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Novo Nordisk A\/S","href":"https:\/\/api.oyez.org\/cases\/2011\/10-844","view_count":0,"docket_number":"10-844","additional_docket_numbers":null,"manner_of_jurisdiction":"Writ of \u003Ci\u003Ecertiorari\u003C\/i\u003E","first_party":"Caraco Pharmaceutical Laboratories, Ltd., et al.","second_party":"Novo Nordisk A\/S, et al.","timeline":[{"event":"Granted","dates":[1309150800],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/41012"},{"event":"Argued","dates":[1323064800],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/41013"},{"event":"Decided","dates":[1334638800],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/41014"}],"lower_court":{"ID":17,"name":"United States Court of Appeals for the Federal Circuit","href":"https:\/\/api.oyez.org\/taxonomy\/term\/17"},"facts_of_the_case":"\u003Cp\u003ENovo Nordisk sued Caraco Pharmaceutical Laboratories and Sun Pharmaceutical Industries Ltd. for infringement in the wake of Caraco filing an abbreviated new drug application (\u0022ANDA\u0022) for a generic version of the Type 2 diabetes drug Prandin. Caraco and Sun promptly countersued. While the litigation was pending, Novo changed the FDA Orange Book\u0027s use code \u2014 a description of the scope of the patent \u2014undermining Caraco\u0027s argument that patent did not apply to the purpose for which the generic product would be marketed. Caraco filed a counterclaim requesting an order that would require Novo Nordisk to change back the use code.\u003C\/p\u003E\n\u003Cp\u003EThe Medicare Prescription Drug, Improvement and Modernization Act of 2003 authorized ANDA applicants to assert a counterclaim seeking an order requiring the brand to correct or delete submitted patent information on the grounds that the patent does not claim 1) the drug for which the brand\u0027s new drug application was approved or 2) an approved method of using the drug.\u003C\/p\u003E\n\u003Cp\u003EThe U.S. District Court for the Eastern District of Michigan granted the counterclaim and issued an injunction ordering Novo Nordisk to change the code. Novo appealed to the United States Court of Appeals for the Federal Circuit, arguing that the district court had abused its discretion. The Federal Circuit ruled in favor of Novo, holding that Caraco could only assert a counterclaim if Novo\u0027s patent did not claim \u003Cem\u003Eany\u003C\/em\u003E approved method of use.\u003C\/p\u003E\n","question":"\u003Cp\u003E(1) Does the counterclaim provision of the Hatch-Waxman Act only apply if Novo\u0027s Prandin patent does not claim any approved method of use?\u003C\/p\u003E\n\u003Cp\u003E(2) Does Novo\u0027s use code for Prandin qualify as \u0022patent information submitted under subsections (b) and (c)\u0022 for the purposes of the act?\u003C\/p\u003E\n","conclusion":"\u003Cp\u003EYes and yes. In a unanimous decision written by Justice Elena Kagan, the Court held that the Hatch-Waxman Act allows counterclaims to challenge unpatented uses of generic drugs even if other approved uses are still under patent. Justice Kagan looked to the language and purpose of the statute, focusing on the meaning of the phrase, \u0022the patent does \u003Cem\u003Enot\u003C\/em\u003E claim... \u003Cem\u003Ean\u003C\/em\u003E approved method of using the drug.\u0022 While acknowledging that the words \u0022not an\u0022 could be interpreted to mean \u0022not any,\u0022 as Novo suggested, Justice Kagan rejected Novo\u0027s argument that the counterclaim right evaporates if Novo has a patent over another use not claimed or contested by Caraco and Sun. She argued that the act\u0027s counterclaim provision essentially allows a generic drug marketer to challenge a brand\u0027s assertion of rights over whichever use the generic drug marketer wishes to pursue. Justice Kagan noted that if Congress intended Novo\u0027s \u0022not any\u0022 interpretation, it could have used that exact phrasing.\u003C\/p\u003E\n\u003Cp\u003EJustice Kagan also held that Novo\u0027s use code was \u0022patent information submitted by the brand under subsection (b) or (c)\u0022 for the purposes of the act. She pointed out that the use code describes the methods of use claimed in a patent, and must qualify as \u0022patent information\u0022 under any ordinary understanding of that phrase. Looking to the Court\u0027s precedent, Justice Kagan determined that information \u0022submitted under\u0022 a federal law suggests doing so in furtherance of or in compliance with a comprehensive scheme of regulation. Justice Kagan noted that subsections (b) and (c) provide the basis for the regulation requiring brands to submit use codes and dictate the form of those submissions; thus, a brand use code is \u0022submitted under\u0022 sections (b) and (c). She rejected Novo\u0027s argument that congress only intended to allow generic drug marketers to correct improperly numbered or listed patents.\u003C\/p\u003E\n","advocates":[{"advocate":{"ID":30681,"name":"James F. Hurst","href":"https:\/\/api.oyez.org\/people\/james_f_hurst","view_count":0,"last_name":"Hurst","roles":null,"thumbnail":null,"length_of_service":0,"identifier":"james_f_hurst"},"advocate_description":"for the petitioners","href":"https:\/\/api.oyez.org\/case_advocate\/case_advocate\/20420"},{"advocate":{"ID":17700,"name":"Benjamin J. Horwich","href":"https:\/\/api.oyez.org\/people\/benjamin_j_horwich","view_count":0,"last_name":"Horwich","roles":null,"thumbnail":null,"length_of_service":0,"identifier":"benjamin_j_horwich"},"advocate_description":"Assistant to the Solicitor General, Department of Justice, as amicus curiae, supporting the petitioners","href":"https:\/\/api.oyez.org\/case_advocate\/case_advocate\/20421"},{"advocate":{"ID":36483,"name":"Mark A. 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