RESTASIS (CYCLOSPORINE OPHTHALMIC EMULSION) ANTITRUST LITIGATION

FREQUENTLY ASKED QUESTIONS

You received this notice because, according to sales data produced by Allergan, you purchased Restasis during the period after May 2014 through and including February 16, 2020, directly from Allergan.

A federal court authorized this notice because you have a right to know about the proposed Settlement and about all of your options before the Court decides whether to grant final approval of the Settlement. This notice explains the Lawsuit, the Settlement, your legal rights, what benefits are available, and your eligibility for those benefits. Note that you may have received this Notice in error; simply receiving this Notice does not mean you are definitely a member of the Proposed Direct Purchaser Settlement Class. You may confirm that you are a member of the Proposed Direct Purchaser Settlement Class by reviewing the criteria set forth in Question 5 below. You may also call or write to the lawyers in this case at the telephone numbers or addresses listed in Question 9 below.

Direct Purchaser Class Plaintiffs allege that Allergan, following the Food and Drug Administration’s (FDA) June 2013 issuance of a draft guidance relating to the approval of generic versions of Restasis, engaged in anticompetitive behavior to delay entry of generic Restasis.

The plaintiffs allege that Allergan obtained an illegal monopoly on Restasis by submitting fraudulent patent applications to the U.S. Patent and Trademark Office (PTO), obtaining fraudulent patents, and then listing those fraudulent patents in the FDA’s “Orange Book.” Specifically, the plaintiffs allege that Allergan procured these fraudulent patents by submitting misleading declarations, presentations, and filings to the PTO that falsely claimed to have found new and unexpected results for an old invention. During the same period, the plaintiffs also allege that Allergan submitted lengthy, baseless citizen petitions to the FDA – a tactic that plaintiffs allege can delay generic competition. Lastly, the plaintiffs allege that Allergan transferred ownership of its fraudulently acquired patents to the Saint Regis Mohawk Tribe and then claimed that its patents could not be challenged or thrown out because the Tribe was immune from certain types of patent challenges.

The plaintiffs claim that class members were injured as a result of the challenged conduct because they paid more for branded Restasis than they would have paid for generic Restasis and brand Restasis during the class period absent Allergan’s misconduct. A copy of the plaintiff’s First Amended Consolidated Class Action Complaint and Jury Demand, dated February 11, 2019, is available for download at www.RestasisAntitrustSettlement.com.

Allergan denies all of these allegations, including that the plaintiffs or class members are entitled to damages or any other relief. Among other things, Allergan contends that its actions in pursuing its patent rights were reasonable and had a legitimate basis, that its citizen petitions filed with the FDA had scientific and legal merit, and that generic versions of Restasis have not been delayed by the conduct the plaintiffs challenge.

Following full investigation of relevant facts, and negotiations, including use of a court-appointed mediator, the class representatives of the Proposed Direct Purchaser Settlement Class, on behalf of the proposed Class, entered into the Settlement Agreement with Allergan.

THIS NOTICE IS NOT AN EXPRESSION OF ANY OPINION BY THE COURT AS TO THE MERITS OF DIRECT PURCHASER CLASS PLAINTIFFS’ CLAIMS AGAINST ALLERGAN OR THE DEFENSES ASSERTED BY ALLERGAN.

There has been no determination by the Court or a jury that the allegations against Allergan have been proven or that, if proven, Allergan’s conduct caused harm to any purchasers.

The Honorable Nina Gershon of the United States District Court for the Eastern District of New York is overseeing this class action and the Settlement. The lawsuit is known as In re: Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819.

In a class action lawsuit, one or more persons or entities (called the “plaintiff(s)” or “class representative(s)”) sue on behalf of others who have similar claims. Together, the group is typically known as a “class” or “class members.” Accordingly, entities that purchased Restasis directly from Allergan during the relevant time period are considered part of a “class” or “class members.” The companies that filed suit are called the plaintiffs (or class representatives). The company that is sued, in this case Allergan, is called the defendant.

In a class action lawsuit, one court resolves the issues for everyone in the class, except for those class members who exclude themselves from the class.

Although a decision on certification of a Direct Purchaser Class for purposes of litigation has not been rendered by the Court, the Court in this case decided that the plaintiffs’ lawsuit against Allergan can likely proceed as a class action, for the purpose of settlement, because the Proposed Direct Purchaser Settlement Class likely meets the requirements of Federal Rule of Civil Procedure 23, which governs class actions in federal courts. Specifically, the Court will likely find that, for the purpose of this settlement:

  • The number of class members is so numerous that joining them all into one suit is impractical.
  • Members of the class share common legal or factual issues relating to the claims in this case.
  • The claims of the class representatives are typical of the claims of the rest of the class.
  • The class representatives and the lawyers representing the class will fairly and adequately protect the class’s interests.
  • Common legal and factual questions predominate over any questions affecting only individual members of the class, and this class action will be more efficient than individual lawsuits.

The common legal and factual questions include:
  • Whether Allergan had monopoly power over cyclosporine ophthalmic emulsion 0.05% products;
  • Whether Allergan engaged in unlawful conduct with respect to its prosecution of the Restasis patents at issue, listing those patents in the Orange Book, and filing infringement actions based on those patents;
  • Whether Allergan engaged in unlawful conduct with respect to submitting citizen petitions;
  • Whether Allergan’s conduct violated the antitrust laws; and
  • Whether Allergan’s conduct delayed the entry of generic Restasis.

The plaintiffs and Allergan were preparing to proceed with the litigation and go forward with summary judgment and/or trial, but agreed to a settlement. By settling, the plaintiffs and Allergan both avoid the risks and uncertainties of trial and the continued costs of litigation. The plaintiffs and Class Counsel believe that the proposed Settlement is fair, adequate, reasonable, and in the best interests of the Proposed Direct Purchaser Settlement Class.

On May 15, 2020, a federal court found that it will likely certify the following class at or following the final fairness hearing:

  • All persons who or entities which purchased Restasis in the United States or its territories and possessions directly from Allergan at any time after May 2014 through and including February 16, 2020 (the “Class Period”). Excluded from the class are Allergan and its officers, directors, management, employees, subsidiaries, or affiliates, and all governmental entities.

  • Also excluded from the Class are the following entities, in their own capacity or as assignees, who have filed separate, but coordinated, actions against Allergan: CVS Pharmacy, Inc., Rite Aid Corporation, Rite Aid Hdqtrs. Corp., Walgreen Co., The Kroger, Co., Albertsons Companies, Inc., and HEB Grocery Company L.P.

  • If you fit within the definition of the Proposed Direct Purchaser Settlement Class, once certified, you are a member of the Class for purposes of the Settlement unless you ask to be excluded from the Class.

  • If you are not sure whether you are included, you may call or write to the lawyers in this case at the telephone numbers, email addresses, or addresses listed in Question 9 below.

Allergan has agreed to pay $51,250,000.00 in cash into an interest-bearing escrow account (“Settlement Fund”) for the benefit of the Proposed Direct Purchaser Settlement Class. If approved by the Court, the Settlement Fund, minus any Court-awarded fees and expenses to Class Counsel, the cost of settlement notice and administration, and a service award to the plaintiffs (the “Net Settlement Fund”) will be distributed to Proposed Direct Purchaser Settlement Class Members who return valid and timely claim forms. The distribution will be made on a pro rata basis, consistent with each Direct Purchaser Settlement Class Member’s aggregate share of purchases of Restasis.

Transactional sales data produced by Allergan in the Lawsuit will be used to make these calculations. Class Members will be given the opportunity to provide data or information to supplement or correct this information, by mail (or email), if they choose. If the Settlement receives final approval from the Court, each Direct Purchaser Settlement Class Member will receive a claim form pre-populated with information about their purchases for review and signature.

Class Counsel will ask for a service award for the plaintiffs of up to $150,000 each from the Settlement Fund in recognition of their efforts to date on behalf of the Class.

In exchange for the Settlement Fund, Allergan will be released and discharged from all antitrust and similar claims relating to Restasis (“Releasees” and “Released Claims” as defined in the Settlement Agreement). The full text of the releases is included in the Settlement Agreement, available at www.RestasisAntitrustSettlement.com..

Each Class Member’s pro rata recovery will be determined using a Court-approved Plan of Allocation. The detailed Plan of Allocation is posted and can be reviewed at www.RestasisAntitrustSettlement.com. Under the proposed Plan of Allocation, your share of the Net Settlement Fund will depend on the total amount of Restasis that you purchased after May 2014 to March 31, 2019. This calculation utilizes all transactional sales data produced during the litigation. Generally, those entities that purchased more Restasis will be awarded a higher recovery.

Your share of the Net Settlement Fund will also depend on the number of valid claim forms that Class Members submit. If fewer than 100% of the Class Members send in a claim form, you could obtain a larger pro rata share.

Money from the Settlement will only be distributed to Class Members if the Court grants final approval of the Settlement. Payment is conditioned on several matters, including the Court’s final approval of the Settlement and such approval no longer being subject to any appeals or, if there is an appeal, such appeal being final and no longer subject to any further appeal.

The Settlement Agreement may be terminated if, for example, the Court does not approve the Settlement or materially modifies it. If the Settlement Agreement is terminated, the Lawsuit will proceed against Allergan as if such settlement had not been reached.

If the proposed Settlement is approved by the Court and the Court certifies the proposed class, all Direct Purchaser Settlement Class members will receive a claim form by both mail and email to request a pro rata share of the Net Settlement Fund. Court-approved fees and expenses for the attorneys and a service award to the plaintiffs will also be paid from the Settlement Fund. Transactional sales data from Allergan will be used to make the pro rata share calculations. You will be asked to verify the accuracy of the information in the claim form that will be mailed and emailed to you if the Court approves the Settlement, and to sign and return the form according to the directions on the form. Class Members will be given the opportunity to provide data or information to supplement or correct this information.

The Court appointed the following attorneys to serve as interim lead class counsel to represent you and all Class Members (“Interim Lead Class Counsel”). Their contact information is as follows:

Thomas M. Sobol
Kristen A. Johnson
HAGENS BERMAN SOBOL SHAPIRO LLP
55 Cambridge Parkway, Suite 301
Cambridge, MA 02142
Telephone: (617) 482-3700
Facsimile: (617) 482-3003
tom@hbsslaw.com
kristenj@hbsslaw.com

You do not need to hire your own lawyer if you remain in the Class because the lawyers appointed by the Court are working on your behalf. You may hire a lawyer and enter an appearance through your lawyer at your own expense if you so desire.

The Court will be asked to approve reimbursement of the litigation expenses that the plaintiffs’ Counsel have advanced on behalf of the Class and reasonable fees up to one-third of the net Settlement Fund. If the Court grants Class Counsel’s requests, attorney’s fees and expenses would be deducted from the Settlement Fund. Members of the Class will not have to pay any attorney’s fees or expenses out of their own pockets.

Any application by Class Counsel for an award of attorney’s fees, reimbursement of expenses, and service awards to the plaintiffs will be filed with the Court and made available for download and/or viewing no later than 30 days after the date on this Notice to the Class at www.RestasisAntitrustSettlement.com as well as the offices of the Clerk of Court for the United States District Court for the Eastern District of New York, 225 Cadman Plaza East, Brooklyn, NY 11201, during normal business hours but subject to any closures caused by the current health crisis.

Yes, you may exclude yourself from the Proposed Direct Purchaser Settlement Class no later than 50 days from the date this notice was mailed. To exclude yourself, you must send a letter via first-class U.S. mail saying that you want to exclude yourself from the Settlement in the Direct Purchaser Class Action in In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819 (NG) (E.D.N.Y.). Be sure to include your name, address, telephone number, your signature, and the Settlement from which you want to be excluded. Mail the exclusion to: RG/2 Claims Administration, P.O. Box 59479, Philadelphia, PA 19102-9479. Your letter requesting exclusion must be postmarked no later than 50 days from the date this notice was mailed. In the event that you are unable to send a letter via first-class U.S. mail, the letter may be emailed to restasisDPPsettlement@rg2claims.com no later than 50 days from the date this notice was mailed.

Due to the COVID-19 pandemic and the current global health crisis, please include in your communication secondary contact information such as email addresses and cell phone numbers to ensure that any changes in deadlines or hearing dates can be communicated to you effectively. Please also continue to check www.RestasisAntitrustSettlement.com for important updates.

If you ask to be excluded from the Proposed Direct Purchaser Settlement Class, you will not get to share in the Settlement. You will not be legally bound by the Settlement, and you may be able to sue Allergan in the future about the legal issues resolved by this Settlement.

If you exclude yourself so that you can start or continue your own lawsuit against Allergan, you should talk to your own lawyer soon, because your claims will be subject to a statute of limitations, which means that your claims may expire if you do not take timely action. You need to contact your own lawyer at your own expense about this issue.

If you do not exclude yourself, you will not be able to start a lawsuit, continue with a lawsuit, or be part of any other lawsuit against Allergan arising from the claims brought in this Lawsuit and resolved by the Settlement. All of the Court’s orders concerning the Lawsuit will apply to you and legally bind you. You will be bound by the Settlement with Allergan, if the Court grants final approval, and the final judgment entered in the case.

No, you may not sue Allergan for the same thing if you remain in the Proposed Direct Purchaser Settlement Class and are not excluded from the Settlement. By staying in the Proposed Direct Purchaser Settlement Class, you give up your right to sue —or “release”— Allergan for your claims and potential claims relating to your purchases of Restasis from Allergan. The full text of the release is included in the Settlement Agreement available for download at www.RestasisAntitrustSettlement.com.

If you have your own pending lawsuit, speak to your lawyer in that case immediately, because you must exclude yourself from this Class to continue your own lawsuit. Remember, the exclusion deadline 50 days from the date this notice was mailed.

If you are a member of the Proposed Direct Purchaser Settlement Class, you can object to the Settlement if you do not like it. The Court will consider your views. To object, you must send an email to the Court and the parties’ Counsel (listed below) stating that you object to the Settlement in In re: Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819. Be sure to include your name, email address, physical address, best telephone number, the specific reasons why you object to the Settlement, and whether the objection applies only to yourself, a specific subset of the class, or the entire class. Please email the objection to all of the email addresses bolded below:

Counsel for Allergan Eric Stock
EStock@gibsondunn.com

GIBSON DUNN & CRUTCHER, LLP
200 Park Avenue
New York, NY 10166

M. Sean Royall
sean.royall@kirkland.com

KIRKLAND & ELLIS LLP
1601 Elm Street
Dallas, TX 75201

Interim Lead Class Counsel
Thomas M. Sobol
Kristen A. Johnson
tom@hbsslaw.com
kristen@hbsslaw.com
With copy to: jessicam@hbsslaw.com

HAGENS BERMAN SOBOL SHAPIRO LLP
55 Cambridge Parkway, Suite 301
Cambridge, MA 02142

Courtroom Deputy of Judge Gershon
Victor Joe
Courtroom Deputy of Judge Gershon
Victor_Joe@nyed.uscourts.gov

UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK
225 Cadman Plaza East
Brooklyn, NY 11201

Your objection must be emailed no later than August 3, 2020.

Please also continue to check www.RestasisAntitrustSettlement.com for important updates. Interim Lead Class Counsel will file any objection to the settlement on the electronic docket for In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819 (NG) (E.D.N.Y.). Interim Lead Class Counsel will provide any objecting member a receipt of this filing by email.

The Court will hold a hearing, called a Fairness Hearing on September 29, 2020 at 10:30 a.m., to decide whether to finally approve the Settlement and certify the proposed class. The hearing will be held at the United States District Court for the Eastern District of New York, 225 Cadman Plaza East, Brooklyn, NY 11201 in Courtroom 6D South. You may attend, and you may ask to speak, but you do not have to.

Please continue to check www.RestasisAntitrustSettlement.com for important updates.

The Court will hold a hearing to determine: (1) whether to certify the Proposed Direct Purchaser Settlement Class (the Court has already ruled that it is “likely” to certify the proposed settlement class), (2) whether to grant final approval to the settlement, (3) the plan for allocating the Settlement Fund to the Direct Purchaser Settlement Class Members (summarized in the responses to Questions 6 and 7 above), and (4) Class Counsel’s request to pay settlement administration costs, award attorney’s fees, reimburse Class Counsel’s out-of-pocket expenses and costs, and authorize service awards to the Class Representatives. That hearing is scheduled for September 29, 2020 at 10:30 a.m., before U.S. District Court Judge Nina Gershon in Courtroom 6D South of the United States District Court for the Eastern District of New York, 225 Cadman Plaza East, Brooklyn, NY 11201. At this hearing, the Court will consider whether the Settlement is fair, reasonable, and adequate. If there are objections, the Court will consider them. After the hearing, the Court will decide whether to approve the Settlement. We do not know how long these decisions will take.

No, you do not have to attend the Fairness Hearing. Class Counsel will answer any questions that Judge Gershon may have. You are welcome to attend at your own expense.

If you choose to opt out of the proposed settlement class and exclude yourself from the Settlement, you cannot object to the Settlement or be heard at the hearing.

If you send an objection, you do not have to come to Court to talk about it. So long as you email your written objection on time, the Court will consider it. You may also pay your own lawyer to attend, but it is not necessary to receive a pro rata share of the Net Settlement Fund.

If you are a member of the Direct Purchaser Settlement Class, you may ask the Court for permission to speak at the Fairness Hearing. To do so, you must send an email stating that it is your “Notice of Intention to Appear in In re: Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819.” Be sure to include your name, email address, physical address, best telephone number, a summary statement outlining your positions and the reasons for them, and copies of any supporting documents or briefs you want the Court to consider. Your Notice of Intention to Appear must be emailed no later than August 3, 2020 and must be sent to the Courtroom Deputy of Judge Gershon (Mr. Victor Joe, Victor_Joe@nyed.uscourts.gov), Interim Lead Class Counsel (tom@hbsslaw.com, kristen@hbsslaw.com, jessicam@hbsslaw.com), and Counsel for Allergan (EStock@gibsondunn.com, sean.royall@kirkland.com) at the indicated email addresses.

Please also continue to check www.RestasisAntitrustSettlement.com for important updates.

You cannot speak at the hearing if you do not send a Notice of Intention to Appear.

Interim Lead Class Counsel will file any Notice of Intention to Appear on the electronic docket for In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819 (NG) (E.D.N.Y.). Interim Lead Class Counsel will provide any class member who emails a Notice of Intention to Appear a receipt of this filing by email.

If you are a member of the Proposed Direct Purchaser Settlement Class and you do nothing, and the Court certifies the class and approves the Settlement, then you will remain in the Direct Purchaser Settlement Class and be eligible to participate in the Settlement as described in this Notice and you will release your claims against Allergan as described in the Settlement Agreement. However, you will need to complete, sign, and return the claim form (once it is sent to you) in order to obtain a payment.

For more detailed information about this litigation, please refer to the papers on file in this litigation, which may be inspected at the Office of the Clerk, United States District Court for the Eastern District of New York, 225 Cadman Plaza East, Brooklyn, NY 11201, during regular business hours but subject to any closures caused by the current health crisis. You may also obtain additional information about the Settlement by calling, emailing, or writing to Interim Lead Class Counsel as indicated above, by visiting www.RestasisAntitrustSettlement.com, or by writing to the Notice Administrator, RG/2 Claims Administration, at the following address:

RG/2 Claims Administration
P.O. Box 59479
Philadelphia, PA 19102-9479
restasisDPPsettlement@rg2claims.com