See CLASSEN IMMUNO v. BIOGEN IDEC
Issue(s): Was the district court’s application of the common-law exclusions from §101 of “laws of nature, natural phenomena, and abstract ideas” correct with regard to method of immunization claims comprising mental steps of selection, identification, and immunization?
CLASSEN IMMUNOTHERAPIES, INC., Plaintiff-Appellant, v. BIOGEN IDEC, et al. Defendant-Appellee, (2006-1634,-1649) Appeal from the United States District Court for the District of Maryland in Case No. 04-CV-2607, Judge William D. Quarles, Jr. (Decided: August 31, 2011); Before RADER(Author), NEWMAN, AND MOORE (dissenting),
Facts: This appeal reaches us on remand from the Supreme Court, the Court having vacated our decision in Classen Immunotherapies, Inc. v. Biogen IDEC, 304 F. App’x 866 (Fed. Cir. 2008), in view of the Court’s decision in Bilski v. Kappos, 561 U.S. ___, 130 S. Ct. 3218 (2010). We have received additional briefing, and now reconsider the appeal of the district court’s rulings, on motions for summary judgment, in Classen Immunotherapies, Inc. v. Biogen IDEC, No. WDQ-04-2607, 2006 WL 6161856 (D. Md. Aug. 16, 2006); 381 F. Supp. 2d 452 (D. Md. 2005).
The Court’s remand concerns the question of patent-eligibility, 35 U.S.C. §101, of the subject matter claimed in the Classen patents in suit. The question arises on the district court’s application of the common-law exclusions from §101 of “laws of nature, natural phenomena, and abstract ideas.”
In suit are three related patents, each entitled “Method and Composition for an Early Vaccine to Protect Against Both Common Infectious Diseases and Chronic Immune Mediated Disorders or their Sequelae”: United States Patents No. 6,638,739 (“the ’739 patent”), No. 6,420,139 (“the ’139 patent”), and No. 5,723,283 (“the ’283 patent”). The inventor is Dr. John Barthelow Classen, and the patents are assigned to Classen Immunotherapies, Inc. (“Classen”). The patents state Dr. Classen’s thesis that the schedule of infant immunization for infectious diseases can affect the later occurrence of chronic immune-mediated disorders such as diabetes, asthma, hay fever, cancer, multiple sclerosis, and schizophrenia, and that immunization should be conducted on the schedule that presents the lowest risk with respect to such disorders. The three patents state that Dr. Classen has discovered that “when one or more immunogens . . . is first administered at an early age (typically prior to 42 days of age), it can substantially decrease the incidence, frequency, prevalence or severity of, or prevent, at least one chronic immune mediated disorder, and/or a surrogate marker thereof.”
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. Classen states that “The patented method of the ’139 and ’739 patents is exemplified by Claim 1 of the ’739 patent.” Classen Br. 11. Claim 1 states:
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.
Classen states that the ’139 and ’739 patents are infringed when a health care provider reads the relevant literature and selects and uses an immunization schedule that is of lower risk for development of a chronic immune-mediated disorder. Classen states that the patents are infringed by the act of reviewing the published information, whether or not any change in the immunization schedule is made upon such review.
Classen states that the ’283 patent is infringed when a person reviews relevant information, whether the person is a producer of vaccines, a health care provider, or a concerned parent. Classen Br. 41 (“the infringer need only assess risk, it is not necessary for the infringer to conduct its own clinical trials or prove the cause of any adverse effects”). The ’283 patent claims do not include performing immunizations in accordance with the information learned by the claimed method.
Findings upon remand from SCOTUS: Now upon the Supreme Court’s ruling in Bilski v. Kappos that the machine-or-transformation test is not the sole standard of eligibility for patenting, we again review the district court’s decision, with the benefit of this court’s analyses of eligibility in Research Corporation Technologies, Inc. v. Microsoft Corporation, 627 F.3d 859 (Fed. Cir. 2010); Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010), cert. granted, _ S. Ct. _ , 2011 WL 973139 (June 20, 2011); and Association for Molecular Pathology v. U.S. Patent & Trademark Office, _ F.3d _, 2011 WL 3211513 (Fed. Cir. July 29, 2011).
The defendants argue that the Classen methods are directed to no more than the steps of reading published information, that the “determining” and “comparing” steps of the claims are performed in the mind, and that any immunizing step is simply conventional activity, citing the Court’s negation of the “notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process,” Parker v. Flook, 437 U.S. 584, 590 (1978).
Classen disputes this characterization, and argues that Dr. Classen discovered a method of immunizing that lowers the risk of chronic immune-mediated disease. Classen states that this method is not an abstract idea, but a new and useful application of a newly discovered scientific fact. Thus Classen argues that the method is within the statutory classes of patent-eligible subject matter. Classen also points to the subordinate claims that were not considered by the district court, that are directed to specific immunogens, specific immunization schedules, and specific immune-mediated disorders. Classen states that even if the representative claims are deemed to be unduly broad, other claims are more specific and cannot be characterized as “abstract.” Classen states that these other claims were not considered by the district court, and were improperly invalidated on summary judgment.
The district court held that none of the Classen claims meets the threshold under §101 of eligibility for patenting, reasoning that the method claimed in all three patents includes the mental step of reviewing the relevant literature to determine the lower-risk immunization schedule. The district court did not discuss whether the claims were anticipated or obvious in view of the prior art, and it appears that this aspect was not raised, in the district court, in the context of §101. However, precedent 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).
Classen states that its claims include physical steps of immunization, and are not entire “[s]ets of steps occurring only in the mind,” In re Sarkar, 588 F.2d 1330, 1333 (CCPA 1979). Classen argues that the immunization step is conducted after selection of a lower risk schedule, as in the ’139 and ’739 claims, or that immunization produces information about immunization effects, as in the ’283 claims. Thus Classen states that its claims are not directed to an abstract idea like the commodity hedging method in Bilski v. Kappos.
The claims of the ’139 and ’739 patents are directed to a method of lowering the risk of chronic immune-mediated disorder, including the physical step of immunization on the determined schedule. These claims are directed to a specific, tangible application, as in Research Corporation, and in accordance with the guidance of Bilski v. Kappos that “[r]ather than adopting categorical rules that might have wide-ranging and unforeseen impacts,” exclusions from patent-eligibility should be applied “narrowly,” 130 S. Ct. at 3229, we conclude that the subject matter of these two patents traverses the coarse eligibility filter of §101. Although, as we have remarked, the claims of these patents appear to raise cogent questions of substantive patentability, patentability of subject matter that is facially within the classes set forth in §101 is most reliably resolved in accordance with the conditions of §§102, 103, and 112.
Classen also argues that the claims of all three patents meet the machine-or-transformation test of this court’s vacated In re Bilski opinion, citing Prometheus Laboratories, supra, where this court held that “claims to methods of treatment . . . are always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” 628 F.3d at 1356. On the materially different facts in Prometheus and in the Classen specifications, the analogy is inapt, for the claims in Prometheus are for a method of controlling individualized dosages of a specific drug by measuring its metabolic products in the blood of individual patients, while the Classen patents operate on published information to determine general immunization schedules. The principles applied in Prometheus support the patent eligibility of the Classen claims that include such transformative steps, but are not relevant to claims that require no more than referring to known information but do not include immunization in light of that information.
We conclude that the immunization step moves the ’139 and ’739 claims through the coarse filter of §101, while the abstraction of the ’283 claim is unrelieved by any movement from principle to application. The principles applied in Prometheus support the patent eligibility of the Classen claims that include such transformative steps, but are not relevant to claims that require no more than referring to known information but do not include immunization in light of that information.
- ANTICIPATION BY PRIOR USE – 35 U.S.C. §102: There is no record, no factual findings or representations on which such findings might be made, indeed no basis for factual inferences, even on the premises of summary adjudication. Thus this question is not before us on this appeal.
- INFRINGEMENT A. Merck’s Motion for Summary Judgment: The district court granted Merck’s motion for summary judgment of non-infringement, on the ground that “[t]he only specific act of infringement alleged in Classen’s amended complaint was Merck’s participation in or facilitation of the 2001 study conducted by Dr. Frank DeStefano” for the Centers for Disease Control, and that “Merck offered uncontroverted evidence that it had no involvement in the DeStefano study.” Classen appeals, arguing that even if Merck did not “participate in or facilitate” the DeStefano study, Merck infringed the Classen patents when Merck “reviewed” the study and “evaluated the correlation” therein. We do not disturb the grant of summary judgment on the ground that no evidence of Merck’s involvement in this study was presented by Classen. The district court did not abuse its discretion in declining to consider Classen’s subsequent proffer of evidence, after summary judgment was granted.
- B. The “Safe-harbor” Provision, 35 U.S.C. §271(e)(1) Classen charged Biogen and GlaxoSmithKline with direct infringement on the ground that both companies participated in studies “to evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenza . . . and risk of developing type 1 diabetes; and to determine whether timing of vaccination influences risk.” The district court granted summary judgment that these activities are within the safe-harbor provision of the Hatch-Waxman Act.
Classen argues that the district court erred in its application of §271(e)(1). Classen states that this statute, as enacted and intended, and as judicially interpreted, is limited to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions, before patent expiration. GlaxoSmithKline and Biogen respond that their reporting of vaccine relationships, or recommendations in view of the relevant literature, or other activity in conformity with FDA regulations, are within the infringement safe-harbor of §271(e)(1). Classen states that the district court extended §271(e)(1) beyond its statutory and legislative purpose, for there is no issue in this case of submissions for regulatory approval of generic products, or like policy considerations.
Every decision examining the statute has appreciated that §271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration. The Court applied this limitation to medical devices in Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 671 (1990), stating that “[Section §271(e)(1)] allows competitors, prior to the expiration of a patent, to engage in otherwise infringing activities necessary to obtain regulatory approval.” The Court stated that activities “could not constitute infringement if they had been undertaken to develop information reasonably related to the development and submission of information necessary to obtain regulatory approval under the [Food, Drug, and Cosmetic Act].”
The court erred in its application of §271(e)(1) to the activities of Biogen and GlaxoSmithKline in providing vaccines, in advising on immunization schedules, and in reporting any adverse vaccine effects to the FDA. The judgment of noninfringement based on the safe-harbor of §271(e)(1) is vacated.
C. Study of the Classen Information: Classen’s position in the district court appears to have been that the Classen claims are infringed if the subject thereof is the subject of study, analysis, verification, or other scientific inquiry. As the district court remarked, Classen’s view of its claims appears to have been that they covered “thinking” about their subject matter. That is, of course, incorrect. The information in patents is added to the store of knowledge with the publication/issuance of the patent. An important purpose of the system of patents is to negate secrecy, and to provide otherwise unknown knowledge to the interested public.
Were such information prohibited from study until patent expiration, not only would the advance of science be slowed, but the design-around of patented subject matter would be inhibited, if not excluded, if a new design could not be derived from study of the old. Justice Story commented in Whittemore v. Cutter, 29 F. Cas. 1120, 1121 (C.C.D. Mass. 1813) (No. 17,600), that “it could never have been the intention of the legislature to punish a man, who constructed such a machine merely for philosophical5 experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects.” Such use of the information in the patent is not a violation of the patent, whereas “the making of a machine fit for use, and with a design to use it for profit, was an infringement of the patent right.”
The district court reported that Classen charges the defendants with infringement based on their participation in studies “to evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenza . . . and risk of developing type 1 diabetes; and to determine whether timing of vaccination influences risk.” Classen, 381 F. Supp. 2d at 455. The district court accepted the premise that such activities could be infringing, in deciding the defendants’ motions for summary judgment. Should the question arise on remand, the court may consider whether such a scientific investigation of the Classen position is subject to preclusion by the patentee, or is permissible under patent principles.
SUMMARY: The district court’s holding of ineligibility for patenting under §101 is reversed as to the claims of the ’139 and ’739 patents, and affirmed as to the ’283 patent. The judgment of non-infringement is affirmed as to Merck, and is vacated as to Biogen and GlaxoSmithKline insofar as based on §271(e)(1). Other claims, counterclaims, and defenses raised by complaint and answer were not decided by summary judgment, and are not before us on this appeal. We remand for appropriate further proceedings.
MOORE, Circuit Judge, dissenting. Respectfully, I must dissent from the majority opinion on several grounds. I believe that the claims at issue are to a fundamental scientific principle so basic and abstract as to be unpatentable subject matter and therefore I would affirm the district court’s grant of summary judgment of invalidity under § 101. Classen claimed a monopoly over the scientific method itself. I also dissent from the majority’s refusal to reach Merck’s appeal of the denial of its motion for summary judgment of anticipation. Instead, I would affirm because the district court properly concluded that summary judgment was improper where Merck failed to offer any proof that its prior use included one of the claim elements. Finally, I dissent from the majority’s analysis of infringement and its construction of the safe harbor provision under § 271(e)(1) which is contrary to the plain language of the statute and clear Supreme Court guidance.
Allen’s Observations: This is a wickedly difficult case created by a wickedly clever draftsman (kudos). It should never have been heard by just a panel on remand. Moreover, where one judge on the panel completely disagrees about what SCOTUS intended, there should be a moment of pause. Bilski is as much as useless in analyzing these claims because the claims are something of a tautology. Basically, the claims are to a “method” of how (and on whom) to use a treatment method. The fact that immunization is a medical procedure (i.e., treatment method) seems like a clever way to bootstrap these “method of using a method” claims into eligible subject matter. Much like a Beauregard claim, the fact that the end result is tangible does not really address what the claim is truly trying to encompass.
The really weird part of these claims is that infringement can only occur in treating a population, not in treating an individual. Normally, a medical method would infringe on any one patient you choose to perform it on. Here though if you immunize the entire population, then you do not infringe. However, if you immunize less than 100% of the population you could infringe. The only difference between infringing and not infringing is in the mental choice a doctor makes as to who gets treated. Mind-boggling stuff. No wonder the Europeans think our patent system is crazy.
