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Recent Cases
United States
Court of Appeals for the Federal Circuit
03-1069
CHRISTIAN J.
JANSEN, JR.,
Plaintiff-Appellant,
v.
REXALL SUNDOWN,
INC.,
Defendant-Appellee.
John
C. McNett, Woodard, Emhardt, Naughton, Moriarty & McNett, of Indianapolis,
Indiana, argued for
plaintiff-appellant. With him
on the brief was Steve E. Zlatos.
Gary
H. Levin, Woodcock Washburn LLP, of Philadelphia,
Pennsylvania, argued for
defendant-appellee. With him on
the brief was Lynn B. Morreale.
Appealed from: United
States District Court for the Southern
District of Indiana
Judge John Daniel Tinder
United States
Court of Appeals for the Federal Circuit
03-1069
CHRISTIAN
J. JANSEN, JR.,
Plaintiff-Appellant,
v.
REXALL SUNDOWN, INC.,
Defendant-Appellee.
__________________________
DECIDED: September 8, 2003
__________________________
Before LOURIE, RADER, and
SCHALL, Circuit Judges.
LOURIE, Circuit Judge.
Christian
J. Jansen, Jr., appeals from the final decision of the United States
District Court for the Southern District of Indiana granting summary judgment
that Rexall Sundown, Inc. has not infringed Jansen’s U.S. Patent
4,945,083. Jansen v. Rexall
Sundown, Inc., No. IP 00-1495-C-T/G (S.D. Ind.
Sept. 25, 2002). Because the court correctly
construed the patent claims and correctly found no genuine issues of
material fact on the question of infringement, we affirm.
BACKGROUND
Jansen is the
sole inventor and owner of the ’083 patent, which is directed to
methods of “treating or preventing macrocytic-megaloblastic
anemia” by administering a combination of folic acid and vitamin B12
“to a human in need thereof.” ’083 patent, col. 6, ll.
20-24, ll. 37-41. According to
the patent, deficiencies of either folic acid or vitamin B12 can
cause macrocytic-megaloblastic anemia, also referred to as pernicious
anemia, while a deficiency of vitamin B12 can also cause
neurological problems. Id.
at col. 4, ll. 13-25. When
folic acid alone is utilized to treat macrocytic-megaloblastic anemia, the
folic acid may mask a vitamin B12 deficiency. Id.;
see also id. at col. 3, l. 65 – col. 4, l. 5. An objective of Jansen’s
invention is to administer both supplements together to avoid the masking
problem. Id.
at col. 4, ll. 25-48. The
independent claims read as follows:
1. A method of treating or
preventing macrocytic-megaloblastic anemia in humans which anemia is
caused by either folic acid deficiency or by vitamin B12
deficiency which comprises administering a daily oral dosage of a vitamin
preparation to a human in need thereof comprising at least about 0.5
mg. of vitamin B12 and at least about 0.5 mg. of folic acid.
4. A method of treating or
preventing macrocytic-magaloblastic [sic] anemia in humans which anemia
is caused by either folic acid deficiency or by vitamin B12
deficiency which comprises orally administering combined vitamin B12
and folic acid to a human in need thereof in sufficient amounts to
achieve an oral administration of at least about 0.5 mg. of vitamin B12
and at least about 0.5 mg. of folic acid within one day.
Id.
at col. 6, ll. 20-24, ll. 37-41 (emphases added).
The ’083 patent is a seventh-generation
continuation of a patent application filed in 1970. Every member of the ’083
patent’s lineage was abandoned in favor of the succeeding application
until the ’083 patent issued in 1990. Jansen’s first application
claimed the method as follows:
A method of treating or
preventing anemia in humans which comprises administering a daily oral
dosage of a vitamin preparation containing at least .5 mg. of vitamin B12
and at least .5 mg. of folic acid, whereby anemia can safely be treated
orally without determining whether it is caused by folic acid deficiency or
by vitamin B12 deficiency.
In re
Jansen, 187 USPQ 743, 744 (CCPA 1975). That original claim, while
specifying approximately the same amounts of folic acid and vitamin B12,
does not specify the type of anemia being treated and says nothing about
any need on the part of the human subject. The U.S. Patent and Trademark Office
(“PTO”) found that claim, as well as claims directed to the
composition of matter, to be obvious in light of prior art that taught
administration of folic acid alone in the claimed range, vitamin B12 alone
in the claimed range, and combinations of the two in smaller doses than
claimed. The PTO found
unpersuasive Jansen’s argument that administration of both components
in the higher, claimed doses was an unexpected solution to the masking
problem, and the Court of Customs and Patent Appeals affirmed the
PTO’s rejections. Id.
at 746. In his next five
applications, Jansen persistently attempted to gain allowance of his claims
in slightly different form, yet the PTO consistently rejected his
attempts. In the prosecution of
his seventh application, Jansen repeated his masking-avoidance argument and
submitted an article that asserted that the medical community had come to
realize the effectiveness of folic acid-vitamin B12 combination
therapy to treat pernicious anemia only after Jansen’s invention
date. See William H.
Crosby, Improvisation Revisited — Oral Cyanocobalamin Without
Intrinsic Factor for Pernicious Anemia, 140 Arch. Intern. Med.
1582 (1980). The examiner
agreed but noted that the claims, being directed to unspecified anemia,
were not commensurate in scope with Jansen’s showing of unexpected
results. Jansen thereafter
agreed to cancel his composition of matter claims and to narrow his method
claims by requiring a specific type of anemia, viz.,
macrocytic-megaloblastic anemia, rather than anemia generally, and by
adding to the claims the phrase “to a human in need
thereof.” The PTO then
issued the ’083 patent to Jansen.
Rexall markets
to the general public an over-the-counter dietary supplement presently
known as Folic Acid XTRATM that contains folic acid and vitamin
B12 within the claimed ranges. The Rexall product is labeled and
advertised for maintenance of proper blood homocysteine levels, but not for
prevention or treatment of macrocytic-megaloblastic anemia.
Jansen sued Rexall for inducement of and contributory
infringement of the ’083 patent.
In the district court Jansen argued that all people are
“human[s] in need” of “treat[ment] or prevent[ion] of
macrocytic-megaloblastic anemia,” but the court, without definitively
construing the “in need” phrase, rejected that argument. Jansen, slip op. at 14. Citing, inter alia, Rapoport
v. Dement, 254 F.3d 1053 (Fed. Cir. 2001), the court then construed the
phrase “treating or preventing macrocytic-megaloblastic anemia”
to require that, in order to infringe the patent, the human subject of the
claimed method take the compound with the intent of treating or preventing
macrocytic-megaloblastic anemia.
Jansen, slip op. at 16.
Because the court found no evidence of such intent or purpose on the
part of Rexall’s customers, the court granted summary judgment of noninfringement. Id. at 16-17.
Jansen timely appealed to this court, and we have
jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
DISCUSSION
A
determination of patent infringement requires a two-step analysis. “First, the court determines
the scope and meaning of the patent claims asserted . . . [Second,] the properly construed
claims are compared to the allegedly infringing device.” Cybor Corp. v. FAS Techs., Inc.,
138 F.3d 1448, 1454 (Fed. Cir. 1998) (en banc) (citations omitted). Step one, claim construction, is an
issue of law, Markman v. Westview Instruments, Inc., 52 F.3d 967,
970-71 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996),
that we review de novo, Cybor, 138 F.3d at 1456. Step two, comparison of the claim to
the accused device, requires a determination that every claim limitation or
its equivalent is found in the accused device. Warner-Jenkinson Co. v. Hilton
Davis Chem. Co., 520 U.S. 17, 29 (1997). Those determinations are questions
of fact. Bai v. L & L Wings,
Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998).
On
appeal, Jansen first argues that the court improperly construed the
claims. More specifically, he
contends that the court’s construction improperly added to the claims
an intent element, which is contrary to law as well as contrary to the
ordinary meaning of the claim language, which does not suggest that the
infringer’s state of mind is relevant. Nor does the ’083
patent’s prosecution history, according to Jansen, suggest that the
infringer’s state of mind is relevant. He also argues that Rapoport
does not support the court’s view that a direct infringer must
purposefully perform the claimed method, and that in any event Rapoport
is distinguishable because that case, unlike this case, did not involve a
claim to a method of prevention of a disease. According to Jansen, the phrase
“a human in need thereof” encompasses a person who does not
know that his or her serum levels of folic acid and vitamin B12
are adequate. Jansen secondly
argues that he presented sufficient evidence of infringement to avoid
summary judgment. According to
Jansen, Rexall’s formulation and labeling are circumstantial evidence
of direct infringement by Rexall’s customers.
Rexall
responds that the court’s claim construction does not add an intent
element to the claims except as required by the particular language of the
claims themselves. Rexall also
contends that, just as in Rapoport, the claims in the ’083
patent should be interpreted to require that the target group
(“human[s] in need thereof”) practice the method for the stated
purpose (“treating or preventing macrocytic-megaloblastic
anemia”), especially where, as here, the prosecution history reveals
that both limitations were added for patentability. According to Rexall, a “human
in need thereof” is someone either suffering from
macrocytic-megaloblastic anemia or at a recognized risk, such as by medical
diagnosis, of developing that condition. Rexall also responds that there is
no evidence that it markets its product to the target group for the claimed
purpose; on the contrary, it contends that it markets its product only for
regulation of blood homocysteine levels. Rexall further contends that, even
if there were some evidence of direct infringement by its customers, it is
not liable for indirect infringement, for it has not intended to cause
infringement and there are substantial noninfringing uses of its product,
thereby negating inducement of and contributory infringement.
We
begin our claim construction, as always, with the ordinary meaning of the
claim language. Rexnord
Corp. v. Laitram Corp., 274 F.3d 1336, 1341 (Fed. Cir. 2001). That language requires that the
method be performed on “a human in need thereof” and that the
method be used “for treating or preventing macrocytic-megaloblastic
anemia.” The parties do
not dispute what “macrocytic-megaloblastic anemia” means;
instead, they dispute how the “treating or preventing” phrase
and the “to a human in need thereof” phrase should be
read. The issue reduces to whether
such a human must know that he is in need of either treatment or prevention
of that condition.
A
similar issue arose in Rapoport, an interference proceeding before
the PTO’s Board of Patent Appeals and Interferences. The count in that case read as follows:
A method for treatment of sleep apneas comprising
administration of a therapeutically effective amount of a Formula I
azapirone compound or a pharmaceutically effective acid addition salt
thereof to a patient in need of such treatment . . . .
254 F.3d at 1056
(emphases added). On appeal we
gave weight to the ordinary meaning of the preamble phrase “for
treatment of sleep apneas,” interpreting it to refer to sleep apnea, per
se, not just “symptoms associated with sleep
apnea.” Id. at
1059. Rapoport argued that the count was unpatentable on the ground that a
prior art reference disclosed that a form of the compound recited in the
claim could be administered, not for treatment of sleep apnea itself, but
for treatment of anxiety and breathing difficulty, a symptom of apnea. Id. at 1061. We rejected that argument, stating,
“There is no disclosure in the [prior art reference that the
compound] is administered to patients suffering from sleep apnea with
the intent to cure the underlying condition.” Id. (emphasis added). Thus, the claim was interpreted to
require that the method be practiced with the intent to achieve the
objective stated in the preamble.
Just
as in Rapoport, it is natural to interpret the nearly parallel
language in the ’083 patent claims in the same way. In both Rapoport and this
case, the claim preamble sets forth the objective of the method, and the
body of the claim directs that the method be performed on someone “in
need.” In both cases, the
claims’ recitation of a patient or a human “in need”
gives life and meaning to the preambles’ statement of purpose. See Kropa v. Robie,
187 F.2d 150, 152 (CCPA 1951) (stating the rule that a preamble is treated
as a limitation if it gives “life and meaning” to the
claim). The preamble is
therefore not merely a statement of effect that may or may not be desired
or appreciated. Rather, it is a
statement of the intentional purpose for which the method must be
performed. We need not decide
whether we would reach the same conclusion if either of the “treating
or preventing” phrase or the “to a human in need thereof”
phrase was not a part of the claim; together, however, they compel the
claim construction arrived at by both the district court and this court.
Our
conclusion as to the meaning of the claims is bolstered by an analysis of
the prosecution history. The
prosecution history is often useful to ascertain the meaning of the claim
language. Indeed, claims are
not construed in a vacuum, but rather in the context of the intrinsic
evidence, viz., the other claims, the specification, and the
prosecution history. See
DeMarini Sports, Inc. v. Worth, Inc., 239 F.3d 1314, 1327 (Fed. Cir.
2001). In this case, the
“treating or preventing macrocytic-megaloblastic anemia” phrase
and the “to a human in need thereof” phrase were added to gain
allowance of the claims after almost twenty years of repeatedly
unsuccessful attempts to gain allowance of claims without those
phrases. We must therefore give
them weight, for the patentability of the claims hinged upon their presence
in the claim language. See
Smith v. Magic City Kennel Club, Inc., 282 U.S. 784, 790 (1931)
(“The applicant[,] having limited his claim by amendment and accepted
a patent, brings himself within the rules that if the claim to a combination
be restricted to specified elements, all must be regarded as material, and
that limitations imposed by the inventor, especially such as were
introduced into an application after it had been persistently rejected,
must be strictly construed against the inventor and looked upon as
disclaimers.”).
Furthermore, because both phrases were added simultaneously to
overcome the same rejection, they should be read together, meaning that the
word “thereof” in the phrase “to a human in need
thereof” should be construed to refer to the treatment or prevention
of macrocytic-megaloblastic anemia.
Finally, that “need” must be recognized and appreciated,
for otherwise the added phrases do not carry the meaning that the
circumstances of their addition suggest that they carry. In other words, administering the
claimed vitamins in the claimed doses for some purpose other than treating
or preventing macrocytic-megaloblastic anemia is not practicing the claimed
method, because Jansen limited his claims to treatment or prevention of
that particular condition in those who need such treatment or
prevention. Thus, the
’083 patent claims are properly interpreted to mean that the
combination of folic acid and vitamin B12 must be administered
to a human with a recognized need to treat or prevent
macrocytic-megaloblastic anemia.
Given that
claim construction, we turn to the issue whether Jansen has raised a
genuine issue of material fact regarding infringement. We conclude that he has not. Jansen has asserted indirect infringement
by Rexall, premised on direct infringement by Rexall’s
customers. See Met-Coil
Sys. Corp. v. Korners Unlimited, Inc., 803 F.2d 684, 687 (Fed. Cir.
1986) (“Absent direct infringement of the patent claims, there can be
neither contributory infringement nor inducement of infringement.”
(citations omitted)).
Jansen’s theory of infringement is primarily based upon his
construction of the claim that those who do not affirmatively know that
they do not need to take steps to prevent or treat macrocytic-megaloblastic
anemia are still “in need thereof.” As explained above, that claim
construction is incorrect.
Jansen nonetheless asserts that he has circumstantial evidence of
direct infringement by Rexall’s customers under the claim
construction we and the district court have adopted. Specifically, he contends that
Rexall’s formulation, having folic acid and vitamin B12 in
such large quantities as his claims call for, as well as Rexall’s
labeling stating that “[i]t is especially important to take B-12
along with Folic acid because Folic acid can mask a B-12 deficiency,”
are evidence that some customers do knowingly take the Rexall product to
treat or prevent macrocytic-megaloblastic anemia.
While Jansen
is correct that it is theoretically possible that some of Rexall’s
customers do take the Rexall product knowingly to treat or prevent
macrocytic-megaloblastic anemia, and therefore directly infringe his
patent, his evidence is quite weak.
In fact, he has shown no more than a theoretical possibility or
“metaphysical doubt,” which is insufficient to create a genuine
issue of material fact. See
Anderson, 477 U.S. at 261 (citing Matsushita Elec. Indus. Co. v.
Zenith Radio Corp., 475 U.S. 574, 586 (1986)). The district court’s decision
that there were no genuine issues of material fact on the question of
infringement was therefore correct.
Use of an
over-the-counter product like Rexall’s is quite different from the
use of a product pursuant to a prescription from a medical doctor. In the latter case, a prescription
is evidence of a diagnosis and a knowing need to use the product for the
stated purpose. Jansen does not
have evidence of that in this case.
Rexall’s product is provided with a label stating that the
product can be used for maintenance of blood homocysteine levels, and
purchasers do not necessarily know that they are in need of preventing or
treating macrocytic-megaloblastic anemia. Instead, Jansen has only
conjecture that some purchasers of the Rexall product might meet the claim
requirements. The district
court therefore did not err in holding that he failed to present sufficient
proof of infringement to create a genuine issue of material fact and to
thereby avoid summary judgment of noninfringement.
CONCLUSION
The
district court correctly construed the claims of the ’083 patent and
properly determined that Jansen did not present sufficient evidence to
create a genuine issue of material fact relating to infringement by
Rexall. Accordingly, we
AFFIRM.
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