Classen Immunotherapies  v. Biogen et al (CAFC 2006-1634, -1649) precedential; Judges Rader (chiming in), Newman (author), Moore (dissent)

The three patents contain a total of 230 claims. The summary judgment proceedings were directed to the "representative claims" selected by Classen. The claims of the '139 and '739 patents state the method whereby information on immunization schedules and the occurrence of chronic disease is "screened" and "compared," the lower risk schedule is "identified," and the vaccine is "administered" on that schedule.

The majority found '283 not patentable subject matter, but the claims of '139 and '739 §101 eligible. Judge Moore, in dissent, comparing claims of '283 and '739 (as representative of both '139 and '739):

There is virtually no difference between these two claims for the purposes of our § 101 analysis. One involves immunizing and then comparing ('283 patent); the other comparing then immunizing ('739 patent).

While I confess the precise line to be drawn between patentable subject matter and abstract idea is quite elusive, at least for me, this case is not even close. In the '283 patent, Classen claims the scientific method as applied to the field of immunization. No limitations exist on the type of drug to immunize with, the schedules that should be used for the immunization, the type of chronic immune disorder 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.

To determine whether a claim is directed to patentable subject matter, we must look to the whole claim. Diamond v. Diehr, 450 U.S. 175, 192 (1981). These claims do nothing more than suggest that two immunized groups be compared to determine which one is better. These are exactly the type of "abstract intellectual concepts" that "are the basic tools of scientific and technological work." Gottschalk v. Benson, 409 U.S. 63, 67 (1972). Classen cannot escape the fundamental abstractness of his claims by limiting them to a single field of use - immunization - since "the prohibition against patenting abstract ideas cannot be circumvented by attempting to limit the use . . . to a particular technological environment." Bilski v. Kappos, 130 S. Ct. 3218, 3230 (2010) (citations omitted) (internal quotation marks omitted); id. at 3231 ("Flook established that limiting an abstract idea to one field of use . . . did not make the concept patentable.").

Although "[t]he line between a patentable 'process' and an unpatentable 'principle' is not always clear," Parker v. Flook, 437 U.S. 584, 589 (1978), Classen's claims clearly cross that line. That Classen seeks to preempt the field is readily apparent as his claims require only two steps: immunizing and comparing. Of course any researcher seeking to investigate new immunogens or immunization schedules relevant to chronic immune-mediated disorders would infringe. But a doctor might also infringe the '283 patent claim by immunizing a patient and comparing the patient's outcome to another patient's. Or a doctor could infringe the '739 patent claim by comparing well known schedules and then immunizing according to the one he thinks best. A patient might be liable for joint infringement by receiving an immunization, and then wondering why their friend got sick when he got the same immunization. Many other examples, each more absurd than the last, spring to mind, any one of which would result in infringement.

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. In the '283 patent, he accomplishes this goal by claiming the use of the scientific method to study the incidence of chronic immune mediated disorders. This preempts the field of study, and prevents any investigation into any immunogen, known or unknown, and to any disease, known or unknown, over any period of time. Where, as here, a patent preempts an idea, a basic building block of science, within a field of study, the patent in practical effect is a patent on the idea itself. Gottschalk, 409 U.S. at 72.

The intent and effect of the Classen claims is clear: to keep others from exploring the same principle. "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." Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 127 (2006) (Breyer, J., dissenting from dismissal of petition). Extending patent protection here would "severely interfere with, or discourage, development and the further spread of useful knowledge itself." Id. at 128. To wit, nobody else can search for new immunogens, for use of new immunizations, to treat either existing or currently unknown chronic immunemediated disorders without infringing.

Classen did not invent the immunological response measured in his claim, and the discovery of this phenomenon alone "cannot support a patent unless there is some other inventive concept in its application." Flook, 437 U.S. at 594. Classen's whole '283 patent claim is to the use of the scientific method by immunizing groups and comparing results. The immunization step in the '283 patent is nothing more than a data gathering step necessary to explore the effects of different immunization schedules. Classen's whole '739 patent claim is to compare any two schedules for any drug and choose the one with fewer incidence of any chronic immune disease and then immunize. The immunization step of the '739 patent, like updating the alarm limit in Parker v. Flook, 437 U.S. 584 (1978), is nothing more than post-solution activity. As the Supreme Court explained:

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.

Id. at 590. Similarly, claim 1 of the '739 patent is not directed to patentable subject matter. The post-solution immunization does not transform the unpatentable principle - that a correlation exists between vaccination schedules and incidence of chronic immune disease - into a patentable process.

In the end, Mr. Classen's claims seek to monopolize the process of discovery itself, albeit limited to a single field. Our patent system, however, does not award a monopoly that precludes others from using the basic procedures of scientific investigation to study the same phenomenon. See Bilski, 130 S. Ct. at 3253 (Stevens, J., concurring) (Patents on laws of nature, natural phenomena, and abstract ideas "would stifle the very progress that Congress is authorized to promote."). Ultimately, the exceptions to patentable subject matter germane to this case rest on the "fundamental understanding that they are not the kind of 'discoveries' that the statute was enacted to protect." Flook, 437 U.S. at 593. When, 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.

Tying an abstract idea to a tangible result or a specific field of endeavor does not make the idea any less abstract. Bilski, 130 S. Ct. at 3230. "To hold otherwise would allow a competent draftsman to evade the recognized limitations on the type of subject matter eligible for patent protection." Diamond, 450 U.S. at 192. The scientific method is an abstract idea, fundamental to all scientific inquiry, and must be a tool reserved to all men, regardless of its specific application. No one is entitled to patent using the scientific method to discover a cure for a newly discovered disease - undeniably a tangible result - merely because they discovered the disease itself. Classen's claims readily illustrate that linking a natural phenomenon or abstract idea to a useful or practical result is no barrier for a competent patent drafter attempting to monopolize unpatentable subject matter.

But that was nothing more than the musings of an idealistic young jurist in dissent, perhaps telling the world what the court really thought. The fix was in from sages more invested in the system. Judge Newman in stem-winder mode, with enough hot air to float any balloon, just like Supreme Court rulings:

A. The §101 Threshold

The statement of patent-eligible subject matter has been substantially unchanged since the first Patent Act in 1790. As now codified:

§101. 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.

Interpretation of this provision early reached the courts in the context of charges of infringement, where the parties disputed the scope available to the patent. In 1839 Justice Story referred to patents as "securing to the whole community great advantages from the free communication of secrets, and processes, and machinery, which may be most important to all the great interests of society, to agriculture, to commerce and to manufactures, as well as to the cause of science and art," Blanchard v. Sprague, 3 F. Cas. 648, 650 (C.C.D. Mass. 1839) (No. 1518) (Story, J.), and also explained that "a claim for an art or principle in the abstract, and not for any particular method or machinery," is "utterly unmaintainable in point of law," Wyeth v. Stone, 30 F. Cas. 723, 727 (C.C.D. Mass. 1840) (No. 18,107) (Story, J.). In Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852), the Court reiterated that "A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right."

These principles, based on the statute and elaborated in the common law of patents, continue to be reinforced. In Diamond v. Chakrabarty, 447 U.S. 303 (1980), the Court considered the new concepts and capabilities of the biological sciences, and stated:

The subject-matter provisions of the patent law have been cast in broad terms to fulfill the constitutional and statutory goal of promoting "the Progress of Science and the useful Arts" with all that means for the social and economic benefits envisioned by Jefferson. Broad general language is not necessarily ambiguous when congressional objectives require broad terms.

Id. at 315. Concurrently, the Court was considering the evolving fields of computer science and technology, and observed that while the exclusion from patentability of abstract principle and fundamental truth is well established in the common law, the boundary between abstract principle and practical application may vary with the subject matter. Thus in Diamond v. Diehr, 450 U.S. 175 (1981), the Court stated that "[i]t is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection," id. at 187. The Court explained in Diehr that "Arrhenius' equation is not patentable in isolation, but when a process for curing rubber is devised which incorporates in it a more efficient solution of the equation, that process is at the very least not barred at the threshold by §101." Id. at 188.

These principles have steadfastly guided the patent law, and in Bilski v. Kappos the Court reiterated its concern for "barr[ing] at the threshold," id., and encouraged preservation of the legal and practical distinctions between the threshold inquiry of patent-eligibility, and the substantive conditions of patentability. The Court explained:

The §101 patent-eligibility inquiry is only a threshold test. Even if an invention qualifies as a process, machine, manufacture, or composition of matter, in order to receive the Patent Act's protection the claimed invention must also satisfy "the conditions and requirements of this title." §101. Those requirements include that the invention be novel, see §102, nonobvious, see §103, and fully and particularly described, see §112.

130 S. Ct. at 3225.

The Court in Diehr also discussed the statutory meaning of "new" in §101 as compared with "new" in §102; the former being a general statement governing the threshold of entry into the patent system for further consideration, the latter setting the conditions and limitations of patentable novelty:

It has been urged that novelty is an appropriate consideration under §101. . . . Section 101, however, is a general statement of the type of subject matter that is eligible for patent protection "subject to the conditions and requirements of this title." Specific conditions for patentability follow and § 102 covers in detail the conditions relating to novelty. The question therefore of whether a particular invention is novel is "wholly apart from whether the invention falls into a category of statutory subject matter."

450 U.S. at 189-190 (quoting In re Bergy, 596 F.2d 952, 961 (CCPA 1979)). The Court recognized the separation of the §101 "categories" of eligible subject matter from the §102 "conditions" of patentability, explaining that "rejection on either of [§102 or 103] does not affect the determination that respondents' claims recited subject matter which was eligible for patent protection under §101," id. at 191. We apply this distinction to the Classen patents, and conclude, as we shall discuss, that the '139 and '739 claims cross this threshold, while the '283 claims do not state a patent-eligible process.

Here the going gets woolier...

B. Mental Steps

[P]recedent has recognized that the presence of a mental step is not of itself fatal to §101 eligibility, and that the "infinite variety" of mental and physical activity negates application of a rigid rule of ineligibility. See Application of Prater, 415 F.2d 1393, 1402 n.22 (CCPA 1969).

The Court in Bilski v. Kappos did not define "abstract," and Justice Stevens observed in concurrence that "[t]he Court, in sum, never provides a satisfying account of what constitutes an unpatentable abstract idea," 130 S. Ct. at 3236. Acknowledging the difficulty of providing such an all-purpose definition, this court in Research Corporation stated that

this court also will not presume to define "abstract" beyond the recognition that this disqualifying characteristic should exhibit itself so manifestly as to override the broad statutory categories of eligible subject matter and the statutory context that directs primary attention on the patentability criteria of the rest of the Patent Act.

627 F.3d at 868.

Abstraction is like pornography - a judge only knows it when s/he sees it. To keep the party hardy, what the courts seek to avoid is anything less than "liberal encouragement."

The distinction between a concrete, physical step of a process claim, as compared with data gathering or insignificant extra-solution activity, warrants specific consideration in the context of evolving technologies, for "Congress took [a] permissive approach to patent eligibility to ensure that 'ingenuity should receive a liberal encouragement.'" Bilski, 130 S. Ct. at 3225 (quoting Chakrabarty, 447 U.S. at 308, in turn quoting Thomas Jefferson). The Bilski Court emphasized the "expansive terms" of §101 as evidence of the intent "that the patent laws would be given wide scope," id. (quoting Chakrabarty, 447 U.S. at 308). Thus the Court rejected the Federal Circuit's proposal in Bilski that the "machine-or-transformation" test should be the exclusive test for patent-eligible processes, and emphasized the classical "three specific exceptions to §101's broad patent-eligibility principles: 'laws of nature, physical phenomena, and abstract ideas.'" Id. (quoting Chakrabarty, 447 U.S. at 309). The Court reaffirmed the proposition that "the prohibition against patenting abstract ideas 'cannot be circumvented by attempting to limit the use of [a] formula to a particular technological environment' or adding 'insignificant postsolution activity.'" Id. at 3230 (quoting Diehr, 450 U.S. at 191-92).

In conclusion, Judge Newman makes a rare descent into gibberish ("pragmatic thoroughness..."), which is designed to let courts rule as they wish, case by case.

Viewing the representative claims of the Classen patents in accordance with their purported scope, we conclude that the claims of the '139 and '739 patents reasonably meet the threshold of §101 eligibility, and that analysis of the subject matter of these claims, and other claims in these patents, should proceed by way of the statutory criteria of patentability. Pragmatic thoroughness is thereby achieved, for extensive precedent guides the continuum from abstractness to specificity, in the context of a vast breadth of subject matter. Aided by this experience, courts may more readily resolve close questions such as are here presented.

Judge Rader concurred, playing to the larger issues, ultimately addressing plutocratic protection - doing his bit to help large corporations.

Excluding categories of subject matter from the patent system achieves no substantive improvement in the patent landscape... In addition to gamesmanship, eligibility restrictions increase the expense and difficulty in obtaining a patent. By creating obstacles to patent protection, the real-world impact is to frustrate innovation and drive research funding to more hospitable locations. To be direct, if one nation makes patent protection difficult, it will drive research to another, more accommodating, nation.

Judge Rader's remarks are musings beyond his pay grade and comprehension. No company makes large-scale investment decisions based upon national patent regime. If so, the software industry would be in Europe. The inappropriateness of such irrelevance to lawful adjudication is astounding. It signals Rader's rationalized corruption, as well as his arrogance and stupidity. The courts are supposed to enforce the law by interpretation, not architect industrial policy, but that is how the CAFC is behaving.

What is going on here is the ruse called "justice." Courts don't like to foreclose their options for later cases. The majority want to leave the door open to patent eligibility, as the Supreme Court does on most rulings, with its gauzy pronouncements on conceptual issues, while ruling narrowly.

There is strong indication that the Classen patents will be killed in due time by prior art. The majority ruling thus leaves the §101 door ajar, knowing that Classen's patents will be eliminated more directly by Obzilla (§103).

This ruling highlights a sharp contrast between Chief Judge Rader and his predecessor, Chief Judge Michel. Michel was fond of rigid rules, which, while providing clear metrics for lower courts, repeatedly got swatted at the Supreme Court. Rader is more comfortable with adjudicative corruption, bent to corporate desires, and its attendant appearance of fuzziness, all the while fixing outcomes, like the best of mob bosses.