Supreme Court Grants Certiorari In Patent Dispute Over Hatch-Waxman Provision

WASHINGTON, D.C. - (Mealey's) The U.S. Supreme Court will review the Federal Circuit U.S. Court of Appeals' ruling, 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 on June 27 (Caraco Pharmaceutical, et al. v. Novo Nordisk A/S, et al., No. 10-844, U.S. Sup.). 

The 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 'correct[ion].'" 

Respondents 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."   

Novo 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 infringement. 

Caraco's 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. 

Caraco 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." 

Rehearing was denied in July 2010. 

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