Classen Immunotherapies, Inc. v. Biogen Idec

United States Court of Appeals
for the Federal Circuit
__________________________

CLASSEN IMMUNOTHERAPIES, INC.,
Plaintiff-Appellant,
v.
BIOGEN IDEC,
Defendant-Appellee,
and
GLAXOSMITHKLINE,
Defendant-Appellee,
and
MERCK & CO., INC.,
Defendant-Cross-Appellant,
and
CHIRON 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.
CLASSEN IMMUNO v. BIOGEN IDEC 2

__________________________

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
___________________________

JOSEPH J. ZITO, Zito tlp, of Washington, DC, for plain-
tiff-appellant.

JOSHUA M. HILLER, Wilmer Cutler Pickering Hale and
Dorr LLP, of Boston, Massachusetts, for defendant-
appellee, Biogen IDEC. On the brief were DAVID B.
BASSETT, of New York, New York, and DAVID A. WILSON,
of Washington, DC.

GEORGE F. PAPPAS, Covington & Burling LLP, of
Washington, DC, for defendant-appellee, GlaxoSmith-
Kline. 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, Delaware, for defendant-cross appel-
lant. 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, New
York; and EDWARD W. MURRAY and MARY J. MORRY,
Merck & Co., Inc., of Rahway, New Jersey.
__________________________
3 CLASSEN IMMUNO v. BIOGEN IDEC

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 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 sum-
mary 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
(1981). The district court granted summary judgment
that all of the claims in the Classen patents are ineligible

1 Classen Immunotherapies, Inc. v. Biogen IDEC,
561 U.S. ___, 130 S. Ct. 3541 (2010) (GVR). GVR is a
procedure whereby the Court, having decided an issue in
another case, Grants, Vacates, and Remands “for the sake
of judicial economy—so that the lower court can more
fully consider the issue with the wisdom of the interven-
ing development.” United States v. Norman, 427 F.3d
537, 538 n.1 (8th Cir. 2005) (citing Lawrence v. Chater,
516 U.S. 163, 167–68, 174 (1996)).
CLASSEN IMMUNO v. BIOGEN IDEC 4

for patenting because they are directed to the “abstract
idea” that there is a relation between the infant immuni-
zation 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 pat-
entability 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 judg-
ment as to Merck. However, since §271(e)(1) is not appli-
cable to the cited activities, we vacate the judgment that
was granted on this ground.
We now consider the issues on appeal and cross-
appeal.

I
5 CLASSEN IMMUNO v. BIOGEN IDEC

SUBJECT 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 Immunothera-
pies, Inc. (“Classen”). The patents state Dr. Classen’s
thesis that the schedule of infant immunization for infec-
tious 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 sched-
ule 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 admin-
istered at an early age (typically prior to 42 days
of age), it can substantially decrease the inci-
dence, frequency, prevalence or severity of, or pre-
vent, 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 occur-
rence 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
CLASSEN IMMUNO v. BIOGEN IDEC 6

patented method of the ’139 and ’739 patents is exempli-
fied 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 sched-
ules, 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 accord-
ing to a first screened immunization schedule, and
the second group of mammals having been immu-
nized with one or more doses of one or more infec-
tious disease-causing organism-associated
immunogens according to a second screened im-
munization 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 pro-
tecting against or inducing a chronic immune-
mediated disorder in said first and second groups,
as a result of which one of said screened immuni-
zation 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 disor-
der(s),
7 CLASSEN IMMUNO v. BIOGEN IDEC

(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 im-
mune-mediated disorder(s) than when said im-
munogen was administered according to said
higher risk screened immunization schedule.
Classen states that the ’139 and ’739 patents are in-
fringed 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 in-
fringed when a physician, hospital or other health
care provider reads the relevant literature and se-
lects an immunization schedule and immunizes a
patient in accordance with the schedule which ap-
pears to have minimal risk.
Classen Br. 22. Classen states that the patents are
infringed by the act of reviewing the published informa-
tion, 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 informa-
tion 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:
CLASSEN IMMUNO v. BIOGEN IDEC 8

1. A method of determining whether an immuni-
zation schedule affects the incidence or severity of
a chronic immune-mediated disorder in a treat-
ment 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 immuno-
gens, according to said immunization schedule,
and comparing the incidence, prevalence, fre-
quency 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 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 infor-
mation learned by the claimed method.
The three patents list over four hundred references
related to immunization schedules, the occurrence of
immune-mediated disorders, and various studies and
reports in this field. For example, the patents cite a
publication entitled “The Swedish Childhood Diabetes
Study: Vaccinations and Infections as Risk Determinants
for Diabetes in Childhood,” L. Blom et al., Diabetologia,
34(3):176-81 (1991); this publication states that: “The
possible association between viral diseases and diabetes
has also prompted an interest in vaccinations as possible
risk factors for diabetes,” id. at 176, and describes “a
nationwide incident case referent study [where] we have
evaluated vaccinations, early and recent infections and
9 CLASSEN IMMUNO v. BIOGEN IDEC

the use of medicines as possible risk determinants for
Type 1 (insulin-dependent) diabetes mellitus in child-
hood.” Id. The study concludes:
When vaccinations were considered as possible
risk factors for diabetes, a significant decrease in
relative risk estimated as odds ratio (OR) was
noted for measles vaccination . . . . In conclusion,
a protective effect of measles vaccination for Type
1 diabetes in childhood is indicated as well as a
possible causal relationship between the onset of
the disease and the total load of recent infections.
Id. The Classen patents acknowledge that this study
“suggested that vaccination against measles may influ-
ence a reduction in the incidence of diabetes,” but criticize
the study for the asserted absence of controls.
The Classen patents list several publications of
Huang et al., including “The Effect of Pertussis Vaccine on
the Insulin-Dependent Diabetes Induced by Streptozoto-
cin in Mice,” Pediatric Research, vol. 18, No. 2, pp. 221-
226 (1984). This reference was cited by the patent exam-
iner under §102 (anticipation) during prosecution of
Classen’s parent application, but the rejection was with-
drawn on Classen’s argument that the claims require
vaccination before 42 days from birth, as distinguished
from the schedule used by Huang. Classen wrote to the
examiner:
Claims 2, 3, 6, 7, 9-14, 16 and 33 are rejected as
anticipated by Huang et al. (1984), which al-
leged[ly] discloses both immunization against per-
tussis by administering a pertussis immunogen at
45, 55, 59 and 85 days of life (see p. 221), and re-
duction in the incidence of diabetes.
CLASSEN IMMUNO v. BIOGEN IDEC 10

Huang et al. (1984) cannot anticipate claims 2,
3, 6, 7, 9-14 and 16 because his first administra-
tion was to mice which were 45 days old, and
claim 3 (the independent claim) requires a first
administration before 42 days from birth.
Appl. Ser. No. 08/104,529, Attorney Letter, Nov. 21, 1996,
at 21-22.
The district court was not asked, in the summary
judgment phase, to consider the effects of these and other
references on the substantive conditions of patentability.
The Classen patents state that “prior to the present
invention, chronic immune mediated diseases, such as
diabetes mellitus, were not considered vaccine complica-
tions.” ’283 patent col.3 ll.54-56; ’139 patent col.3 ll.54-56;
’739 patent col.3 ll.54-56. However, issues of validity
based on prior publications were not presented for sum-
mary judgment. The only patentability issue was raised
in Merck’s motion for anticipation based on prior use, as
we discuss in Part II, post.
The defendants’ motions for summary judgment in-
cluded the ground that the subject matter did not meet
the threshold eligibility requirements of 35 U.S.C. §101.
In granting this motion, the district court accepted Clas-
sen’s theory that there is a relation between childhood
immunization schedules and the occurrence of chronic
immune-mediated disorders. The defendants challenged
the correctness of Dr. Classen’s theory, citing a study by
Dr. Frank DeStefano for the Centers for Disease Control,
published as “Childhood Vaccinations, Vaccination Tim-
ing and Risk of Type I Diabetes Mellitus,” Pediatrics, Dec.
2001. The district court did not hold a Daubert hearing –
about which Classen now complains – but accepted Clas-
sen’s premise for the purpose of deciding eligibility of the
subject matter under §101.
11 CLASSEN IMMUNO v. BIOGEN IDEC

The district court stated that the claims “describe lit-
tle more than an inquiry of the extent of the proposed
correlation between vaccines and chronic disorders.”
Classen, 2006 WL 6161856, at *5. The court observed
that “thinking about” the risks of vaccination is a mental
process, and held that the claims are for an abstract idea
and therefore not eligible for patenting. On the initial
appeal of that ruling, this court applied its en banc deci-
sion of In re Bilski, 545 F.3d 943 (Fed. Cir. 2008), held
that the Classen methods are not associated with a ma-
chine and do not transform matter, and affirmed the
district court’s holding of ineligibility under §101 on that
ground. 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 Technolo-
gies, Inc. v. Microsoft Corporation, 627 F.3d 859 (Fed. Cir.
2010); Prometheus Laboratories, Inc. v. Mayo Collabora-
tive Services, 628 F.3d 1347 (Fed. Cir. 2010), cert. granted,
_ S. Ct. _ , 2011 WL 973139 (June 20, 2011); and Associa-
tion 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 IMMUNO v. BIOGEN IDEC 12

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.
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 composi-
tion of matter, or any new and useful improve-
ment 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 Jus-
tice Story referred to patents as “securing to the whole
community great advantages from the free communica-
tion of secrets, and processes, and machinery, which may
be most important to all the great interests of society, to
13 CLASSEN IMMUNO v. BIOGEN IDEC

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 prin-
ciple, 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 consti-
tutional and statutory goal of promoting “the Pro-
gress of Science and the useful Arts” with all that
means for the social and economic benefits envi-
sioned by Jefferson. Broad general language is
not necessarily ambiguous when congressional ob-
jectives 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 estab-
lished 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
CLASSEN IMMUNO v. BIOGEN IDEC 14

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 pat-
entable in isolation, but when a process for curing rubber
is devised which incorporates in it a more efficient solu-
tion 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 encour-
aged 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 protec-
tion 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 mean-
ing 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 pat-
entable novelty:
It has been urged that novelty is an appropriate
consideration under §101. . . . Section 101, how-
ever, is a general statement of the type of subject
15 CLASSEN IMMUNO v. BIOGEN IDEC

matter that is eligible for patent protection “sub-
ject to the conditions and requirements of this ti-
tle.” 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 “rejec-
tion on either of [§102 or 103] does not affect the determi-
nation 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.
B. Mental Steps
The district court held that none of the Classen claims
meets the threshold under §101 of eligibility for patent-
ing, reasoning that the method claimed in all three pat-
ents 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 vari-
ety” 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 IMMUNO v. BIOGEN IDEC 16

In Prater the court explained the inappropriateness of
attempting to establish a universal rule for all situations
that include mental activity:
Between the purely mental and purely physical
end of the spectrum there lies an infinite variety
of steps that may be either machine-implemented
or performed in, or with the aid of, the human
mind (e.g., “comparing” and “determining”). In
ascertaining whether a particular step is “mental”
or “physical,” each case must be decided on its
own facts, considering all of the surrounding cir-
cumstances, to determine which end of the spec-
trum that step is nearer. It may well be that the
step of “comparing” may be “mental” in one proc-
ess, yet “physical” in another.
Id. 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 di-
rected to an abstract idea like the commodity hedging
method in Bilski v. Kappos.
The Court in Bilski v. Kappos did not define “ab-
stract,” 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 “ab-
stract” beyond the recognition that this disqualify-
17 CLASSEN IMMUNO v. BIOGEN IDEC

ing characteristic should exhibit itself so mani-
festly as to override the broad statutory categories
of eligible subject matter and the statutory con-
text that directs primary attention on the pat-
entability criteria of the rest of the Patent Act.
627 F.3d at 868. In Research Corporation the question on
appeal was whether the computer-conducted method of
comparing images was an abstract idea, and thus not
patent-eligible under §101. This court concluded that the
specified method is “functional and palpable,” and that
the claims recite tangible limitations on performing the
specified method of comparing images.
The court in Research Corporation, explaining that
the claims must be considered as a whole when determin-
ing eligibility to seek patentability, described the statu-
tory role of §101 as a “coarse eligibility filter,” not the
final arbiter of patentability. The court explained that
the substantive conditions of Title 35 must be applied,
and remarked that “section 112 [is a] powerful tool[] to
weed out claims that may present a vague or indefinite
disclosure of the invention,” and observed that “a patent
that presents a process sufficient to pass the coarse eligi-
bility filter may nonetheless be invalid as indefinite.” 627
F.3d at 869; see generally Star Scientific, Inc., v. R.J.
Reynolds Tobacco Co., 537 F.3d 1357, 1371 (Fed. Cir.
2008) (“[I]f reasonable efforts at claim construction result
in a definition that does not provide sufficient particular-
ity and clarity to inform skilled artisans of the bounds of
the claim, the claim is insolubly ambiguous and invalid
for indefiniteness.”).
The Research Corporation court also explained that
the “subject matter might also be so conceptual that the
written description does not enable a person of ordinary
skill in the art to replicate the process,” and that this too
CLASSEN IMMUNO v. BIOGEN IDEC 18

is a matter of patentability under §112, not eligibility
under §101. 627 F.3d at 869. In Diamond v. Diehr the
Court had recognized that although subject matter may
be of an eligible statutory class in §101, “it may later be
determined that the respondents’ process is not deserving
of patent protection because it fails to satisfy the statu-
tory conditions of novelty under §102 or nonobviousness
under §103.” 450 U.S. at 191. Applying this guidance, in
Research Corporation the court held that the preferable
procedure, when the claims are within the general classes
of §101 subject matter and not manifestly abstract, is to
apply the substantive conditions and requirements of
patentability. 627 F.3d at 868-69.
The court in Research Corporation observed that the
commercial application of the technology is relevant to
deciding whether an invention is so abstract as to negate
§101 subject matter. Id. at 869 (“Indeed, this court notes
that inventions with specific applications or improve-
ments to technologies in the marketplace are not likely to
be so abstract that they override the statutory language
and framework of the Patent Act.”); see Diehr, 450 U.S. at
184 (“Industrial processes such as this are the types
which have historically been eligible to receive the protec-
tion of our patent laws.”).
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 immuni-
zation 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
19 CLASSEN IMMUNO v. BIOGEN IDEC

coarse eligibility filter of §101. Although, as we have
remarked, the claims of these patents appear to raise
cogent questions of substantive patentability, patentabil-
ity 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. See Diehr, 450 U.S.
at 190; Research Corporation, 627 F.3d at 868 (determin-
ing whether the claims are so manifestly abstract “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”).
Claim 1 of the ‘283 patent states the method of “de-
termining whether an immunization schedule affects the
incidence or severity of a chronic immune-mediated
disorder” by reviewing information on whether an immu-
nization schedule affects the incidence or severity of a
chronic immune-mediated disorder. This stands in con-
trast to the ’139 and ’739 patent claims, which include the
subsequent step of immunization on an optimum sched-
ule. Claim 1 of the ’283 patent claims the idea of compar-
ing known immunization results that are, according to the
patent, found in the scientific literature, but does not
require using this information for immunization purposes.
Classen states, for example, that Merck induces direct
infringement by parents when Merck provides and physi-
cians distribute the book “What Every Parent Should
Know About Vaccines,” because the book advises parents
to understand vaccines and vaccination schedules. Clas-
sen Br. 18.
Claim 1 of the ’283 patent states the idea of collecting
and comparing known information. As discussed in
Association for Molecular Pathology, supra, methods that
simply collect and compare data, without applying the
data in a step of the overall method, may fail to traverse
CLASSEN IMMUNO v. BIOGEN IDEC 20

the §101 filter. 2011 WL 3211513, at *21 (citing Bilski,
130 S. Ct. at 3230). The ’139 and ’739 claims are not
simply the ’283 patent steps in reverse, as the dissent
argues. The “immunizing” in the ’283 patent refers to the
gathering of published data, while the immunizing of the
’139 and ’739 patent claims is the physical implementa-
tion of the mental step claimed in the ’283 patent.
The distinction between a concrete, physical step of a
process claim, as compared with data gathering or insig-
nificant extra-solution activity, warrants specific consid-
eration in the context of evolving technologies, for
“Congress took [a] permissive approach to patent eligibil-
ity 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 Chakra-
barty, 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).
The representative claim of the ’283 patent is directed
to the single step of reviewing the effects of known immu-
nization schedules, as shown in the relevant literature.
Although recourse to existing knowledge is the first step
21 CLASSEN IMMUNO v. BIOGEN IDEC

of the scientific method, the method claimed in the ’283
patent simply invites the reader to determine the content
of that knowledge. The ’283 claims do not include putting
this knowledge to practical use, but are directed to the
abstract principle that variation in immunization sched-
ules may have consequences for certain diseases. In
contrast, the claims of the ’139 and ’739 patents require
the further act of immunization in accordance with a
lower-risk schedule, thus moving from abstract scientific
principle to specific application. Determination of
whether a proffered invention, as claimed, transcends an
“abstract idea” is not subject to “categorical rules that
might have wide-ranging and unforeseen impacts,” Bilski,
130 S. Ct. at 3229. The invention as a whole, including
the scope asserted by the patentee must be considered.
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. 2
Classen also argues that the claims of all three pat-
ents 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
2 The dissent argues that there is “no distinction”
between the claims of the ’283 patent and the claims of
the ’139 and ’739 patents. The patents, which were
separately filed after the patent examiner required re-
striction because “the inventions are distinct,” distinguish
the ’283 method where, according to Classen, a person
simply reviews known knowledge on immunization ef-
fects, from the ’139/’739 methods that require physical
immunization based on that review. Even if the question
as to the ’139 and ’739 patents were deemed to be close,
the ’139/’739 method of immunizing on the low-risk
schedule determined by the ’283 method of reading the
literature, may be generously viewed as traversing the
boundary into eligibility for substantive review.
CLASSEN IMMUNO v. BIOGEN IDEC 22

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 individ-
ual patients, while the Classen patents operate on pub-
lished 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 informa-
tion.
Viewing the representative claims of the Classen pat-
ents in accordance with their purported scope, we con-
clude 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. 3 Pragmatic thorough-
3 The dissent, in its description of the claimed sub-
ject matter, states, for example, that “The Classen claims
are not directed to any specific treatment steps or drugs
or even any specific chronic immune disorder,” Diss. Op.
at 3. That is incorrect. Observe, for example, the claimed
immunization schedule of administration of hepatitis B
immunogen in two doses, first before 42 days after birth
and second between 41-180 days after birth; identifying
specific immunogens, with diabetes as the chronic im-
mune-mediated disorder:

’139 patent cl. 32. The method of claim 30
[including diabetes as the chronic disorder]
where the hepatitis B immunogen is a
23 CLASSEN IMMUNO v. BIOGEN IDEC

ness 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 ques-
tions such as are here presented. Since the patentability
issues of anticipation by prior art, obviousness, and
specificity were not decided by the district court, they are
not before us on this appeal of the grant of summary
judgment on other issues.

killed immunogen administered prior to 42
days after birth, and at least one further
immunogen is administered after 41 and
before 180 days after birth in a screened
schedule, and said further immunogen is
selected from the group consisting of BCG,
measles, mumps, rubella, diphtheria, per-
tussis, Hemophilus influenza, tetanus,
hepatitis B, polio, anthrax, plague, en-
cephalitis, meningococcal, meningitis,
pneumococcus, typhus, typhoid fever,
streptococcus, staphylococcus, neisseria,
lyme, cytomegalovirus (CMV), respiratory
syncytial virus, Epstein Barr virus, herpes,
influenza, parainfluenza, rotavirus, adeno-
virus, human immunodeficiency virus
(HIV), hepatitis A, NonA NonB hepatitis,
varicella, rabies, yellow fever, rabies,
Japanese encephalitis, flavivirus, dengue,
toxoplasmosis, cocidiomycosis, schisto-
somiasis, and malaria immunogens.

All three Classen patents contain claims whose
breadth is not of “staggering” character. Our holding is
not that any claim is “patentable,” whatever its breadth,
but that the claims are eligible at the threshold for review
for substantive patentability.
CLASSEN IMMUNO v. BIOGEN IDEC 24

II
ANTICIPATION BY PRIOR USE – 35 U.S.C. §102
The district court declined to decide Merck’s motion
for summary judgment based on Merck’s asserted prior
use. Merck’s motion was premised on the ground that an
activity for which Classen charges Merck with infringe-
ment is the same activity that was known and used and
recommended by Merck more than a year before Classen’s
earliest filing date. Merck states that Classen’s claims
are anticipated by the prior use of that schedule, for “that
which infringes if later anticipates if earlier,” Polaroid
Corp. v. Eastman Kodak Co., 789 F.2d 1556, 1573 (Fed.
Cir. 1986) (quoting Peters v. Active Mfg. Co., 129 U.S. 530,
537 (1889)). The district court denied summary judg-
ment, stating that facts were in dispute.
On appeal, Merck asks this court to decide this antici-
pation question ab initio, despite the general rule that the
denial of a summary judgment motion is not appealable.
Kendall v. City of Chesapeake, Va., 174 F.3d 437, 443-44
(4th Cir. 1999). However, 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 ques-
tion is not before us on this appeal.
III
INFRINGEMENT
A. Merck’s Motion for Summary Judgment
The district court granted Merck’s motion for sum-
mary 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 facili-
tation of the 2001 study conducted by Dr. Frank DeSte-
25 CLASSEN IMMUNO v. BIOGEN IDEC

fano” for the Centers for Disease Control, and that “Merck
offered uncontroverted evidence that it had no involve-
ment in the DeStefano study.” Classen, 2006 WL
6161856, at *2.
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. Classen
states that Merck’s “screening of the trials, papers, etc.” of
the DeStefano study of itself was an act of infringement.
Classen Br. 40. Classen also argues that Merck infringed
the representative claims based on its funding of studies
of the relationship between the hepatitis B vaccine and
the occurrence of multiple sclerosis. Classen also com-
plains that the district court did not address Classen’s
allegations of Merck’s contributory infringement.
The district court observed that it was undisputed
that Merck did not participate in the DeStefano study,
and that Classen had not “offered any evidence linking
Merck to any other study or evaluation of the correlation
between vaccination schedules and inciden[ce] of immune
mediated disorders.” Classen Immunotherapies, Inc. v.
Biogen IDEC, No. WDQ-04-2607, slip op. at 5 (D. Md. Dec.
14, 2005). The district court stated that “Classen’s claims
rely on Merck’s participation in or inducement of an
examination of the correlation between vaccine schedules
and immune mediated disorders,” and that no evidence
supported this charge. Id. 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.
CLASSEN IMMUNO v. BIOGEN IDEC 26

The district court also acted within its discretion in
declining to accept GlaxoSmithKline and Biogen’s un-
timely motion for summary judgment on the same
grounds.
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.” Classen, 381 F.
Supp. 2d at 455 (quoting Am. Compl. ¶7). Classen also
stated that Biogen induced infringement by licensing
technology to GlaxoSmithKline and “providing instruc-
tions and/or recommendations on a proper immunization
schedule for vaccines.” Am. Compl. counts I, II, and IV.
The district court granted summary judgment that these
activities are within the safe-harbor provision of the
Hatch-Waxman Act:
§271(e)(1). It shall not be an act of infringement
to make, use, offer to sell, or sell within the
United States . . . a patented invention . . . solely
for uses reasonably related to the development
and submission of information under a Federal
law which regulates the manufacture, use, or sale
of drugs or veterinary biological products.
Classen argues that the district court erred in its applica-
tion 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
27 CLASSEN IMMUNO v. BIOGEN IDEC

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). Clas-
sen 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 ap-
proval of generic products, or like policy considerations.
Classen is correct, for §271(e)(1) provides an exception to
the law of infringement in order to expedite development
of information for regulatory approval of generic counter-
parts of patented products. The statute does not apply to
information that may be routinely reported to the FDA,
long after marketing approval has been obtained.
Section 271(e)(1) arose in the Drug Price Competition
and Patent Term Restoration Act of 1984 (“Hatch-
Waxman Act”), 98 Stat. 1585. The House Report explains
that the Act “provides that it is not an act of patent in-
fringement for a generic drug maker to import or to test a
patented drug in preparation for seeking FDA approval if
marketing of the drug would occur after expiration of the
patent.” H.R. Rep. No. 98-857, pt. 1, at 15 (1984). The
Report is replete with statements that the legislation
concerns premarketing approval of generic drugs. The
Report emphasizes that “The information which can be
developed under this provision is the type which is re-
quired to obtain approval of the drug.” Id. at 45.
This purpose was emphasized throughout the legisla-
tive process: “The purpose of sections 271(e)(1) and (2) is
to establish that experimentation with a patented drug
product, when the purpose is to prepare for commercial
activity which will begin after a valid patent expires, is
not a patent infringement.” Id. Again in Part 2 of H.R.
Rep. No. 98-857, at 8 (1984), the Report is explicit that
“the only activity which will be permitted by the bill is a
limited amount of testing so that generic manufacturers
CLASSEN IMMUNO v. BIOGEN IDEC 28

can establish the bioequivalency of a generic substitute.”
The Report states that “the generic manufacturer is not
permitted to market the patented drug during the life of
the patent; all that the generic can do is test the drug for
purposes of submitting data to the FDA for approval.” Id.
at 30. The activities of which Biogen and GlaxoSmith-
Kline are accused by Classen cannot be stretched into this
role.
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 in-
fringement if they had been undertaken to develop infor-
mation reasonably related to the development and
submission of information necessary to obtain regulatory
approval under the [Food, Drug, and Cosmetic Act].” Id.
at 664. The Court explained that “the [Hatch-Waxman]
Act was designed to respond to two unintended distor-
tions of the 17-year patent term produced by the require-
ment that certain products must receive premarket
regulatory approval.” Id. at 669. The first “distortion”
was the exhaustion of patent life while the patentee was
obtaining regulatory approval, by procedures that usually
consumed several years. The second distortion was that
would-be competitors after patent expiration experienced
delay in market entry while obtaining regulatory ap-
proval for their generic counterparts. The Hatch-
Waxman Act remedied both distortions, striking a careful
balance that is embodied in the statute and reflected in
precedent.
29 CLASSEN IMMUNO v. BIOGEN IDEC

In Merck KGaA v. Integra Lifesciences I, Ltd., 545
U.S. 193, 207 (2005) the Court again analyzed the statu-
tory purpose, and explained that Ҥ271(e)(1) leaves ade-
quate space for experimentation and failure on the road to
regulatory approval . . . .” The Court held that preclinical
research, whether or not ultimately included in a submis-
sion to the Food and Drug Administration, is exempted
from infringement by §271(e)(1) “as long as there is a
reasonable basis for believing that the experiments will
produce ‘the types of information that are relevant to an
IND [investigational new drug application] or NDA [new
drug application].’” Id. at 208 (quoting Brief for United
States as Amicus Curiae 23). In contrast, the Biogen and
Glaxo activities charged with infringement are not related
to producing information for an IND or NDA, and are not
a “phase of research” possibly leading to marketing ap-
proval. Merck v. Integra does not provide a §271(e)(1) safe
harbor for these activities.
Extensive precedent recites the purpose of §271(e)(1)
to facilitate market entry upon patent expiration. See,
e.g., Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348,
1358 (Fed. Cir. 2003) (“[§271(e)(1)] enabled generic manu-
facturers to test and seek approval to market during the
patent term”); Proveris Scientific Corp. v. Innovasystems,
Inc., 536 F.3d 1256, 1265 (Fed. Cir. 2008) (examining for
purposes of the exemption whether the infringer is “seek-
ing FDA approval for a product in order to enter the
market to compete with patentees.”). There is no dispute
as to the statutory purpose, and no contrary precedent. 4

4 Our colleague in dissent strays from statute and
precedent, in arguing that any activity by any entity
concerning any adversely patented product or method is
exempted from infringement by §271(e)(1), provided only
that the information obtained is “reasonably related to
submitting any information under the FDCA,” Diss. Op.
CLASSEN IMMUNO v. BIOGEN IDEC 30

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 publica-
tion/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.
As the Court stated in J.E.M. Ag Supply, Inc. v. Pioneer
Hi-Bred International, Inc., 534 U.S. 124, 142 (2001):
“The disclosure required by the Patent Act is ‘the quid pro
quo of the right to exclude.’” (quoting Kewanee Oil Co. v.
Bicron Corp., 416 U.S. 470, 484 (1974)). In turn, the
subject matter of patents may be investigated and verified
and elaborated; the technological/scientific contribution to
knowledge is not insulated from analysis, study, and
experimentation for the twenty years until patent expira-
tion.
This quid pro quo is fundamental to patent systems.
The statutory requirements of description, enablement,
and best mode, implement this policy, for these require-

at 17 (emphasis in dissent), “including information re-
garding post-approval uses.” Id. Such a massive
enlargement of the statutory exemption is incorrect.
31 CLASSEN IMMUNO v. BIOGEN IDEC

ments facilitate understanding and elaboration of the
inventor’s contribution. 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 ex-
cluded, 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 legisla-
ture to punish a man, who constructed such a machine
merely for philosophical 5 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.” Id.
Our colleague in dissent argues that the Classen
claims “preempt[] the field of study and prevents any
investigation into any immunogen, known or unknown,
and to any disease.” Diss. Op. at 8. Study of the informa-
tion in patents is not preempted, whether that informa-
tion is broadly claimed, as in Classen’s “representative”
claims, or more narrowly claimed, as in other Classen
claims. A pioneering invention, that meets the substan-
tive criteria of patentability, may indeed warrant broad
scope. Breadth does not negative patent eligibility, al-
though it may not meet the conditions of patentability.
Nor does breadth preclude investigation by others. To the
contrary, a fundamental purpose of patenting is to pro-
vide knowledge, to achieve further advance. The dissent’s
“absurd” examples are indeed absurd.

5 “Natural philosophy” was the term for “science” in
the usage of that era.
CLASSEN IMMUNO v. BIOGEN IDEC 32

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 (quoting Am. Compl. ¶7). 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 patent-
ing 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 de-
cided by summary judgment, and are not before us on this
appeal. We remand for appropriate further proceedings.

AFFIRMED IN PART, REVERSED IN PART,
VACATED IN PART, AND REMANDED
 United States Court of Appeals
for the Federal Circuit
__________________________

CLASSEN IMMUNOTHERAPIES, INC.,
Plaintiff-Appellant,
v.
BIOGEN IDEC,
Defendant-Appellee,
and
GLAXOSMITHKLINE,
Defendant-Appellee,
and
MERCK & CO., INC.,
Defendant-Cross-Appellant,
and
CHIRON 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.
__________________________
CLASSEN IMMUNO v. BIOGEN IDEC 2

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.
__________________________

RADER, Chief Judge, additional views, joined by PAULINE
NEWMAN, Circuit Judge.

In the last several years, this court has confronted a
rising number of challenges under 35 U.S.C. § 101. The
language of § 101 is very broad. Nevertheless, litigants
continue to urge this court to impose limitations not
present in the statute. Subject matter eligibility under
section 101 has become the “substantive due process” of
patent law – except that reading non-procedural require-
ments into the constitutional word “process” has more
historical and contextual support than reading abstract-
ness into the statutory word “process” because Title 35
already contains ample protections against vague claims.
See 35 U.S.C. § 112. Indeed it is difficult to “invent” any
category of subject matter that does not fit within the four
classes acknowledged by Title 35: process, machine,
[article of] manufacture, or composition of matter. This
court should decline to accept invitations to restrict
subject matter eligibility. In order to highlight some
public policy reasons that the statute places few, if any,
limits on subject matter eligibility, these additional views
are offered.
The patent eligibility doctrine has always had signifi-
cant unintended implications because patent eligibility is
a “coarse filter” that excludes entire areas of human
inventiveness from the patent system on the basis of
3 CLASSEN IMMUNO v. BIOGEN IDEC

judge-created standards. For instance, eligibility restric-
tions usually engender a healthy dose of claim-drafting
ingenuity. In almost every instance, patent claim drafters
devise new claim forms and language that evade the
subject matter exclusions. These evasions, however, add
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.
The first unintended consequence, claim drafting eva-
sion, has occurred several times in the past. After all,
patents require a translation of technology into text, i.e.,
patent claims. Inevitably the subject matter exclusions of
eligibility doctrines depend on the way that claims are
drafted. Thus, careful claim drafting or new claim forms
can often avoid eligibility restrictions. Eligibility then
becomes a game where lawyers learn ingenious ways to
recast technology in terms that satisfy eligibility concerns.
Two well-known examples of claim drafting to cir-
cumvent eligibility restrictions are the Beauregard claim
and the Swiss claim. The Beauregard claim was devised
to draft around restrictions on software imposed in
Gottschalk v. Benson, 409 U.S. 63 (1972). Benson denied
eligibility to mathematical algorithms, a category broad
enough to endanger computer software in general. The
Beauregard claim form, however, was for “computer
programs embodied in a tangible medium.” In re Beaure-
gard, 53 F.3d 1583 (Fed. Cir. 1995). Claims were re-
drafted so that the intangible computer code in Benson
instead became an encoded tangible medium in Beaure-
gard. See id. at 1584 (PTO stating it will treat such
claims as patent eligible subject matter); MPEP § 2106
(8th ed. Rev. 8, July 2010) (same).
The Swiss claim was devised to draft around restric-
tions on medical treatment methods imposed by the
CLASSEN IMMUNO v. BIOGEN IDEC 4

European Patent Convention (“EPC”). EPC, art. 52(4)
prohibited patents on the use of a compound X for the
treatment of disease Y. The Swiss claim form, however,
was for the use of a compound X for the manufacture of a
medicament for the treatment of disease Y. Claims were
redrafted so that the focus became the manufacture of a
product instead of the direct treatment using that prod-
uct. The theory was that the claimed use was restricted
to the patentable (initial) industrial use instead of the
ineligible (ultimate) therapeutic use. See Eisai/Second
Medical Indication, G05/83 O.J. (EPO Enlarged Bd. of
Appeals 1984) (allowing Swiss claims); Preparatory
Documents to Revision of EPC art. 54(5), CA/PL 4/00
(EPO Jan. 24, 2000) (revising the EPC to make clear that
such subject matter is patent eligible so that Swiss claims
are not needed).
When careful claim drafting or new claim formats
avoid eligibility restrictions, the doctrine becomes very
hollow. Excluding categories of subject matter from the
patent system achieves no substantive improvement in
the patent landscape. Yet, these language games impose
high costs on patent prosecution and litigation. At the
same time, the new games can cheat naïve inventors out
of their inventions due to poor claim drafting. Moreover,
our national innovation policy takes on characteristics of
rewarding gamesmanship.
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.
5 CLASSEN IMMUNO v. BIOGEN IDEC

Once again, this unintended consequence is not the-
ory but history. In the past, this cause-effect relationship
of eligibility restrictions and stifling innovation favored
our country in, for example, biotechnology. While Europe
imposed eligibility restrictions, the United States em-
braced strong patent protection. Compare Diamond v.
Chakrabarty, 447 U.S. 303 (1980) with EPC, art. 53
(1973) (exceptions to patentability) and Harvard/Onco-
Mouse, T19/901 E.P.O.R. 501 (Technical Bd. of Appeal
3.3.21 1990) (eventually deciding against an outright ban
but continuing to impose restrictions).
Europe became known for subjecting such inventions
to delays in the patent office, challenges in litigation,
increases in cost, and uncertainties in the legal landscape.
With those difficulties as a primary contributing factor,
investors, corporations, and clinics shifted their research
from Europe to the United States. See Opinion of Euro-
pean Union Economic and Social Committee, COM (1995)
661 final (July 11, 1996), (recognizing that “Europe is
lagging further and further behind the USA,” as evi-
denced by the stark contrast in number of biotech patents,
firms, and products; proposing strong patent protection as
in the United States to solve “Europe’s backwardness”);
Council Directive 98/44, 1998 O.J. (L 213) (EC) (finally
providing some protection for biotech inventions to
counter the trend of companies preferring to patent in the
United States). Thus, with some considerable blame on
its eligibility doctrines, Europe lost innovation investment
to the United States. Our country became the world
leader in biotechnology innovation. Nevertheless, the tide
can turn against us, too. The effect of eligibility restric-
tions can send innovation investment elsewhere. Maybe
an accommodating clinic in another country would be
happy to take the additional funding and opportunity. In
sum, judges should tread carefully when imposing new
CLASSEN IMMUNO v. BIOGEN IDEC 6

limits on the protection for categories of human innova-
tion.
These public policy reasons are consistent with the
broad language of § 101. As discussed in the majority
opinion, section 101 is a general statement of subject
matter eligibility. It is a threshold statement that explic-
itly directs attention to the “conditions and requirements
of this title” to qualify for a patent. Thus, patentability,
as opposed to subject matter eligibility, depends on the
substantive conditions in the rest of the title. See 35
U.S.C. §§ 102, 103, 112. Many litigation-spawned appli-
cations of section 101 do not focus on categories of subject
matter that deserve no patent protection but on the
particularities of claim language, a question of patentabil-
ity depending on prior art and adequate disclosure.
 United States Court of Appeals
for the Federal Circuit
__________________________

CLASSEN IMMUNOTHERAPIES, INC.,
Plaintiff-Appellant,

v.
BIOGEN IDEC,
Defendant-Appellee,

and
GLAXOSMITHKLINE,
Defendant-Appellee,

and
MERCK & CO., INC.,
Defendant-Cross-Appellant,

and
CHIRON 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.
CLASSEN IMMUNO v. BIOGEN IDEC 2

__________________________

2006-1634, -1649
__________________________

Appeal from the United States District Court for the
District of Maryland in Case No. 04-CV-2607, Judge Wil-
liam D. Quarles, Jr.
__________________________

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 sum-
mary 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 infringe-
ment 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.

I. Invalidity under 35 U.S.C. § 101

In Prometheus Laboratories, Inc. v. Mayo Collaborative
Services, 628 F.3d 1347, 1350 (Fed. Cir. 2010), cert granted,
__ S. Ct. __ (June 20, 2011), this court held the asserted
claims which recited a method comprising administering a
3 CLASSEN IMMUNO v. BIOGEN IDEC

specific drug to a subject and determining the level of the
drug in that subject were directed to patentable subject
matter. Though both the Prometheus and Classen claims
involve administering a drug (immunizing in Classen), the
majority concludes that “the analogy [between Prometheus
and Classen] is inapt”. Maj. Op. at 22. I agree. The Prome-
theus court explained that administered drugs “do not pass
through the body untouched without affecting it,” thus “the
human body necessarily undergoes a transformation.” 628
F.3d at 1356. The Prometheus court did not stop its analysis
at the generality of the transformation concept. In a de-
tailed comparison to In re Grams, 888 F.2d 835 (Fed. Cir.
1989), the Prometheus court concluded that the transforma-
tive steps in the claims were not merely data gathering
steps or insignificant post-solution activity. Finally, the
Prometheus court concluded that the claims, which were
drawn to the administration of specific drugs providing 6-
thioguanine to a subject and then measuring specific me-
tabolites, do not preempt broadly the use of any natural
correlation, but rather recite specific treatment steps with
specific drugs. 628 F.3d at 1355. None of this analysis
exists in the majority opinion here in Classen. There is no
consideration of the extent of preemption by these stagger-
ingly broad and abstract claims.

The Classen claims are not directed to any specific
treatment steps or drugs or even any specific chronic im-
mune disorder. The majority concludes that the ’283 patent
claims are not directed to patentable subject matter, but
that the claims of the ’139 and ’739 patents are directed to
patentable subject matter. With all due respect to the
majority, I see no distinction between the ’283 claims and
’139 and ’739 claims which warrants differing treatment.
Moreover, I am troubled by the majority’s conclusion that
the ’139 and ’739 patent claims are directed to patentable
subject matter without any analysis of the staggering
CLASSEN IMMUNO v. BIOGEN IDEC 4

breadth of the claims and the preemption issues inherent in
claims directed to such fundamental principles.

Claim 1 of the ’283 patent was designated as represen-
tative:

1. A method of determining whether an immuniza-
tion 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.

This claim requires two steps: (1) immunizing a group of
mammals according to a schedule and then (2) comparing
the incidence of chronic immune mediated disorder in the
group to a control group. 1

1 I am perplexed by the majority’s suggestion that this
claim “is directed to the single step of reviewing the effects
of known immunization schedules,” Maj. Op. at 20, as the
claim clearly requires immunizing mammals and then
comparing the results to the known group. Moreover, the
majority unfairly mischaracterizes Classen’s arguments
regarding the ’283 patent. While Classen says “the claims
of the patents in suit,” it is clear from the context that
Classen is referring only to the comparison step of the ’139
and ’739 patents not requiring clinical trials. As that para-
graph explains, the claims being discussed [the ’139 and
’739 claims] contain the two steps of “Step (I) screening” and
“step (II)” immunizing. Moreover, the preceding paragraph
clearly demonstrates his claim is that “neither the ’139 nor
5 CLASSEN IMMUNO v. BIOGEN IDEC

Claim 1 of the ’739 patent (which is being treated as
representative of the ’139 and ’739 patents) 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 mam-
mals and at least a second group of mam-
mals, 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 or-
ganism-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 sec-
ond 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

the ’739 patents require actual participation in conducting a
study.” Classen Br. 40. When Classen actually references
the ’283 patent, he correctly describes the ’283 claims as
requiring “two method steps: (I) immunization and (II)
comparison.” Classen Br. 7. The ’283 patent claim clearly
and unequivocally requires the physical act of immunization
and it is unfair of the majority to analyze the claim for § 101
purposes as though it did not have that step.
CLASSEN IMMUNO v. BIOGEN IDEC 6

one of said screened immunization sched-
ules 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 sub-
ject 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 immuno-
gen was administered according to said higher
risk screened immunization schedule.

This claim requires two steps: (1) compare the incidence of
chronic immune mediated disease in two groups of mam-
mals who were immunized according to different schedules
and then (2) immunize a mammal according to the lower
risk schedule. 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
7 CLASSEN IMMUNO v. BIOGEN IDEC

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 funda-
mental 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 omit-
ted); id. at 3231 (“Flook established that limiting an ab-
CLASSEN IMMUNO v. BIOGEN IDEC 8

stract 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 infringe-
ment.

Having discovered a principle – that changing the tim-
ing 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 inci-
dence of chronic immune mediated disorders. This pre-
empts 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.
9 CLASSEN IMMUNO v. BIOGEN IDEC

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 discour-
age, development and the further spread of useful knowl-
edge 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 immune-
mediated disorders without infringing.

Classen did not invent the immunological response
measured in his claim, and the discovery of this phenome-
non 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 noth-
ing 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 immuni-
zation 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 ex-
plained:

The notion that post-solution activity, no matter
how conventional or obvious in itself, can transform
an unpatentable principle into a patentable process
exalts form over substance. A competent draftsman
could attach some form of post-solution activity to
CLASSEN IMMUNO v. BIOGEN IDEC 10

almost any mathematical formula; the Pythagorean
theorem would not have been patentable, or par-
tially patentable, because a patent application con-
tained 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 di-
rected to patentable subject matter. The post-solution
immunization does not transform the unpatentable princi-
ple – that a correlation exists between vaccination schedules
and incidence of chronic immune disease – into a patentable
process.

“[O]ne can reduce any process to a series of steps. The
question is what those steps embody. And here, aside from
the unpatented test, they embody only the correlation
between [immunization and the chronic immune-mediated
disorder] . . . that the researchers uncovered.” Lab. Corp.,
548 U.S. at 137-38. The fact that the claimed method is
both useful and uses tangible tools does not change the
ultimate purpose of the claim to monopolize that natural
phenomenon and preempt the field of study; nor does the
fact that someone must carry out the immunization to
trigger the natural response which is subsequently com-
pared to the control group. “Indeed, to use virtually any
natural phenomenon for virtually any useful purpose could
well involve the use of empirical information obtained
through an unpatented means that might have involved
transforming matter.” Id. at 136.

The claims in this case certainly illustrate the challenge
our patent system faces “in striking the balance between
protecting inventors and not granting monopolies over
procedures that others would discover by independent,
creative application of general principles.” Bilski, 130 S. Ct.
11 CLASSEN IMMUNO v. BIOGEN IDEC

at 3228. Mr. Classen and inventors like him are not with-
out incentives to innovate in this area. He could, of course,
claim a method of treating a chronic immune-mediated
disorder by using a new and specific immunization schedule.
He could also claim new therapeutic immunogens which
were identified as potential compounds of interest. He could
even claim specific testing methods to assay and explore his
new discovery. But Classen does none of this; instead he
claims the study of and merely comparing whether the
timing of immunization affects chronic immune-mediated
disorders. “A patent is not good for an effect, or the result of
a certain process, as that would prohibit all other persons
from making the same thing by any means whatsoever.
This, by creating monopolies, would discourage arts and
manufactures, against the avowed policy of the patent
laws.” Le Roy v. Tatham, 14 How. 156, 173 (1853); cf.
O’Reilly v. Morse, 15 How. 62, 113 (1854) (“[W]hile he shuts
the door against inventions of other persons, the patentee
would be able to avail himself of new discoveries in the
properties and powers of electro-magnetism which scientific
men might bring to light. . . . The court is of opinion that
the claim is too broad . . . .”).

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 “fundamen-
tal 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 consti-
CLASSEN IMMUNO v. BIOGEN IDEC 12

tutional 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.

I do not understand the distinction that the majority
draws between claim 1 of the ’283 patent and claim 1 of the
’739 patent. Nor do I understand the test the majority
proposes for determining patentability under § 101. In
reaching its conclusion that the ’739 patent claims are
directed to patent eligible subject matter, the majority relies
heavily on Research Corp. Technologies v. Microsoft Corp.,
627 F.3d 859 (Fed. Cir. 2010). Research Corp. explains that
claims “are not likely to be so abstract that they” recite
nonstatutory subject matter if they are directed to “inven-
tions with specific applications or improvements to tech-
nologies in the marketplace.” Id. at 869. In my view, the
claimed inventions in Bilski and Flook have specific applica-
tions to the marketplace, but those claims nonetheless recite
nonstatutory subject matter under § 101. Citing Research
Corp. the majority holds that if the specified method is
“functional and palpable,” the claims are drawn to statutory
subject matter. Maj. Op. at 17. How do we determine
whether any given method or claim is “functional” or “pal-
pable?” Is this a return to the rejected notions of “useful,
concrete, and tangible?” The majority concludes that the
claims of the ’139 and ’739 patents “are directed to a spe-
cific, tangible application” because they “includ[e] the physi-
cal step of immunization on the determined schedule.” Maj.
Op. at 18. The majority points to nothing else in the claims
and does not at all consider how these staggeringly broad
claims will preempt the entire immunization field from
considering any two schedules prior to immunizing any
patient with any drug – clearly a sweepingly broad princi-
13 CLASSEN IMMUNO v. BIOGEN IDEC

ple. I cannot agree that this single physical immunization
step makes this principle patentable subject matter. 2

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 discov-
ered 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. I would conclude that the Classen claims
are directed to unpatentable subject matter. 3

2 The majority explains the difference between the
’283 claim (which it holds is not directed to patentable
subject matter) and the ’139 and ’739 patent claims (which
it holds are directed to patentable subject matter) as follows:
“[Claim 1 of the ’283 patent] stands in contrast to the ’139
and ’739 patent claims, which include the subsequent step
of immunization on an optimal schedule.” Maj. Op. at 19.
3 With all due respect to my colleagues, I do not agree
with the additional views. First, the additional views im-
properly criticizes litigants for arguing that abstract ideas
are exempt from patent protection. We are bound to follow
Supreme Court precedent which clearly and explicitly holds
that abstract ideas are not eligible for patent protection.
Diamond, 450 U.S. at 185 (“Excluded from such patent
protection are . . . abstract ideas.”); Parker, 437 U.S. at 589
(“[A]bstract intellectual concepts are not patentable . . . .”).
Second, I favor “careful claim drafting” and think it a virtue,
CLASSEN IMMUNO v. BIOGEN IDEC 14

II. Invalidity under 35 U.S.C. § 102

I dissent from the majority’s refusal to reach Merck’s
argument on appeal that it was entitled to summary judg-
ment that the claims were invalid for anticipation. I agree
that, in general, a denial of summary judgment standing
alone is not immediately appealable. But here Merck prop-
erly presented us with an alternative grounds for affirming
the district court’s summary judgment of invalidity, and this
issue was thoroughly briefed below and decided by the
district court. There is no basis upon which we could or
should simply turn our back and refuse to decide an issue
that is squarely before us.

In its motion for summary judgment of invalidity, Merck
asserted that Classen’s claims were anticipated because a
vaccination schedule for the Recombivax HB hepatitis
vaccine was already in use before Classen filed his patents.
The district court denied Merck’s motion for summary
judgment of anticipation because Merck proffered no evi-
dence that the correlation between immune-mediate disor-
ders and the vaccine were evaluated as required by the
representative claims. As the district court correctly noted,

not a vice. If § 101 causes the drafting of careful, concrete,
specific claims over abstract, conceptual claims, I see no
harm. The world will have clear notice of the scope of such
patent rights. Finally, in this global age, it is not immedi-
ately clear to me why the scope of patent rights should
dictate the location of the innovation. Chinese companies do
not move to the U.S. to carry out their research when they
want a U.S. patent. Regardless, any decision on “national
innovation policy” such as what will “frustrate innovation”
or “drive research funding” should be left to Congress. We
do not have the resources, institutional expertise or the
mandate to weigh the competing incentives to innovation.
Our job is to take the statute as we find it and apply it to
the facts of the case before us.
15 CLASSEN IMMUNO v. BIOGEN IDEC

the ’283 patent requires “immunizing a treatment group and
comparing incidence of a chronic immune-mediated disorder
to that of a control group.” Classen Immunotherapies v.
Biogen IDEC, No. WDQ-04-2607, slip op. at 8 (D. Md. Aug.
16, 2006). As the district court held, Merck did not present
any evidence that there was a comparison to a control group
to determine the incidence of chronic immune-mediated
disorders. All Merck demonstrated was that it was using its
Recombivax HB hepatitis vaccination on its 0,1,6 schedule
prior to the Classen patents. Even if the court accepted this
proposition, Merck does not demonstrate that the rest of the
method was performed – there is no evidence of comparison
to a control group as required by the claims. Both the ’139
and ’739 patents similarly “require comparing the incidence
of immune-mediated disorders in treatment groups with
different vaccination schedules and immunizing patients of
a schedule identified as low risk.” Classen, No. WDQ-04-
2607, slip op. at 9. Again, the district court correctly held
that Merck offered no evidence that any comparison with
different schedules or evaluation of incidence of immune-
mediated disorders occurred. Merck’s proof was limited to
the fact that it was immunizing on the 0,1,6 schedule prior
to the Classen patents. This does not prove that it per-
formed the rest of the method – the comparisons which
Classen claimed. Accordingly, the district court correctly
denied summary judgment. On this record, Merck failed to
prove that it had performed all the steps of the method
claims and therefore its prior use could not anticipate as a
matter of law.

These claims are extremely broad, and Merck may well
be able to offer proof of anticipation, but it failed to do so at
the summary judgment stage – therefore I would affirm the
district court’s denial of Merck’s summary judgment.
CLASSEN IMMUNO v. BIOGEN IDEC 16

III. Infringement

In this case, the district court dismissed Classen’s
claims against GlaxoSmithKline (GSK) and Biogen under
Rule 12(b)(6), finding that the alleged uses fall into the safe
harbor described by 35 U.S.C. § 271(e)(1). The majority
concludes that the district court incorrectly interpreted the
safe harbor of § 271(e)(1) because, according to the majority,
§ 271(e)(1) is limited to pre-approval activities. The major-
ity’s construction is contrary to the plain language of the
statute and Supreme Court precedent. The statute broadly
recites that “[i]t shall not be an act of infringement to make,
use, offer to sell, or sell within the United States or import
into the United States a patented invention . . . solely for
uses reasonably related to the development and submission
of information under a Federal law which regulates the
manufacture, use, or sale of drugs . . . .” 35 U.S.C.
§ 271(e)(1). Nowhere does the statute limit the safe harbor
to pre-approval uses.

The Supreme Court explored the boundaries of this safe
harbor in Merck KGaA v. Integra Lifesciences I, Ltd., 545
U.S. 193 (2005), when it reversed this court’s narrow inter-
pretation of § 271(e)(1). The Court stated that:

the statutory text makes clear that it provides a
wide berth for the use of patented drugs in activities
related to the federal regulatory process. As an ini-
tial matter, we think it is apparent from the statu-
tory text that § 271(e)(1)’s exemption from
infringement extends to all uses of patented inven-
tions that are reasonably related to the development
and submission of any information under the FDCA.

Merck, 545 U.S at 202 (emphasis in original). The Court
continued, “[t]here is simply no room in the statute for
17 CLASSEN IMMUNO v. BIOGEN IDEC

excluding certain information from the exemption on the
basis of the phase of research in which it is developed or the
particular submission in which it could be included.” Id. To
eliminate any lingering doubts, the Court emphasized yet a
third time that “[Congress] exempted from infringement all
uses of patented compounds ‘reasonably related’ to the
process of developing information for submission under any
federal law regulating the manufacture, use, or distribution
of drugs.” Id. at 206 (emphases in original).

While it is true that the Supreme Court decided Integra
in the context of pre-approval activities, the Court repeat-
edly underscored the breadth of the statute’s text. Accord-
ingly, I conclude that the safe harbor extends to all uses
that are reasonably related to submitting any information
under the FDCA, including information regarding post-
approval uses.

The majority cites extensively from the legislative his-
tory in an attempt to justify its construction. But these
citations miss the point entirely. There is no dispute that
§ 271(e)(1) covers pre-approval studies, as the legislative
history indicates. None of the legislative history cited by
the majority, nor the cases it references, speak to the ques-
tion at issue here – whether the statute as enacted also
covers post-approval activities. The question is not whether
Congress intended to protect pre-approval activity – but
whether the enacted legislation covers more than just pre-
approval activity. The language Congress chose to enact
and that was signed into law by the President is plain on its
face. There is no “pre-approval” limitation. The statute
includes within the safe harbor activity “solely for uses
reasonably related to the development and submission of
information under a Federal law.” 35 U.S.C. § 271(e)(1).
This statute could have been written to indicate solely for
uses seeking federal approval or solely for pre-approval
CLASSEN IMMUNO v. BIOGEN IDEC 18

uses. It was not. The plain language of this statutory text
is broader. Any activity solely for uses reasonably related to
the development and submission of information under a
Federal law is included in § 271(e)(1).

I agree with the district court’s plain language construc-
tion of the statute, and I agree that, in this case, the alleged
participation by GSK and Biogen in studies evaluating risks
associated with different vaccination schedules is reasona-
bly related to their requirement to review and report ad-
verse information to the FDA. See, e.g., 21 C.F.R. § 601.70
(requiring annual progress reports of post-approval studies);
21 C.F.R. § 600.80 (requiring the reporting of post-approval
adverse reactions). This conclusion, however, disposes of
only some of the allegations against GSK and Biogen.
Classen also alleges that GSK and Biogen vaccinated pa-
tients according to the patented methods, which I believe is
not anchored within the statutory safe harbor.

Specifically, in Counts I, II, and IV, Classen accuses
GSK of infringing through “the administration of vaccines
according to the patented method[s].” Am. Compl. ¶¶ 27,
35, 51. Thus, in Counts I and II, Classen accuses GSK of
screening schedules and then immunizing subjects in accor-
dance with a lower risk schedule. In Count IV, Classen
accuses GSK of determining the risk of an immunization
schedule by immunizing subjects and then comparing the
incidence of a disorder (i.e., an adverse event) to that in a
control group. Biogen is similarly accused of “adminis-
ter[ing] the vaccines according to a [risk-reducing] protocol.”
Am. Compl. ¶ 6. Although GSK and Biogen might be
required to report adverse events that occur as a result of
their vaccines, they are not required by law or regulation to
perform such post-approval vaccinations in order to gener-
ate data. Accordingly, I conclude that these activities are
not reasonably related to the development and submission
19 CLASSEN IMMUNO v. BIOGEN IDEC

of data to the FDA and therefore do not fall within
§ 271(e)(1)’s safe harbor exception.

The general administration of drugs or vaccines is not
reasonably related to post-approval reporting requirements.
For example, while the FDA requires the reporting of post-
approval adverse reactions, this does not mean that all
commercial uses of the vaccine are “solely for uses reasona-
bly related to the development and submission of informa-
tion under a Federal law.” The fact that GSK or Biogen
would have to report to the FDA any adverse reaction after
administering a vaccine does not mean the administration
itself is noninfringing.

For these reasons, I would vacate the district court’s
dismissal of counts I, II, and IV against GSK and Biogen
because some of the alleged activities do not fall within the
safe harbor of § 271(e)(1), and I would remand for further
proceedings as to those parties. With respect to the district
court’s grant of summary judgment of noninfringement to
Merck, I agree with the majority’s affirmance because
Classen failed to provide any record evidence sufficient to
create a genuine issue of material fact.