

In contrast, Judge Moore (at left) contends in her dissent that the majority gave "no consideration of the extent of preemption by these staggeringly broad and abstract claims" in the instant case.  This included no specificity for treatment steps, "drugs" (including immunogens) or ("even") specific chronic immune disorders.  In addition, the dissent fails to discern the distinctions between the claims of the '283 patent that the majority found patent-ineligible and the claims of the '139 and '739 patents that the majority find patent-eligible.  In Judge Moore's analysis, claim 1 of the '283 patent has two steps:  immunizing mammals according to a schedule and comparing the incidence of chronic immune mediated disorder (CIMD) to a control group:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

(In a footnote, she says that she is "perplexed" that the majority sees this as reciting one step, when she clearly sees two, i.e., the immunizing step and the comparison step).  She contrasts this with claim 1 of the '739 patent, which she says requires the steps of "comparing the incidence of [CIMD] between two groups of mammals . . . immunized according to different schedules and immuniz[ing] a mammal according to the lower risk schedule":

1.  A method of immunizing a mammalian subject which comprises:
    (I)  screening a plurality of immunization schedules, by

        (a)  identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and
        (b)  comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),

    (II)  immunizing said subject according to a subject immunization schedule, according to which at least one of said infectious disease-causing organism-associated immunogens of said lower risk schedule is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

She sees "virtually no difference" between the claims with regard to the § 101 analysis:  immunizing and then comparing (the '238 patent) versus comparing and immunizing (the '139 and '739 patents).

For Judge Moore, "this case is not even close" regarding patent-eligibility.  In her view, the '283 patent "claims the scientific method as applied to the field of immunization," since there are no limits on "the type of drug used to immunize[], the schedules that should be used for immunization, the type of [CIMD] to look for, or any limitation on the control group":

It is hard to imagine broader claims.  It is harder to imagine a more conceptually abstract claim in the immunization area.  Classen's claims are directed to a thought apart from any concrete realities, specific objects or actual instances.  This is very much like patenting E=mc².  Compare any two schedules to determine which one has fewer instances of immune disorders.  Compare two substances to determine which one tastes sweeter.  Compare two cups of coffee to determine which one is stronger.  Actually these examples are more concrete than the Classen claims in that I tell you what to look for — sweetness or strength.  The Classen claims do not even specify which immune disorder should be studied.  Likewise the representative claim from the '139 and '739 patents specifies no specific immune disease, drug, or schedule.  These claims cover any kind of comparison between any two schedules, using any drugs and comparing the incidence of any chronic immune disease.  After the user performs this completely abstract mental comparison, then the user should immunize the subject with the drug they choose on the schedule they deem lower risk.

Citing Diamond v. Diehr for the principle that claims must be considered as a whole, Judge Moore also opines that these claims are "exactly the type of 'abstract intellectual concepts' that 'are the basic tools of scientific and technological work,'" citing Gottschalk v. Benson, 408 U.S. 63, 67 (1972).  And she rejects the idea that the claims are patent-eligible because they are limited to a single field of use, citing Parker v. Flook as cited with approval in Bilski v. Kappos, 130 S. Ct. 3218, 3230 (2010).

In Judge Moore's view, the very simplicity of the claims (requiring only two steps, immunizing and comparing regardless of the order), mandates the conclusion that they impermissibly preempt a fundamental principle, which the dissent illustrates with scenarios of infringement.n  The opinion contends that "any researcher seeking to investigate new immunogens or immunization schedules relevant to chronic immune-mediated disorders would infringe," as would a doctor who "immuniz[es] a patient and compar[es] the patient's outcome to another patient's" (regarding the '283 patent) or "compar[es] well known schedules and then immuniz[es] according to the one he thinks best" (regarding the '739 patent).  Even a patient could be jointly liable for infringement, the opinion suggests, if the patient receives an immunization and then "wonder[s]" why a friend got sick even though he got the same immunization (this is a reach).  Even Judge Moore realizes there are "[m]any other examples, more absurd than the last" that could be envisioned — for her this is additional evidence that the claims should not be eligible for patenting.  In words reminiscent of Justice Frankfurter in Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), the claim's principal defect is that:

Having discovered a principle — that changing the timing of immunization may change the incidence of chronic immune mediated disorders — Classen now seeks to keep it for himself.

Compare:

Insofar as the court below concluded that the packaging of a particular mixture of compatible strains is an invention and as such patentable, I agree, provided not only that a new and useful property results from their combination, but also that the particular strains are identifiable and adequately identified.  I do not find that Bond's combination of strains satisfies these requirements.  The strains by which Bond secured compatibility are not identified and are identifiable only by their compatibility . . .  [The patentee] appears to claim that since he was the originator of the idea that there might be mutually compatible strains and had practically demonstrated that some such strains exist, everyone else is forbidden to use a combination of strains whether they are or are not identical with the combinations that Bond selected and packaged together.  It was this claim that, as I understand it, the District Court found not to be patentable, but which, if valid, had been infringed . . . The consequences of such a conclusion call for its rejection.  Its acceptance would require, for instance in the field of alloys, that if one discovered a particular mixture of metals, which when alloyed had some particular desirable properties, he could patent not merely this particular mixture but the idea of alloying metals for this purpose, and thus exclude everyone else from contriving some other combination of metals which, when alloyed, had the same desirable properties.  In patenting an alloy, I assume that both the qualities of the product and its specific composition would need to be specified.  The strains that Bond put together in the product which he patented can be specified only by the properties of the mixture.

Id. at 133-34.

In Judge Moore's view, because the '283 patent claims "the use of the scientific method to study the incidence of [CIMD]," the entire field of study is preempted, which "prevents any investigation into any immunogen, known or unknown, and to any disease, known or unknown, over any period of time."  Again citing Gottschalk, the dissent concludes that this is the same as patenting "the idea itself."

The dissent also cites (somewhat unfortunately) Justice Breyer for the idea that patent law "seeks to avoid the dangers of overprotection just as surely as it seeks to avoid the diminished incentive to invent that underprotection can threaten," Laboratory Corp. v. Metabolite Labs., Inc. ("LabCorp"), because if Classen's claims are patent-eligible "nobody else can search for new immunogens, for use of new immunizations, to treat either existing or currently unknown chronic immune-mediated disorders without infringing."  Returning to the language of Parker v. Flook, the dissent characterizes the immunizing step recited in the '283 claim as "mere data-gathering" and compares the immunization step in claim 1 of the '739 patent with "updating the alarm limit" in Flook as insignificant post-solution activity."  In doing so, the dissent apparently ignores the distinction that Flook involved an algorithm for resetting the alarm limit, and that the Court was concerned with permitting patent protection for a purely mathematical formula.  Ironically, the dissent then cites the very portion of the Supreme Court opinion that illustrates this distinction:

The notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance.  A competent draftsman could attach some form of post-solution activity to almost any mathematical formula; the Pythagorean theorem would not have been patentable, or partially patentable, because a patent application contained a final step indicating that the formula, when solved could be usefully applied to existing survey techniques.

For Judge Moore, it appears that Classen's claims are similar to the claims in LabCorp, and that her reasoning parallels Justice Breyer's that "one can reduce any process to a series of steps.  The question is what those steps embody.  And here, aside from the unpatented test, they embody only the correlation between [immunization and the chronic immune-mediated disorder] . . . that the researchers uncovered," citing LabCorp, 548 U.S. at 137-38.

The dissent characterizes this case as "illustrat[ing] the challenge our patent system faces 'in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles," citing Bilski.  And that is an analytical error, because Judge Moore (and some Supreme Court Justices) seems to consider invention to be continuous, in that "someone would otherwise have discovered any invention 'by independent, creative application of general principles.'"  However, the only honest assessment of this statement can be "maybe," because invention tends to be sporadic and "lumpy" rather than continuous.  In addition, the sentiment removes the temporal element:  yes, someone may discover the same invention using these "general principles," but then the question is, when?  There are many inventions that seem self-evident once they are arrived at that are not arrived at as quickly or as timely as would be expected — hence the phrase "why didn't I think of that?"  Finally, even if this other mythical inventor would arrive at the same invention "by independent, creative application of general principle" in a timely fashion (i.e., at about the same time as the patentee), prohibiting patent protection disincentives disclosure of the invention (particularly in view of the soon to be enacted "prior user rights "provisions of the Leahy-Smith America Invents Act).  Judge Moore believes that the inventor here (and ones like him) "are not without incentives to innovate in this area," setting forth a variety of potential alternative inventions that could be claimed ("a method of treating a chronic immune-mediated disorder by using a new and specific immunization schedule" or "new therapeutic immunogens which were identified as potential compounds of interest" or (even) "specific testing methods to assay and explore his new discovery").  While Judge Moore is concerned with the inventor choosing instead to claim "the study of" immunization schedules and their relationship to CIMD, and that this is thus too broad to be patent-eligible, her dissent ignores the alternative that the correlation is valuable in itself and potentially protectable as a trade secret, with equally (or greater) deleterious effects on "the Progress of Science and the Useful Arts."  This is not to say that the Classen claims are not overbroad, just that the "blunt tool" of patent-eligibility may not be the best implement to restrict their scope.

Nevertheless, Judge Moore ultimately believes that the claims embody a law of nature and thus are not patent-eligible:  "[w]hen, as here, the claims so clearly offend the constitutional imperative to promote the useful arts, where they preempt all application of a principle or idea, it is entirely appropriate to hold them unpatentable subject matter before reaching anticipation, obviousness, or any other statutory section that might also prove invalidity."  And the step of immunizing post rather than ante that the majority uses to distinguish the claims of the '283 patent from the '139 and '739 patents is unpersuasive, since in her view the claims nonetheless preempt the "scientific method" for discovering the correlation between immunization schedule and CIMD.

Turning to the § 102 issue, Judge Moore believes that Merck had provided "alternative grounds for affirming" the District Court, and she believes the Court should have considered them.

Regarding infringement and whether the activities of some of the defendants fell within the ambit of the "safe harbor" provisions of 35 U.S.C. § 271(e)(1), Judge Moore believes that the scope of the safe harbor is broader than simply "pre-approval" activities, citing Merck KGAA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), for an expansive reading of the statute.  In doing so, Judge Moore focuses on the several times the Merck opinion emphasized that the statute provided a safe harbor against infringement liability for "all" activities related to submitting information under "any" federal law regulating "the manufacture, use, or distribution of drugs."  For Judge Moore, this interpretation includes activities related to post-approval activities, such as monitoring drugs to detect adverse event.  This is a textual argument, sounding very much like the arguments used by the Supreme Court in deciding not only Merck v. Integra but many other statutory construction cases (including, for example, Stanford v. Roche earlier this summer).  However, the dissent draws a distinction between post-approval activities that do not fall within the safe harbor, specifically where "[defendants] are not required by law or regulation to perform such post-approval vaccinations in order to generate data," which are thus not "reasonably related to the development and submission of data to the FDA and therefore do not fall within § 271(e)(1)'s safe harbor exception."  Thus, the dissent would have vacated dismissal of Counts I, II, and IV against GlaxoSmtithKline and Biogen and remanded to the District Court.

Judge Moore's dissent illustrates the difficulties the Federal Circuit, and the Supreme Court, can have with drawing the distinctions between patent-eligible and patent–ineligible claims.  Part of this difficulty has to do with the vagaries of claim drafting, and (frankly) the expansive scope for these claims advanced by the inventor.  Perhaps the Court would have had less difficulty if the claims were drawn to specific activities informed by the correlation rather than focusing on methods for developing the correlation in the first place; for example:

For the '283 patent claim:

A method for immunizing a mammal with a vaccine effective in provoking a desired immune response in the mammal, according to an immunization schedule that minimizes chronic immune-mediated disorder or the incidence, severity, prevalence or frequency thereof, wherein said immunization schedule is produced by a) immunizing a treatment group of mammals with one or more doses of one or more immunogens according to a first immunization schedule, and b) determining whether the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, is higher or lower than the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder that occurs when a control group of mammals is immunized with said one or more doses of one or more antigens according to a second, control immunization schedule, and
immunizing said mammal according to said first immunization schedule when the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder is lower in said first immunization schedule than in said control immunization schedule.

For the '739 patent claim:

1.  A method of immunizing a mammalian subject with a vaccine specific for an infectious disease-causing organism, the method comprising:
    (I) immunizing each of a plurality of treatment groups of mammals with an vaccine effective in provoking a desired immune response according to a plurality of immunization schedules; and
    (II) immunizing said mammalian subject according to the immunization schedule in step (i) that produces the lowest incidence, prevalence, frequency or severity of a chronic immune-mediated disorder in said treatment groups.

Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011)
Panel:  Chief Judge Rader and Circuit Judges Newman and Moore
Opinion for the court by Circuit Judge Newman; additional views by Chief Judge Rader; dissenting opinion by Circuit Judge Moore