LOUISIANA WHOLESALE DRUG CO., INC. v. SMITHKLINE BEECHAM CORPORATION

District Court, D. New Jersey·Decided June 7, 2021·No. 2:12-cv-00995·Unknown

Opinion

Not for Publication

UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

In re: Lamictal Direct Purchaser Antitrust Litigation Civil Action No. 12-995

OPINION

John Michael Vazquez, U.S.D.J. This antitrust class action stems from a settlement in a patent lawsuit concerning a brand drug, Lamictal, and its generic competitor, lamotrigine. In the patent case, Defendant SmithKline Beecham Corporation d/b/a GlaxoSmithKline (“GSK”) sued Defendants Teva Pharmaceutical Industries LTD and its subsidiary Teva Pharmaceuticals USA, Inc. (collectively “Teva”). GSK and Teva settled the matter, with GSK promising not to launch an authorized generic version of Lamictal for a specified period. Plaintiffs in the current matter are purchasers of Lamictal and lamotrigine and claim that the agreement not to launch an authorized generic constituted an improper “reverse payment,” causing Plaintiffs to pay more than they would have if GSK had sold the authorized generic. But there is a twist. GSK claims that Plaintiffs were not harmed because GSK lowered the prices of Lamictal through a contracting strategy. And Teva adds that it learned of GSK’s contracting strategy and preemptively lowered the price of lamotrigine. This matter is on remand from the Third Circuit Court of Appeals’ decision in In re Lamictal Direct Purchaser Antitrust Litig., 957 F.3d 184 (3d Cir. 2020), which vacated this Court’s previous Opinion, D.E. 428, and Order, D.E. 429, granting Plaintiffs’ motion for class certification, D.E. 371.1 The Third Circuit instructed the Court to perform a rigorous analysis in determining whether to certify the class as to direct purchasers of lamotrigine.2 The Third Circuit further instructed the Court to address certain predicate questions before assessing Plaintiffs’ use of averages to prove antitrust injury as to each class member. Following remand, the parties filed supplemental briefs, D.E. 478 (“Br.”), D.E. 479 (“Opp.”), D.E. 483 (“Reply”). The Court then

held oral argument. D.E. 498. For the reasons that follow, the Court determines that Plaintiffs have not shown by a preponderance of the evidence that they can prove antitrust injury through common evidence as to generic-only purchasers. I. BACKGROUND The underlying patent suit was filed in April 2002 and involved litigation pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch- Waxman Act, 21 U.S.C. § 355, et seq., which was discussed in detail in the Court’s prior Opinions. See e.g., D.E. 105 at 2-4. GSK sued Teva, alleging that Teva’s generic drug, lamotrigine, infringed GSK’s patent for Lamictal. See D.E. 55 (“Class Compl.”) ¶ 13. Lamictal is used to treat epilepsy and bipolar disorder. On February 16, 2005, GSK and Teva settled the patent case. D.E. 373-3 at 2.3 As part of the settlement, GSK agreed that Teva could begin selling lamotrigine on July 22,

2008. D.E. 373-4 at 16. GSK further promised that it would refrain from launching its own competing authorized generic version of Lamictal (the “No-AG Promise”) until Lamictal’s patent expired on January 22, 2009. See id.; see also D.E. 406-2 at 10-11, ¶ 17. This No-AG promise is

1 The matter was transferred to the undersigned following the remand.

2 The proposed class includes direct purchasers of both Lamictal and generic lamotrigine. The Circuit’s opinion, however, only addressed the purchasers of the generic.

3 Unless otherwise specified, page numbers for exhibits reflect the Court’s electronic filing system’s generated page numbers. at the heart of the current dispute, with Plaintiffs contending that it constituted an improper reverse payment. Plaintiffs claim that absent the settlement agreement, either (1) Teva would have prevailed in the patent litigation, allowing for an earlier launch of generic lamotrigine tablets as well as triggering Teva’s 180-day generic exclusivity, or (2) Teva would have launched its generic version

of lamotrigine tablets “at risk” (i.e., before the patent case was decided) following the FDA’s final approval and the expiration of the 30-month statutory stay. Id. ¶ 26. Thus, Plaintiffs contend that absent the settlement, GSK would have faced price competition for its Lamictal products through Teva’s generic launch, and that absent the No-AG Promise, Teva’s generic drug would have faced pricing competition from GSK’s authorized generic. Id. ¶ 28. Plaintiffs continue that the lack of competition that resulted from the No-AG promise forced Plaintiffs to purchase both Lamictal and lamotrigine at artificially inflated prices. Id. On June 28, 2018, Plaintiffs moved to certify the following class: All persons or entities in the United States and its territories who purchased Lamictal Tablets directly from GSK, or who purchased a generic version of lamotrigine tablets directly from Teva, at any time during the Class Period from February 17, 2008 until January 22, 2009.

D.E. 372 at 3. As to the predominance requirement of Fed R. Civ. P. 23(b)(3), Plaintiffs argued that it was met because Plaintiffs could show antitrust impact through common evidence – “empirical economic research,” id. at 32, “documents, testimony, and forecasting documents regarding the effects of generic competition,” id. at 33, and data, id. at 34. Defendants countered that this case was different from other reverse-payment cases because GSK employed a “contracting strategy” (“Contracting Strategy”) for Lamictal. D.E. 406 at 5. GSK asserted that because “[m]any doctors were concerned that switching to a generic could reduce the drug’s effectiveness[,]” GSK believed that “the magnitude of [generic] erosion [would] not approach that seen in most other disease areas.” Id. Thus, GSK offered discounts up to 40% on Lamictal to certain customers to compete with Teva’s generic. Id. at 6. In exchange for GSK’s discount, the customers receiving discounts agreed to dispense “[Lamictal] as a generic.” Id. Defendants further claimed that Teva learned of

GSK’s Contracting Strategy, sued GSK for breach of the parties’ settlement agreement, and preemptively lowered the price for lamotrigine. Id. at 6-7. Therefore, Defendants contended that Plaintiffs could not use evidence about average changes in generic prices when a second generic enters the market to prove antitrust injury because doing so would ignore the reality that Teva faced competition – through the Contracting Strategy – from GSK’s discounted brand Lamictal. Id. at 20-22. Judge Walls rejected Defendants’ arguments and certified the class. D.E. 428 at 13- 15. On appeal, Defendants only challenged “the [d]istrict [c]ourt’s predominance finding,” id. at 190, “as to the members who purchased generic lamotrigine from Teva.” Lamictal, 957 F.3d at

195. The Third Circuit first reviewed a district judge’s duties in assessing a class certification motion, stating that a district court “must conduct a ‘rigorous analysis’ of the evidence and arguments presented” at class certification. Id. at 190-91 (citing In re Hydrogen Peroxide Antitrust Litig., 552 F.3d 305, 309 (3d Cir. 2008), as amended (Jan. 16, 2009)).

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LOUISIANA WHOLESALE DRUG CO., INC. v. SMITHKLINE BEECHAM CORPORATION, (D.N.J. 2021).

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