CAFC tackles colon cleansing and purgation; Braintree wins its appeal

The decision Braintree v. Breckenridge by the SDNY is reversed by the CAFC in
2017 U.S. App. LEXIS 7980: "we reverse the district court's grant
of summary judgment of noninfringement and remand for
entry of judgment for Braintree."


Braintree Laboratories, Inc. (“Braintree”) appeals
from the Southern District of New York’s summary judgment
that Breckenridge Pharmaceutical, Inc. (“Breckenridge”)
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.



The subject matter related to bowel preps for colonoscopies:


The ’149 patent is directed to compositions and methods
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 hypertonic
solution of potassium sulfate, magnesium sulfate,
and sodium sulfate.



At issue was the meaning of "purgation":


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 “purgation”
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 district
court’s construction of “purgation” to mean “an
evacuation of a copious amount of stool from the bowels
after oral administration of the solution.” Id. at 1354–55.
We reasoned the claims only require “inducing purgation.”
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 construction.
Id. at 1354.

The dissent stated that Braintree’s “one bottle” infringement
theory is erroneous as a matter of law because
under 35 U.S.C. § 271(e), Braintree can only assert infringement
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.

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 infringement
because the effective amount that is administered
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).



Reviewing the past-->

There was a parallel case:


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 "purgation"
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 construction of “purgation”
and held that “while cleansing is the goal specifically
articulated in the specification, it is not a claim requirement.”
Novel, 749 F.3d at 1355. We concurrently interpreted
“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 comprising
from about 100 ml to about 500 ml” derives antecedent
basis from the preamble. The same composition
for “inducing purgation” must be “from about 100 ml to
about 500 ml.”


The "due process" issue:


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
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 construction
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 construction
of “from about 100 ml to about 500 ml.”



Of label infringement:


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 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 physician
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 cleansing
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]
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.



**Separately, from blawgsearch on 6 May 2017