Saturday, April 14, 2018

Vanda v. West-Ward. Hatch-Waxman issues AND inducement AND 101

D. Delaware was affirmed:

West-Ward Pharmaceuticals International Limited
and West-Ward Pharmaceuticals Corp. (collectively,
“West-Ward”) appeal from the decision of the United
States District Court for the District of Delaware holding,
after a bench trial, claims 1–9, 11–13, and 16 (“the asserted
claims”) of U.S. Patent 8,586,610 (“the ’610 patent”)
infringed and not invalid. See Vanda Pharm. Inc. v.
Roxane Labs., Inc., 203 F. Supp. 3d 412 (D. Del. 2016)
(“Opinion”). For the following reasons, we affirm.

We first address whether, beyond the jurisdictional
question, a claim for infringement of the ’610 patent
under 35 U.S.C. § 271(e)(2)(A) can lie where the ’610
patent issued after the original ANDA was submitted and
Vanda sued West-Ward for infringement of the asserted
claims prior to West-Ward submitting a Paragraph IV
certification. The district court held that West-Ward’s
submission of the Paragraph IV certification for the ’610
patent was an act of infringement. See Opinion, 203 F.
Supp. 3d at 433. We review the district court’s statutory
interpretation without deference. Warner–Lambert, 316
F.3d at 1355.

Vanda argues that it proved an act of infringement
under 35 U.S.C. § 271(e)(2). According to Vanda, “[w]here
a patent issues after an ANDA is filed but before FDA
approval, and where—as here—the applicant submits a
Paragraph IV certification directed at the new patent,
that amendment of the ANDA is an act of infringement
under Section 271(e)(2).” Appellee Br. 60

West-Ward responds that there can be no infringement
under § 271(e)(2) because the ANDA was filed
before the ’610 patent issued. West-Ward contends that
the statutorily defined act of infringement excludes
amendments to an ANDA and “only reaches ANDAs
submitted ‘for a drug claimed in a patent or the use of
which is claimed in a patent’—not a drug that might or
might not later be claimed in a patent or one that has
been claimed in a provisional patent application or a
patent-pending.” Reply Br. 33 (emphases in original)
(quoting 35 U.S.C. § 271(e)(2)(A)) (other internal quotation
marks omitted).

The CAFC observed:

Although we agree with West-Ward that only an issued
patent can give rise to a valid infringement claim
under § 271(e)(2)(A), we disagree that that conclusion
precludes Vanda’s infringement claim in this case. The
’610 patent is a patent “for a drug . . . the use of which is
claimed in a patent,” 35 U.S.C. § 271(e)(2)(A), as contemplated
in the Act even though it issued after West-Ward
filed its ANDA. West-Ward subsequently amended its
ANDA to include a Paragraph IV certification for the ’610
patent after it issued. The infringement analysis under
§ 271(e)(2)(A) “require[s] consideration of the amended
ANDA.” Ferring B.V. v. Watson Labs., Inc.-Fla., 764 F.3d
1382, 1390 (Fed. Cir. 2014). “There is no support for the
proposition that the question of infringement must be
addressed solely based on the initial ANDA filing, given
that the statute contemplates that the ANDA will be
amended as a matter of course.”


Here, it is undisputed that West-Ward amended the
ANDA by submitting a Paragraph IV certification regarding
the ’610 patent after that patent issued. J.A. 19696;
J.A. 6414–15; Appellant Br. 10; Appellee Br. 59. Such an
act is a qualifying act of infringement under
§ 271(e)(2)(A).6 A filer of an ANDA is therefore subject to
a § 271(e)(2)(A) infringement claim on a patent that
issues after the filing of the ANDA, but before FDA approval.
The resolution of infringement claims under
§ 271(e)(2)(A) for patents that issue after an ANDA is
submitted, but before it is approved, “facilitates the early
resolution of patent disputes between generic and pioneering
drug companies” in accordance with the purpose
of § 271(e)(2)(A). Caraco I, 527 F.3d at 1283.
The FDA regulatory framework and the legislative
history further demonstrate that West-Ward is incorrect
in asserting that “application” in § 271(e)(2)(A) excludes
amendments to the ANDA.


Thus, the district court properly conducted its
infringement analysis for the ’610 patent pursuant to 35
U.S.C. § 271(e)(2)(A).

As to 101:

We next address whether the asserted claims are directed
to patent-eligible subject matter. West-Ward
argues that the asserted claims are ineligible under § 101
because they are directed to a natural relationship between
iloperidone, CYP2D6 metabolism, and QT prolongation,
and add nothing inventive to those natural laws
and phenomena. West-Ward contends that the asserted
claims are indistinguishable from those held invalid in
Association for Molecular Pathology v. Myriad Genetics,
Inc., 569 U.S. 576 (2013) and Mayo Collaborative Services
v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).
Vanda responds that the asserted claims are patenteligible
under § 101 at both steps of Mayo/Alice. Vanda
contends that the district court erred in holding that the
asserted claims are directed to a law of nature.

CJ Prost dissenting:

I would find the asserted patent claims to be directed
to a law of nature. The majority finds the claims herein
are not directed to a natural law at step one of the § 101
analysis, but its efforts to distinguish Mayo cannot withstand
scrutiny. The majority relies on the claims’ recitation
of specific applications of the discovery underpinning
the patent to find no natural law is claimed. But it conflates
the inquiry at step one with the search for an


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