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In re Glumetza Antitrust Litig.

United States District Court for the Northern District of California

August 15, 2020, Decided; August 15, 2020, Filed

No. C 19-05822 WHA; No. C 19-06138 WHA; No. C 19-06839 WHA; No. C 19-07843 WHA; No. C 19-08155 WHA; No. C 20-01198 WHA; No. C 20-05251 WHA (Consolidated)




In this antitrust action arising from an alleged reverse-payment settlement of a patent infringement suit between brand and generic marketers of the diabetes drug Glumetza, direct purchaser plaintiffs move for class certification. Common issues predominate, the putative class's market-impact and damages models adequately reflect the theory of liability, and any assumptions underlying the model either go to the heart of the merits or can be modified to account for a range of jury determinations. A class is Certified.


A prior order details this case (Dkt. No. 188 as amended Dkt. No. 204). In re Glumetza Antitrust Litigation,     F. Supp. 3d    , 2020 WL 1066934 (N.D. Cal. Mar. 5, 2020). But the essence bears restating. This case arises from a perversion of the patent and pharmaceutical-regulatory framework. See generally 35 U.S.C. § 156 et seq., 21 U.S.C. § 301 et seq. The Hatch-Waxman Act implements a network of incentives to encourage faster introduction of low-cost generics into the pharmaceutical market, yet still drive new drug development. To ease FDA approval, generic manufacturers may file an Abbreviated [*11]  New Drug Application to piggyback on the approval process for the underlying brand drug. See FTC v. Actavis, 570 U.S. 136, 142, 133 S. Ct. 2223, 186 L. Ed. 2d 343 (2013); 21 U.S.C. §§ 355(j)(2)(A)(ii), (iv).

Patents covering the brand drug can still spoil the fun, though. To gain approval, an ANDA applicant must certify to the FDA that no brand patents block the generic drug's market entry. If the brand holds live patents, for example, the generic must file a "Paragraph IV certification" of noninfringement or invalidity. Even so, if the brand manufacturer promptly sues for infringement, the FDA can't approve the generic for 30 months (or until the end of the suit, whichever comes first). Actavis, 570 U.S. at 143; 21 U.S.C. §§ 355(j)(2)(A)(vii)(I)—(IV), (5)(B)(iii); 35 U.S.C. § 271(e)(2)(A).

The Hatch-Waxman scheme encourages patent-challenge certifications by granting 180 days of generic market exclusivity to the first generic to file such an application. If this "first filer" wins the infringement suit and markets, it gets 180 days to compete alone with the brand drug, meaning the FDA can't approve any other generics during that time. This can be "worth several hundred million dollars" to the generic manufacturer and outweigh the risk of infringement suit. Actavis, 570 U.S. at 143-44; 21 U.S.C. § 355(j)(5)(B)(iv). But this 180-day exclusivity period doesn't stop the brand manufacturer from marketing an "authorized generic" to recoup some [*12]  of those millions. See Teva Pharm. v. Crawford, 410 F.3d 51, 55, 366 U.S. App. D.C. 203 (D.C. Cir. 2005). Moreover, the first filer can forfeit the 180-day exclusivity if it stalls too long. 21 U.S.C. § 355(j)(5)(D)(i)(I)(aa), (iii).

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2020 U.S. Dist. LEXIS 148096 *


Prior History: In re Glumetza Antitrust Litig., 2020 U.S. Dist. LEXIS 39649 (N.D. Cal., Mar. 5, 2020)


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