In re Lamictal Indirect Purchaser & Antitrust Consumer Litigation

172 F. Supp. 3d 724, 2016 WL 1135368, 2016 U.S. Dist. LEXIS 37664
CourtDistrict Court, D. New Jersey
DecidedMarch 22, 2016
DocketCiv. No. 12-5120 (WHW)(CLW)
StatusPublished
Cited by12 cases

This text of 172 F. Supp. 3d 724 (In re Lamictal Indirect Purchaser & Antitrust Consumer Litigation) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Lamictal Indirect Purchaser & Antitrust Consumer Litigation, 172 F. Supp. 3d 724, 2016 WL 1135368, 2016 U.S. Dist. LEXIS 37664 (D.N.J. 2016).

Opinion

[731]*731OPINION

Walls, Senior District Judge

This putative class action concerns the legality of a settlement between two pharmaceutical. companies. Plaintiffs are indirect purchasers of the drug lamotrigine, known by its brand name Lamictal, whieh was the subject of patent litigation between the Defendant pharmaceutical companies. Plaintiffs allege that the terms of the litigation settlement and the resulting sales of branded and generic versions of Lamictal violated federal and state antitrust and consumer protection laws. Defendants move ■ to dismiss on - various grounds, including that Plaintiffs’ state law claims are time-barred, Plaintiffs fail to adequately plead several causes of action, and Plaintiffs’ federal claims fail to allege a justiciable case or controversy. Decided without.oral argument under Federal Rule of Civil Procedure 78(b), Defendants’ joint motion is granted in part and denied in part.

FACTUAL AND PROCEDURAL BACKGROUND

This case arises out of the same set of circumstances as another case pending before this Court, In re: Lamictal Direct Purchaser Antitrust Litig., Civ. No. 12-995 (D.N.J.2012) (the “Direct Purchaser Class Action”), referenced by Plaintiffs in the amended complaint. Amended Complaint, ECF Ño. 38 at 1. The Court takes the following allegations from the amended complaint as true.

Defendant GlaxoSmithKline (“GSK”), a pharmaceutical company, manufactures and sells Lamictal Tablets and Lamictal Chewables, which treat epilepsy and bipolar disorder. ECF No. 38 ¶¶1-2. From Marph 2007 to March 2008, GSK’s domestic sales of Lamictal Tablets exceeded $2 billion. Id. ¶ 2. During the same period, the lower-dosage Lamictal Chewables had domestic sales of about $50 million. Id. GSK held a patent, U.S. Patent No. 4,602,017 (the “017 patent”), for the active ingredient in Lamictal products, lamotrigine, that [732]*732gave GSK the exclusive right to sell Lam-ictal Tablets and Chewables until the patent expired on July 22, 2008. Id. ¶¶ 8, 59.

Defendant Téva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. (collectively, “Téva”) is a pharmaceutical company that wanted to market a generic version of Lamictal and filed applications with U.S. Food and Drug Administration (“FDA”) seeking to do so. Id. ¶ 3. GSK sued Tevá in 2002 for patent infringement under Hatch-Waxman Act procedures, Pub. L. No. 98-417, 98 Stat. 1585 (1984). Id. ¶¶4, 46-49, 65.

I, The Hatch-Waxman Act Procedures

The FDA must approve any. new drug a manufacturer seeks to introduce onto the market. 21 U.S.C. § 355(a). To apply for approval, the manufacturer files a New Drug Application (“NDA”) containing detailed information about the drug, its chemical composition, reports about its safety and effectiveness as shown through extensive clinical trials, and descriptions of its production and packaging processes. Id. § 355(b)(1). The application must also identify any patent associated with the drug and its expiration date. Id. If the FDA approves the drug, it publishes the drug and patent information in a book called “Approved Drug Products with Therapeutic Equivalence and Evaluations,” commonly referred to as the “Orange Book.” Id. § 355(j')(7)(A).

Generic drugs are therapeutically and pharmaceutically equivalent to corresponding brand name drugs and sold at lower prices. Congress passed the Hatch-Wax-man Act in 1984 to encourage the entry of generics onto the market. A generic manufacturer may file an Abbreviated New Drug Application (“ANDA”), which does not need to contain the same level of detail as is required for an NDA. 21 U.S.C. § 355(j). The ANDA must make one of four certifications:

(1) that no patent information for the brand name drug has been filed;
(2) that the patent for the brand name drug has expired;
(3) that the patent will expire on a specifically identified date;
(4) that the “patent is invalid or will not' be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.”

21 . U.S.C. § 355(j)(2)(A)(vii) (emphasis added).

Filing a certification under paragraph IV frequently leads to litigation because it constitutes a technical act. of patent infringement. 35 U.S.C. § 271(e)(2)(A). If the applicant makes a certification under paragraph IV, the patent holder must be notified. .21 U.S.C. § 355(j)(2)(B). The patent holder then has 45 days to file an infringement lawsuit against the ANDA applicant. Id. § 355(j)(5)(B)(iii). When a suit is filed, the FDA stays the ANDA approval process until either (1) 30 months have run, or (2) the court decides that the patent is invalid or not infringed, whichever is earlier. Id.; ECF No. 38 ¶ 49.

Generic manufacturers are incentivized to be the first to file a paragraph IV certification because the first ANDA applicant to do so is granted a 180-day “exclusivity period.” During that time, the FDA will not grant final approval to any other ANDA for the same generic drug. 21 U.S.C. § 355(j)(5)(B)(iv); ECF No. 38 ¶ 50. For the first filer, the potential reward is half-a-year’s period when it is the only generic drug company on the market competing with the brand name drug company. This 180-day exclusivity period is triggered by either the generic manufacturer’s entry into the market with the drug or a court’s final decision that the patent subject to the paragraph IV certification is invalid or not infringed. 21 U.S.C. [733]*733§ 355(j)(5)(B)(iv)(I); 21 C.F.R. § 314,-107(c)(1); ECF No. 38 ¶ 50.

Another concept relevant to this case is pediatric exclusivity. Only a small fraction of drugs are tested on pediatric patients. To address this problem, the FDA will request that a drug company seeking to market drugs for pediatric use conduct pediatric trials. 21 U.S.C. § 355a.1 If the company successfully completes the trials and the FDA accepts the results, then the FDA will award the company six months of additional market exclusivity (the “Pediatric Exclusivity”)., In practical terms, this means that after a drug company’s patent expires, the FDA will delay approval of generic ANDAs for another six months, essentially protecting the market from the entry of generics. Id. § 355a(c)(2).

II. GSK’s Patent Litigation with Teva

Teva filed ANDAs with the FDA in 2002 seeking approval to manufacture and sell generic versions of lamotrigine tablets and chewables. ECF No. 38 ¶ 61.

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172 F. Supp. 3d 724, 2016 WL 1135368, 2016 U.S. Dist. LEXIS 37664, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-lamictal-indirect-purchaser-antitrust-consumer-litigation-njd-2016.