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Originally published in V&E IP Insights E-communication,
July 31, 2012
On July 30, 2012, the Federal Circuit issued an opinion on
remand in the Novo Nordisk v. Caraco Pharm. Labs case holding that
injunctions issued to correct use codes cannot specify the
particular use codes and descriptions to be listed in the FDA's
Orange Book.
Previously in this case, the U.S. Supreme Court held that the
Hatch Waxman Act provides a generic drug manufacturer (generic)
with a counterclaim to force the branded drug manufacturer (brand)
to correct a use code that inaccurately describes the brand's
patent as covering a particular use for the drug. Caraco Pharm.
Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670 (2012).
Novo owns a patent covering only one of the three FDA-approved
uses of its brand-name drug. In 2005, Caraco filed an abbreviated
new drug application (ANDA) seeking to market its generic drug
under paragraph IV. See 21 U.S.C. §355(j)(2)(A)(vii)(IV). This
prompted a patent infringement suit by Novo in the Eastern District
of Michigan. While the suit was pending, Novo amended its use code
in the Orange Book to cover all three FDA-approved uses. As such,
Caraco's proposed uses overlapped with Novo's use codes.
Accordingly, Caraco was no longer able to seek the shorter route to
market under section viii and instead needed to resort to the
lengthier paragraph IV process. See §355(j)(2)(A)(viii).
Caraco responded by filing a counterclaim to "correct"
Novo's use code on the grounds that the patent covers only one
of the three uses. Under an amendment to the Hatch Waxman Act, a
successful counterclaim achieves "an order requiring the
[brand] to correct or delete the patent information submitted by
the [brand in the Orange Book] on the ground that the patent does
not claim . . . an approved method of using the drug." 21
U.S.C. §355(j)(5)(C)(ii)(I). The Supreme Court reversed the
Federal Circuit and held that a generic may employ the counterclaim
provision to force correction of a use code that inaccurately
describes the uses of a brand's patent.
On remand, the Eastern District of Michigan issued an injunction
requiring Novo to reinstate its prior use code with the particular
description "use of repaglinide in combination with metformin
to lower blood glucose." On appeal, the Federal Circuit
affirmed the injunction but modified it to require a use code that
"accurately describes the scope" of the patent and a
description that "shall be clearly limited to use of
repaglinide in combination with metformin to treat non-insulin
dependent diabetes mellitus." The Federal Circuit reasoned
that the court could not dictate the specific language submitted to
the FDA because FDA regulations give the responsibility for
drafting appropriate use codes to the branded company. See 21
C.F.R. § 314.53(c)(2)(ii)(P).
In dissent, Judge Dyk argued that the counterclaim provision of
the Hatch Waxman Act does not limit the authority of the district
court to dictate the precise use code and description submitted to
the FDA. Further, he was concerned that branded companies will
continue using overbroad use codes that will require generics to
seek additional time-consuming corrections.
What This Means for You
the Federal Circuit has limited the ability of the district
courts to direct the correction of inaccurate use codes. It remains
to be seen whether branded companies will use this restriction to
submit overbroad use codes as the dissent predicts.
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