D.C. - (Mealey's) The U.S. Supreme Court will review the Federal Circuit U.S.
Court of Appeals' ruling [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law],
in a case of first impression, that the counterclaim provision of the
Hatch-Waxman Act is available "only if the listed patent does not claim any
approved methods of using the listed drug"; the high court granted certiorari
in the dispute this morning (Caraco Pharmaceutical, et al. v. Novo Nordisk
A/S, et al., No. 10-844, U.S. Sup.; See 4/18/11, Page 38).
Federal Circuit, sitting en banc, later denied rehearing, leading
petitioners Caraco Pharmaceutical Laboratories Ltd. and Caraco parent Sun
Pharmaceuticals Industries Ltd. (collectively, Caraco) to seek clarification
from the Supreme Court on whether the
counterclaim provision applies "where (1) there is 'an approved method of
using the drug' that 'the patent does not claim,' and (2) the brand submits
'patent information' to the FDA that misstates the patent's scope, requiring
Novo Nordisk and Novo Nordisk Inc. (collectively, Novo), in turn, presented the
high court with the question of whether the Federal Circuit correctly concluded
that neither the cause of action nor the remedy provided for by the
Hatch-Waxman Act's counterclaim provision is available to Caraco "on the
particular facts of this case."
sells the drug repaglinide as Prandin for the treatment of diabetes. One
Novo patent, No. RE 37,035, related to use of repaglinide alone, expired in
2009, while another, No. 6,677,358, related only to the combination of
repaglinide with metformin, does not expire until 2018. In anticipation
of the expiration of the '035 patent, Caraco sought permission to
market a generic version of repaglinide. Because Caraco's proposed drug
label listed all U.S. Food and Drug Administration-approved uses of
repaglinide, Novo sued Caraco for patent infringement in the U.S. District
Court for the Eastern District of Michigan, alleging that any generic label
referencing the replaglinide-metformin combination would represent induced
petition invoked Section viii of the Hatch-Waxman Act, however, declaring that
it was not seeking approval for the repaglinide-metformin combination therapy,
and requested that the FDA carve out of the label any reference to that
drug. Based on Novo's use code of repaglinide-metformin in the FDA's
"Orange Book: Approved Products with Therapeutic Equivalence
Evaluations," the FDA ruled that Caraco's carve-out label would be
proper. In response to the Section viii ruling, Novo amended the '358
patent's use code in the Orange Book to cover use of repaglinide in general,
not specifying use alone or in a combination. Based on Novo's new use
code, the FDA reversed itself and rejected Caraco's proposed labeling
carve-out, requiring Caraco to include the patented repaglinide-metformin
combination on its label.
filed a counterclaim, seeking partial summary judgment and an injunction, and
the District Court ruled in Caraco's favor, enjoining Novo to restore its
original use code. The court found that the amended code "seriously
misrepresents the approved method of use covered by" the '358 patent.
Novo appealed to the Federal Circuit, which in April 2010 reversed the District
Court's ruling and vacated the injunction. Reading the phrase "an
approved method of use" to mean "any approved method of use," the majority held
in a divided opinion that the counterclaim provision of the Hatch-Waxman Act is
available "only if the listed patent does not claim any approved methods of
using the listed drug." The majority also held that the term "patent
information" in the statute is limited to "an erroneous patent number or
expiration date" and "does not extend to the use code narrative."
was denied in July 2010.
Note: Full coverage will be in the July 1 issue of Mealey'sTM Litigation
Report: Intellectual Property. For
all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
more information, call editor Melissa Ritti at 215-988-7744, or email her at firstname.lastname@example.org.
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