Colonoscopies contemplated in Braintree v. Novel; DNJ errs in construing "electrolyte shifts;" "it’s quite a bit of diarrhea that comes out.”

The CAFC found that DNJ erred in claim construction in Braintree v. Novel :


Because we agree with Novel that the district court
erred in its construction of the claim term “clinically
significant electrolyte shifts,” we reverse the district
court’s claim construction of that term, vacate the district
court’s grant of summary judgment of infringement, and
remand for further factual findings to determine whether
the composition covered by Novel’s ANDA product infringes
under the new claim construction articulated
herein. Further, we affirm the district court’s findings
that the asserted claims of the ’149 patent are not invalid.



The case is about preparation for colonoscopies:


Braintree is a pharmaceutical company that manufactures
the SUPREP® Bowel Prep Kit (“SUPREP”), which
helps to prepare patients for colonoscopies. The colon
needs to be visually clear in order to successfully perform
a colonoscopy, so prior to the examination patients typically
drink several liters of a solution to induce diarrhea.



The focal point of contention was a composition that does not produce
any clinically significant electrolyte shifts

The background law on claim construction:


Claim construction is a question of law, Markman v.
Westview Instruments, Inc., 52 F.3d 967, 976-79 (Fed. Cir.
1995) (en banc), aff’d, 517 U.S. 370 (1996), that we review
de novo without deference. Cybor Corp. v. FAS Techs.,
Inc., 138 F.3d 1448, 1454-55 (Fed. Cir. 1998) (en banc).



There was a moving target:



in considering the
parties’ summary-judgment motions, the district court
amended its construction and re-defined “clinically significant
electrolyte shifts” to be “alterations in blood chemistry
that are both outside the normal upper or lower limits
of their range and accompanied by or manifested as other
untoward effects.” Infringement Opinion at *7 (emphases
added). The district court explained that it modified its
original construction to make it conjunctive because the
specification refers to “electrolyte shifts leading to serious
health problems for the patient.” Id.


The term was defined in the specification:


On appeal, Novel argues that in requiring both alterations
in blood chemistry and other untoward effects, the
district court ignored the inventor’s clear definition of the
term “clinically significant electrolyte shifts” in the specification.
See ’149 patent col. 2 ll. 47-51 (“The terms ‘clinically
significant’ as used herein are meant to convey
alterations in blood chemistry that are outside the normal
upper or lower limits of their normal range or other
untoward effects.”).



Thus, the CAFC was direct:


Under our precedent, the patentee’s lexicography
must govern the claim construction analysis. See Phillips
v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en
banc). Therefore, we disagree with the district court’s
modification of the clear language found in the specification.
We reverse the district court’s claim construction
and construe “clinically significant electrolyte shifts” to be
“alterations in blood chemistry that are outside the normal
upper or lower limits of their normal range or other
untoward effects.”



Anticipation was dealt with quickly:



Anticipation is a question of fact, and a district court’s
findings on this issue are reviewed for clear error. See
Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082
(Fed. Cir. 2008). Below, the district court found that
Novel “did not show proof that met the clear and convincing
standard” that the asserted claims were anticipated
by Hechter. Validity Opinion at *25. The district court
credited Braintree’s expert witness’s opinion that Hechter
does not disclose several limitations of the asserted
claims. Id. at *24. On appeal Novel argues again that
Hechter anticipates the asserted claims of the ’149 patent.
(...)
For at least these three reasons, we affirm the district
court’s finding that Hechter does not anticipate the asserted
claims of the ’149 patent.


As to obviousness:


As the district court correctly noted,
Novel did not prove that one of skill in the art would have
been motivated to combine so many references. In other
words, it failed to prove a “plausible rational[e] as to why
the prior art references would have worked together.”
Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1343,
1352 (Fed. Cir. 2010). Further, in building its obviousness
case, Novel relies on expert testimony which the
district court found to be less credible. Validity Opinion
at *25. And the prior art, including Hechter, taught that
safe bowel preps should be isotonic, not hypertonic like
the claimed compositions. See, e.g., Hechter col. 2 ll. 60-
64. Therefore, we conclude that the district court did not
err in finding that Novel failed to demonstrate that the
asserted claims of the ’149 patent would have been obvious
at the time of the invention.



Of descriptive words in claims:




Descriptive words like “copious” are
commonly used in patent claims, to “avoid[] a strict numerical
boundary to the specified parameter.” See Pall
Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217
(Fed. Cir. 1995). Further, when asked what copious
would mean to one of skill in the art, Braintree’s expert
witness stated “[w]ell, copious is a lot. . . . I think anyone
who has taken a bowel prep prior to [a] colonoscopy,
knows that it’s quite a bit of diarrhea that comes out.”
J.A. 20161. We agree, and therefore we conclude that one
of skill in the art would understand what a “copious”
amount of diarrhea is in this context.



There was a dissent on the infringement matter:


However, I respectfully dissent from the majority’s
conclusion that Novel’s ANDA meets the volume limitation
of the asserted claims. Under the proper interpretation
of the volume limitation, Novel established noninfringement
as a matter of law. In my view, the majority’s
contrary conclusion is inconsistent with established
authority under the Hatch-Waxman Act.



Of Hatch-Wawman infringement:


In ANDA litigation, because a generic company seeking
FDA approval does not yet “make[], use[], offer[] to
sell, or sell[]” the product and therefore cannot infringe
under 35 U.S.C. § 271(a), pharmaceutical companies must
rely on 35 U.S.C. § 271(e)(2)(A), which creates an “artificial”
act of infringement when the generic company submits
an ANDA seeking approval “‘for a drug claimed in a
patent or the use of which is claimed in a patent.’” Eli
Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 675, 676
(1990) (quoting § 271(e)(2)(A)). The infringement occurs
only if the generic company seeks approval for a patented
composition or use that has been approved by the FDA.
Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316,
1319 (Fed. Cir. 2012) (citing Warner-Lambert Co. v.
Apotex Corp., 316 F.3d 1348, 1356 (Fed. Cir. 2003) (“‘[T]he
use’ in § 271(e)(2)(A) refers to the use for which the FDA
has granted an NDA.”)); Glaxo, Inc. v. Novopharm, Ltd.,
110 F.3d 1562, 1567–68 (Fed. Cir. 1997) (composition is
determined by the composition in the ANDA).2
Under the Hatch-Waxman Act, the infringement inquiry
“must focus on what the ANDA applicant will likely
market if its application is approved.” Id. at 1569. Novel’s
ANDA does not cover administration of the drug for
purgation sufficient for “evacuation of a copious amount of
stool from the bowels.” Claim Construction Order at *6.
Rather, Novel’s ANDA states specifically that the drug “is
indicated for cleansing of the colon as a preparation for
colonoscopy in adults.” J.A. 5280.



AND


The majority’s contrary interpretation is inconsistent
with this court’s longstanding precedent. An ANDA
cannot infringe an asserted patent when the FDA approved
dose is not the dose claimed in the patent. As
we held in Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d
1322, 1332 (Fed. Cir. 2003), “a method of use patent
holder may not sue an ANDA applicant for induced infringement
of its patent, if the ANDA applicant is not
seeking FDA approval for the use claimed in the patent
and if the use claimed in the patent is not FDA-approved.”
(emphasis added) (citing Warner-Lambert, 316 F.3d at
1354–55). While the patent here includes both composition
and method of use claims, all claims are limited to
the use of a specified volume of the composition.