On July 30, 2012, the Federal Circuit issued a decision in
Caraco Pharmaceuticals, Ltd. v. Novo Nordisk on remand
from the Supreme Court. As summarized in an earlier client alert
here for the previous alert), the Supreme Court held in April
2012 that a generic pharmaceutical company may pursue a
counterclaim against a brand pharmaceutical company to force a
correction of a use code listed with the FDA regarding
method-of-use patents. On remand, the Federal Circuit held that
even if a court orders the brand company to correct a use code, the
brand company must be allowed to come up with its own revised use
code. According to the Federal Circuit, a court cannot dictate the
precise terms of the use code to be submitted by the brand company,
but may only provide general guidance regarding the proper scope of
the use code.
This article is intended to provide information of general
interest to the public and is not intended to offer legal advice
about specific situations or problems. Brinks Hofer Gilson &
Lione does not intend to create an attorney-client relationship by
offering this information and review of the information shall not
be deemed to create such a relationship. You should consult a
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information, please contact a Brinks Hofer Gilson & Lione
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