Court Opinion

ID: 4166529
Source: CourtListenerOpinion
Date Created: 2017-05-05 15:04:42.719674+00
Date Added: 2024-06-11T14:23:03.523228
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                ______________________

        BRAINTREE LABORATORIES, INC.,
               Plaintiff-Appellant

                           v.

   BRECKENRIDGE PHARMACEUTICAL, INC.,
             Defendant-Appellee
           ______________________

                      2016-1731
                ______________________

   Appeal from the United States District Court for the
Southern District of New York in No. 1:12-cv-06851-AJN,
Judge Alison J. Nathan.
                 ______________________

                 Decided: May 5, 2017
                ______________________

    MARK CHRISTOPHER FLEMING, Wilmer Cutler Picker-
ing Hale and Dorr LLP, Boston, MA, argued for plaintiff-
appellant. Also represented by JOHN JOSEPH REGAN, JR.,
MICHAEL    ADAM     GREENE,    ANNA    E.   LUMELSKY;
CHRISTOPHER R. NOYES, New York, NY.

   STEVEN M. LIEBERMAN, Rothwell, Figg, Ernst &
Manbeck, P.C., Washington, DC, argued for defendant-
appellee. Also represented by JENNIFER NOCK, LISA N.
2          BRAINTREE LABS., INC.   v. BRECKENRIDGE PHARM., INC.

PHILLIPS; ROBERT VROOM, Breckenridge Pharmaceutical,
Inc., New York, NY.
                 ______________________

    Before NEWMAN, MOORE, and WALLACH, Circuit Judges.
MOORE, Circuit Judge.
    Braintree Laboratories, Inc. (“Braintree”) appeals
from the Southern District of New York’s summary judg-
ment that Breckenridge Pharmaceutical, Inc. (“Brecken-
ridge”) does not directly infringe or induce infringement of
the asserted claims of U.S. Patent No. 6,946,149 (“the
’149 patent”). For the reasons discussed below, we reverse
and remand.
                        BACKGROUND
     The ’149 patent is directed to compositions and meth-
ods for purging a patient’s colon, as is routinely performed
prior to a colonoscopy. Braintree markets a bowel prep
kit named SUPREP, which is listed in the Food and Drug
Administration’s (“FDA”) Approved Drug Products with
Therapeutic Equivalence Evaluations as covered by one or
more claims of the ’149 patent. SUPREP is sold as a kit
consisting of two six-ounce bottles of an aqueous hyper-
tonic solution of potassium sulfate, magnesium sulfate,
and sodium sulfate. Its FDA-approved label instructs
patients to fill each bottle with water to the sixteen-ounce
line (473 mL) prior to consumption and directs that the
first bottle be taken the evening before and the second
bottle the morning of the colonoscopy. According to
SUPREP’s label, “[t]he dose for colon cleansing requires
administration of two bottles of SUPREP.” J.A. 2028.
    On March 15, 2012, Breckenridge submitted an
Abbreviated New Drug Application (“ANDA”) to the FDA,
seeking approval to market a generic version of SUPREP.
After Breckenridge sent Braintree a Paragraph IV letter
asserting that the ’149 patent was invalid or not infringed
BRAINTREE LABS., INC.   v. BRECKENRIDGE PHARM., INC.      3

by its proposed product, Braintree filed the instant action
accusing Breckenridge of infringement. Braintree asserts
that Breckenridge’s proposed product infringes composi-
tion claims 15 and 18 and method claims 19, 20, and 23.
Each of the asserted method claims recite, inter alia,
methods for “inducing colonic purgation” through oral
administration of the claimed compositions. For purposes
of this appeal, claim 15 is representative:
    15. A composition for inducing purgation of the co-
    lon of a patient, the composition comprising from
    about 100 ml to about 500 ml of an aqueous hy-
    pertonic solution comprising an effective amount
    of Na2SO4, an effective amount of MgSO4, and an
    effective amount of K2SO4, wherein the composi-
    tion does not produce any clinically significant
    electrolyte shifts and does not include phosphate.
The parties’ dispute centers on the relationship between
the “purgation” and “from about 100 ml to about 500 ml”
limitations.
     We previously construed the “purgation” limitation of
the ’149 patent in Braintree Laboratories, Inc. v. Novel
Laboratories, Inc., 749 F.3d 1349 (Fed. Cir. 2014). In that
appeal, Novel—another ANDA applicant for a generic
version of SUPREP—argued the district court erred in
construing “purgation” to encompass something less than
full colon cleansing. Novel argued “purgation” must mean
full cleansing of the colon sufficient for a colonoscopy.
Under Novel’s noninfringement theory, one bottle of its
generic version of SUPREP could not satisfy the “purga-
tion” limitation because full cleansing only occurs after
ingestion of two bottles. But two bottles could not satisfy
the volume limitation “from about 100 ml to about
500 ml” because two bottles contain 946 mL of solution.
     We rejected Novel’s argument and affirmed the dis-
trict court’s construction of “purgation” to mean “an
evacuation of a copious amount of stool from the bowels
4        BRAINTREE LABS., INC.   v. BRECKENRIDGE PHARM., INC.

after oral administration of the solution.” Id. at 1354–55.
We reasoned the claims only require “inducing purga-
tion.” Id. We stated Braintree’s “one bottle” theory of
infringement—in which one bottle of Novel’s proposed
product both induces “purgation” and satisfies the volume
limitation—“can prevail” under the district court’s con-
struction. Id. at 1354.
    The dissent stated that Braintree’s “one bottle” in-
fringement theory is erroneous as a matter of law because
under 35 U.S.C. § 271(e), Braintree can only assert in-
fringement over the product as described in Novel’s
ANDA, which discloses 946 mL in volume. Id. at 1361–
63. The dissent added that apart from the § 271(e) issue,
Braintree’s “one bottle” theory rests on an incorrect claim
construction because “from about 100 ml to about 500 ml”
must refer to the total volume of consumed solution. Id.
at 1363–65.
    While the Novel appeal was pending, Breckenridge
stipulated that the district court’s Novel construction of
“purgation” would apply in this case. Breckenridge
further stipulated to “be bound by a final decision in the
Novel Case . . . on any issues having to do with patent
invalidity . . . and non-infringement” other than the “from
about 100 ml to about 500 ml” limitation. J.A. 296–27
¶¶ 3, 8. Breckenridge subsequently moved for summary
judgment of noninfringement based on this limitation,
arguing its proposed generic does not infringe the claims
of the ’149 patent “because it is administered as 946 ml of
aqueous solution, and thus falls outside the recited vol-
ume range.” J.A. 1228. It argued that based both on the
claim construction of the term and the infringement
inquiry under § 271(e), “from about 100 ml to about
500 ml” must refer to the total volume of solution admin-
istered. It argued its proposed label could not induce
infringement of method claims 19, 20, and 23 under
§ 271(e) because its ANDA label instructs patients to
consume the “entire amount” of solution (946 mL) for the
BRAINTREE LABS., INC.   v. BRECKENRIDGE PHARM., INC.      5

sole indication of “preparation for colonoscopy”—not only
one bottle to “induce colonic purgation.”
    The district court granted Breckenridge’s motion for
summary judgment of noninfringement. It held that
Novel did not preclude Breckenridge’s noninfringement
theory because that opinion did not address the separate
volume limitation. It construed “from about 100 ml to
about 500 ml” to mean “the entire volume of solution
administered to a patient over a treatment period rather
than the volume of a single bottle, or half-dose.” J.A. 13–
14. Because every asserted claim requires “from about
100 ml to about 500 ml,” the district court found that
Breckenridge’s proposed product, with a total volume of
946 mL, does not infringe any of the asserted claims. The
district court also agreed that Breckenridge’s ANDA label
could not induce infringement under § 271(e), finding
inducing purgation without “achieving a fully cleansed
colon” is not an FDA-approved use of Breckenridge’s
product. For method claim 23, it found no induced in-
fringement because the effective amount that is adminis-
tered in two or more doses must be in the range of from
about 100 ml to about 500 ml. Braintree appeals. We
have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
                          DISCUSSION
                  A. Claim Construction
    The parties dispute Novel’s preclusive effect on the
district court’s construction of “from about 100 ml to about
500 ml.” Breckenridge argues that Novel is irrelevant
because the construction of “from about 100 ml to about
500 ml” was not at issue in Novel. We disagree.
    The meaning of the term “from about 100 ml to about
500 ml” was necessarily connected to our construction of
“purgation.” Novel intertwined the volume and purgation
limitations throughout its briefing to argue noninfringe-
ment under its construction of “purgation.” See, e.g.,
6          BRAINTREE LABS., INC.   v. BRECKENRIDGE PHARM., INC.

J.A. 1598–99. We rejected Novel’s construction of “purga-
tion” and held that “while cleansing is the goal specifically
articulated in the specification, it is not a claim require-
ment.” Novel, 749 F.3d at 1355. We concurrently inter-
preted “from about 100 ml to about 500 ml” as what is
necessary to induce purgation. Our construction stemmed
from the arguments presented and the claim language,
which linked the “purgation” and “from about 100 ml to
about 500 ml” limitations. The parties do not dispute that
the preamble, “[a] composition for inducing purgation,” is
limiting. The claim’s recitation of “the composition com-
prising from about 100 ml to about 500 ml” derives ante-
cedent basis from the preamble. The same composition
for “inducing purgation” must be “from about 100 ml to
about 500 ml.” In Novel, this court construed “from about
100 ml to about 500 ml” to be the amount of the composi-
tion that induces “purgation,” which is less than full
cleansing. 749 F.3d at 1354. We further explained,
      Each of those half-dose sixteen ounce solutions
      has a total volume of 473 mL, which is within the
      range found in the asserted claims of the
      ’149 patent, but Braintree concedes that neither
      dose accomplishes a full cleansing.          Thus,
      Braintree’s “one bottle” infringement theory as-
      serts that one (half-dose) bottle of SUPREP, dilut-
      ed with water to become a sixteen ounce solution,
      falls within the asserted claims. This infringe-
      ment theory can prevail if purgation means the
      “evacuation of a copious amount of stool from the
      bowels after oral administration of the solution,”
      which is something less than a full cleansing.
Id.
     We are mindful of the due process implications of
binding Breckenridge to a claim construction decision in
which it was neither a party nor in privity with one. See,
e.g., Blonder-Tongue Labs., Inc. v. Univ. of Ill. Found., 402
BRAINTREE LABS., INC.   v. BRECKENRIDGE PHARM., INC.      7

U.S. 313, 329 (1971) (“Due process prohibits estopping
[litigants who never appeared in a prior action] despite
one or more existing adjudications of the identical issue
which stand squarely against their position.”). However,
Breckenridge expressly stipulated that “the claim con-
struction of ‘purgation’ adopted by the District Court in
the Novel Case will apply.” J.A. 296 ¶ 5. Breckenridge
further agreed “to be bound by a final decision in the
Novel Case” on “any issues” related to patent invalidity
and noninfringement. J.A. 297 ¶ 8. Whether or not the
construction Breckenridge advocates has merit, in light of
its stipulations, Novel foreclosed the district court’s con-
struction of “from about 100 ml to about 500 ml.”
        B. Noninfringement Under 35 U.S.C. § 271(e)
    Breckenridge argues the district court’s summary
judgment of noninfringement should be affirmed notwith-
standing its construction of the volume limitation because
Braintree’s infringement theory is contrary to 35 U.S.C.
§ 271(e). We disagree.
    The district court held Breckenridge’s ANDA label
could not induce infringement of method claims 19 and 20
because inducing purgation is not an FDA-approved use
of Breckenridge’s proposed product. J.A. 18. 1 It reasoned

    1    The district court further held that Breckenridge
does not infringe method claim 23, which provides “the
effective amount of the composition is administered in two
or more doses within a treatment period,” by construing
this limitation to mean dividing the total composition (of
“from about 100 ml to about 500 ml) into separate dosag-
es, as compared to repeating administration of the compo-
sition. J.A. 19–20. We agree with Braintree that the
district court’s noninfringement decision based on this
limitation contradicts the parties’ stipulation to limit
summary judgment. Appellee’s Br. 52 (citing J.A. 296
8        BRAINTREE LABS., INC.   v. BRECKENRIDGE PHARM., INC.

that because our Novel decision distinguished “purgation”
from full colon cleansing, purgation is a distinct treat-
ment, rather than merely a mechanism to achieve the
goal of full colon cleansing. J.A. 17–18. We do not agree.
    This case is distinguishable from the cases in which
we have held an ANDA applicant’s proposed label would
not induce infringement. In Warner-Lambert Co v. Apotex
Corp., 316 F.3d 1348 (Fed. Cir. 2003), we held that an
ANDA applicant’s labeled indication for partial seizures
would not induce infringement of a “method for treating
neurodegenerative diseases.” We noted that the two
indications were entirely distinct because partial seizure
is not a neurodegenerative disease. Id. at 1353. We
explained that to gain approval for the neurodegenerative
disease indication, which was not an approved indication
for the brand product, the ANDA applicant would have
had to submit safety and efficacy data to the FDA. Id.
at 1360, 1361 n.6. Similarly, in Allergan, Inc. v. Alcon
Labs., Inc., 324 F.3d 1322 (Fed. Cir. 2003), we held that
an ANDA applicant’s labeled indication for reducing
intraocular pressure would not induce infringement of
methods of “protecting the optic nerve and retina” and
“providing neural protection.” Because the claimed uses
were not approved by the FDA, the ANDA applicant could
not be held liable for infringement “even though [the
proposed drug] necessarily had those protective effects in
patients who took the drug for the approved purpose.”
Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316,
1321 (Fed. Cir. 2012) (citing Allergan, 324 F.3d at 1324).
In Bayer, we addressed induced infringement of method
claims for “simultaneously achieving, during premeno-
pause or menopause, a contraceptive effect, an anti-
androgenic effect, and an antialdosterone effect” based on

¶ 3). We thus reverse this portion of the district court’s
decision.
BRAINTREE LABS., INC.   v. BRECKENRIDGE PHARM., INC.      9

an ANDA label with the indication “for oral contracep-
tion.” 676 F.3d at 1319–20. We explained that while the
ANDA label mentioned the potential for the claimed
effects, “it does not do so in any way that recommends or
suggests to physicians that the drug is safe and effective
for administration to patients for the purposes of inducing
these effects.” Id. at 1322. We therefore held the ANDA
applicant could not be held liable for inducing a physician
to infringe the method claims. Id. at 1326.
    In contrast, inducing purgation is not a distinct use of
Breckenridge’s proposed product; inducing purgation is
the means by which the approved indication achieves its
result. Breckenridge concedes that its proposed product
“cleanses the colon of a patient by inducing purgation”
when taken as directed by its label. J.A. 1780–81 ¶¶ 25,
37–38 (emphasis added). Its stipulations make clear that
inducing purgation is not supplemental or ancillary to its
proposed indication of colon cleansing—it is plainly within
the scope of Breckenridge’s proposed indication.
    We hold that Breckenridge’s labeled indication for
colon cleansing “recommends or suggests to physicians
that the drug is safe and effective for administration to
patients for the purposes of inducing [purgation].” Bayer,
676 F.3d at 1322. There can be no dispute that, given
SUPREP’s sole approved use, the FDA has approved
SUPREP as safe and effective for the indication of colon
cleansing. Because Breckenridge’s labeled indication of
colon cleansing requires performing the claimed steps in
order to achieve colon cleansing, it follows that a physi-
cian would understand Breckenridge’s ANDA label to
recommend or suggest that “inducing purgation” is safe
and effective. To hold otherwise would lead to the absurd
result that a physician would understand Breckenridge’s
proposed product to be safe and effective for fully cleans-
ing the colon, but not safe and effective at accomplishing a
partial colon cleansing. Because Breckenridge’s ANDA
label “instruct[s] how to engage in an infringing use, [it]
10        BRAINTREE LABS., INC.   v. BRECKENRIDGE PHARM., INC.

show[s] an affirmative intent that the product be used to
infringe.” AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042,
1059 (Fed. Cir. 2010) (citation omitted).
    Breckenridge stipulated that its proposed product
infringes claims 15, 18, 19, 20, and 23 of the ’149 patent if
its motion for summary judgment of noninfringement is
denied. J.A. 296 ¶ 3. It further agreed not to raise any
defenses or counterclaims other than the noninfringement
defense articulated in its motion for summary judgment.
Id. ¶¶ 4, 6. We thus reverse the district court’s grant of
summary judgment and remand with an instruction to
enter judgment for Braintree.
                           CONCLUSION
    We have considered all of Breckenridge’s arguments
on appeal and find them to be without merit. For the
foregoing reasons, we reverse the district court’s grant of
summary judgment of noninfringement and remand for
entry of judgment for Braintree.
             REVERSED AND REMANDED
                             COSTS
     Costs to Braintree.