Litigation Details for Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund v. Allergan, Inc. (E.D.N.Y 2018)

Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund v. Allergan, Inc. (E.D.N.Y 2018)

Docket	1:18-cv-00969	Date Filed	2018-02-14
Court	District Court, E.D. New York	Date Terminated	2023-08-01
Cause	15:1 Antitrust Litigation	Assigned To	Nina Gershon
Jury Demand	Plaintiff	Referred To	Lois Bloom
Patents	8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930; 9,248,191
Link to Docket	External link to docket

Details for Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund v. Allergan, Inc. (E.D.N.Y 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-02-14				External link to document
2018-02-14	1		early 2014 as U.S. Patent Nos. 8,629,111 (“the ’111 patent”), 8,633,162 (“the ’162 patent”), 8,642,556 (“… Jan. 14, 2014); U.S. Patent No. 8,633,162 (dated Jan. 21, 2014); U.S. Patent No. 8,642,556 (dated Feb….S. Patent No. 4,839,342 to Kaswan (“the ’342 patent” or “the Kaswan patent”). The Kaswan patent claimed… Ding I patent. 64. The second patent, U.S. Patent No. 5,981,607 (“the ’607 patent” or “the…protected by the U.S. Patent No. 5, 474, 979 (the “’979 Patent” or “Ding I patent,”) which issued in 1995	External link to document

Fraternal Order of Police Miami Lodge 20 v. Allergan: Restasis Antitrust Litigation Summary

Last updated: August 23, 2026

The Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund v. Allergan, Inc., No. 1:18-cv-00969, is a private antitrust action concerning Allergan’s efforts to delay generic competition to Restasis, its cyclosporine ophthalmic emulsion for chronic dry-eye disease. The complaint targeted Allergan’s patent strategy, Orange Book listings, patent litigation against generic applicants and transfer of Restasis-related patents to the Saint Regis Mohawk Tribe.

The case was one of several actions consolidated in the Restasis antitrust multidistrict litigation in the Eastern District of New York. The central theory was that Allergan used allegedly weak or improperly listed patents to trigger Hatch-Waxman litigation and obtain additional regulatory exclusivity after its primary Restasis patent protection had expired or weakened. The litigation risk was tied to generic cyclosporine ophthalmic emulsion products, not to biosimilar competition.

What is Fraternal Order of Police Miami Lodge 20 v. Allergan?

The case is a purchaser antitrust action against Allergan arising from the Restasis patent estate.

Item	Detail
Case	Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund v. Allergan, Inc.
Case number	1:18-cv-00969
Subject product	Restasis, cyclosporine ophthalmic emulsion 0.05%
Defendant	Allergan, Inc., later part of AbbVie
Plaintiff type	Health-plan and third-party-payer purchaser
Principal legal theories	Sherman Act monopolization and attempted monopolization; Clayton Act damages claims; related state-law claims
Patent dispute	Restasis Orange Book patents and Allergan’s enforcement strategy
Related proceeding	In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, MDL No. 2804, Eastern District of New York
Market	Prescription ophthalmic products for chronic dry-eye disease

The plaintiff alleged that Allergan maintained monopoly power in the U.S. market for cyclosporine ophthalmic emulsion by combining patent enforcement, regulatory filings and a patent assignment to the Saint Regis Mohawk Tribe. The alleged conduct was intended to delay generic entry and preserve branded Restasis pricing.

What patents protected Restasis?

Restasis was protected by a combination of composition, formulation and use-related intellectual property. The litigation focused primarily on later-filed patents covering the formulation and delivery characteristics of cyclosporine ophthalmic emulsion rather than only the active ingredient.

Key Restasis-related patents included:

Patent	General subject matter	Relevance
U.S. Patent No. 8,629,111	Cyclosporine ophthalmic emulsion formulation	Asserted against generic applicants
U.S. Patent No. 9,248,191	Restasis formulation and emulsion characteristics	Part of Allergan’s later Orange Book strategy
U.S. Patent No. 9,669,090	Ophthalmic emulsion-related claims	Alleged barrier to generic entry
U.S. Patent No. 9,700,491	Cyclosporine ophthalmic composition or use	Part of the asserted portfolio
U.S. Patent No. 9,907,782	Later Restasis-related formulation claims	Added protection after the original product patent cycle

The patents were important because FDA-listed patents can trigger a 30-month stay when a generic applicant files a Paragraph IV certification and the brand company brings a timely infringement action under the Hatch-Waxman Act.

The antitrust plaintiffs argued that Allergan’s patents were invalid, unenforceable or insufficiently connected to the commercial Restasis product. They also challenged the timing and manner of the listings. Allergan maintained that the patents were legitimate and that asserting them in response to Paragraph IV certifications was protected litigation activity.

What was the Saint Regis Mohawk Tribe patent transfer?

In September 2017, Allergan transferred certain Restasis patents to the Saint Regis Mohawk Tribe. Under the agreement, the tribe received an upfront payment reported at approximately $13.75 million and ongoing royalty rights. Allergan received an exclusive license to continue practicing and enforcing the patents.

The transaction was designed to invoke tribal sovereign immunity in inter partes review proceedings before the Patent Trial and Appeal Board. Allergan sought to prevent generic challengers from using IPR to attack the validity of the Restasis patents.

The antitrust plaintiffs characterized the transaction as a sham designed to shield weak patents from administrative review and prolong Allergan’s monopoly. Allergan argued that the transaction was a lawful assignment and licensing arrangement.

The Federal Circuit held in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc. that tribal sovereign immunity did not prevent the Patent Trial and Appeal Board from proceeding with IPRs involving the Restasis patents. The court treated the tribe as a real party in interest but held that IPR is an agency-initiated process in which sovereign immunity does not require dismissal. (Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc., 896 F.3d 1322, 2018).

That ruling materially weakened the practical value of the patent transfer. It also supplied the antitrust plaintiffs with a concrete event supporting their allegation that Allergan attempted to obstruct patent validity review.

What antitrust conduct did the plaintiff allege?

The complaint alleged a coordinated scheme with four principal components.

Allegedly improper Orange Book listings

The plaintiff alleged that Allergan listed patents in the FDA’s Orange Book even though the patents did not properly claim the approved Restasis product or an approved method of using it. An improper listing can force a generic applicant into patent litigation and generate a statutory 30-month stay of FDA approval.

The theory depended on the connection between the patent claims and the regulatory approval. Allergan disputed that its listings were improper and argued that the patents covered the marketed formulation or approved use.

Sham patent litigation

The complaint alleged that Allergan sued generic applicants despite lacking a reasonable basis for infringement claims. The alleged objective was to obtain automatic regulatory stays rather than to win on the merits.

The Supreme Court’s Noerr-Pennington doctrine generally protects genuine petitioning of government entities, including patent litigation. A patent suit can lose that protection if it is objectively baseless and brought subjectively to interfere with a competitor through use of the governmental process.

The Restasis plaintiffs relied on the asserted patents’ later invalidation or adverse treatment in patent proceedings to support their sham-litigation theory. Allergan argued that later patent losses do not establish that the original lawsuits were objectively baseless when filed.

Patent-transfer strategy

The tribe assignment was alleged to be part of the same exclusionary scheme. Plaintiffs argued that Allergan transferred the patents to create an artificial sovereign-immunity defense and prevent generic applicants from using IPR.

The Federal Circuit’s decision eliminated the claimed immunity from IPR, but the antitrust issue remained whether the transaction itself was exclusionary conduct and whether it caused measurable delay or overcharges.

Maintenance of monopoly power

The overall theory was monopolization under Section 2 of the Sherman Act. Plaintiffs alleged that Allergan used multiple legal and regulatory mechanisms to preserve monopoly pricing after competitors were prepared to enter.

The key causation question was whether generic entry would have occurred earlier absent the challenged conduct. That required analysis of patent validity, FDA approval timing, generic formulation development, Paragraph IV litigation and possible noninfringing alternatives.

What did the Restasis patent litigation establish?

The underlying patent litigation reduced the strength of Allergan’s Restasis patent estate.

In a Delaware patent case involving generic applicants, the asserted Restasis patents were challenged on invalidity grounds. The litigation addressed obviousness and related issues affecting the enforceability of Allergan’s later-filed patents. The Federal Circuit’s treatment of the patents and the separate Saint Regis decision weakened Allergan’s ability to rely on the portfolio as a long-term barrier to generic entry.

The antitrust plaintiffs used those results to argue that Allergan had prolonged its monopoly through patents that could not withstand substantive review. Allergan’s response was that patent validity is not equivalent to antitrust liability. A patent holder may assert a patent in good faith even if the patent is later invalidated.

This distinction was central to the case. The plaintiffs had to prove more than that Allergan lost patent disputes. They needed to establish that the challenged conduct was exclusionary, caused delayed generic entry and produced antitrust injury.

What was the procedural history of the case?

The action was filed in 2018 and became part of the broader Restasis antitrust litigation.

Date	Event
2017	Allergan transferred Restasis patents to the Saint Regis Mohawk Tribe
2017	Generic applicants challenged the Restasis patents and Allergan sued under Hatch-Waxman
2018	FOP Miami Lodge 20 filed No. 1:18-cv-00969
2018	Federal Circuit rejected tribal sovereign immunity as a basis for terminating the Restasis IPR proceedings
2018	Restasis antitrust actions proceeded in coordinated MDL litigation in the Eastern District of New York
2018	The court issued a significant motion-to-dismiss ruling in the Restasis MDL
Later proceedings	The parties litigated pleading sufficiency, antitrust standing, causation, patent-related conduct and damages

The leading MDL decision is In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 335 F. Supp. 3d 498 (E.D.N.Y. 2018). The court treated the complaint as presenting a plausible antitrust theory based on the alleged patent and regulatory scheme, while applying Noerr-Pennington principles to determine which aspects of Allergan’s conduct could support liability.

The MDL posture matters because the FOP action’s claims, discovery and motion practice were affected by consolidated proceedings. A docket entry in the original Delaware action should not be read in isolation from the MDL record.

Did Allergan face Paragraph IV challenges to Restasis?

Yes. Generic applicants filed Paragraph IV certifications challenging Restasis-related patents. Allergan responded with infringement litigation, creating potential 30-month FDA approval stays.

The Hatch-Waxman sequence was commercially significant:

1. A generic applicant filed an Abbreviated New Drug Application.
2. The applicant certified that one or more Orange Book patents were invalid, unenforceable or would not be infringed.
3. Allergan filed infringement litigation.
4. The filing triggered a statutory stay of final FDA approval.
5. The generic applicant pursued patent invalidity and noninfringement defenses.
6. Generic launch depended on the outcome of the litigation, patent expiry, settlement terms and FDA approval.

The antitrust claim depended on whether Allergan’s patent assertions caused an entry delay beyond the delay that would have resulted from legitimate patent enforcement.

What was the FDA and Orange Book status of Restasis?

Restasis was approved by the FDA as cyclosporine ophthalmic emulsion 0.05% for increasing tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.

Restasis was not a biologic. Biosimilar substitution rules therefore did not apply. Competitive products followed the ANDA generic pathway rather than the 351(k) biosimilar pathway.

The Orange Book listings were important because they connected Allergan’s patent portfolio to FDA approval timing. The principal commercial risks were:

• whether each patent was properly listable;
• whether a generic product would infringe;
• whether the generic applicant could invalidate the patents;
• whether a Paragraph IV filing would trigger a 30-month stay;
• whether FDA approval would be delayed by unresolved patent litigation.

The FDA’s Orange Book did not determine patent validity. It provided the regulatory mechanism through which listed patents could delay generic approval.

When did Restasis lose exclusivity?

Restasis lost practical exclusivity in stages rather than on a single date.

The original cyclosporine and product protection had a different life cycle from the later formulation patents. Allergan’s commercial exclusivity was extended through later patent filings, Orange Book listings, Hatch-Waxman litigation and the absence of an approved generic for several years after the original patent cycle.

FDA approval of generic cyclosporine ophthalmic emulsion products in 2022 marked the end of effective single-source Restasis control. Generic launches and subsequent competition created direct price and volume pressure on the branded product.

Exclusivity element	Commercial effect
Original Restasis approval	Established the branded market
Original patent protection	Delayed conventional generic competition
Later formulation patents	Created additional patent litigation risk
Paragraph IV litigation	Triggered potential FDA approval stays
Saint Regis assignment	Attempted to limit IPR-based validity challenges
Federal Circuit IPR ruling	Removed tribal-immunity protection
2022 generic approvals	Began practical loss of market exclusivity

Exact patent expiry analysis must be performed patent by patent because term adjustments, pediatric extensions, terminal disclaimers and the specific Orange Book listing can change the effective date.

How strong was Allergan’s Restasis patent estate?

The estate was commercially effective but legally vulnerable.

Strengths

• Multiple later-filed formulation patents created several litigation points.
• Orange Book listings could trigger FDA approval stays.
• Allergan had substantial experience litigating ophthalmic formulations.
• The formulation complexity made generic development and bioequivalence more difficult than for a conventional tablet.
• The patents increased settlement leverage even when ultimate validity was contested.

Weaknesses

• The later patents faced obviousness and claim-scope challenges.
• Several patents were challenged in coordinated proceedings.
• The Saint Regis transfer failed to block IPR.
• Generic applicants had strong economic incentives to pursue entry.
• The antitrust plaintiffs could use adverse patent rulings as evidence supporting their exclusionary-conduct theory.

The portfolio’s principal value was delay. It was less secure as a long-term barrier once generic applicants obtained favorable validity rulings and FDA approvals.

What litigation risks did Allergan face?

Allergan faced three principal categories of risk.

Treble-damages exposure

Private plaintiffs sought damages under federal antitrust law. A successful Clayton Act claim can result in treble damages, attorneys’ fees and litigation costs. Health plans and other payers alleged that they paid inflated prices for Restasis during the delay period.

Damages depended on:

• the but-for generic entry date;
• the number of generic competitors that would have entered;
• the price decline after generic entry;
• the volume of Restasis purchases;
• the allocation of purchases between direct and indirect channels;
• the effect of rebates and formulary decisions.

Class-certification risk

The plaintiffs’ ability to certify a damages class depended on common proof of overcharge and injury. Health-plan purchasing patterns, rebates, pharmacy benefit manager arrangements and state-law variations could complicate class treatment.

Precedent risk

A ruling treating aggressive Orange Book listing, patent assignment or Hatch-Waxman litigation as anticompetitive could affect pharmaceutical patent strategies beyond Restasis. Allergan therefore had incentives to defend the case even apart from the product-specific damages.

Were there settlement agreements?

The key public record for this litigation is the complaint, MDL docket and court rulings. Settlement analysis must distinguish between settlements involving Allergan and settlements involving generic manufacturers or other defendants.

A settlement with a generic applicant would not necessarily resolve the FOP plaintiff’s claims. It could affect the damages model, however, by changing the estimated but-for entry date. Similarly, a resolution of the patent litigation would not automatically dispose of the separate antitrust claims.

The commercially relevant settlement terms would include:

• the generic launch date;
• any licensed-entry date;
• cash payments;
• supply or co-promotion arrangements;
• releases;
• admissions or denials;
• treatment of indirect-purchaser claims;
• allocation among federal and state causes of action.

The case should not be treated as resolved solely because the underlying patent disputes ended or generic products entered the market.

Which companies challenged Restasis?

Restasis faced generic challenges from multiple pharmaceutical companies, including Mylan and Teva-affiliated entities, among other applicants involved in the patent proceedings.

The competitive landscape included:

Competitor category	Regulatory pathway	Risk to Restasis
Generic cyclosporine ophthalmic emulsion	ANDA	Direct substitution and price erosion
Authorized or licensed generic	ANDA or commercial agreement	Controlled erosion of branded share
Alternative dry-eye therapies	NDA, OTC or prescription pathways	Therapeutic substitution
Other ophthalmic immunomodulators	NDA or generic pathway	Treatment substitution
Biosimilars	Not applicable	No direct biosimilar pathway for Restasis

The commercial challenge was not limited to one generic entrant. The first approved generic could obtain substantial volume, while later entrants would accelerate price erosion.

What generic launch risks existed?

The Restasis generic-entry risk was high once the key patents were weakened and FDA approvals became available.

The main launch scenarios were:

Single generic launch

A first generic entrant could obtain significant share while pricing below Restasis but above the level expected after multiple generic entrants. Branded net sales would decline through volume loss, rebate pressure and formulary displacement.

Multiple generic launch

Several approved generics could enter in a compressed period, producing sharper price erosion. The effect would depend on pharmacy substitution, payer formularies and the extent to which the products were therapeutically and pharmaceutically substitutable.

Authorized-generic strategy

Allergan or its successor could use an authorized generic or supply arrangement to moderate the impact of independent generic entry. Such a strategy could preserve some economics while reducing the price gap between Restasis and generic products.

Delayed generic launch

Patent settlements, manufacturing problems or FDA deficiencies could delay commercial entry even after patent litigation ended. The antitrust damages period would turn on the legally and economically supportable but-for launch date.

How did the litigation affect Allergan and AbbVie?

Allergan’s exposure was later inherited within AbbVie’s acquisition of Allergan. The litigation involved a mature, high-value ophthalmic product with substantial cumulative sales and a significant payer base.

Revenue exposure was driven by:

• Restasis prescription volume;
• branded net price;
• duration of delayed generic entry;
• number and timing of generic launches;
• payer substitution;
• competitive products such as Xiidra;
• the portion of prescriptions retained after generic entry.

The antitrust case had greater financial significance than a conventional patent-infringement dispute because plaintiffs sought damages for historical purchases across health plans and other payers. The alleged overcharge period could extend across the interval between the claimed lawful generic-entry date and actual generic availability.

What is the legal significance of the case?

The case illustrates the limits of using patent and FDA mechanisms to preserve pharmaceutical exclusivity.

Three legal points are central:

1. A patent holder may generally enforce valid patents, but objectively baseless litigation can lose Noerr-Pennington protection.
2. Orange Book listing decisions can create antitrust exposure when plaintiffs plausibly allege that the listed patents do not cover the approved product or use.
3. A patent assignment designed to invoke sovereign immunity does not necessarily prevent IPR review, and the transaction may become evidence in a broader exclusionary-conduct case.

The case also demonstrates that patent invalidity alone does not establish antitrust liability. Plaintiffs still must prove exclusionary conduct, causation, antitrust injury and damages.

Key Takeaways

• FOP Miami Lodge 20 v. Allergan is a Restasis antitrust case focused on delayed generic entry.
• The challenged conduct included Orange Book listings, Hatch-Waxman patent suits and the Saint Regis Mohawk Tribe patent transfer.
• The Federal Circuit rejected tribal sovereign immunity as a bar to IPR of the Restasis patents.
• Restasis was a small-molecule drug, so biosimilar litigation was not relevant.
• Generic cyclosporine ophthalmic emulsion approvals in 2022 ended effective single-source control.
• The principal litigation issues were sham litigation, patent-listing conduct, causation, antitrust standing and damages.
• The commercial exposure depended on the but-for generic launch date and the price decline following entry.
• The Restasis patent estate created meaningful delay leverage but became materially weaker after adverse patent and IPR rulings.

FAQs About the Restasis Antitrust Case

Did the Restasis case involve product hopping?

The principal allegations concerned patent enforcement, Orange Book listings and the Saint Regis patent transfer. Product hopping was not the central theory identified in the Restasis antitrust pleadings.

Was Restasis protected by pediatric exclusivity?

Any pediatric-exclusivity analysis must be separated from patent expiry and FDA approval stays. Pediatric exclusivity can add six months to qualifying listed patents, but it does not independently establish antitrust liability.

Could pharmacies substitute generic cyclosporine for Restasis?

Generic substitution depends on FDA rating, state substitution rules, payer formularies and the specific product approval. FDA approval alone does not guarantee automatic pharmacy substitution in every jurisdiction.

Did Allergan’s patent transfer permanently block generic challenges?

No. The Federal Circuit held that the transfer to the Saint Regis Mohawk Tribe did not prevent IPR proceedings against the Restasis patents.

What product replaced Restasis commercially?

Xiidra and other dry-eye therapies competed with Restasis at the treatment level, while generic cyclosporine ophthalmic emulsion competed directly at the product level.

References

1. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j).

2. Federal Trade Commission. (n.d.). Approved drug products with therapeutic equivalence evaluations (Orange Book). U.S. Food and Drug Administration.

3. In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 335 F. Supp. 3d 498 (E.D.N.Y. 2018).

4. Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc., 896 F.3d 1322 (Fed. Cir. 2018).

5. U.S. Food and Drug Administration. (2003). Restasis approval package: Cyclosporine ophthalmic emulsion 0.05%. FDA.

6. U.S. District Court for the District of Delaware. (2018). Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund v. Allergan, Inc., No. 1:18-cv-00969. Docket record.