Classen Immunotherapies Inc. v. Idec

• Decision Date: 30 November 2011
• Docket Number: Nos. 2006–1634,2006–1649.,s. 2006–1634
• Parties: CLASSEN IMMUNOTHERAPIES, INC., Plaintiff–Appellant,v.BIOGEN IDEC, Defendant–Appellee,andGlaxoSmithKline, Defendant–Appellee,andMerck & Co., Inc., Defendant–Cross–Appellant,andChiron Corporation, Kaiser–Permanente, Inc., Kaiser Permanente Ventures, Kaiser Permanente International, Kaiser Permanente Insurance Company, the Permanente Federation, LLC, the Permanente Company, LLC, the Permanente Foundation, the Permanente Medical Group, Inc., Kaiser Foundation Hospitals, Kaiser Foundation Added Choice Health Plan, Inc., and Kaiser Foundation Health Plan Inc., Defendants.
• Court: U.S. Court of Appeals — Federal Circuit

659 F.3d 1057

100 U.S.P.Q.2d 1492

CLASSEN IMMUNOTHERAPIES, INC., Plaintiff–Appellant,

v.BIOGEN IDEC, Defendant–Appellee,andGlaxoSmithKline, Defendant–Appellee,andMerck & Co., Inc., Defendant–Cross–Appellant,andChiron Corporation, Kaiser–Permanente, Inc., Kaiser Permanente Ventures, Kaiser Permanente International, Kaiser Permanente Insurance Company, the Permanente Federation, LLC, the Permanente Company, LLC, the Permanente Foundation, the Permanente Medical Group, Inc., Kaiser Foundation Hospitals, Kaiser Foundation Added Choice Health Plan, Inc., and Kaiser Foundation Health Plan Inc., Defendants.

Nos. 2006–1634

2006–1649.

United States Court of Appeals, Federal Circuit.

Aug. 31, 2011.Rehearing En Banc Denied Nov. 30, 2011.*

Joseph J. Zito, Zito tlp, of Washington, DC, for plaintiff-appellant.Donald R. Ware, Foley Hoag LLP, of Boston, Massachusetts, for defendant-appellee, Biogen IDEC. With him on the brief were Barbara A. Fiacco and Jeremy A. Younkin. Of counsel were Joshua M. Hiller, Wilmer Cutler Pickering Hale and Dorr LLP, of Boston, Massachusetts, and David A. Wilson, of Washington, DC.George F. Pappas, Covington & Burling LLP, of Washington, DC, for defendant-appellee, GlaxoSmithKline. With him on the brief were Jeffrey B. Elikan and Kevin B. Collins. Of counsel was Scott C. Weidenfeller.

Mary B. Graham, Morris, Nichols, Arsht & Tunnell, LLP, of Wilmington, DE, for defendant-cross appellant. With her on the brief was James W. Parrett, Jr. Of counsel on the brief were Robert L. Baechtold, Fitzpatrick, Cella, Harper & Scinto, of New York, NY; and Edward W. Murray and Mary J. Morry, Merck & Co., Inc., of Rahway, NJ.Before RADER, Chief Judge, NEWMAN, AND MOORE, Circuit Judges.Opinion for the court filed by Circuit Judge NEWMAN. Additional views filed by Chief Judge RADER, in which Circuit Judge NEWMAN joins. Dissenting opinion filed by Circuit Judge MOORE.NEWMAN, Circuit Judge.

This appeal reaches us on remand from the Supreme Court,¹ the Court having vacated our decision in Classen Immunotherapies, Inc. v. Biogen Idec, 304 Fed.Appx. 866 (Fed.Cir.2008), in view of the Court's decision in Bilski v. Kappos, 561 U.S. ––––, 130 S.Ct. 3218, 177 L.Ed.2d 792 (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.” Diamond v. Diehr, 450 U.S. 175, 185, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981). The district court granted summary judgment that all of the claims in the Classen patents are ineligible for patenting because they are directed to the “abstract idea” that there is a relation between the infant immunization schedule for infectious diseases and the later occurrence of chronic immune-mediated (non-infectious) disorders. We review the question of eligibility with the Court's guidance in Bilski v. Kappos that “[r]ather than adopting categorical rules that might have wide-ranging and unforeseen impacts,” exclusions from patent-eligibility should be considered in view of the particular case and applied narrowly. 130 S.Ct. at 3229.

We conclude that the claimed subject matter of two of the three Classen patents is eligible under § 101 to be considered for patenting, although we recognize that the claims may not meet the substantive criteria of patentability as set forth in § 102, § 103, and § 112 of Title 35. However, questions of patent validity are not before us on this appeal, for the only motion for summary judgment under these substantive provisions was based on prior use asserted by defendant Merck, and was denied by the district court because facts were in dispute. Denials of summary judgment are not appealable.

The district court granted summary judgment that the claims are not infringed, based on Classen's failure to allege facts sufficient to establish infringement by Merck, and based on the safe-harbor provision of 35 U.S.C. § 271(e)(1) as to other defendants. We affirm the judgment as to Merck. However, since § 271(e)(1) is not applicable to the cited activities, we vacate the judgment that was granted on this ground.

We now consider the issues on appeal and cross-appeal.

ISubject Matter Eligibility—35 U.S.C. § 101

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.

'283 patent col.7 ll.35–41; '739 patent col.7 ll.39–45; '139 patent col.7 ll.35–41.

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. 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:

[T]he '139 and '739 patents in suit are directly infringed when a physician, hospital or other health care provider reads the relevant literature and selects an immunization schedule and immunizes a patient in accordance with the schedule which appears to have minimal risk.

Classen Br. 22. 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 Br. 41 (“maintenance of the current schedule is step (II) of the Classen method”).

The '283 patent claims the first step of the above method, by reviewing and comparing published information on the effects of immunization schedules in treated and control groups of mammals, with respect to the occurrence of immune-mediated disorders. Claim 1 was designated as 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.

Classen states that the '283 patent is infringed when a person reviews relevant information, whether the person is a producer...