Term: 2011
Docket: 10-844
Caraco Pharmaceutical Laboratories, Ltd., Et Al., Petitioners v. Novo Nordisk A/s Et Al.
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10-844 CARACO PHARMACEUTICAL V. NOVO NORDISK A/S DECISION BELOW: 601 F.3d 1359 CERT. GRANTED 6/27/2011 QUESTION PRESENTED: When the Food & Drug Administration (FDA) approves a drug for multiple uses, the Hatch-Waxman Act allows generic drug makers to avoid contested patent litigation by marketing generic versions of the drug solely for non-patented uses. The FDA lacks the authority and expertise needed to verify the patent information submitted by name-brand drug companies, however, so it defers to their descriptions of the scope of their patents. Such companies can therefore block the approval of generic drugs by submitting overbroad patent descriptions to the FDA, effectively extending their patents to cover non-infringing uses. To combat this problem, the Act allows a "counterclaim seeking an order requiring the [patent] holder to correct or delete the patent information submitted by the holder * * * 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). In a 2-1 decision that conflicts with this Court's precedents and recent D.C. Circuit authority, the Federal Circuit held that the counterclaim provision effectively authorizes only "delet[ingl" improperly listed patents, but not "correct[ing]" information that misrepresents the scope of the approved uses claimed by a patent. That ruling expressly invalidates longstanding FDA regulations defining "patent information," which the FDA deems "essential" to administering the Act, without seeking the agency's views. The question presented is: Whether this 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]." LOWER COURT CASE NUMBER: 2010-1001
The U.S. Supreme Court case Caraco Pharmaceutical Laboratories, Ltd., et al., v. Novo Nordisk A/S et al., 2011 revolved around the interpretation of a provision in the Hatch-Waxman Act, which regulates competition between brand-name and generic drugs. The dispute began when Novo Nordisk obtained a new use patent for its diabetes drug repaglinide and submitted an overly broad description to FDA's Orange Book that effectively blocked Caraco from selling a generic version for other approved uses not covered by the patent. In response, Caraco sought to "counterclaim" under Section 505(j)(5)(C)(ii)(I) of Hatch-Waxman Act to correct the patent information filed by Novo Nordisk with FDA. Lower courts were divided over whether such counterclaims could be used only against inaccuracies about patent scope or also against misdescriptions of patented methods-of-use as well; hence it reached Supreme Court. In April 2012, Supreme Court unanimously ruled in favor of Caraco stating that generics can indeed file such counterclaims not just on issues related directly to patents' scope but also on how those patents are described regarding their approved uses.
In the dissenting opinion for Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, Justice Sotomayor argued that the majority's interpretation of "patent information" and "not an" in 21 U.S.C §355(j)(5)(C)(ii) was incorrect. She contended that this statute only allows a generic manufacturer to file a counterclaim when there is no patent at all covering the brand-name drug or method of use rather than when there are inaccuracies in how it’s described by the brand-name company. The justice believed that Congress intended to limit counterclaims to situations where patents were improperly listed because they did not claim either the drug or its approved uses; she disagreed with extending this provision to disputes over patent scope as well.
