Just as all of us have slowly started to absorb the implications of the remand in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, as well as the triumvirate of opinions in Association for Molecular Pathology (AMP) v. USPTO, on the standard for patent-eligibility under 35 U.S.C. §101, the Federal Circuit (finally) issued its long awaited (by some of us) remand decision in Classen Immunotherapies, Inc. v. Biogen IDEC. That there was a majority (and a dissenting) opinion in the remand of Classen wasn’t surprising. But that there was yet a third “additional views” opinion would likely not have been predicted by anyone. And it is that “additional views” opinion, along with the majority and dissenting opinions, that will certainly generate a “firestorm” through the Federal Circuit, and which may eventually reach the Supreme Court. The judicial donnybrook on the question of what the standard is (or should be) for patent-eligibility under 35 U.S.C. §101 is about to begin in earnest.
As my fellow patent attorney, Kevin Noonan, poignantly says on Patent Docs, the Classen remand decision “[couldn’t] be more different from the Federal Circuit’s earlier decision.” That earlier decision (with Judges Moore and Newman on the panel), which came out not long after the Federal Circuit’s famous (and some would say “infamous”) en banc Bilski decision, is astounding for its brevity (one paragraph of 69 words), or as Kevin also poignantly observed, the claimed method was longer than the opinion by 20 words. As I also commented when that earlier opinion came out, it was ghastly for completely failing to explain how the “new” Bilski “machine or transformation” test was applied to the claimed method. See CAFC: Method for Calibrating Drug Dosage is Transformative.
Compared to the “nanomeric” earlier decision (which was also deemed “non-precedential”), the Classen remand decision is a veritable treatise (and very precedential one at that) at a “robust” 57 pages. Briefly, Classen involved three related patents (the ‘739 patent, the ‘139 patent, and the ‘283 patent) directed generally to a method for essentially evaluating an immunization schedule for a treatment group, relative to a control group. But where the ‘739 and ‘139 patents differ from the ‘283 patent is in how this immunization schedule calibration method is claimed (and which became a contentious issue between Judge Newman and Chief Judge Rader in the majority, and Judge Moore in the dissent). In the ‘283 patent, this immunization schedule method is claimed simply as “immunizing” the mammals in the control group according to the immunization schedule and then “comparing” the “incidence, prevalence, frequency or severity of [the] chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.” (As my patent attorney brother Mark has astutely observed, how the method is claimed in the ‘283 patent leaves much to be desired because it never says what “end result” is caused by this claimed method). By contrast, the ‘739 and ‘139 patents start out similarly to the ‘283 patent in defining the claimed method initially as “screening a plurality of immunization schedules” by “identifying” first and second groups of mammals, “immunizing” the first and second groups by different immunization schedules, and then “comparing” the effectiveness of the different immunization schedules. (A side note: the “comparing” step also recites that the “screened immunization schedules may be identified as a lower risk and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing [the] chronic immune mediated disorder(s),” which raises another “can of worms” with regard to the underlined word, also noted by my brother Mark, as to whether the 739 and ‘139 patent claims would even pass muster under 35 U.S.C. §112, second paragraph.) But where the claimed methods of the ‘739 and ‘139 patents part company with the ‘283 patent is in an additional “immunization” step which is carried out on a “subject” by using the “lower risk” immunization schedule (characterized by the majority opinion as the “optimum schedule”) that resulted from the initial “screening” step. (Or to use my brother Mark’s words, we now have an “end result” caused by the “immunization” step of the method claimed in the ‘739 and ‘139 patents.)
The district court ruled (on summary judgment) that the claimed methods in all three patents were invalid as being patent-ineligible under 35 U.S.C. §101, stating that these claims “describe little more than an inquiry of the extent of the proposed correlation between vaccines and chronic disorders.” As Judge Newman and Chief Judge Rader were to lament in their respective majority and “additional view” opinions, the district court’s haste in ruling the claims in these three patents invalid based solely on 35 U.S.C. §101 created a sparse factual record, and particularly an appeal record bereft of questions relating to other “substantive criteria of patentability” under 35 U.S.C. §§ 102, 103, and 112. In fact, Judge Newman and Chief Judge Rader freely acknowledged that these claims “may not meet the substantive criteria” of one or more of other patent statutes (see my comment above relative to the “may” recitation in the claims of the ‘739 and ‘139 patents). But in an additional collective judicial “sigh,” Newman and Rader observed that these other questions of “patent validity are not before us on this appeal,” and “the only motion for summary judgment under these substantive provisions was based on prior use” asserted by the accused infringer (Merck) which “was denied by the district court because facts were in dispute,” such a denial “not [being] appealable.”
The majority opinion by Judge Newman (joined by Chief Judge Rader) provides an excellent summary of the case law history on determining patent-eligibility under 35 U.S.C. §101 and its predecessor statutes. Of significant note in this majority opinion was its emphasis on the stated concern from the Supreme Court’s Opinion of the Court in Bilski v. Kappos about “barr[ing] at the threshold [inquiry of patent-eligibility]” and thus “encouraging preservation of legal and practical distinctions between the threshold inquiry of patent-eligibility and the substantive conditions of patentability [as reflected in 35 U.S.C. §§ 102, 103, and 112].” Newman’s opinion then followed with a discussion of “mental steps” (which the district court also asserted were present in invalidating the method claims of the three patents), and that the mere “presence of a mental step is not of itself fatal” to patent-eligibility under 35 U.S.C. §§ 101. Newman’s opinion also refreshingly restated the caution from Chief Judge Rader’s 2010 opinion in Research Corporation Technologies, Inc. v. Microsoft Corporation that “claims must be considered as a whole when determining eligibility to seek patentability,” and which “described the statutory role of [35 U.S.C.] § 101 as a ‘coarse eligibility filter’, not the final arbiter of patentability.”
Judge Newman’s majority opinion then dug into the language of claims of the three patents (something which Judge Moore should have done but didn’t). Judge Newman especially noted the significant difference between what was claimed in the ‘739 and ‘139 patents, versus what was claimed in the ‘283 patent (a “not so subtle” difference unfortunately completely lost upon Judge Moore who said “I see no distinction between the ’283 claims and ‘139 and ‘739 claims which warrants differing treatment”). As Judge Newman astutely observed, the ‘283 claims of the patent “stand in contrast the ’139 and ’739 patent claims, which include the subsequent step of immunization on an optimum schedule.” With that significant difference in mind, Judge Newman’s opinion ruled that the ’139 and ’739 patent claims passed the “threshold inquiry” for patent-eligibility under 35 U.S.C. §101, while those of the ‘283 patent did not.
In the verbiage of Judge Newman’s opinion for why the ’139 and ’739 patent claims passed the “threshold inquiry,” while those of the ‘283 patent did not, resides the following “kernel of truth”: “The ‘283 [patent] do not include putting this knowledge [of immunization schedules] to practical use, but are directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases” (emphasis added). (Judge Newman also paid homage to the Prometheus remand in noting that the “immunization”step in the ‘739 and ‘139 patent claims was also “transformative.”) Could Judge Newman have been making an oblique reference to the discarded “tangible, concrete, and useful result” test? Perhaps, but as Judge Newman certainly realized, she was barred from a direct reference by Federal Circuit precedent, namely their en banc decision in In re Bilski.
An unfortunate “casualty” from the Federal Circuit’s en banc decision in Bilski (besides the inane “machine or transformation only” test) was dumping the “tangible, concrete, and useful result” test for judging patent-eligibility. Frankly, the “tangible, concrete, and useful result” is the only objective test for judging patent-eligibility that has been articulated by any court. All other efforts to define patent-eligibility are phrased in terms of “exceptions” (e.g., it can’t be merely “an abstract idea, natural phenomena, or discovery of a law of nature”), and ultimately reduce down to a subjective “I know it when I see it” standard. Now that the Supreme Court has said in its Bilski v. Kappos decision that the “machine or transformation” isn’t the exclusive test for patent-eligibility, the Federal Circuit would be wise to take that as a “cue,” and bring back the “tangible, concrete, and useful result” test (call it a “standard” if you need to avoid the potential taint of “inflexibility” that has unfortunately been inflicted by the Supreme Court on such tests) pronto before the “fiery furnace” of 35 U.S.C. §101 gets any hotter. And an en banc rehearing in the Classen remand (which appears likely) would be the perfect vehicle to do so.
The “plot” in the Classen remand truly “thickened” with the “additional views’ opinion authored by Chief Judge Rader (also joined by Judge Newman). To put it mildly, the Chief Judge “let it all hang out” (and rightly so) by essentially castigating the “rising number of challenges under 35 U.S.C. §101.” For example, Rader (somewhat sarcastically) observes that:
Subject matter eligibility under section 101 has become the “substantive due process” of patent law – except that reading non-procedural requirements into the constitutional word “process” has more historical and contextual support than reading abstractness into the statutory word “process” because Title 35 already contains ample protections against vague claims.
Amen to that observation by the Chief Judge!
Even more astute are Rader’s observations on the “unintended implications” of patent-eligibility under 35 U.S.C. §101 being used as a “coarse filter that excludes entire areas of human inventiveness from the patent system on the basis of judge-created standards.” One such “unintended implication” is what the Chief Judge refers to as “claim drafting evasion,” which he characterizes (accurately) as adding “to the cost and complexity of the patent system and may cause technology research to shift to countries where protection is not so difficult or expensive.” Rader also gives two good examples of such “claim drafting evasion,” one of U.S. vintage called “Beauregard claims” (“devised to draft around restrictions on software imposed [in the Supreme Court’s 1972 decision] in Gottschalk v. Benson,” a monstrosity of an opinion based on the all too apparent technological ignorance of the Supreme Court), the other of European vintage called “Swiss-style claims” (to “draft around restrictions on medical treatment methods imposed by the European Patent Convention,” which creates some really bizarre claim language, typically in the form of “the use of a compound X for the manufacture of a medicament for the treatment of disease Y”). As Rader adroitly (and in my opinion, correctly) notes, these “claim drafting evasion” techniques are spurred by “our national innovation policy tak[ing] on characteristics of rewarding gamesmanship.”
While the Federal Circuit has certainly been a “culprit” in creating this “gamesmanship,” the ultimate “villain” in this “tragedy” is our Judicial Mount Olympus, the Supreme Court. See Through the Fuzzy Bilski Looking Glass: The Meaning of Patent-Eligible under 35 U.S.C. §101. Starting with Gottschalk v. Benson in 1972, and ending with Bilski v. Kappos in 2010, our Judicial Mount Olympus has primarily hurled destructive thunderbolts at the Federal Circuit, and its predecessor, the Court of Customs and Patent Appeals (CCPA), on what is the appropriate standard for determining patent-eligibility under 35 U.S.C. §101, thus forcing us “mere mortal” patent attorneys and agents to resort to such “gamesmanship” described by Chief Judge Rader to protect (appropriately in my view) the rights of our clients. The Supreme Court has now so “mucked up” the patent-eligibility standard in its Bilski v. Kappos decision that we “mere mortals” are left with no objective definition to work with of what an “abstract idea” is (the only point I agree with in Justice Stevens concurring, and in actuality, dissenting opinion in Bilski v. Kappos). No amount of smirking, arrogance, or reveling in their technological ignorance can hide the fact that the Supreme Court has failed (miserably in my view) in rendering any “order” out of the “chaos” of what is the appropriate standard for patent-eligibility under 35 U.S.C. §101.
The remand in Prometheus is now before the High Court. The likelihood is that the remand the decision in Classen, as well as the decision in AMP, will end up there as well. The High Court would do well to “humble itself,” cast aside its thunderbolts (and arrogance), listen to those who are technologically savvy (and know quite a bit more about patent law), and especially pay close attention to the majority and “additional views” opinions by Judge Newman and Chief Judge Rader in the Classen remand. The time for smirking and arrogance is OVER when it comes to rendering “order” out of the “chaos” that the patent-eligibility standard has now become. And please IMMEDIATELY resurrect the objective “tangible, concrete, and useful result” test for judging patent-eligibility under 35 U.S.C. §101 before hell truly descends on all of us “mere mortals” below.
*© 2011 Eric W. Guttag.