Classen v. Biogen: CAFC Tries To Target Patent Eligibility But Misses


Ryan Chirnomas, Partner in the Biotechnology group at Westerman, Hattori, Daniels and Adrian, sent in this article discussing the Court of Appeals for the Federal Circuit’s recent Classen v. Biogen decision.  He highlights the key points of the decision and why he believes this case is a missed opportunity to clarify the machine-or-transformation test of Bilski.

Not long after issuing opinions in AMP v. USPTO and Prometheus v. Mayo, the CAFC has again taken on the difficult questions of patent eligible subject matter in Classen v. Biogen.  In 2008, the CAFC issued a three-sentence non-precedential opinion holding that Classen’s claims do not recite patent eligible subject matter.  This decision was appealed to the Supreme Court and subsequently remanded to the CAFC after the Supreme Court’s Bilski decision.  The instant decision includes a discussion of patent-eligible subject matter, as well as the safe harbor exception to infringement of pharmaceutical patents.  This discussion is limited to questions of patent eligible subject matter.  This decision relates to three patents:  U.S. Patent Nos. 6,638,739 (“the ‘739 patent”), 6,420,139 (“the ‘139 patent”) and 5,723,283 (“the ‘283 patent”).

The technology in question relates to an association between a schedule of immunization against various infectious diseases, and the later occurrence of other diseases.  Particularly, Dr. Classen found that immunizing a child for infectious diseases such as measles and mumps prior to 42 days of age can reduce the occurrence of chronic diseases such as diabetes and asthma.  The following claim is representative of the ‘139 patent and the ‘739 patent:

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.

The following claim is representative of the ‘283 patent:

1. 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.

Thus, the ‘139 and ‘739 claims recite a method including analysis followed by immunization based on the information learned in this analysis.  On the other hand, the ‘283 claim recites immunization, and then performing an analysis based on this immunization.

Majority Opinion:  Newman

The majority opinion, written by Judge Newman, reaches a different conclusion for the ‘139 and ‘739 claims as it does for the ‘283 claim.  Based on Classen’s arguments in support of a finding of infringement, the majority decision interpreted the ‘139 and ‘739 claims such that they are infringed when a doctor reviews relevant information and then uses a particular immunization schedule, even if the immunization schedule used is the same as that considered prior to the review of the relevant information.

Meanwhile, even though the first step of the ‘139 and ’739 claims does not include “immunizing”, the majority regards the ‘283 claim as reciting the first step of the method recited in the ‘139 and ‘739 claims.  Also based on Classen’s arguments in support of a finding of infringement, the majority decision interpreted the ‘283 claims as being infringed merely when risk is assessed, and stated that actual immunization is not including an immunization step required.  Crucially, the majority interprets the ‘139 and ‘739 claims as requiring two steps, and interprets the ‘283 claims as requiring only a single claim.

Biogen argued that the claimed methods recite only reading published information (“identifying…”), thinking about what to do (“comparing…”) and carrying out conventional immunization activities.  Citing Parker v. Flook, Biogen argued against the “notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process.”  On the other hand, Classen argued that the claims do not recite an abstract idea, but rather a new and useful application of a new scientific discovery.

Throughout the opinion, Judge Newman repeatedly indicates that §101 should be a “coarse filter” for analyzing “categories” of patent eligibility, but that §§112, 102 and 103 should be heavily relied upon, since they provide the substantive “conditions” of patent eligibility.  In this sense, Judge Newman seems eager to analyze the claims based on §§112, 102 and 103, but not based on §101, as was encouraged in Research Corporation v. Microsoft.  In Research Corporation, the CAFC held that “inventions with specific applications or improvements to technologies in the marketplace are not likely to be so abstract that they override the statutory language and framework of the Patent Act.”  In other words, the CAFC held that if an invention has a specific application, it passes the coarse filter of §101, even though it might ultimately fail to be patent eligible due to the requirements of §§112, 102 and 103.

In view of this, the majority states that the ‘139 and ‘739 claims, which are regarded as including a physical step of immunization, meet the requirements of §101 because they are directed at a “specific, tangible application.”  The majority thus concludes that these claims recite patent-eligible subject matter, but again reiterates that they might be invalid for failing to meet the requirements of §§112, 102 or 103.  The majority opinion provides no comments about whether the physical immunizing step of the ‘139 and ‘739 claims are central to the claims, or whether they merely recite extra-solution activity.

With respect to the ‘283 claim, the majority regards the claims as reciting “the idea of” comparing known immunization results, but not claiming “using this information” for immunization purposes.  In other words, the majority regards the ‘283 claim as merely collecting and comparing known information.  In particular, the majority states that the “immunizing” step in this claim is merely gathering of published data, but the “immunizing” step of the ‘139 and ‘739 claims is a physical immunization.  As noted above, the majority regards the ‘283 claim as reciting a single step, which is apparently regarded as a mental step.

The majority then distinguishes over Prometheus v. Mayo, stating that an analogy to that case is relevant where there is a transformative step (as the majority sees in the ‘139 and ‘739 claims), but is not relevant where the claims lack a transformative step (as the majority sees in the ‘283 claim).  Accordingly, the majority concludes that the ‘139 and ‘739 claims pass the “coarse filter” of §101, but the ‘283 claim does not.

Dissent:  Moore

Judge Moore, who was a panel member on cases involving this issue in AMP v. USPTO and Prometheus v. Mayo, offers a strong dissent of Judge Newman’s majority opinion.  In particular, Judge Moore notes that in Prometheus, a multi-step analysis was done—deciding whether there was a transformative step, then deciding whether any transformative steps are mere data gathering or extra-solution activity, then determining whether the claims preempt other applications of the natural correlation.  The dissent correctly notes the lack of any such analysis in the majority opinion in this case.

Moreover, Judge Moore indicates that she sees no distinction between the comparing-then-immunizing claims of the ‘139 and ‘739 patents and the immunizing-then-comparing claim of the ‘283 patent.  Judge Moore also states that she is “perplexed” by the majority decision’s interpretation that the ‘283 claim only recites a single step, arguing that this holding is based on a mischaracterization of Classen’s arguments.  Judge Moore states that the ‘283 patent “clearly and unequivocally” requires the physical act of immunization.

Judge Moore is deeply troubled by the fact that the claims do not relate to a specific disease, a specific drug, or a specific immunization schedule, stating that it is “hard to imagine broader claims.”  Citing Gottschalk v. Benson, Judge Moore raises the issue of these claims pre-empting the “idea” of the immunization-disease correlation from being applied to other activities of researchers, doctors and patients not contemplated by Classen.  In short, Judge Moore views all of the claims as reciting the use of the scientific method to study the incidence of chronic immune mediated disorders.

In Judge Moore’s analysis, both types of claims recite a transformative step.  However, the immunizing step of the ‘139 and ‘739 patents is insignificant post-solution activity, while the immunizing step of the ‘283 patent is merely data gathering.  As such, these transformative steps are insufficient to make the immunization-diseases correlation principle patent eligible.

Finally, Judge Moore criticizes the majority opinion, particularly with respect to its reliance on Research Corporation and the question of whether there is a specific application in the marketplace.  Judge Moore notes that cases such as Bilski and Flook had functional and palpable commercial applications, yet were not regarded as reciting patent-eligible subject matter.  Judge Moore notes that the majority has not presented a sufficient test, and ignores the possibility of broad preemption by claims such as those presented in Classen.

“Additional Views”:  Rader and Newman

In an unusual move, Judges Rader and Newman drafted a separate opinion to explain their “additional views.”  This is neither a dissent nor a concurrence, but rather is commentary on §101 as it applies to broader issues of patent law and innovation.  Judges Rader and Newman express frustration with claim drafting which is purely for the sake of avoiding §101 problems, giving Swiss-type claims and Beauregard claims as examples.  Judges Rader and Newman dismiss these strategies as “language games” which increase the cost of litigation and patent prosecution.

Furthermore, Judges Rader and Newman seem to advocate diminishing the focus on §101, as it creates a non-substantive obstacle to patent protection.  In their view, §§112, 102 and 103 should bear most of the burden of screening out non-patentable subject matter, while §101 should screen only that subject matter which is blatantly outside of the broad categories of patent-eligible subject matter.  Finally, these additional views close with commentary that current practices of emphasizing §101 give rise to the above-mentioned “language games,” which in their view could stifle innovation and drive emerging technologies to develop more quickly outside of the United States.

Take-Away Message

Since Classen is exploring the outer boundaries of patent-eligible subject matter, the lessons from the case will be somewhat limited in practical application.  However, this case serves as an important reminder of the fact that patents are granted for inventions, not for discoveries.  To this point, it is important to include at least some claims which recite specific applications of whatever principle is underlying the invention.  In this case, such specific applications would include claims reciting particular diseases, schedules, dosages, etc.  Claims such as these would not suffer from the pre-emption problems which were raised by Judge Moore.

Additionally, this case serves as a reminder that it may be useful to include an “action” step after any step of determining, comparing, etc.  In this case, the immunizing step in the ‘139 and ‘739 claims was such an action step, which saved those claims from failing to pass through the coarse filter of §101, at least in the eyes of the majority.

More generally, this case is a missed opportunity to clarify the machine-or-transformation test of Bilski.  In the majority opinion, Judge Newman recognized a transformative step in the ‘139 and ‘739 claims, but did not explain why the transformative step was not considered extra-solution activity, and thus apparently was considered as being central to the claims.  As for Judge Moore, she regarded both claim types as reciting transformative steps which were either data-gathering or extra-solution activity, but provided little commentary as to why such steps were data-gathering or extra-solution activity, respectively.  Perhaps when the Supreme Court hears the Prometheus case in the coming year, some guidance on this point will be provided.


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