Zetia (Ezetimibe) Antitrust v. Merck & Company, Inc.

CourtCourt of Appeals for the Fourth Circuit
DecidedAugust 4, 2021
Docket20-2184
StatusPublished

This text of Zetia (Ezetimibe) Antitrust v. Merck & Company, Inc. (Zetia (Ezetimibe) Antitrust v. Merck & Company, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fourth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Zetia (Ezetimibe) Antitrust v. Merck & Company, Inc., (4th Cir. 2021).

Opinion

PUBLISHED

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 20-2184

In re: ZETIA (EZETIMIBE) ANTITRUST LITIGATION.

-------------------------------

FWK HOLDINGS, LLC; CESAR CASTILLO, INC., individually and on behalf of all those similarly situated; ROCHESTER DRUG COOPERATIVE, INC.,

Plaintiffs - Appellees,

v.

MERCK & COMPANY, INC.; MERCK SHARP & DOHME CORPORATION; SCHERING PLOUGH CORPORATION; SCHERING CORPORATION; MSP SINGAPORE CO. LLC; GLENMARK PHARMACEUTICALS, LTD.; GLENMARK GENERICS INC., USA,

Defendants - Appellants.

Appeal from the United States District Court for the Eastern District of Virginia, at Norfolk. Rebecca Beach Smith, Senior District Judge. (2:18-md-02836-RBS-DEM)

Argued: May 6, 2021 Decided: August 4, 2021

Before NIEMEYER, FLOYD, and RUSHING, Circuit Judges.

Vacated and remanded by published opinion. Judge Floyd wrote the opinion, in which Judge Niemeyer and Judge Rushing joined. Judge Niemeyer wrote a separate concurring opinion. ARGUED: Theodore J. Boutrous, Jr., GIBSON, DUNN & CRUTCHER LLP, Los Angeles, California, for Appellants. Thomas M. Sobol, HAGENS BERMAN SOBOL SHAPIRO LLP, Cambridge, Massachusetts, for Appellee. ON BRIEF: Eric J. Stock, New York, New York, Veronica S. Lewis, Ashley Johnson, Dallas, Texas, Samuel J. Liversidge, Christopher D. Dusseault, Bradley J. Hamburger, Daniel R. Adler, GIBSON, DUNN & CRUTCHER LLP, Los Angeles, California; Stephen E. Noona, KAUFMAN & CANOLES, P.C., Norfolk, Virginia, for Appellants Merck & Co., Inc.; Merck Sharp & Dohme Corp.; Schering-Plough Corp.; Schering Corp.; and MSP Singapore Co. LLC. Steven A. Reed, R. Brendan Fee, Zachary M. Johns, Jessica J. Taticchi, Philadelphia, Pennsylvania, Stacey Anne Mahoney, MORGAN, LEWIS & BOCKIUS LLP, New York, New York; Richard H. Ottinger, Dustin M. Paul, Jennifer L. Eaton, VANDEVENTER BLACK LLP, Norfolk, Virginia, for Appellants Glenmark Pharmaceuticals Ltd. and Glenmark Pharmaceuticals Inc., USA. Erin C. Burns, Hannah Schwarzchild, Bradley J. Vettraino, HAGENS BERMAN SOBOL SHAPIRO LLP, Cambridge, Massachusetts, for Appellee FWK Holdings, LLC and the Direct Purchaser Class. William H. Monroe, Jr., Marc C. Greco, Kip A. Harbison, Michael A. Glasser, GLASSER & GLASSER, P.L.C., Norfolk, Virginia, for Appellees FWK Holdings, LLC; César Castillo, Inc.; and Rochester Drug Co-Operative, Inc. John D. Radice, RADICE LAW FIRM, P.C., Princeton, New Jersey; Paul E. Slater, Joseph M. Vanek, David P. Germaine, Alberto Rodriguez, SPERLING & SLATER, P.C., Chicago, Illinois; Michael Roberts, Stephanie Smith, Karen Halbert, Will Wilson, ROBERTS LAW FIRM, P.A., Little Rock, Arkansas; Sharon K. Robertson, Donna M. Evans, COHEN MILSTEIN SELLERS & TOLL PLLC, New York, New York; Steve D. Shadowen, Matthew C. Weiner, HILLIARD & SHADOWEN LLP, Austin, Texas; Joseph H. Meltzer, Terence S. Ziegler, KESSLER TOPAZ MELTZER & CHECK LLP, Radnor, Pennsylvania, for Appellee FWK Holdings, LLC and the Direct Purchaser Class. Linda P. Nussbaum, NUSSBAUM LAW GROUP, P.C., New York, New York; Jayne A. Goldstein, SHEPHERD, FINKELMAN, MILLER & SHAH, LLP, Fort Lauderdale, Florida, for Appellee César Castillo and the Direct Purchaser Class. David F. Sorensen, Ellen T. Noteware, Nicholas Urban, BERGER MONTAGUE PC, Philadelphia, Pennsylvania; Barry Taus, Archana Tamoschunas, Kevin Landau, TAUS, CEBULASH & LANDAU, LLC, New York, New York; Peter R. Kohn, Joseph T. Lukens, Philadelphia, Pennsylvania, Bradley J. Demuth, FARUQI & FARUQI, LLP, New York, New York, for Appellee Rochester Drug Co-Coperative, Inc. and the Direct Purchaser Class.

2 FLOYD, Circuit Judge:

A group of pharmaceutical buyers brought this class action against two

manufacturers who allegedly reached an anticompetitive settlement in a patent dispute.

Defendants-Appellants Merck 1 and Glenmark 2 challenge the district court’s class

certification order. Plaintiffs-Appellees are a class of direct purchasers of Merck’s brand-

name drug and Glenmark’s generic version of that drug. The district court determined that

the putative class of thirty-five purchasers satisfied the class certification requirements set

forth in Federal Rule of Civil Procedure 23. We hold that the district court’s numerosity

analysis fell short in several respects, so we vacate the district court’s order and remand for

further proceedings.

I.

In the 1980s, Merck began developing a cholesterol-lowering drug. Eventually,

Merck invented ezetimibe, patented and marketed under the name Zetia. Merck’s patent

was exclusive through April 2017, meaning that Merck had the exclusive right to develop

ezetimibe through that date. In 2006, Glenmark sought FDA approval to market a generic

version of Zetia, claiming that Merck’s Zetia patent was “invalid or w[ould] not be

infringed by the manufacture, use, or sale of” Glenmark’s generic. See 21 U.S.C.

“Merck” refers to Defendants-Appellants Merck & Co., Inc.; Merck Sharp & 1

Dohme Corp.; Schering-Plough Corp.; Schering Corp.; and MSP Singapore Co. LLC.

“Glenmark” refers to Defendants-Appellants Glenmark Pharmaceuticals Ltd. and 2

Glenmark Pharmaceuticals Inc., USA.

3 § 355(j)(2)(A)(vii)(IV). 3 As required by law, Glenmark notified Merck of its generic drug

application. Merck promptly sued Glenmark for patent infringement. Glenmark did not

contest that its proposed generic infringed on Merck’s patent. Instead, Glenmark argued

that Merck’s patent was invalid. In 2010, Merck and Glenmark settled the patent dispute.

The settlement agreement allowed Glenmark to launch its generic in December 2016—

over four months before the expiration of Merck’s exclusivity period.

Plaintiffs, on behalf of a small group of drug wholesalers that purchased Zetia

directly from Merck, sued Merck and Glenmark under federal antitrust law, alleging that

the two companies conspired to inflate the drug’s price. Plaintiffs’ case drew parallels to

the Supreme Court’s decision in FTC v. Actavis, Inc., 570 U.S. 136 (2013), which

concerned the anticompetitive settlement of a patent case. In Actavis, a brand-name

manufacturer sued generic manufacturers for patent infringement. Under the parties’

settlement agreement, the brand-name manufacturer agreed to a reverse payment in which

it agreed to pay the generic manufacturers between $240 and $342 million to delay the

launch of their generic products. Id. at 144–45. The FTC then sued both parties, alleging

that the reverse payment was anticompetitive and therefore in violation of federal antitrust

law. Id. at 145. The Supreme Court agreed, holding that a “large and unjustified” reverse

payment made “in return for staying out of the market” may give rise to antitrust liability.

Id. at 154, 158.

3 Federal law gives competing drug manufacturers the opportunity to introduce generic versions of branded drugs. Generic manufacturers may obtain FDA approval through an abbreviated review process so long as the generic is a bioequivalent of the approved, brand-name drug.

4 In this case, Plaintiffs allege that Merck made a “reverse payment” by giving up its

right to sell a generic version of ezetimibe for the six-month period after Glenmark

introduced its own generic. Because Glenmark was the first to seek FDA approval for a

generic ezetimibe, it had the near-exclusive right to sell a generic for 180 days after

launching it. 21 U.S.C. § 355(j)(5)(B)(iv). The right is near-exclusive because the brand-

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