Vista Healthplan, Inc. v. Cephalon, Inc., CIVIL ACTION No. 2:06-cv-1833
| Decision Date | 20 April 2020 |
| Docket Number | CIVIL ACTION No. 2:06-cv-1833 |
| Parties | VISTA HEALTHPLAN, INC., et al., Plaintiffs, v. CEPHALON, INC., et al., Defendants. |
| Court | U.S. District Court — Eastern District of Pennsylvania |
MEMORANDUM
This case arises out of a set of antitrust actions which involve reverse settlement payments involving the drug Provigil®. The parties included a brand-name drug manufacturer, numerous generic drug companies, retail drug distributors, the Federal Trade Commission, States Attorneys General, direct purchasers, and end-payors. The End-Payor Plaintiff ("EPP") action, captioned under Vista Healthplan et al. v. Cephalon, et. al., Civ. A. No. 06-1833, culminated in a settlement for which the EPPs now seek approval. On August 8, 2019, I granted preliminary approval of the settlement and preliminarily certified two classes for settlement purposes.
The EPPs now move for final approval of the settlement. Upon review of the parties' briefing and considering the arguments at the final fairness hearing on February 26, 2020, I will certify a settlement class, grant final approval of the class action settlement, and award attorneys' fees, costs, and incentive payments as requested.
In May and June 2006, several now-consolidated cases were filed on behalf all persons who paid for Provigil and/or generic modafinil in twenty-seven states and the District of Columbia, against Defendants Cephalon, Inc., Barr Laboratories, Inc., Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA, Inc. (collectively, "the Cephalon Parties"),1 Mylan Inc., Mylan Pharmaceuticals Inc. (collectively "Mylan"), and Sun Pharmaceutical Industries, Ltd. as successor-in-interest to Ranbaxy Laboratories, Ltd. and Ranbaxy Pharmaceuticals, Inc. ("Ranbaxy") (all of the foregoing collectively referenced as "Defendants").
The lawsuit alleged that, in April 1997, the Patent and Trademark Office issued U.S. Patent No. 5,618,845 ("the '845 patent") to Cephalon, Inc., which patented a specific formulation of modafinil known as Provigil, a wakefulness-promoting drug. In 2002, Cephalon, Inc. was granted a reissue patent on Provigil, U.S. Patent No. RE 37,516 ("the RE '516 patent"), which was scheduled to expire October 6, 2014. As a result of studying the drug's effects on children, Cephalon, Inc. received an additional six months of pediatric exclusivity on Provigil, extending Cephalon, Inc.'s exclusivity period through April 6, 2015.
On December 24, 2002, four generic drug manufacturers—Barr Laboratories, Inc., Teva Pharmaceutical Industries Ltd./Teva Pharmaceuticals USA, Inc., Mylan Inc./Mylan Pharmaceuticals Inc., and Ranbaxy Pharmaceuticals, Inc. (collectively, the "Generics")— filed Abbreviated New Drug Applications ("ANDAs") for generic Provigil, each certifying that Cephalon Inc.'s patent was either invalid or would not be infringed by their generic modafinilproduct. As first-filers, all of the Generics, upon FDA approval, were entitled to share in 180 days of exclusive marketing, a characteristic of the Hatch-Waxman Act, Pub. L. No. 98-417. On March 28, 2003, following the Generics' ANDA filings, Cephalon, Inc. sued the Generics for patent infringement.
All of the litigation between Cephalon, Inc. and the Generics was settled between December 2005 and February 2006, while motions for summary judgment were pending. The settlements each permitted the Generics to launch their generic Provigil product on April 6, 2012, prior to the expiration of the RE '516 patent. The agreements further contained "contingent-launch provisions," which permitted each Generic to market generic Provigil prior to that date if any other company marketed generic Provigil, whether through a license or at-risk, or if the RE '516 patent was declared invalid, unenforceable, or not infringed by generic Provigil. Each of these settlement agreements contained provisions for and/or were signed alongside licenses for intellectual property, active pharmaceutical ingredient supply agreements, and pharmaceutical development agreements. Cephalon, Inc. agreed to pay a total of approximately $300 million to the Generics as a result of these agreements.
In subsequently-filed litigation, various groups—including direct purchasers, end-payors, a generic drug companies, retail drug distributors, the Federal Trade Commission, and States Attorneys General—alleged that these settlement transactions between Cephalon, Inc. and the Generics were anticompetitive "reverse-settlement" payments that violated antitrust laws. Specifically, they contended that but for these payments, the Generics would have launched generic Provigil at risk, and thus lower-cost generic competition would have been brought to the relevant market by June 2006.
Multiple end-payor plaintiffs, or EPPs—including both consumers and large Third-Party payors ("TPPs") who paid for Provigil and/or modafinil in twenty-seven states and the District of Columbia—filed antitrust complaints against Defendants. By way of an August 8, 2006 Court Order, all actions that had been filed alleging claims against Defendants and seeking damages and other relief for injuries allegedly sustained as a result of Defendants' anti-competitive conduct were consolidated for pre-trial purposes.
On April 6, 2009, the consolidated cases were transferred from the Honorable R. Barclay Surrick to my docket for all further proceedings. The same day I entered an order vacating the previous case management orders, and consolidating all EPP actions for all purposes under the caption of Vista Healthplan Inc. v. Cephalon, Inc. et al., Civ. A. No. 06-1833.
An Amended Consolidated Class Action Complaint was filed in August 2009 on behalf of all of the EPPs. On August 18, 2009, I entered an order formally appointing Kessler Topaz Meltzer & Check, LLP, Spector Roseman & Kodroff, P.C. and Criden & Love, P.A. as Interim Co-Lead Class Counsel to act on behalf of all plaintiffs in the EPP putative class action.
At the end of August 2009, Defendants filed renewed motions to dismiss. Following oral argument, I substantially denied the motions to dismiss. Thereafter, over the next several years, the parties engaged in extensive discovery involving written discovery, more than 180 depositions, significant expert discovery, and extensive motion practice.
In 2013, the parties filed summary judgment motions. In March and June 2014, I granted in part and denied in part the EPPs' motion, and granted Defendants' motions on the EPPs' allegations of an overall conspiracy.
In the interim, the United States Supreme Court issued a decision in F.T.C. v. Actavis, Inc., 570 U.S. 136 (2013), which recognized that settlements in which a holder of a pharmaceutical patent makes a payment to an alleged patent infringer to resolve a challenge to the patent—i.e., a reverse payment settlement—"can sometimes violate the antitrust laws." Id. at 141. In light of the guidance provided by Actavis, Defendants filed motions for summary judgment on the EPPs' claims, which I denied.
The EPPs moved for class certification on May 12, 2014. Following extensive briefing and a certification hearing, I denied class certification on June 10, 2015. Vista Healthplan, Inc. v. Cephalon, Inc., No. 06-1833, 2015 WL 3623005 (E.D. Pa. June 10, 2015). Specifically, I found that the EPPs had not met their burden of proving ascertainability for any class, predominance as to antitrust impact for the proposed antitrust class, or predominance and superiority as to the proposed unjust enrichment/consumer protection class. Id. Class Counsel sought immediate review of this decision under Federal Rule of Civil Procedure 23(f), but the United States Court of Appeals for the Third Circuit denied the petition.
In January 2014, settlement discussions among the EPPs and Defendants began before United States Magistrate Judge David R. Strawbridge and two Special Masters, Robert Heim and Constantine Canon. Following two full days of mediation, Class Counsel continued to engage in settlement negotiations with Defendants.
The EPPs first reached a settlement with Mylan, which was announced at the class certification hearing on March 24, 2015. Mylan agreed to pay the EPPs a total of $14,377,600 to fully resolve all claims against it ("Mylan Settlement Agreement").
In October 2015, following the Cephalon Defendants' $1.2 billion settlement with the Federal Trade Commission ("FTC"), the Cephalon Defendants orally agreed to a settlement with the EPPS and a separate group of over forty health plans (the "Settling Health Plans" or "SHPs"), who opted to proceed separately from the class proceedings following the denial of class certification. The EPPs, SHPs, and the Cephalon Defendants entered a Memorandum of Understanding ("MOU") in December 2015, providing for Cephalon to pay $125 million—$48 million to the EPPs and $77 million to the SHPs—in exchange for releases ("Cephalon Settlement Agreement").
The Cephalon Settlement Agreement was delayed when United Health Care ("United"), one of the SHPs that signed the MOU, renounced its agreement to settle and initiated its own litigation against the Cephalon Defendants, Ranbaxy, and Mylan under Civil Action No. 17-555. The Cephalon Defendants then sued United, under Civil Action No. 16-4870, to enforce the MOU. Following summary judgment briefing and a non-jury trial, I determined, on September 19, 2018, that United was bound by the terms of the MOU. While that litigation was pending, however, the EPPs, SHPs, and the Cephalon Defendants executed a May 2018 settlement agreement, which created a carve-out for United, while acknowledging the existence and lack of impact of the MOU litigation.
The EPPs and Ranbaxy reached a settlement on the eve of trial in September 2018. The settlement with Ranbaxy is for $3.5 million ("Ranbaxy Settlement Agreement").
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