King Pharmaceuticals, Inc. v. Eon Labels, Inc ( 2010 )

United States Court of Appeals
for the Federal Circuit
__________________________
KING PHARMACEUTICALS, INC.,
AND KING PHARMACEUTICALS RESEARCH AND
DEVELOPMENT, INC,
Plaintiffs-Appellants,
v.
EON LABS, INC.,
Defendant-Appellee,
v.
ELAN PHARMACEUTICALS, INC.,
Counterclaim Defendant-Appellant.
__________________________
2009-1437, -1438
__________________________
Appeal from the United States District Court for the
Eastern District of New York in 04-CV-5540, Senior
Judge David G. Trager.
___________________________
Decided: August 2, 2010
___________________________
GREGORY A. CASTANIAS, Jones Day, of Washington,
DC, argued for plaintiffs-appellants. With him on the
brief were F. DOMINIC CERRITO, DANIEL L. MALONE and
ERIC C. STOPS, of New York, New York. Of counsel was
EVANGELINE SHIH.
KING PHARMACEUTICALS v. EON LABS 2
MARTIN B. PAVANE, Cohen Pontani Lieberman &
Pavane LLP, of New York, New York, argued for defen-
dant-appellee. With him on the brief were ALFRED H.
HEMINGWAY, JR. and MARILYN NEIMAN.
JAMES B. MONROE, Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP, of Washington, DC, argued for
counterclaim defendant-appellant. With him on the brief
were PAUL W. BROWNING and KAKOLI CAPRIHAN. Of
counsel were JUSTIN J. HASFORD and LAWRENCE L. ILAG.
__________________________
Before BRYSON, GAJARSA, and PROST, Circuit Judges.
GAJARSA, Circuit Judge.
King Pharmaceuticals, Inc. and King Pharmaceuticals
Research and Development, Inc. (“King”) appeal the U.S.
District Court for the Eastern District of New York’s
grant of Eon Labs, Inc.’s (“Eon”) motion for summary
judgment that all claims of U.S. Patent Nos. 6,407,128
(the “’128 patent”) and 6,683,102 (the “’102 patent”) are
invalid. See King Pharms., Inc. v. Eon Labs, Inc., 593 F.
Supp. 2d 501 (E.D.N.Y. 2009). In granting Eon’s motion,
the district court held four claims invalid under 35 U.S.C.
§ 101, three claims invalid under 35 U.S.C. § 103, and the
remaining claims invalid under 35 U.S.C. § 102. See id.
at 506-15.
Following the summary judgment order, the district
court entered a final judgment against both King and
Elan Pharmaceuticals, Inc. (“Elan”), a prior owner of one
of the asserted patents and a third-party, counterclaim
defendant. Elan filed a “cautionary” notice of appeal on
July 2, 2009 contending that the district court lacked
jurisdiction to enter a final judgment against it. Elan
3 KING PHARMACEUTICALS v. EON LABS
then moved to be dismissed as a party from this appeal
for lack of subject matter jurisdiction and to vacate the
district court’s judgment as to Elan. A Federal Circuit
motions panel denied the motion because the jurisdic-
tional facts went to the merits of the case. Elan reasserts
its jurisdictional arguments in the present appeal.
For the reasons stated below, we affirm the district
court’s grant of summary judgment of invalidity. We
vacate the district court’s invalidity order against Elan
because the district court lacked subject matter jurisdic-
tion to adjudicate the invalidity counterclaim.
BACKGROUND
King markets and sells a name brand version of
metaxalone called Skelaxin. Metaxalone is a muscle
relaxant that is used to treat “discomforts associated with
acute, painful musculosketal conditions.” ’128 patent
col.1 ll.21-23. Metaxalone was first discovered in the
1960s, and the first patent claiming the method of produc-
ing the compound, U.S. Patent No. 3,062,827, issued in
1962 to A.H. Robins Company, Inc. A.H. Robins began
selling metaxalone under the brand name Skelaxin in
1962. Elan eventually acquired the rights to Skelaxin
and sold those rights in 2003 to King, which now markets
and sells Skelaxin.
On August 31, 2004, Eon filed an Abbreviated New
Drug Application (“ANDA”) for a generic 800 mg metax-
alone tablet. Eon filed with the ANDA a patent certifica-
tion pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
(“Paragraph IV Certification”), which alleged that none of
the claims of the ’128 patent would be infringed by the
manufacture, use, or sale of Eon’s generic 800 mg metax-
alone tablet, and that all the claims of the ’128 patent are
invalid. In response to the ANDA and Paragraph IV
Certification, King filed suit against Eon under the
KING PHARMACEUTICALS v. EON LABS 4
Hatch-Waxman Act (the “800 mg Action”). The complaint
accused Eon of infringing the ’128 and ’102 patents.
King’s action was consolidated with an earlier, related
action, Elan Pharmaceuticals, Inc. v. Eon Labs, Inc., No.
03-0006 (E.D.N.Y.) (the “400 mg Action”), that Elan filed
in 2001 against Eon after Eon filed an ANDA for a generic
400 mg metaxalone tablet. Elan asserted the ’128 patent
in the 400 mg Action, but the case was dismissed after
Eon withdrew its 400 mg ANDA. The district court then
severed Eon’s claims for attorneys fees against King and
Elan and consolidated those claims with the 800 mg
Action.
The ’128 patent, titled “Method for Increasing the
Bioavailability of Metaxalone,” issued on June 18, 2002
and was initially assigned to Elan. Elan subsequently
assigned the ’128 patent to King in 2003. The patent
discloses a method of “increasing the bioavailability of
metaxalone by administration of an oral dosage form with
food.” ’128 patent [Abstract]. The claimed invention is
the result of “the unexpected finding that administration
of metaxalone with food increases both the rate and
extent of absorption via the oral dosage form in human
subjects.” Id. at col.2 ll.6-9.
The ’128 patent has three independent claims, claims
1, 9, and 17. Claim 1 claims “a method of increasing the
oral bioavailability of metaxalone” by “administering to
the patient a therapeutically effective amount of metax-
alone in a pharmaceutical composition with food.” Claim
9 claims a method for increasing “the rate and extent of
absorption . . . of metaxalone . . . in the blood stream” by
“administering to the patient a therapeutically effective
amount of metaxalone in a pharmaceutical composition
with food.” Claim 17 claims a method similar to claim 1,
but limits the effective amount of metaxalone to between
400 and 800 mg and defines an increase in bioavailability
5 KING PHARMACEUTICALS v. EON LABS
as “an increase in the maximal plasma concentration
(Cmax) and extent of absorption (AUC(last)) of metax-
alone compared to administration without food.”
Dependent claims 2, 3, 10, and 11 specify that the
“therapeutically effective amount” of metaxalone is “200
mg to 900 mg” (claims 2 and 10) or “400 mg to 800 mg”
(claims 3 and 11). Dependent claims 4-6, 12-14, and 18-20
specify specific times for administering the metaxalone
relative to the consumption of food, either thirty minutes
prior to two hours after consumption of food (claims 4, 12
and 18), “substantially at the same time” as consumption
of food (claims 5, 13 and 19), or up to one hour after
consumption of food (claims 6, 14 and 20). Dependent
claims 7 and 15 limit the dosage to a tablet form, and
dependent claims 8 and 16 limit the dosage to a “unit
dosage form.” Dependent claim 21 claims the method of
claim 1 with the additional limitation of “informing” the
patient that taking metaxalone with food will increase the
drug’s bioavailability, and dependent claim 22 claims the
method of claim 1 with the additional limitation that “the
metaxalone is from a container with printed labeling
advising” that taking metaxalone with food will increase
the drug’s bioavailability.
The ’102 patent issued on January 27, 2004 and is ti-
tled “Methods of Using Metaxalone in the Treatment of
Musculoskeletal Conditions.” Elan assigned the applica-
tion that resulted in the ’102 patent to King in 2003. Like
the ’128 patent, the ’102 patent discloses a method of
“increasing the bioavailability of metaxalone by admini-
stration of an oral dosage form with food.” ’102 patent
[Abstract]. Independent claim 1 claims a method for
using metaxalone in the treatment of musculosketal
conditions comprising both “providing” a patient with a
“therapeutically effective amount of metaxalone” and
“informing” the patient that taking metaxalone with food
KING PHARMACEUTICALS v. EON LABS 6
increases the bioavailability of the drug. Claims 2
through 5 depend from claim 1 and either specify the
“therapeutically effective amount” as 200 mg to 900 mg
(claim 2) or 400 mg to 800 mg (claim 3), or limit the
dosage to a tablet form (claim 4) or a “unit dosage form”
(claim 5).
Independent claim 6 claims a “method of using
metaxalone in the treatment of musculosketal conditions”
consisting of “informing a patient” that taking metaxalone
with food increases the bioavailability of the drug com-
pared to taking metaxalone without food. Independent
claim 7 claims a “method of using metaxalone in the
treatment of musculosketal conditions” by “obtaining
metaxalone from a container providing information that
administration of metaxalone with food” increases the
drug’s bioavailability and “ingesting the metaxalone with
food.”
Independent claim 8 claims a “method of using
metaxalone in the treatment of musculosketal conditions”
comprising both administering metaxalone with food and
informing the patient that such administration increases
the bioavailability of the drug. Dependent claims 9
through 11 limit claim 8 to metaxalone from a container
with printed information concerning the increased
bioavailability of the drug (claim 9), metaxalone in a
tablet form (claim 10), and 400 mg of metaxalone (claim
11). Claims 12, 13, and 14 depend from claim 9 and limit
the printed label to stating certain percentage increases
in the bioavailability of metaxalone. Finally, claim 15
depends from claim 8 and limits the metaxalone to a 400
mg tablet with a printed label that states certain percent-
age increases in the bioavailability of the metaxalone.
Before the district court, Eon presented six prior art
references it contended invalidated the ’128 and ’102
7 KING PHARMACEUTICALS v. EON LABS
patents. See King Pharms., Inc., 593 F. Supp. 2d at 504-
06. In granting Eon’s motion for summary judgment, the
district court relied only upon three references: KAZEM
FATHIE, Musculoskeletal Disorders and Their Manage-
ment with a New Relaxant, CLINICAL MEDICINE 678 (April
1965) (“Fathie II”); JOSEPH A. ALBANESE, NURSES’ DRUG
REFERENCE 427 (2 ed. 1982) (“Albanese”); and ANNE C.
ABRAMS, CLINICAL DRUG THERAPY 145 (1995) (“Abrams”).
See id. at 506-15.
Fathie II describes a clinical study in which patients
were given 800 mg of metaxalone to be taken three to five
times a day. The article notes that several patients
complained of nausea and that “[n]ausea might have been
less prominent if the medication had been taken with
food.” J.A.3054.
Albanese is a reference guide for registered nurses.
The guide discloses that metaxalone is available in 400
mg tablets and recommends a dosage range of 800 mg
three to four times daily. The guide also notes that
“[a]dministration with meals will help reduce gastric
upset.” J.A.3065.
Abrams is another reference guide for registered
nurses. The reference guide discloses providing patients
with 800 mg of metaxalone three or four times daily for
not more than ten consecutive days. The reference guide
also instructs nurses to give metaxalone “with milk or
food” in order to “decrease gastrointestinal distress.”
J.A.3072.
Eon moved for summary judgment of invalidity.
Eon’s motion asserted that all claims of the ’128 and ’102
patents were either anticipated by or obvious in light of
the prior art. The district court granted Eon’s motion.
See King Pharms., Inc., 593 F. Supp. 2d 501.
KING PHARMACEUTICALS v. EON LABS 8
Starting with independent claim 1 of the ’128 patent,
the district court found the claim’s preamble – “[a]
method of increasing the oral bioavailability of metax-
alone to a patient receiving metaxalone therapy” – inher-
ently anticipated because “an increase in the
bioavailability of metaxalone is inherent when the drug is
taken with food.” Id. at 508. The district court then
concluded that “because the ’128 patent teaches nothing
more than administering metaxalone with food to in-
crease its bioavailability and because Fathie II, Albanese
and Abrams all teach administering metaxalone with food
– which inherently increases metaxalone’s bioavailability
– claim 1 is anticipated.” Id. at 509.
Turning to the ’128 patent’s dependent claims, the
district court found claims 2 and 3 anticipated because
the prior art references disclosed dosage amounts within
the claimed “therapeutically effective” range. See id. at
510. Claims 4 through 7 were also found anticipated
because the prior art disclosed taking metaxalone with
food within the various time frames claimed. See id. As
for claim 8, the district court found that no reference
disclosed taking a single tablet of metaxalone with food,
but held the claim obvious in light of a prior art reference,
18 R.W. DENT, JR. AND DOROTHY K. ERVIN, A Study of
Metaxalone (Skelaxin) vs. Placebo in Acute Musculoskele-
tal Disorders: A Cooperative Study, CURRENT
THERAPEUTIC RESEARCH (1975) (“Dent”), which discloses a
single tablet dosage and Albanese, which discloses taking
dosages with food. See id. at 510-11.
The district court then found claims 9 through 16 mir-
rored claims 1 through 7, and found the claims antici-
pated for the earlier stated reasons. See id. at 512. Claim
17 was also found anticipated because the claim’s
“wherein the administration [of metaxalone] results in an
increase in [bioavailability]” language, like claim 1’s
9 KING PHARMACEUTICALS v. EON LABS
preamble, is an inherent property of the prior art. See id.
Claims 18 through 20, which depend from claim 17,
include the same timing limitations as claims 4 through 6,
and were anticipated for the same reasons. See id. The
district court then found claim 21 invalid under 35 U.S.C.
§ 101 because the claim’s “informing” limitation did not
“transform the metaxalone into a different state or thing.”
Id. at 513 (citing In re Bilski, 545 F.3d 943 (Fed. Cir.
2008), aff’d sub nom, Bilski v. Kappos, 130 S. Ct. 3218
(2010)). Finally, the district court held claim 22 antici-
pated because the inclusion of an instruction sheet with a
known compound did not make the claim patentably
distinct from the prior art. See id. (citing In re Nagi, 367
F.3d 1336 (Fed. Cir. 2004) (per curiam)).
The district court next addressed the ’102 patent,
reading claim 1 to “require[] giving a patient metaxalone
and informing the patient about an inherent property of
the drug.” Id. at 514 (alteration added). In analyzing
claim 1, the district court held that administering metax-
alone to a patient was disclosed in the prior art, the
“informing” limitation was not patentable for the same
reasons as claim 21 of the ’128 patent, and the entire
claim was invalid under § 101. See id. Claims 2 through
4 contained dosage limitations similar to the limitations
disclosed in anticipated claims 2, 3, and 7 of the ’128
patent, and the district court found the claims to be
similarly anticipated under § 102. See id. Claim 5 was
similar to claim 8 of the ’128 patent and was obvious for
the same reasons. See id.
The district court found claim 6 claimed solely the “in-
forming” limitation and invalidated it under § 101. 1 See
id. The district court then found claims 7 and 9 invalid
1 King does not appeal this finding of invalidity
of claim 6.
KING PHARMACEUTICALS v. EON LABS 10
for the same reasons as claim 22 of the ’128 patent, and
claim 8 invalid for the same reasons as claim 21 of the
’128 patent. See id. at 514-15. Claims 10 and 11 were
found invalid for the same reasons as claim 7 of the ’128
patent. See id. at 515. Finally, claims 12 through 15,
which “differ from the prior art only in the content of the
written material that accompanies the metaxalone,” were,
like claim 22 of the ’128 patent, anticipated because “a
variation in written material that is not functionally
related to the invention does not render a known product
patentable.” Id.
In light of its invalidity determination, the district
court granted King’s motion to dismiss Eon’s counter-
claims for fraud and unclean hands as moot. See id. at
516. The district court, however, permitted Eon to brief
its argument that the case was exceptional under 35
U.S.C. § 285. See id. at 515. The district court then
entered its invalidity judgment against not only King, but
also Elan, which had not participated in the summary
judgment proceeding.
DISCUSSION
A. Legal Standards
We review the district court’s grant of summary
judgment de novo. See ICU Med., Inc. v. Alaris Med. Sys.,
Inc., 558 F.3d 1368, 1374 (Fed. Cir. 2009). Summary
judgment is appropriate when, drawing all justifiable
inferences in the non-movant’s favor, there exists no
genuine issue of material fact and the movant is entitled
to judgment as a matter of law. See Fed. R. Civ. P. 56(c);
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).
Under 35 U.S.C. § 102 a claim is anticipated “if each
and every limitation is found either expressly or inher-
ently in a single prior art reference.” Celeritas Techs. Ltd.
11 KING PHARMACEUTICALS v. EON LABS
v. Rockwell Int’l Corp., 150 F.3d 1354, 1360 (Fed. Cir.
1998). “[A]nticipation by inherent disclosure is appropri-
ate only when the reference discloses prior art that must
necessarily include the unstated limitation. . . .”
Transclean Corp. v. Bridgewood Servs., Inc., 290 F.3d
1364, 1373 (Fed. Cir. 2002) (emphasis in original). A
claim is obvious when “the differences between the subject
matter sought to be patented and the prior art are such
that the subject matter as a whole would have been
obvious at the time the invention was made to a person
having ordinary skill in the art to which said subject
matter pertains.” 35 U.S.C. § 103.
Moreover, “[t]he laws of nature, physical phenomena,
and abstract ideas have been held not patentable.” Dia-
mond v. Chakrabarty, 447 U.S. 303, 309 (1980). While a
process may be patentable if “(1) it is tied to a particular
machine or apparatus, or (2) it transforms a particular
article into a different state or thing,” In re Bilski, 545
F.3d at 954, there is no exclusive test for determining
patentability under § 101, Bilski, 130 S. Ct. at 3226-27.
B. Analysis
The district court considered and invalidated all
thirty-seven claims of the ’128 and ’102 patents, and King
appeals thirty-six of those findings. We begin, as the
district court did, with the ’128 patent and then turn to
the ’102 patent.
I. The ’128 Patent
a. Claim 1
Claim 1 is an independent claim requiring the ad-
ministration of “a therapeutically effective amount of
metaxalone in a pharmaceutical composition with food.”
Claim 1 contains a preamble, which King argues is the
claim’s source of novelty. The preamble reads, “[a]
KING PHARMACEUTICALS v. EON LABS 12
method of increasing the bioavailability of metaxalone to
a patient receiving metaxalone therapy.” According to
King, while the prior art may disclose taking metaxalone
with food, it does not disclose increasing the bioavailabil-
ity of the drug.
In its summary judgment opinion, the district court
rejected King’s argument and found claim 1’s preamble
inherently anticipated. See King Pharms., Inc., 593 F.
Supp. 2d at 507-09. According to the district court, an
increase in the bioavailability of metaxalone is an inher-
ent property of taking metaxalone with food, which is
disclosed in each of Fathie II, Albanese, and Abrams. See
id.
On appeal, King argues the district court erred be-
cause Eon did not provide any evidence or expert testi-
mony that the prior art would necessarily result in an
increase in metaxalone’s bioavailability. King argues that
the prior art’s disclosure (taking metaxalone with food to
reduce gastric discomfort) is vague as to the conditions
under which the food was administered such that it was
improper for the district court to assume that an increase
in bioavailability was necessarily disclosed. Specifically,
King contrasts the precise conditions on food consumption
disclosed in the ’128 patent with the vague conditions
disclosed in Fathie II, Albanese, and Abrams. 2 For fur-
ther support, King cites its own expert reports which
conclude that “even a disclosure of taking metaxalone
with food would not inherently disclose increasing the
bioavailability of metaxalone.”
2 Participants in the study were given fifteen
minutes to eat the following before administration of the
metaxalone: two eggs (fried in butter), two strips of
bacon, two slices of toast with butter, four ounces of hash
brown potatoes, and one glass whole milk (eight ounces).
See ’128 patent col.3 ll.14-25.
13 KING PHARMACEUTICALS v. EON LABS
As an initial matter, King’s attempt to link an in-
crease in metaxalone’s bioavailability to specific food
conditions is untenable. While the ’128 patent’s written
description discloses specific conditions for food consump-
tion, its claims only recite taking metaxalone “with food.”
It would be improper to limit the broad terms used in the
’128 patent’s claims to the specific food conditions dis-
closed in the written description. See Kara Tech. Inc. v.
Stamps.com Inc., 582 F.3d 1341, 1348 (Fed. Cir. 2009)
(“The claims, not specification embodiments, define the
scope of patent protection. The patentee is entitled to the
full scope of his claims, and we will not limit him to his
preferred embodiment or import a limitation from the
specification into the claims.”). Moreover, the written
description in no way suggests that the specific food
conditions disclosed were necessary for increasing metax-
alone’s bioavailability. Rather, the written description
teaches that the claimed increase in metaxalone’s
bioavailability can be achieved through the consumption
of “a meal, such as breakfast, lunch or dinner.” ’128
patent col.2 ll.37-38. The district court was therefore
correct in finding that “the ’128 patent does not identify
any additional conditions that must be present for the
food effect to occur. Rather, it occurs naturally in most
people when they take metaxalone with food.” King
Pharms., Inc., 593 F. Supp. 2d at 508; see also Verdegaal
Bros., Inc. v. Union Oil Co. of California, 814 F.2d 628,
632 (Fed. Cir. 1987) (holding reliance on non-claimed
distinction between prior art method and claimed method
“inappropriate” and insufficient to save the claim from
inherent anticipation).
As for the merits of King’s argument, we first note
that Fathie II, Albanese, and Abrams each disclose ad-
ministering metaxalone “with food” or “with meals” to
treat musculosketal conditions. Fathie II, published
KING PHARMACEUTICALS v. EON LABS 14
thirty-six years prior to the filing of the ’128 patent,
teaches administering metaxalone “with food” to reduce
nausea. J.A.3054. Albanese, published nineteen years
prior to the filing of the ’128 patent, teaches administer-
ing metaxalone “with meals” to “reduce gastric upset.”
J.A.3065. And, Abrams, published six years prior to the
filing of the ’128 patent, teaches administering metax-
alone “with milk or food” to “decrease gastrointestinal
distress.” J.A.3072.
We have held that “[i]t is a general rule that merely
discovering and claiming a new benefit of an old process
cannot render the process again patentable.” In re Wood-
ruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Such newly
discovered benefits are not patentable because they are
inherent in the prior art. See Bristol-Myers Squibb Co. v.
Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir.
2001). While inherent anticipation “may not be estab-
lished by probabilities or possibilities,” In re Oelrich, 666
F.2d 578, 581 (CCPA 1981), if “the [prior art’s] disclosure
is sufficient to show that the natural result flowing from
the operation as taught would result in the performance
of the questioned function, it seems to be well-settled that
the disclosure should be regarded as sufficient,” id.
(alterations added).
According to the ’128 patent, the natural result of tak-
ing metaxalone with food is an increase in the bioavail-
ability of the drug. The prior art discloses taking
metaxalone with food, but not the natural result of this
process. However, because the prior art methods in their
“normal and usual operation . . . perform the function
which [King] claims in [the ’128 patent], then such [pat-
ent] will be considered, to have been anticipated by the
[prior art].” In re Ackenbach, 45 F.2d 437, 439 (CCPA
1930) (alterations added). As taught by the ’128 patent,
the only steps required to increase metaxalone’s bioavail-
15 KING PHARMACEUTICALS v. EON LABS
ability are (1) ingesting metaxalone (2) with food. These
steps are undeniably disclosed by the prior art. An in-
crease in metaxalone’s bioavailability is, therefore, an
inherent aspect of the prior art. In other words, the
increase in metaxalone’s bioavailability is the “‘natural
result’ flowing from the [prior art’s] explicitly explicated
limitations.” Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d
955, 970 (Fed. Cir. 2001) (alterations added); see also
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1331,
1336 (Fed. Cir. 1999) (“[T]o the extent the embodiment in
the patent achieves [the limitation], so does the [prior
art].”) (alterations added). Accordingly, claim 1’s pream-
ble is inherently anticipated.
King’s experts’ opinions that “even a disclosure of tak-
ing metaxalone with food would not inherently disclose
increasing the bioavailability of metaxalone,” do not
undermine our analysis. To anticipate, the prior art need
only meet the inherently disclosed limitation to the extent
the patented method does. See Hewlett-Packard Co. v.
Mustek Systems, Inc., 340 F.3d 1314, 1326 (Fed. Cir.
2003) (“[A] prior art product that sometimes, but not
always, embodies a claimed method nonetheless teaches
that aspect of the invention.”). Because the ’128 patent
discloses no more than taking metaxalone with food, to
the extent such a method increases the bioavailability of
metaxalone, the identical prior art method does as well.
As the district court aptly stated, “to inherently antici-
pate, the prior art need only give the same results as the
patent, not better.” King Pharms., Inc., 593 F. Supp. 2d
at 509.
For the foregoing reasons, the district court’s inherent
anticipation analysis was proper. The preamble to claim
1 is inherently anticipated. To hold otherwise would
remove from the public a method of treating muscle pain
that has been performed for decades. See Atlas Powder
KING PHARMACEUTICALS v. EON LABS 16
Co. v. Ireco, Inc., 190 F.3d 1342, 1348 (Fed. Cir. 1999)
(“The public remains free to make, use, or sell prior art
compositions or processes, regardless of whether or not
they understand their complete makeup or the underlying
scientific principles which allow them to operate. The
doctrine of anticipation by inherency, among other doc-
trines, enforces that basic principle.”). Accordingly, the
district court’s finding that claim 1 is anticipated is af-
firmed.
Because we reject King’s argument that claim 1’s pre-
amble is novel, we also affirm the district court’s findings
of invalidity as to claims 2, 3, 8-11, and 15-17. For these
claims, King’s sole argument on appeal was that their
incorporation of claim 1’s preamble (claims 2, 3, 7, and 8)
or their recitation of a similar preamble (claims 9-11 and
15-17) made the claims novel. Like claim 1, these claims
are anticipated because their sole source of novelty is
inherently disclosed by the prior art.
b. Claims 4-6, 12-14, and 18-20.
Claims 4-6 depend from claim 1. The claims limit the
time frame in which the patient must ingest the metax-
alone in relation to consuming food. Claim 4 limits the
time frame to “30 minutes prior to 2 hours after consump-
tion of the food,” claim 5 limits it to “substantially at the
same time,” and claim 6 limits it to “immediately after the
consumption of food up to 1 hour after.” Fathie II, Al-
banese, and Abrams respectively disclose administering
metaxalone “with food,” “with meals,” and “with food or
milk.” J.A.3054, 3065, 3072.
On appeal, King argues that none of the claims’ spe-
cific timeframe requirements is disclosed in Fathie II,
Albanese, or Abrams. Yet, according to King’s own ex-
perts, “with food” could mean taking metaxalone “1 hour
prior to up to about 2 hours after eating.” J.A.3221 (Decl.
17 KING PHARMACEUTICALS v. EON LABS
of Dr. Elia). Under this common-sense definition of “with
food,” the prior art discloses a timeframe for ingesting
metaxalone in relation to consuming food that falls within
the timeframes claimed by claims 4-6. The district court’s
finding that claims 4-6 are anticipated is therefore af-
firmed. See Titanium Metals Corp. of America v. Banner,
778 F.2d 775, 782 (Fed. Cir. 1985) (“[It is] an elementary
principle of patent law that when, as by a recitation of
ranges or otherwise, a claim covers several compositions,
the claim is ‘anticipated’ if one of them is in the prior
art.”); Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d
1288, 1298 (Fed. Cir. 2009).
Claims 12-14 and 18-20 contain identical timeframe
requirements. The district court invalidated these claims
for the same reasons it invalidated claims 4-6. We there-
fore affirm the district court’s invalidation of these claims
for the same reasons we affirmed its invalidation of
claims 4-6.
c. Claim 21
Claim 21 depends from claim 1 and adds the limita-
tion “informing the patient that administration of a
therapeutically effective amount of metaxalone in a
pharmaceutical composition with food results in an in-
crease in the maximal plasma concentration (Cmax) and
extent of absorption (AUC(last)) of metaxalone compared
to administration without food.” The district court invali-
dated claim 21 pursuant to 35 U.S.C. § 101. In invalidat-
ing claim 21, the district court cited this court’s opinion in
In re Bilski and held that “the act of informing another
person of the food effect of metaxalone does not transform
metaxalone into a different state or thing.” King
Pharms., Inc., 593 F. Supp. 2d at 513.
On appeal, King contends it was legal error for the
district court to focus solely on the “informing” limitation
KING PHARMACEUTICALS v. EON LABS 18
in invalidating the claim. Instead, according to King, the
district court should have examined the claim as a whole
to determine whether it recited patent eligible subject
matter. King is correct.
The Supreme Court has stated that a § 101 pat-
entability analysis is directed to the claim as a whole, not
individual limitations. See Parker v. Flook, 437 U.S. 584,
590 (1978) (“[A] process is not unpatentable simply be-
cause it contains a law of nature or a mathematical
algorithm.” (alterations added)); see also In re Bilski, 545
F.3d at 958 (“[T]he [Supreme] Court has made clear that
it is inappropriate to determine the patent-eligibility of a
claim as a whole based on whether selected limitations
constitute patent-eligible subject matter.” (alterations
added)). Contrary to the Supreme Court’s instructions,
the district court ignored the claim as a whole and im-
properly focused on one limitation, the “informing” limita-
tion, in invalidating the claim under § 101. Such an
analysis is improper.
Reviewed as a whole, claim 21 teaches a method of
treating patients with metaxalone, whereby the patient is
administered metaxalone with food and informed that
such treatment increases the bioavailability of the drug.
Prior to the Supreme Court’s decision in Bilski, this court
held that such medical treatment methods were pat-
entable processes under § 101 because they fell squarely
within the machine-or-transformation test applied in In re
Bilski. Specifically, we held that methods of treatment
“are always transformative when a defined group of drugs
is administered to the body to ameliorate the effects of an
undesired condition,” because such methods transform the
human body. Prometheus Labs., Inc. v. Mayo Collabora-
tive Serv., 581 F.3d 1336, 1346 (Fed. Cir. 2009), cert.
granted and vacated, No. 09-490, 78 U.S.L.W. 3254 (U.S.
June 29, 2010). While the Supreme Court in Bilski made
19 KING PHARMACEUTICALS v. EON LABS
clear that our machine-or-transformation test is not the
exclusive test for patentability, Bilski, 130 S. Ct. 3226-27,
it also made clear that the test “is a useful and important
clue, an investigative tool, for determining whether some
claimed inventions are processes under § 101,” id. at
3227. We therefore understand the Supreme Court to
have rejected the exclusive nature of our test, but not
necessarily the wisdom behind it.
The present case, however, does not present the
proper vehicle for determining whether claims covering
medical treatment methods are eligible for patenting
under § 101 because even if claim 21 recites patent eligi-
ble subject matter, that subject matter is anticipated for
the reasons discussed below. As an appellate court, we
are not limited to a district court’s stated reasons for
invalidating claims and can affirm a grant of summary
judgment on any ground supported by the record and
adequately raised below. See Glaxo, Inc. v. Torpharm,
Inc.,153 F.3d 1366, 1371 (Fed. Cir. 1998); Jaffke v.
Dunham, 352 U.S. 280, 281 (1957) (per curiam). In
moving for summary judgment, Eon argued that claim 21,
as well as the other claims the district court invalidated
under § 101, was invalid under § 102, not § 101. Accord-
ingly, the novelty of claim 21 was an issue presented to
the district court and an alternative ground upon which
the district court’s invalidation of the claim can be af-
firmed. See Hester Indus., Inc. v. Stein, Inc., 142
F.3d 1472, 1480 (Fed. Cir. 1998) (affirming summary
judgment of invalidity on ground advanced by defendant
in summary judgment motion but not adopted by district
court).
Because we have already determined that independ-
ent claim 1 is anticipated, dependent claim 21’s sole
potential source of novelty is the “informing” limitation.
King argues that the district court committed legal error
KING PHARMACEUTICALS v. EON LABS 20
because it never found the “informing” limitation dis-
closed in the prior art, which it was required to do. See
Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999
(Fed. Cir. 2006) (“Anticipation requires a showing that
each limitation of a claim is found in a single reference,
either expressly or inherently.”). Eon tacitly concedes
that the district court never expressly found the “inform-
ing” limitation disclosed in the prior art, but contends
such a finding was unnecessary because the non-
patentable “informing” limitation cannot breathe novelty
into an otherwise anticipated method.
The specific question before us is whether an other-
wise anticipated method claim becomes patentable be-
cause it includes a step of “informing” someone about the
existence of an inherent property of that method. We hold
it does not. The “informing” limitation adds no novelty to
the method, which is otherwise anticipated by the prior
art. In other words, in light of our holding that the
method of taking metaxalone with food to increase the
drug’s bioavailability, as recited in claim 1, is not pat-
entable, it readily follows that claim 21, which recites the
same method with the sole additional step of informing
the patient about this increase in bioavailability, is not
patentable.
In an analogous context, we have held that “[w]here
the printed matter is not functionally related to the
substrate, the printed matter will not distinguish the
invention from the prior art in terms of patentability.” In
re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (altera-
tions added). In such cases, we have recognized that the
printed matter is not independently patentable, but have
cautioned that the limitation must not be excised from the
claim. See id. at 1385 (“[T]he board cannot dissect a
claim, excise the printed matter from it, and declare the
remaining portion of the mutilated claim to be unpat-
21 KING PHARMACEUTICALS v. EON LABS
entable. The claim must be read as a whole.”) (alterations
added). Instead, the relevant question is whether “there
exists any new and unobvious functional relationship
between the printed matter and the substrate.” Id. at
1386 (citing In re Miller, 418 F.2d 1392, 1396 (CCPA
1969)). The rationale behind this line of cases is prevent-
ing the indefinite patenting of known products by the
simple inclusion of novel, yet functionally unrelated
limitations. See In re Nagi, 367 F.3d at 1339.
Although these “printed matter” cases involved the
addition of printed matter, such as written instructions,
to a known product, we see no principled reason for limit-
ing their reasoning to that specific factual context. See In
re Ngai, 367 F.3d at 1338-39; In re Gulack, 703 F.2d at
1385-87. Rather, we believe that the rationale underlying
these cases extends to the situation presented in this
case, wherein an instructional limitation is added to a
method, as opposed to a product, known in the art. Thus,
the relevant inquiry here is whether the additional in-
structional limitation of claim 21 has a “new and unob-
vious functional relationship” with the known method of
administering metaxalone with food. See In re Ngai, 367
F.3d at 1338 (quoting In re Gulack, 703 F.2d at 1386).
King contends that there is a functional relationship
between the “informing” limitation and the method.
Specifically, at oral argument, King’s counsel argued that
the “informing” limitation increases the likelihood that
the patient will take metaxalone with food, thereby in-
creasing the efficiency of the method. See Oral Arg. at
7:30-8:26. This relationship, however, is not functional.
Informing a patient about the benefits of a drug in no way
transforms the process of taking the drug with food.
Irrespective of whether the patient is informed about the
benefits, the actual method, taking metaxalone with food,
is the same. In other words, the “informing” limitation “in
KING PHARMACEUTICALS v. EON LABS 22
no way depends on the [method], and the [method] does
not depend on the [‘informing’ limitation].” In re Nagi,
367 F.3d at 1339 (alterations added). “It is not invention
to perceive that the product which others had discovered
had qualities they failed to detect.” Gen. Elec. Co. v.
Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945).
Accordingly, we affirm the district court’s finding that
claim 21 is invalid, but on the alternative ground that the
claim is anticipated by the prior art.
d. Claim 22
Claim 22 is closely related to claim 21. Claim 22 de-
pends from claim 1 and limits claim 1’s method to situa-
tions “wherein the metaxalone is from a container with
printed labeling advising that administration with food
results in an increase in the maximal plasma concentra-
tion (Cmax) and extent of absorption (AUC(last)) of
metaxalone compared to administration without food.”
The district court, relying on this court’s printed matter
precedent as articulated in In re Nagi, found the claim
anticipated by Fathie II, Albanese, and Abrams. See King
Pharms., Inc., 593 F. Supp. 2d at 513.
Because it depends from claim 1, the printed label
limitation is claim 22’s only potential source of novelty.
However, as the district court correctly found, the printed
label limitation falls squarely within our printed matter
cases discussed above with respect to claim 21. While
ostensibly a method claim, the potentially novel aspect of
claim 22 concerns a printed label on a product. Like claim
21’s “informing” limitation, the printed label is not func-
tionally related to either the product within the method
claim or the method claim as a whole. Therefore, the
district court was correct in finding the claim anticipated.
See In re Nagi, 367 F.3d at 1339.
23 KING PHARMACEUTICALS v. EON LABS
King attempts to avoid In re Nagi by limiting that
case to product claims. According to King, because claim
22 is a method claim, In re Nagi, which addressed a
product claim, is not applicable. During our discussion of
claim 21, we rejected the notion that In re Nagi’s holding
should be limited solely to product claims. Accordingly,
we reject King’s argument and affirm the district court’s
finding that claim 22 is anticipated.
We also affirm the district court’s invalidation of
claims 7, 9, and 12-15 of the ’102 patent, which are nearly
identical to claim 22 of the ’128 patent. The district court
invalidated these claims for the same reasons it invali-
dated claim 22. On appeal, King argues claims 7, 9, and
12-15 of ’102 patent are novel for the same reasons claim
22 was allegedly novel, i.e., their incorporation of a
printed label limitation. For the reasons discussed above,
we reject this argument and affirm the district court’s
invalidation of claims 7, 9, and 12-15 of ’102 patent.
II. The ’102 Patent
a. Claim 1
Claim 1 of the ’102 patent is an independent claim,
which claims a “method of using metaxalone in the treat-
ment of musculoskeletal conditions” comprising both
“providing the patient with a therapeutically effective
amount of metaxalone” and “informing the patient that
administration with food results in an increase in the
maximal plasma concentration (Cmax) and extent of
absorption (AUC(last)) of metaxalone compared to ad-
ministration without food.” The district court held the
claim was invalid under § 101 for the same reasons it
invalidated claim 21 of the ’128 patent. See King
Pharms., Inc., 593 F. Supp. 2d at 514. King contends the
district court erred because it failed to consider the claim
as a whole.
KING PHARMACEUTICALS v. EON LABS 24
As we discussed with respect to claim 21 of the ’128
patent, we agree with King that the district court’s in-
validation of claim 1 under § 101 is improper because it
ignored the claim as a whole and focused on one limita-
tion. Yet, also like claim 21, claim 1’s sole source of
novelty is the “informing” limitation. Because this limita-
tion is not functionally related to the otherwise antici-
pated method, the claim is anticipated. Accordingly, we
affirm the district court’s finding that claim 1 is invalid,
but on the alternative ground that the claim is antici-
pated by the prior art.
Because we reject King’s argument that claim 1’s “in-
forming” limitation is novel, we also affirm the district
court’s finding of invalidity as to dependent claims 2
through 4 and independent claim 8 and its dependent
claims 10 and 11. For these claims, King argued on
appeal that their incorporation of the “informing” limita-
tion (claims 2-4) or their recitation of a similar limitation
(claims 8, 10, and 11) made the claims novel. For the
reasons discussed above, we reject King’s argument and
find the claims anticipated by the prior art.
b. Claim 5
Claim 5 depends from claim 1 and limits the metax-
alone to a “unit dosage form.” Like claim 8 of the ’128
patent, the district court found claim 5 obvious over
Albanese in light of Dent. See King Pharms., Inc., 593 F.
Supp. 2d at 514.
In addition to arguing that the “informing” limit pro-
vides the claim with novelty, King argues that the district
court improperly disregarded King’s evidence of secondary
indicia of non-obviousness. King’s secondary-
considerations evidence consisted primarily of an expert
report concerning sales of Skelaxin from 1998 to 2003. As
the district court found, however, a significant portion of
25 KING PHARMACEUTICALS v. EON LABS
the increase in Skelaxin sales occurred prior to the de-
termination that ingesting metaxalone with food in-
creases the drug’s bioavailability and well before the
patents issued. Moreover, King has not shown any nexus
between the drug’s alleged commercial success and the
specific invention claimed in claim 5. Brown & William-
son Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120,
1130 (Fed. Cir. 2000) (“A nexus between commercial
success and the claimed features is required.”). With
respect to claim 5, the claimed invention is the admini-
stration of metaxalone in a tablet that constitutes a “unit
dosage form.” King has not shown any connection be-
tween administering metaxalone in a “unit dosage form”
and the alleged commercial success.
Turning to the district court’s obviousness analysis,
the district court held that a prior art reference, Dent,
disclosed taking metaxalone in a single 400 mg tablet four
times a day. King Pharms., Inc., 593 F. Supp. 2d at 511.
Dent does make such a disclosure. It would be obvious to
a person of ordinary skill in the art to combine Dent’s
teaching of taking a tablet dosage of metaxalone four
times a day with Albanese’s teaching of administering
metaxalone with food. See KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 421 (2008) (“A person of ordinary skill is
also a person of ordinary creativity, not an automaton.”).
Accordingly, the district court’s determination that claim
5 is obvious is affirmed.
III. Jurisdiction Over Elan
In January 2003, after Eon filed an ANDA with the
Food and Drug Administration (“FDA”) for a generic 400
mg metaxalone tablet, it was sued by Elan for infringe-
ment of the ’128 patent, the 400 mg Action. While that
suit was pending, Elan entered into a sale agreement
with King in which Elan transferred to King all of Elan’s
KING PHARMACEUTICALS v. EON LABS 26
rights to Skelaxin, including the ’128 patent and the
application that would yield the ’102 patent. The sale
occurred on June 12, 2003, and a month later Elan re-
corded a patent assignment agreement with the Patent
and Trademark Office assigning both the ’128 patent and
the application that would lead to the ’102 patent to King.
Following the sale, Elan attempted to extricate itself
from the 400 mg Action by moving to (1) substitute King
as a plaintiff and (2) dismiss itself from the suit. In
addition to its motion, Elan represented to the district
court in several letters that it no longer possessed any
rights in the ’128 and ’102 patents and that it was willing
to enter into a stipulation to that effect. While Elan’s
motion to substitute King as the plaintiff in the 400 mg
Action was pending, King filed suit against Eon when Eon
filed an ANDA with the FDA for a generic 800 mg metax-
alone tablet, the 800 mg Action. In this second action,
Eon filed several declaratory counterclaims against Elan,
including a counterclaim of invalidity. The district court
initially consolidated the 400 and 800 mg Actions, but
eventually dismissed the 400 mg Action when Eon with-
drew its 400 mg metaxalone ANDA. However, despite the
dismissal of the 400 mg Action, the district court denied
Elan’s motion to substitute King as a plaintiff and dismiss
Elan from the consolidated litigation. Instead, the district
court dismissed various anticompetitive counterclaims
Eon had asserted against Elan, but maintained Eon’s
various invalidity counterclaims against Elan.
Despite not being formally removed from the litiga-
tion, Elan did not participate in the merits proceedings of
the litigation. Indeed, Elan did not submit briefing in
conjunction with Eon’s motion for summary judgment of
invalidity, and Eon stated in a letter to the district court
that its motion was “directed at King, not Elan.”
J.A.9700. Nonetheless, when issuing its final order
27 KING PHARMACEUTICALS v. EON LABS
declaring the ’128 and ’102 patents invalid, the district
court entered the order against both King and Elan.
On appeal, Elan argues that the district court lacked
jurisdiction to enter an invalidity order against it. Ac-
cording to Elan, it sold all its rights to the ’128 and ’102
patents prior to King filing suit, and therefore the district
court lacked jurisdiction to adjudicate the counterclaim.
In granting summary judgment of invalidity, the dis-
trict court did not address whether it had jurisdiction over
Elan. This court, however, must address the issue. See
Jenkins v. McKeithen, 395 U.S. 411, 421 (1969) (“[S]ince
the question of standing goes to this Court’s jurisdiction,
we must decide the issue even though the court below
passed over it without comment.” (citation omitted)).
Whether an actual case or controversy exists is re-
viewed de novo. See Janssen Pharmaceutica, N.V. v.
Apotex, Inc., 540 F.3d 1353, 1359 (Fed. Cir. 2008). A case
or controversy exists when “the facts alleged, under all
the circumstances, show that there is a substantial con-
troversy, between parties having adverse legal interests,
of sufficient immediacy and reality to warrant the issu-
ance of a declaratory judgment.” MedImmune, Inc. v.
Genetech, Inc., 549 U.S. 118, 127 (2007) (quoting Mary-
land Casualty Co. v. Pacific Coal & Oil Co., 312 U.S. 270,
273 (1941)). Eon has the burden of demonstrating an
actual case or controversy. See Benitec Australia, Ltd. v.
Nucleonics, Inc., 495 F.3d 1340, 1344 (Fed. Cir. 2007)
(“The burden is on the party claiming declaratory judg-
ment jurisdiction to establish that such jurisdiction
existed at the time the claim for declaratory relief was
filed and that it has continued since.”).
Eon has not met its burden of demonstrating the exis-
tence of an actual case or controversy between it and
Elan. The acquisition documents between Elan and King
KING PHARMACEUTICALS v. EON LABS 28
demonstrate quite clearly that Elan sold all its interests
in the asserted patents to King. For example, the Asset
Purchase Agreement transferred “all Skelaxin Patent
Rights” from Elan to King. Elan also produced the Patent
Assignment agreement which unambiguously assigns “an
undivided right, title, and interest in and to the Patent
Rights” to King. J.A.9653-54. The “Patent Rights” in-
clude both the ’128 patent and the application (U.S.
Patent Application No. 10/104,044) that issued as the ’102
patent.
Moreover, in a letter to the district court, Elan stated
it “will waive any rights it may have, if any, separate and
apart from any rights it has transferred to the new patent
owners, to pursue any damages or relief from Eon . . .
based on Elan’s past ownership of the ’128 patent.”
J.A.7408. Once the ’102 patent issued, Elan wrote Eon’s
counsel and made a similar proposal concerning that
patent. Elan reiterated its proposals in several pleadings
before the district court and made a similar representa-
tion during oral argument, which Eon’s counsel found
sufficient. See Oral Arg. at 24:32-25:30 (representation),
25:43-25:48 (acceptance by Eon’s counsel).
Elan’s broad and unrestricted covenants not to sue
Eon for infringement of the ’102 or ’128 patents, remove
any case or controversy that may have existed between
the parties at one point. See Microchip Technology Inc. v.
Chamberlain Group, Inc., 441 F.3d 936, 943 (Fed. Cir.
2006) (vacating district court’s summary judgment of
invalidity because the declaratory judgment plaintiff
could “not identif[y] a single legal claim that it believes
[the defendant] could have brought against it in the
absence of [the] declaratory judgment action”); Benitec
Australia, Ltd., 495 F.3d at 1347-48 (finding no case or
controversy where patentee withdrew its infringement
claims and covenanted not to sue the defendant for future
29 KING PHARMACEUTICALS v. EON LABS
acts). Had Elan retained the right to sue Eon in some
instances, then an actual case or controversy may exist.
See Revolution Eyewear, Inc. v. Aspex Eyewear, Inc., 556
F.3d 1294, 1298 (Fed. Cir. 2009) (holding that covenant
not to sue did not divest district court of declaratory
judgment jurisdiction because the covenant did not cover
future products). Elan, however, did not retain any such
rights, and its covenants not to sue confirm that there is
no case or controversy between it and Eon. Accordingly,
we vacate the district court’s order of invalidity as entered
against Elan.
In summary, while the district court erred in invali-
dating several of the claims as unpatentable under § 101,
all the claims of the ’128 and ’102 patents are ultimately
anticipated under 35 U.S.C. § 102 or obvious under 35
U.S.C. § 103 in light of the prior art. Additionally, the
district court erred in entering a judgment of invalidity
against Elan because no case or controversy currently
exists between Elan and Eon. 3
AFFIRMED and VACATED-IN-PART
COSTS
No costs.
3 We take no position as to whether the district
court possesses jurisdiction to hear any claim by Eon
against Elan for attorneys fees under 35 U.S.C. § 285.