Fractured CAFC decision in Braintree v. Novel with two different dissents; case punted back to DNJ
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
masks two strong and conflicting dissents.
The issue raised by the dissent of Judge Dyk argues that the defendant
Novel should not have been found an infringer:
In particular, the majority’s decision is contrary to our
decision in Bayer Schering, where we held that because
“the FDA has not approved [the use claimed in the patent]
. . . the defendants cannot be held liable for infringement
of the patent.” 676 F.3d at 1326. There, the
patent claimed the use of a particular drug to achieve
three effects simultaneously, “a contraceptive effect, an
antiandrogenic effect, and an antialdosterone effect.” Id.
at 1319 (quoting U.S. Patent No. 5,569,652). But the
FDA-approved NDA and label indicated the use of the
branded drug only “for oral contraception.” Id. (internal
quotation marks omitted). We held that the accused
ANDAs did not infringe because they did not seek approval
for two of the claimed uses. Id. at 1326. There was
no infringement under § 271(e)(2)(A) because “the defendants’
ANDAs [sought] approval to market the generic
[drug] for contraceptive use, and there is no valid patent
on the use of the drug for that purpose alone.” Id.
Similarly, in Warner-Lambert, 316 F.3d at 1356, we
held that “because an ANDA may not seek approval for an
unapproved or off-label use of a drug . . . it necessarily
follows that 35 U.S.C. 271(e)(2)(A) does not apply to a use
patent claiming only such [an unapproved or off-label]
use.” See also AstraZeneca LP v. Apotex, Inc., 633 F.3d
1042, 1059–60 (Fed. Cir. 2010) (assuming that an ANDA
seeking approval for a twice-daily dose regimen could not
infringe a patent claiming a once-daily dose regimen). In
short, Braintree’s patent claims a composition and a
method, both of which require using a 100-500 mL solution.
Novel’s ANDA seeking FDA approval for a 946 mL
solution cannot infringe the ’149 patent
Furthermore, the dissent does not rely solely on the
Even if there were no Hatch-Waxman issue,
Braintree’s theory would be unsupportable. Braintree’s
“one bottle” theory rests on a demonstrably incorrect
claim construction. Here, “volume” refers to the total
volume of the recommended dosage and not some portion
of that total volume—whether or not the recommended
dosage is given in one bottle or two bottles.
See the earlier IPBiz post titled Colonoscopies contemplated in Braintree v. Novel; DNJ errs in construing "electrolyte shifts;" "it’s quite a bit of diarrhea that comes out.”
In contrast to Judge Dyk's view, from within Judge Moore's dissent which argues that Novel was an infringer:
Infringement, whether on a large or small scale, is
still infringement.2 See, e.g., Lucent Techs., Inc. v. Gateway,
Inc., 580 F.3d 1301, 1318 (Fed. Cir. 2009). Lucent
makes clear that there is no “rare infringement” exception
to liability, and that even one instance of infringement is
adequate to support a judgment of infringement. Id.
(affirming a finding of direct infringement where a jury
“could have reasonably concluded that . . . more likely
than not one person somewhere in the United States had
performed the claimed method”); see also Broadcom Corp.
v. Emulex Corp., 732 F.3d 1325, 1333 (Fed. Cir. 2013) (“It
is well settled that an accused device that sometimes, but
not always, embodies a claim nonetheless infringes.”).
The law responds to rare infringement not by eliminating
liability, but by providing for a correspondingly low award
of damages. See Lucent, 580 F.3d at 1334 (“The damages
award ought to be correlated, in some respect, to the
extent the infringing method is used by consumers.”).
Moore cites Lamb-Weston:
In an effort to avoid this outcome, the majority rewrites
the claim language to allow infringement only if
the drug works in a patient population rather than a
patient.3 But this we cannot do. Chef Am., Inc. v. Lamb-
Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004) (“[W]e
construe the claim as written . . . .”); Process Control Corp.
v. HydReclaim Corp., 190 F.3d 1350, 1357 (Fed. Cir. 1999)
(“[A] nonsensical result does not require the court to
redraft the claims . . . .”). If the result commanded by the
statute is unsatisfactory, the proper response is for Congress
to amend the statute, making the delayed approval
discretionary rather than mandatory, not for us to redraft
the patent to avoid such a result. For these reasons, I
respectfully dissent. I would affirm the district court’s
summary judgment of infringement.