On February 9, 2012, a three judge panel of the United States
Court of Appeals for the Federal Circuit (Federal Circuit)
confirmed that the filing of an Abbreviated New Drug Application
(ANDA) directed to an FDA-approved unpatented use of a
pharmaceutical composition does not constitute infringement of
method patents covering other FDA-approved uses of the same
composition. Consistent with its precedent, in AstraZeneca
Pharmaceuticals LP v. Apotex Corporation, the Federal Circuit
held that there can be no infringement of a method patent if the
ANDA lists only non-patented uses of the pharmaceutical
composition. Nos. 2011-1182, -1183, -1184, -1185, -1186, -1187,
-1188, -1189, -1190, Slip Op. (Fed. Cir. Feb. 9, 2012); see
also Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed.
Cir. 2003).
The Hatch-Waxman Act allows generic pharmaceutical companies to
file different types of statements along with their ANDA. A
statement made under 21 U.S.C. § 355(j)(2)(A)(viii) certifies
that a method of use patent covers the pharmaceutical composition,
but the ANDA does not seek approval for a use covered by the
patent. Infringement of method claims under § 271(e)(2)
requires filing an ANDA wherein at least one "use" listed
in the ANDA is claimed in a patent. Nothing requires that an ANDA
must encompass every FDA-approved indication. If the FDA approves a
pharmaceutical composition for multiple uses, some of which are
covered by method patents and some of which are not, an ANDA filer
can carve out the patented uses in its application to avoid
infringement of the method patents. Once approved, the ANDA filer
can market a generic version of the pharmaceutical composition for
the unpatented uses.
The argument that even if the generic is only formally approved for
unpatented uses, doctors and pharmacists will nonetheless
substitute the generic for all uses was once again expressly
rejected in AstraZeneca. Judge Lourie, writing on behalf
of the court, explained that allowing a § 271(e)(2)
infringement claim based on this type of speculative argument
"would allow a pioneer drug manufacturer to maintain de facto
indefinite exclusivity over a pharmaceutical compound by obtaining
serial patents for approved methods" and was thus contrary to
the statutory scheme established by the Hatch-Waxman Act. Slip Op.
at 18-19.
What This Means for You
ANDA applicants can effectively carve out patented uses to avoid
infringement of method of use patents for pharmaceutical compounds.
This decision reaffirms that generic drugs may enter the market for
non-patented, approved uses for a pharmaceutical composition that
is not otherwise covered by an unexpired patent on the
pharmaceutical composition itself.
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