In re: Lipitor Antitrust Litigation

NOT PRECEDENTIAL

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

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Nos. 24-2184, 24-2185, 24-2189, 24-2194, 24-2202, 24-2203, 24-2256 & 24-2257

IN RE: LIPITOR ANTITRUST LITIGATION

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Appeal from the United States District Court For the District of New Jersey

(D.C. No. 3:12-cv-2389)

(MDL No. 2332)

District Judge: Peter G. Sheridan ______________

Argued September 30, 2025

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Before: SHWARTZ, MATEY, and SCIRICA,^*Circuit Judges. (Filed: August 13, 2026)

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John P. Bjork

David P. Germaine

Joseph M. Vanek

Sperling Kenny Nachwalter

321 N Clark Street 25th Floor

Chicago, IL 60654 Deborah S. Corbishley Sperling Kenny Nachwalter 1441 Brickell Avenue Four Seasons Tower, Suite 1100 Miami, FL 33131

 The Honorable Anthony J. Scirica was unavailable to participate in the decision in this case after argument before the merits panel. The opinion is filed by a quorum of the panel pursuant to 28 U.S.C. § 46(d) and 3d Cir. I.O.P. 12.1(b).

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Counsel for Appellants Meijer Inc. & Meijer Distribution Inc. Anna T. Neill

Scott E. Perwin

Lauren C. Ravkind

Sperling Kenny Nachwalter

1441 Brickell Avenue

Four Seasons Tower, Suite 1100

Miami, FL 33131

Counsel for Appellants Walgreen Co, The Kroger Co, Safeway Inc, Supervalu Inc and HEB Grocery Co LP

Moira E. Cain-Mannix

Brian C. Hill

Bernard D. Marcus

Marcus & Shapira

301 Grant Street One Oxford Centre, 35th Floor Pittsburgh, PA 15219

Counsel for Appellant Giant Eagle Inc. Eric L. Bloom

Alexander J. Egervry

Caitlin McHugh

Barry L. Refsin [ARGUED]

Hangley Aronchick Segal Pudlin & Schiller One Logan Square

18th & Cherry Streets, 27th Floor Philadelphia, PA 19103

Counsel for Appellants CVS Pharmacy Inc., Rite Aid Corp., Ride Aid Hdqtrs Corp, JCG (PJC) USA LLC, Maxi Drug Inc, DBA Brooks Pharmacy, and Eckerd Corp Gregory T. Arnold

Thomas M. Sobol

Hagens Berman Sobol Shapiro

One Faneuil Hall Square

5th Floor

Boston, MA 02109

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Caitlin G. Coslett Julia R. McGrath^* David F. Sorensen^*[ARGUED] Berger Montague

1818 Market Street Suite 3600

Philadelphia, PA 19103 Stuart E. Des Rochese^* Odom & Des Roches

650 Poydras Street Suite 2350, Poydras Center New Orleans, LA 70130 Deborah A. Elman^*

Bruce E. Gerstein Garwin Gerstein & Fisher

88 Pine Street Wall Street Plaza, 28th Floor New York, NY 10005

Matthew F. Gately

Cohn Lifland Pearlman Herrmann & Knopf Park 80 W. Plaza One

250 Pehle Avenue, Suite 401 Saddle Brook, NJ 07663 Counsel for Drogueria Betances, Professional Drug Co Inc, Rochester Drug Cooperative Inc, Stephen L Lafrance Holdings Inc, and Value Drug Co Deepak Gupta, Esq. [ARGUED]

Gupta Wessler

1400 16th Street NW

Suite 225

 McGrath appeared on behalf of Drogueria Betances, Rochester Drug Cooperative Inc, and Value Drug Co.

 Sorensen appeared on behalf of Drogueria Betances, Rochester Drug Cooperative Inc, and Value Drug Co.

 Des Roches appeared on behalf of Drogueria Betances, Rochester Drug Cooperative Inc, and Value Drug Co.

 Elman appeared on behalf of Drogueria Betances, Rochester Drug Cooperative Inc, Stephen L Lafrance Holdings Inc, and Value Drug Co.

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Washington, DC 20036 Sharon K. Robertson Cohen Milstein

88 Pine Street 14th Floor New York, NY 10005 Lisa J. Rodriguez Dilworth Paxson

457 Haddonfield Road Suite 700

Cherry Hill, NJ 08002 Kenneth A. Wexler Wexler Boley & Elgersma

311 S Wacker Drive Suite 5450

Chicago, IL 60606 Counsel for Appellants AF of L AGC Building Trades Welfare Plan, Mayor and City Council of Baltimore, New Mexico United Food and Commercial Workers Unions and Employers Health and Welfare Trust Fund, Louisiana Health Service Indemnity Co, DBA Blue Cross and Blue Shield of Louisiana, Bakers Local 433 Health Fund, Fraternal Order of Police Fort Lauderdale Lodge 31 Insurance Trust Fund, Nancy Billington, Emilie Heinle, and Andrew Livezey (End-Payor Plaintiffs), on behalf of themselves and all others similarly situated

Devora W. Allon [ARGUED]

Gilad Y. Bendheim

Jay P. Lefkowitz [ARGUED]

Kirkland & Ellis

601 Lexington Avenue New York, NY 10022 George W. Hicks, Jr. Kirkland & Ellis 1301 Pennsylvania Avenue NW Washington, DC 20004 Arnold B. Calmann

Katherine A. Escanlar Saiber

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7 Giralda Farms Suite 360

Madison, NJ 07940 Counsel for Appellees Ranbaxy Inc, Ranbaxy Pharmaceuticals Inc, and Ranbaxy Laboratories Ltd

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OPINION^*

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SHWARTZ, Circuit Judge.

Plaintiffs—direct purchasers, end payors,¹and certain retailers of the brand-name cholesterol-lowering drug Lipitor—brought an antitrust suit against Defendants, Pfizer, Inc., Lipitor's manufacturer, and Ranbaxy, Inc.,²the first generic manufacturer that sought FDA approval to market a generic version of Lipitor. Plaintiffs allege that Defendants entered a settlement agreement regarding certain patent disputes under which Ranbaxy agreed not to sell generic Lipitor until November 30, 2011, several months after Pfizer's contested patent protections were to lapse.³This effectively extended Pfizer's  This disposition is not an opinion of the full court and pursuant to 3d Cir. I.O.P.

5.7 does not constitute binding precedent.

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monopoly and blocked competitors from offering less expensive generic versions of Lipitor to purchasers.

Defendants moved for summary judgment, asserting that Plaintiffs lack antitrust standing⁴and Plaintiffs moved for class certification. Because the District Court correctly held that Plaintiffs lack antitrust standing, and thus are inadequate class representatives, we will affirm the orders granting Ranbaxy summary judgment and denying Plaintiffs' class certification motions.

I

A

Under the Hatch-Waxman Act (the "Act"),⁵a drug manufacturer seeking to market a brand-name drug must submit a New Drug Application ("NDA") to the FDA, undergo a rigorous review process, and receive FDA approval. See 21 U.S.C. § 355(b)(1); In re Lipitor Antitrust Litig., 868 F.3d 231, 240 (3d Cir. 2017) ("Lipitor II"). A generic manufacturer may later "obtain similar marketing approval" by submitting an Abbreviated New Drug Application ("ANDA") demonstrating that "the generic has the 'same active ingredients as,' and is 'biologically equivalent' to, the already-approved brand-name drug," effectively "allowing the generic to piggy-back on the pioneer's approval efforts," which "speed[s] the introduction of low-cost generic drugs to market.'"

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FTC v. Actavis, Inc., 570 U.S. 136, 142 (2013) (quoting Caraco Pharm. Lab'ys, Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 404-05 (2012)); 21 U.S.C. § 355(j)(2)(A)(ii), (iv). The Act sets forth procedures to resolve patent disputes between brand name and generic manufacturers. See Lipitor II, 868 F.3d at 240. When seeking FDA approval, brand-name drug manufacturers must provide a list of patents relating to the drug's composition or methods of use, see 21 U.S.C. § 355(b)(1)(A)(viii), and, upon approval, the FDA publishes the patent information in its "Approved Drug Products with Therapeutic Equivalence Evaluations" report, known as the "Orange Book," see Lipitor II, 868 F.3d at 240. Generic manufacturers are required to "consult[] the Orange Book"

and "assure the FDA that [their] proposed generic drug[s] will not infringe the brand[s' listed] patents." Caraco, 566 U.S. at 406. One method of assurance is known as a

"paragraph IV certification," id. at 407, wherein generic manufacturers certify that the relevant listed patents are "invalid or will not be infringed by the manufacture, use, or sale of the [generic] drug." 21 U.S.C. § 355(j)(2)(A)(vii)(IV). Paragraph IV certifications act as litigation triggers, allowing brand-name manufacturers to file patent suits immediately. See 35 U.S.C. § 271(e)(2)(A). If they do so within forty-five days, the FDA must withhold approval of the generic drug for at least thirty months so courts may resolve the patent issues. See 21 U.S.C. § 355(j)(5)(B)(iii).⁶

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To incentivize generic drug manufacturers to use paragraph IV certifications, the Act provides that the first generic manufacturer to file such a certification enjoys a 180- day exclusivity period upon approval during which no other generic may enter the market. See 21 U.S.C. § 355(j)(5)(B)(iv); Lipitor II, 868 F.3d at 241. However, the first- filing generic manufacturer can lose this exclusivity period if the FDA concludes that its ANDA was not "substantially complete" when filed. See 21 U.S.C. § 355(j)(5)(B)(iii), (iv)(II)(cc).

B

Lipitor is a drug that treats high cholesterol and contains the active pharmaceutical ingredient atorvastatin calcium. Pfizer secured several patents protecting Lipitor and atorvastatin calcium beginning in 1987, received FDA approval in 1996, and brought Lipitor to market in 1997.

In 2002, Ranbaxy became the first manufacturer to file an ANDA for generic Lipitor containing a paragraph IV certification.⁷Ranbaxy thus certified that its generic drug did not infringe on Pfizer's patents because its atorvastatin calcium had a different form than that used in Pfizer's Lipitor. Pfizer successfully sued Ranbaxy for patent infringement,⁸and the District Court enjoined the FDA's approval of Ranbaxy's ANDA until March 24, 2010, the date one of Pfizer's infringed patents would expire. See Lipitor

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II, 868 F.3d at 243. While this dispute was ongoing, Pfizer and Ranbaxy litigated a patent dispute concerning a branded hypertension treatment drug, Accupril and, in 2008, Pfizer filed another Lipitor-related patent suit against Ranbaxy based on process patents. See id. at 243-44. Thereafter, Pfizer and Ranbaxy settled their patent litigations and agreed that (1) Ranbaxy would pay Pfizer $1 million to settle the Accupril litigation, (2) Ranbaxy would stop contesting one of Pfizer's Lipitor patents set to expire in June 2011, and (3) Pfizer would grant Ranbaxy a license to launch its generic Lipitor product on November 30, 2011, assuming it obtained FDA approval. Id. at 244-45. Before that settlement—and while Ranbaxy's Lipitor ANDA was pending—the FDA issued Ranbaxy Warning Letters in 2006 and 2008 stating that, because of problems at Ranbaxy's facility in Paonta Sahib, India, it would recommend withholding approval of any ANDAs that listed this facility as the manufacturer for various drugs, including the generic Lipitor product, until the problems were corrected. Because of these letters, Ranbaxy acknowledged that it did not know when or if the FDA would approve the generic Lipitor ANDA.

In February 2009, the FDA invoked its Application Integrity Policy ("AIP") against Ranbaxy's Paonta Sahib facility, finding that Ranbaxy had submitted untrue statements of fact to the agency, which raised questions regarding the reliability of the data and information contained in ANDAs listing the Paonta Sahib facility. Accordingly, the FDA halted review of Ranbaxy's ANDAs involving the facility, including the generic Lipitor ANDA.

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In August 2009, after its settlement with Pfizer but while the AIP remained in place, Ranbaxy informed the FDA that it planned to launch the generic Lipitor product on November 30, 2011, pending approval of its ANDA. In December 2009 and November 2010, Ranbaxy submitted two amendments to its Lipitor ANDA, including switching some manufacturing from the Paonta Sahib facility to a Pfizer-operated facility, starting production at a different plant in India, and adding its own New Jersey-based Ohm Laboratories as a manufacturing site. Because the AIP remained in place, the FDA did not immediately review the amendments.

By early 2011, the FDA still had not approved Ranbaxy's generic Lipitor ANDA, which was delaying other generic Lipitor manufacturers from entering the market due to Ranbaxy's first-filer exclusivity privilege. The FDA was aware of this logjam. Its then- Deputy Director emailed that he had discussed other generic Lipitor ANDAs with FDA senior personnel "due to the unique nature and medical necessity of Atorvastatin Calcium Tablets," and concluded that the agency would grant expedited review of Ranbaxy's and two other generic manufacturers' ANDAs "to have a generic product in the marketplace as soon as possible."⁹App. 2116.

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In May 2011, the FDA granted Ranbaxy an exception from the AIP so that the agency could review the company's generic Lipitor ANDA on an expedited basis. The FDA explained that while it "anticipate[d] that [its] review of [the ANDA could] be completed by" November 30, 2011, "[p]rompt review of the ANDA does not, of course, guarantee that the application will be ready for final approval by" that date. App. 5610. During the FDA's review, Ranbaxy initiated five more ANDA amendments and, on July 29, 2011, the FDA determined that Ranbaxy's ANDA was "substantially complete" when it was originally submitted to the FDA in 2002. App. 1084. Ranbaxy subsequently made at least two requests that the FDA approve its ANDA before its planned November 30, 2011 entry date, but these requests were rebuffed. In fact, on November 29, 2011, the FDA stated that "it did not appear that [completion of a component of its review that pertained to the fitness of the Paonta Sahib facility] could be reached by tomorrow because multiple parties are involved, and [the FDA] did not venture to guess when resolution would be reached." App. 1169. When Ranbaxy asked whether the ANDA could be approved the next day if the company amended its ANDA again to obviate the need to complete that review component, the FDA replied that "it was possible, but [the agency] could not guarantee it." Id. Later that day, Ranbaxy filed a response to certain concerns the FDA had raised. The next day, November 30, 2011— exclusivity rights), and (2) Teva manufactured certain quantities for commercial sale. Because of various regulatory violations and the need for multiple inspections, the FDA did not give tentative approval to Teva's ANDA until December 1, 2011. All other companies remained subject to Ranbaxy's 180-day exclusivity period and thus could not enter the market, despite also receiving expedited FDA review.

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the same day Lipitor and Ranbaxy had agreed Ranbaxy could enter the market—the FDA approved Ranbaxy's ANDA,¹⁰and its generic Lipitor product entered the market.

C

Plaintiffs sued Pfizer and Ranbaxy, alleging, among other claims, that the companies' settlement agreement constituted an anticompetitive scheme to delay the market entry of generic Lipitor in violation of state and federal antitrust laws.¹¹Pfizer and Ranbaxy moved for summary judgment in March 2023, principally arguing that Plaintiffs lacked antitrust standing because they did not show that Pfizer and Ranbaxy's allegedly anticompetitive conduct caused them antitrust injury. Specifically, they argued that Plaintiffs could not show that but for the settlement agreement, the FDA would have approved Ranbaxy's ANDA and its generic Lipitor product would have entered the market before November 30, 2021.¹²While the summary judgment motion was pending, the direct purchaser and end payor plaintiffs filed separate motions for class certification. The District Court granted the summary judgment motion because Plaintiffs failed to demonstrate antitrust standing as they merely showed that the FDA "may have been able" to approve Ranbaxy's Lipitor ANDA earlier than November 30, 2011, absent Ranbaxy's agreement with Pfizer, rather than that it "would have" approved it. In re

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Lipitor Antitrust Litig., No. 3:12-cv-12-2389, 2024 WL 2866654, at *30 (D.N.J. June 6, 2024) (quoting In re Wellbutrin XL Antitrust Litig. Indirect Purchaser Class, 868 F.3d 132, 167 (3d Cir. 2017) (emphasis omitted)). The Court also denied the direct purchaser and end payor plaintiffs' motions for class certification. See In re Lipitor Antitrust Litig., No. 3:12-cv-12-2389, 2024 WL 2866650, at *2 (D.N.J. June 6, 2024) ("DPP Class Op."); In re Lipitor Antitrust Litig., No. 3:12-cv-12-2389, 2024 WL 2865074, at *2 (D.N.J. June 6, 2024) ("EPP Class Op.").

Plaintiffs appeal.

II¹³

To prevail on an antitrust claim, private plaintiffs must show that they have antitrust standing, which is "properly viewed as an element of an antitrust claim that can be resolved at summary judgment." In re Wellbutrin, 868 F.3d at 160, 163-64.¹⁴To establish antitrust standing, a private plaintiff must show, among other things, that "it has suffered an antitrust injury—that is, an injury of the type the antitrust laws were intended to prevent and that flows from that which makes the defendants' acts unlawful." Id. at

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164 (alteration, footnote, citations, and internal quotation marks omitted). In a reverse payment case like this one, Plaintiffs must show that "the harm they say they experienced—increased drug prices for [Lipitor]—was caused by the settlement they are complaining about." Id. at 164-65. In other words, they must show that, absent the Pfizer-Ranbaxy agreement, a generic version of Lipitor would have entered the market with FDA approval earlier—even if only by one day—than the entry date, which would have lowered prices. See id. Evidence that a generic equivalent "may" have entered the market with FDA approval is insufficient to withstand summary judgment. Id. at 167 (emphasis omitted). Rather, Plaintiffs must show that it is more likely than not that approval "would" have occurred. Id. (emphasis omitted).¹⁵

Plaintiffs rely on evidence that the FDA (1) was aware of the November 30, 2011 entry date contemplated by the Pfizer-Ranbaxy agreement, (2) targeted that date for completing its review, and (3) took steps to complete the review by that date to argue that the jury has a basis to infer that the FDA would have been "motivated . . . to shave at least a day (or more) off of [its] approval period had Pfizer and Ranbaxy agreed to an

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earlier date." Pls.' Br. at 43.¹⁶Although the undisputed evidence demonstrates that the FDA would have endeavored to approve the entry of a generic Lipitor product before November 30, 2011, in the but-for world, Plaintiffs have not shown that the FDA would have succeeded in doing so. Thus, they lack antitrust standing.¹⁷ It is undisputed that the FDA was aware of the entry date to which Pfizer and Ranbaxy agreed throughout its ANDA review process. At every stage of that process, however, the FDA emphasized that although it would target ANDA approval by that date, it could not guarantee it would hit that target. The FDA was motivated to get a generic Lipitor product on the market as soon as possible, but a generic competitor would

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enter the market only if it complied with the law.¹⁸Despite this motivation, it still took the FDA six and one half months to complete its "[e]xpedited" review, which was substantially below the median amount of time taken to complete its review of other ANDAs. App. 1180. Even the day before it granted final approval to Ranbaxy, the FDA again cautioned that it could not guarantee that approval would follow on November 30,

2011.

In short, although it is perhaps "possible" that the FDA could have acted more quickly, it is "also certainly possible" that it would not have, and "[w]ithout more specific or concrete evidence" that the FDA would have granted earlier approval, Plaintiffs cannot establish antitrust standing and summary judgment in favor of Ranbaxy was appropriate. In re Wellbutrin, 868 F.3d at 167-70.

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B¹⁹

Having properly granted Ranbaxy summary judgment, the District Court correctly concluded that the class certification motions should be denied. DPP Class Op., 2024 WL 2866650, at *2; EPP Class Op., 2024 WL 2865074, at *2.²⁰The result of the summary judgment motion was that the named Plaintiffs had no claim to bring. "[I]f [ a plaintiff] has no . . . claim, she cannot represent others who may have such a claim, and her bid to serve as a class representative must fail." Lierboe v. State Farm Mut. Auto. Ins. Co., 350 F.3d 1018, 1022 (9th Cir. 2003); see also Fed. R. Civ. P. 23(a)(4) ("One or more members of a class may sue or be sued as representative parties on behalf of all members only if . . . the representative parties will fairly and adequately protect the interests of the class."); cf. O'Shea v. Littleton, 414 U.S. 488, 494 (1974) ("[I]f none of the named plaintiffs purporting to represent a class establishes the requisite of a case or controversy with the defendants, none may seek relief on behalf of himself or any other member of the class."). Accordingly, because the named Plaintiffs no longer have claims

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against Ranbaxy and thus cannot adequately represent the class, the District Court correctly denied the motions for class certification.²¹

IV

For the foregoing reasons, we will affirm the orders granting Ranbaxy summary judgment and denying the class certification motions.

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