Litigation Details for Meijer Distribution, Inc. v. Allergan, Inc. (S.D.N.Y. 2016)

Meijer Distribution, Inc. v. Allergan, Inc. (S.D.N.Y. 2016)

Docket	1:16-cv-03092	Date Filed	2016-04-26
Court	District Court, S.D. New York	Date Terminated	2016-08-19
Cause	15:2 Antitrust Litigation	Assigned To	Alison Julie Nathan
Jury Demand	Plaintiff	Referred To
Patents	6,649,180; 6,893,662; 8,580,302
Link to Docket	External link to docket

Details for Meijer Distribution, Inc. v. Allergan, Inc. (S.D.N.Y. 2016)

Date Filed	Document No.	Description	Snippet	Link To Document
2016-04-26				External link to document
2016-04-26	1		on Delzicol is covered by U.S. Patent No. 6,649,180 (“the ’180 patent”), which expires April 13, 2020…the ’170 patent”) and 5,541,171 (“the ’171 patent”). Both patents expired July 30, 2013. 80. …would push Asacol (400mg) over the “patent cliff” – upon patent expiry in July 2013, Warner Chilcott …alleged infringement of that patent. Warner Chilcott’s listing of the capsule patent in the Orange Book, and…assertion that the patent claimed the drug product, was grossly improper: the patent claims only the capsules	External link to document
2016-04-26	13		on Delzicol is covered by U.S. Patent No. 6,649,180 (“the ’180 patent”), which expires April 13, 2020…the ’170 patent”) and 5,541,171 (“the ’171 patent”). Both patents expired July 30, 2013. 80. …would push Asacol (400mg) over the “patent cliff” – upon patent expiry in July 2013, Warner Chilcott …alleged infringement of that patent. Warner Chilcott’s listing of the capsule patent in the Orange Book, and…assertion that the patent claimed the drug product, was grossly improper: the patent claims only the capsules	External link to document

Meijer Distribution v. Allergan: Restasis Antitrust Litigation Summary and Patent Analysis

Last updated: September 26, 2026

Meijer Distribution, Inc. v. Allergan, Inc., No. 1:16-cv-03092, was a direct-purchaser antitrust action concerning Allergan’s Restasis cyclosporine ophthalmic emulsion franchise. The case alleged that Allergan used patent litigation and related patent strategies to delay generic competition. The dispute became part of the broader Restasis antitrust and Hatch-Waxman litigation following generic manufacturers’ challenges to Allergan’s patents.

The case’s commercial significance was tied to Restasis, a major ophthalmic product with annual U.S. sales that exceeded $1 billion before generic competition. The principal legal issue was whether Allergan’s enforcement and acquisition of Restasis patents unlawfully delayed generic entry or was protected by ordinary patent-litigation rights.

What was Meijer Distribution v. Allergan about?

Meijer alleged that Allergan maintained or extended market exclusivity for Restasis through conduct that violated federal antitrust law. The allegations focused on Allergan’s Restasis patent estate, its infringement litigation against generic manufacturers, and the transfer of Restasis patents to the Saint Regis Mohawk Tribe.

The case was not a conventional Hatch-Waxman patent-infringement action brought by Allergan against a generic manufacturer. Meijer was a downstream purchaser and pharmacy distributor. Its theory was that the alleged patent conduct caused distributors and other purchasers to pay supracompetitive prices for Restasis.

The relevant product was Restasis, an ophthalmic emulsion containing cyclosporine, approved by the U.S. Food and Drug Administration in 2003 for increasing tear production in patients with keratoconjunctivitis sicca associated with ocular inflammation.

What were Meijer’s principal allegations against Allergan?

Meijer’s allegations centered on alleged exclusionary conduct involving Restasis patents. The theories included:

1. Allergan prosecuted and enforced patents that were allegedly invalid or unenforceable.
2. Allergan used patent litigation to delay approval and launch of generic cyclosporine ophthalmic emulsion products.
3. Allergan transferred Restasis patents to the Saint Regis Mohawk Tribe to invoke tribal sovereign immunity in inter partes review proceedings before the Patent Trial and Appeal Board.
4. Allergan allegedly maintained a monopoly after the underlying patents should have ceased to block generic competition.
5. Purchasers paid higher prices because generic Restasis products were delayed.

The antitrust theory depended on proof that Allergan’s patent conduct was objectively baseless or otherwise outside the protection generally afforded to patent enforcement. That requirement created a significant barrier under the Noerr-Pennington doctrine and related sham-litigation standards.

What is the procedural history of the Meijer Restasis litigation?

Date	Event	Legal significance
2003	FDA approves Restasis	Establishes the branded product and regulatory market
April 2016	Meijer files No. 1:16-cv-03092 in the Northern District of Illinois	Begins the direct-purchaser antitrust action
2014-2016	Generic manufacturers file ANDAs and Allergan initiates patent litigation	Creates the Hatch-Waxman dispute underlying the antitrust claims
2017	Allergan transfers Restasis patents to the Saint Regis Mohawk Tribe	Adds tribal-immunity issues to the patent proceedings
2017	District court invalidates asserted Restasis patents in Allergan’s litigation against generic manufacturers	Weakens Allergan’s patent-based exclusion theory
2018	Restasis antitrust matters are centralized in the Eastern District of New York	Consolidates related purchaser and antitrust claims
2018	Federal Circuit rejects tribal sovereign-immunity defense in the Restasis IPR proceedings	Permits PTAB review to continue
2019	Federal Circuit affirms invalidity findings in the principal Restasis patent litigation	Removes the principal asserted patents as barriers to generic entry
2022	FDA approves generic cyclosporine ophthalmic emulsion products	Ends the practical Restasis monopoly

The Meijer action was transferred or coordinated with broader Restasis proceedings rather than proceeding as an isolated Illinois case. The operative litigation became part of the Restasis antitrust docket in the Eastern District of New York.

What patents protected Restasis?

The Restasis patent estate included patents directed to cyclosporine ophthalmic emulsions and related formulation characteristics. The patents most relevant to the generic litigation included:

Patent	General subject matter	Approximate protection period	Litigation status
U.S. Patent No. 6,262,121	Cyclosporine ophthalmic formulations	Expired or near expiration by the relevant litigation period	Superseded by later patents
U.S. Patent No. 8,629,111	Restasis formulation and emulsion characteristics	Through approximately 2024, subject to patent-term adjustments	Invalidated in district-court litigation
U.S. Patent No. 8,642,556	Cyclosporine ophthalmic emulsion formulation	Through approximately 2024	Invalidated
U.S. Patent No. 9,248,191	Formulation and ophthalmic emulsion claims	Through approximately 2025	Invalidated
U.S. Patent No. 9,669,069	Later Restasis-related formulation claims	Through approximately 2028, subject to adjustments	Challenged in the broader patent dispute

The principal Restasis patents were formulation patents. They did not merely claim cyclosporine as a chemical compound. They covered characteristics of the ophthalmic emulsion, including particle size, composition, and other formulation parameters intended to distinguish Restasis from earlier cyclosporine products.

That distinction mattered to the antitrust case. A generic manufacturer could not avoid infringement simply by using the same active ingredient. It had to develop a formulation that met FDA requirements without falling within the asserted patent claims.

What happened in Allergan’s Restasis patent litigation?

Allergan sued generic manufacturers, including Mylan, Teva and others, after receiving abbreviated new drug applications with Paragraph IV certifications. The generic defendants argued that the asserted Restasis patents were invalid, not infringed or unenforceable.

In 2017, the U.S. District Court for the Eastern District of Texas held the principal Restasis patents invalid for obviousness. The court concluded that the claimed formulations were obvious in view of the prior art and the skilled artisan’s ability to combine known cyclosporine and ophthalmic-emulsion technologies.

Allergan then attempted to use tribal sovereign immunity to prevent the PTAB from reviewing the patents in inter partes review proceedings. Allergan assigned the patents to the Saint Regis Mohawk Tribe and obtained an exclusive license back.

The Federal Circuit rejected that defense in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc. The court held that tribal sovereign immunity did not prevent the PTAB from continuing an inter partes review initiated by a private party. The decision substantially reduced the value of the patent transfer as an exclusivity strategy.

The Federal Circuit later affirmed the invalidity judgment in the underlying Restasis patent litigation. The invalidity rulings were central to Meijer’s antitrust theory because they removed Allergan’s principal patent barriers to generic competition. They did not, by themselves, establish antitrust liability.

Did Meijer bring a Paragraph IV challenge?

No. Meijer was a distributor and purchaser, not an ANDA filer. The Paragraph IV challenges were brought by generic manufacturers in the separate Hatch-Waxman patent litigation.

Meijer’s action depended on the consequences of those challenges. The company alleged that Allergan’s response to generic certifications and its patent-related conduct delayed the date on which a lawful generic competitor could enter the market.

A Paragraph IV certification is a generic applicant’s assertion that a listed patent is invalid, unenforceable or will not be infringed by the proposed product. It permits the branded manufacturer to file an infringement action, which can trigger a statutory 30-month stay of FDA approval under the Hatch-Waxman Act.

What was the Orange Book status of Restasis?

Restasis was listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book. Allergan’s listed patents provided the regulatory framework for the Paragraph IV litigation.

The Orange Book listings mattered because a generic applicant had to address each listed patent. A patent listed for Restasis could delay final FDA approval if Allergan filed a timely infringement action. That regulatory stay could preserve the branded product’s market position even before a court determined whether the patent was valid or infringed.

The FDA’s approval of generic cyclosporine ophthalmic emulsion products in 2022 marked the effective end of Restasis’ principal product-level exclusivity. The approval did not automatically resolve damages claims for the earlier delay period.

What was the legal standard for Meijer’s antitrust claims?

Meijer had to establish more than patent invalidity. The principal legal questions included:

• Whether Allergan’s patent enforcement was objectively baseless.
• Whether Allergan subjectively pursued the litigation to interfere with competition rather than obtain a legitimate patent remedy.
• Whether the patent transfer to the Saint Regis Mohawk Tribe was an anticompetitive sham.
• Whether the alleged conduct caused a legally cognizable overcharge.
• Whether Meijer had standing to recover for purchases made through the distribution chain.
• Whether the claims were barred by the filed-rate doctrine, indirect-purchaser rules or other standing limitations.
• Whether the alleged injury was traceable to Allergan rather than to lawful patent rights or independent generic-development issues.

Invalidating a patent does not establish that the patent owner violated antitrust law by asserting it. Courts generally distinguish between a patent that ultimately fails on validity grounds and a patent lawsuit that was objectively baseless when filed.

The Noerr-Pennington doctrine also protects legitimate efforts to petition courts and regulatory agencies. The sham-litigation exception is narrow. A plaintiff must generally show that the litigation lacked a reasonable basis and was pursued for an improper anticompetitive purpose.

How did the patent transfer to the Saint Regis Mohawk Tribe affect the case?

The transfer became a major strategic and legal issue. Allergan assigned the Restasis patents to the tribe in exchange for an exclusive license and royalty payments. Allergan argued that tribal sovereign immunity should prevent inter partes review of the assigned patents.

The Federal Circuit rejected the defense. The court treated the PTAB proceeding as an administrative process in which the government was a party, rather than a conventional private lawsuit against the tribe. As a result, the tribe could not terminate the review through sovereign immunity.

For Meijer, the transfer supported the allegation that Allergan used an unusual transaction to preserve weak patents. Allergan countered that the transaction was a lawful assignment and licensing arrangement. The transfer increased litigation risk but did not independently prove an antitrust violation.

What was the litigation outcome?

The Restasis patent challenges produced invalidity rulings against Allergan’s principal asserted patents, and the Federal Circuit rejected the tribal-immunity strategy. Generic cyclosporine ophthalmic emulsion products later received FDA approval.

The Meijer antitrust matter was absorbed into the broader Restasis antitrust proceedings. The case’s practical value was as part of a purchaser challenge to Allergan’s efforts to delay generic entry, not as an independent patent judgment against Allergan.

The patent invalidity decisions improved the purchasers’ factual position but did not eliminate the need to prove antitrust elements. The core damages question remained the period during which generic competition allegedly would have entered absent Allergan’s conduct.

How strong was Allergan’s Restasis patent estate?

Allergan’s Restasis estate was commercially important but legally vulnerable.

Strengths

• The patents covered formulation characteristics that could be difficult for a generic manufacturer to design around while meeting FDA requirements.
• Orange Book listing created a statutory approval delay after a Paragraph IV challenge.
• The patents extended beyond the expiration of earlier Restasis protection.
• The product had significant sales and established physician familiarity.

Weaknesses

• The asserted claims were vulnerable to obviousness attacks based on earlier cyclosporine and ophthalmic-emulsion technology.
• Multiple patents were challenged in parallel.
• The district court invalidated the principal asserted patents.
• The tribal-immunity strategy failed at the Federal Circuit.
• Generic manufacturers ultimately obtained FDA approval.

On balance, the estate was commercially effective before the invalidity rulings but had limited litigation durability. Its value depended on regulatory timing and the cost of generic formulation development rather than on a sustained final judgment confirming validity.

What generic entry risks existed for Restasis?

The principal risks were:

1. Formulation complexity. Generic applicants had to match the reference product’s performance and stability while avoiding infringement.
2. Patent litigation delay. Paragraph IV suits could trigger the 30-month stay.
3. Regulatory uncertainty. FDA review of ophthalmic emulsions may require detailed quality and bioequivalence data.
4. Manufacturing barriers. Emulsion particle size, uniformity, sterility and container performance can create development hurdles.
5. Commercial launch risk. A generic applicant could launch at risk while facing damages exposure if the patents survived.

Those barriers delayed competition even though the ultimate patent outcome favored generic manufacturers.

How did Restasis compare with other Allergan products?

Product	Main protection type	Generic or biosimilar risk	Key distinction
Restasis	Formulation patents and Orange Book listings	Generic risk	Small-molecule ophthalmic emulsion; no biosimilar pathway
Botox	Composition, formulation and method-of-use patents	Biosimilar and therapeutic competition	Biologic product with complex manufacturing and clinical-use claims
Lumigan	Composition and formulation patents	Generic risk	Ophthalmic solution with formulation and delivery considerations
Combigan	Combination-product and formulation protection	Generic risk	Combination of brimonidine and timolol
Xifaxan	Composition, formulation and method-of-use patents	Generic risk	Multiple indications and extensive patent litigation

Restasis faced generic rather than biosimilar competition because cyclosporine ophthalmic emulsion is regulated as a drug product, not as a biologic under the Public Health Service Act.

Key Takeaways

• Meijer Distribution v. Allergan was a purchaser antitrust action focused on delayed generic entry for Restasis.
• The case was connected to the broader Restasis patent and antitrust litigation.
• Allergan’s main protection came from formulation patents listed in the Orange Book.
• The principal Restasis patents were invalidated in district-court litigation, and the Federal Circuit affirmed the rejection of the tribal-immunity strategy.
• The patent transfer to the Saint Regis Mohawk Tribe did not prevent PTAB review.
• Generic cyclosporine ophthalmic emulsion products received FDA approval in 2022.
• Patent invalidity supported Meijer’s antitrust theory but did not independently establish sham litigation or damages.
• Restasis had substantial commercial exposure because annual U.S. sales exceeded $1 billion before generic competition.

FAQs About Meijer Distribution v. Allergan

Was Meijer Distribution a generic drug manufacturer?

No. Meijer Distribution was a purchaser and distributor. It challenged Allergan’s alleged conduct from the standpoint of a buyer that allegedly paid inflated prices during the period of delayed generic competition.

Did the Restasis patent transfer eliminate Allergan’s patent rights?

No. The transfer assigned the patents to the Saint Regis Mohawk Tribe, but the Federal Circuit held that tribal sovereign immunity did not bar inter partes review. The patents were later invalidated or otherwise lost their ability to block generic approval.

Was Restasis protected by a method-of-use patent?

The principal litigation involved formulation and product patents rather than a standalone method-of-use strategy. Restasis’ commercial protection came primarily from the formulation claims and the FDA’s Orange Book patent-listing system.

Did Meijer obtain damages from Allergan?

The case was part of coordinated Restasis antitrust litigation. The available procedural record does not establish a standalone damages award to Meijer in the originating Illinois action.

Does the Restasis dispute create biosimilar risk?

No. Restasis is a drug product subject to generic competition, not a biologic subject to the abbreviated biosimilar pathway. The relevant competitive threat was generic cyclosporine ophthalmic emulsion.

References

1. Allergan, Inc. v. Mylan Pharmaceuticals Inc., 950 F.3d 1083 (Fed. Cir. 2020).

2. Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., 2017 WL 4803941 (E.D. Tex. Oct. 25, 2017).

3. Meijer Distribution, Inc. v. Allergan, Inc., No. 1:16-cv-03092, U.S. District Court for the Northern District of Illinois.

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

5. U.S. Food and Drug Administration. (2022). FDA approves first generic of Restasis to treat dry eye disease. FDA.

6. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

7. Judicial Panel on Multidistrict Litigation. (2018). In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, MDL No. 2819.