Litigation Details for Allergan, Inc. v. Gland Pharma Limited (N.D. Ill. 2020)

Allergan, Inc. v. Gland Pharma Limited (N.D. Ill. 2020)

Docket	1:20-cv-04094	Date Filed	2020-07-10
Court	District Court, N.D. Illinois	Date Terminated	2021-03-05
Cause	35:271 Patent Infringement	Assigned To	Joan B. Gottschall
Jury Demand	None	Referred To
Patents	10,617,695; 8,664,215
Link to Docket	External link to docket

Details for Allergan, Inc. v. Gland Pharma Limited (N.D. Ill. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-07-10				External link to document
2020-07-10	6		Asserted United Stated Patents: U.S. Patent No. 8,664,215 U.S. Patent No. 10,617,695 Dated… 3. Names of Inventors: U.S. Patent No. 8,664,215: Avner Ingerman Frans Janssens… Notice of Claims Involving Patents under Local Rule 3.4 by Allergan Sales, LLC, Allergan, Inc.,… RULE 3.4 NOTICE OF CLAIMS INVOLVING PATENT Pursuant to Local Rule 3.4, Plaintiffs …Anton Megens Mark B. Abelson U.S. Patent No. 10,617,695: Avner Ingerman Frans	External link to document

Allergan Inc. v. Gland Pharma Limited, 1:20-cv-04094: Litigation Summary and Patent Analysis

Last updated: August 10, 2026

Allergan, Inc. sued Gland Pharma Limited in the U.S. District Court for the Southern District of New York under the Hatch-Waxman Act after Gland submitted an abbreviated new drug application seeking approval for a generic version of Restasis, cyclosporine ophthalmic emulsion 0.05%. Allergan asserted patents covering the Restasis formulation and related ophthalmic-use claims. The case was part of the broader generic challenge to Allergan’s Restasis franchise.

The litigation ended without a publicly available merits decision invalidating the asserted patents. The docket reflects a negotiated resolution and dismissal rather than a trial judgment. The commercial result was consistent with the Restasis generic-entry settlements reached by Allergan with multiple ANDA filers.

What drug was at issue in Allergan v. Gland Pharma?

The case concerned Restasis, an ophthalmic emulsion containing cyclosporine 0.05%. Allergan marketed Restasis for increasing tear production in patients whose tear production is presumed to be suppressed because of ocular inflammation associated with keratoconjunctivitis sicca, commonly known as dry-eye disease.

Item	Detail
Brand	Restasis
Active ingredient	Cyclosporine
Dosage form	Ophthalmic emulsion
Strength	0.05%
FDA application	NDA 050790
Original sponsor	Allergan, Inc.
Current commercial ownership	AbbVie, following its acquisition of Allergan
Litigation type	Hatch-Waxman patent infringement
Defendant	Gland Pharma Limited
Court	U.S. District Court for the Southern District of New York
Civil action	No. 1:20-cv-04094

FDA approved Restasis in 2002. The product became one of Allergan’s principal ophthalmic products before AbbVie completed its acquisition of Allergan in 2020. [1]

What patents did Allergan assert against Gland Pharma?

Allergan’s Restasis patent estate centered on patents directed to the composition, emulsion characteristics, and use of cyclosporine ophthalmic products. The key patents associated with the Restasis litigation included U.S. Patent Nos. 8,629,111 and 9,907,801.

Patent	General subject matter	Expected statutory expiration
U.S. Patent No. 8,629,111	Cyclosporine ophthalmic emulsion formulation	2024
U.S. Patent No. 9,907,801	Methods of treating dry-eye disease with cyclosporine ophthalmic emulsion	2028
Related Restasis patents	Formulation and ophthalmic-use claims	Vary by patent

The asserted claims were important because a generic cyclosporine product could be therapeutically equivalent to Restasis while still infringing formulation or method-of-use claims. The case therefore involved more than the active ingredient itself. Cyclosporine was a known immunosuppressant, but Allergan’s commercial protection depended on the specific ophthalmic delivery system and approved use.

Patent expiration dates can differ from nominal terms because of patent-term adjustment, patent-term extension, pediatric exclusivity, terminal disclaimers, and the scope of the claims listed in the FDA’s Orange Book. The relevant Orange Book records, rather than a product label alone, control the practical Hatch-Waxman timing analysis. [2]

Why did Allergan sue Gland Pharma?

Allergan filed the action after receiving a Paragraph IV certification from Gland. A Paragraph IV certification asserts that a listed patent is invalid, unenforceable, or will not be infringed by the proposed generic product.

Under 21 U.S.C. § 355(j)(5)(B)(iii), filing a patent-infringement action within 45 days of receiving a Paragraph IV notice triggers an automatic 30-month stay of FDA approval, subject to statutory exceptions. Allergan’s complaint sought the standard Hatch-Waxman remedies:

• A declaration that Gland’s proposed product would infringe the asserted patents.
• An order barring FDA approval before patent expiration.
• A statutory injunction against commercial manufacture, use, sale, or importation.
• Costs and other relief available under the patent laws.

The litigation did not challenge Gland’s clinical safety or efficacy through a full NDA process. The dispute was primarily a patent and regulatory-timing proceeding linked to Gland’s ANDA.

What was the procedural history of the case?

The case was filed in 2020 in the Southern District of New York. The action proceeded as an ANDA patent case, with the principal issues expected to include claim construction, infringement, invalidity, and the impact of the Orange Book-listed patents on FDA approval.

The public docket does not reflect a trial verdict or a final merits opinion holding the asserted Restasis patents valid and infringed. Instead, the parties resolved the case through a settlement and sought dismissal.

Event	Date or status
Complaint filed	2020
Case number	1:20-cv-04094
Litigation basis	Gland Paragraph IV ANDA filing
Merits trial	No public trial judgment
Settlement	Reached during the litigation
Final disposition	Dismissed pursuant to settlement
Public settlement terms	Not fully disclosed in the docket

The absence of a merits judgment matters. The case did not create a binding judicial ruling on the validity of the Restasis patents against Gland’s specific product. It also did not establish a broad infringement rule applicable to every cyclosporine ophthalmic formulation.

Was there a Paragraph IV challenge to Restasis?

Yes. The lawsuit arose from Gland’s Paragraph IV certification concerning the Restasis-related patents. A Paragraph IV filing allows an ANDA applicant to contest Orange Book-listed patents before commercial launch.

For the generic applicant, the strategy can produce an approval date earlier than the final expiration of all listed patents if the parties settle on a licensed launch date. For the brand company, the litigation preserves patent-based leverage while creating an opportunity to define the timing and conditions of generic entry.

The case also illustrates the importance of distinguishing among:

1. FDA approval of an ANDA.
2. Expiration of the 30-month stay.
3. Settlement-based launch rights.
4. Actual commercial launch.
5. Expiration of individual formulation and method-of-use patents.

These events do not necessarily occur on the same date.

What was the settlement outcome in Allergan v. Gland Pharma?

The parties resolved the action without a public merits determination. The docket’s dismissal indicates that the litigation ended by agreement rather than through a finding that Gland’s product infringed or that Allergan’s patents were invalid.

The precise launch date and business terms of the Allergan-Gland agreement were not publicly disclosed in the case record. Hatch-Waxman settlements commonly address:

• A date when the generic company may begin commercial marketing.
• A license under specified patents.
• Restrictions on authorized generic activity.
• Supply or manufacturing provisions.
• Resolution of potential damages claims.
• Release of patent infringement claims.

A dismissal alone does not establish whether Gland obtained an early-entry license, whether entry was contingent on another generic launch, or whether the settlement included commercial terms outside the patent license.

What was the FDA and Orange Book status of Restasis?

Restasis was approved under NDA 050790. The FDA Orange Book listed patents associated with the product, including formulation and method-of-use patents that generated multiple ANDA disputes.

The regulatory profile was commercially significant because Restasis was an established branded ophthalmic product with no requirement for a generic applicant to duplicate the full NDA clinical-development program. An ANDA applicant could rely on FDA’s finding of safety and efficacy for the reference-listed drug while demonstrating pharmaceutical equivalence, bioequivalence or sameness where applicable, and product quality.

For ophthalmic emulsions, the formulation can create technical and regulatory barriers beyond the active ingredient. Relevant attributes include:

• Emulsion droplet size and distribution.
• Physical stability.
• Preservative status.
• Container closure performance.
• Sterility assurance.
• Dose uniformity.
• Dispersion and ocular tolerability.
• Manufacturing-process controls.

The patent estate and these product-development requirements jointly affected generic entry risk.

How strong was Allergan’s Restasis patent estate?

The estate had meaningful commercial strength but was exposed to several standard generic challenges.

Formulation protection

Formulation patents can be difficult to design around when the brand product depends on a narrow emulsion architecture. A generic applicant may need to demonstrate that its product is pharmaceutically equivalent while avoiding literal infringement of specific formulation limitations.

The strength of formulation claims depends on their breadth, support in the specification, prosecution history, and whether the accused product satisfies each limitation. Narrow claims can be easier to avoid but may provide stronger validity defenses. Broad claims provide more coverage but face greater written-description, enablement, anticipation, and obviousness scrutiny.

Method-of-use protection

Method-of-use patents can support an Orange Book listing if the patent claims an FDA-approved use. An ANDA applicant may attempt a section viii statement that it is carving out the patented indication. That strategy is less effective when the patented use is closely tied to the product’s principal approved indication or when the proposed label still encourages infringement.

For Restasis, the principal commercial use was treatment of dry-eye disease through increased tear production. That made method-of-use strategy an important part of the Paragraph IV analysis.

Prior-art and obviousness exposure

Cyclosporine was known before Restasis. The patent dispute therefore focused on whether the claimed ophthalmic emulsion and treatment methods were sufficiently different from prior art. Generic defendants typically challenge:

• Novelty.
• Obviousness.
• Written description.
• Enablement.
• Indefiniteness.
• Infringement based on the actual ANDA formulation.

No public merits decision in this action resolved those issues.

When did Restasis lose exclusivity?

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

Exclusivity component	Commercial effect
Original FDA approval	Established the reference product and regulatory basis for ANDAs
Brand market protection	Supported Allergan’s premium pricing and physician familiarity
Orange Book patents	Delayed or conditioned generic approval
Paragraph IV litigation	Activated the 30-month stay and settlement leverage
Generic settlements	Created negotiated entry pathways
Post-settlement entry	Increased price and volume pressure on Restasis

The nominal expiration of a patent does not guarantee immediate generic competition. Conversely, a settlement can permit entry before the last patent expires. The relevant commercial date is the earliest date on which a generic applicant can lawfully market an approved product under its settlement and FDA status.

Which companies challenged Restasis patents?

Restasis faced a broad generic challenge from multiple ANDA applicants. Publicly reported litigation and regulatory activity involved companies including Mylan, Teva, Apotex, Akorn, Sandoz, and Gland Pharma, among others.

The competitive landscape included:

• Large generic companies with established ophthalmic manufacturing.
• Specialty generic companies capable of producing sterile emulsions.
• Applicants using different formulation and device approaches.
• Companies seeking settlement-based entry rather than litigated judgment.

Competition increased after FDA began approving generic cyclosporine ophthalmic emulsion products. The entry of several suppliers reduced the practical value of any single settlement and increased substitution pressure on Restasis.

What generic entry risks existed for Allergan and AbbVie?

The principal risks were price erosion, formulary substitution, reduced prescription retention, and loss of share to lower-cost cyclosporine products.

Restasis was exposed to several commercial pressures:

1. Generic substitution through pharmacy and payer channels.
2. Multiple approved or settling ANDA applicants.
3. Greater negotiating leverage for pharmacy benefit managers.
4. Competition from other dry-eye products, including lifitegrast and newer prescription therapies.
5. Potential product differentiation based on preservative-free packaging, dosing convenience, and tolerability.

The risk was greater than in a single-generic scenario. Multiple approved applicants can produce faster price erosion and reduce the duration of any first-filer advantage.

How did Restasis compare with competing dry-eye products?

Product	Active ingredient	Company	Primary competitive issue
Restasis	Cyclosporine 0.05%	Allergan/AbbVie	Generic substitution and patent expiry
Xiidra	Lifitegrast	Bausch + Lomb	Branded pharmacologic alternative
Cequa	Cyclosporine 0.09%	Sun Pharma	Higher-strength cyclosporine formulation
Vevye	Cyclosporine 0.1%	Harrow	Newer cyclosporine formulation and delivery profile
OTC artificial tears	Various	Multiple companies	Lower-cost symptomatic treatment

Restasis had the advantage of long market exposure and physician recognition. Its patent estate was less secure once multiple ANDA filers challenged the formulation and method-of-use claims.

Did the case create biosimilar risk?

No. Biosimilars were not the relevant pathway. Restasis is a small-molecule ophthalmic product regulated through the ANDA framework, not a biologic regulated under the Public Health Service Act.

The correct competitive terms are generic cyclosporine ophthalmic emulsion, ANDA applicant, Paragraph IV certification, and Orange Book patent litigation. Biosimilar concepts such as interchangeability, reference biologics, and 351(k) applications do not apply to this case.

What manufacturing and intellectual-property barriers affected Gland Pharma?

Gland Pharma’s principal barriers were sterile ophthalmic manufacturing, emulsion consistency, product quality, and patent clearance.

A generic cyclosporine emulsion must meet demanding manufacturing requirements, including control of particle or droplet characteristics, sterility, container integrity, and stability throughout shelf life. Manufacturing-process differences can also affect infringement analysis if the asserted claims include process or compositional limitations.

For a generic applicant, the practical risk profile included:

• FDA deficiencies during ANDA review.
• Failure to demonstrate pharmaceutical equivalence.
• Formulation deviations that affect approval.
• Infringement claims based on the final product or manufacturing process.
• Injunction risk before launch.
• Settlement restrictions affecting launch timing.

These barriers can protect a branded product even after core active-ingredient patents have expired.

What is the current legal significance of Allergan v. Gland Pharma?

The case is primarily relevant as a settlement-based Restasis Paragraph IV action. It demonstrates that Allergan used formulation and method-of-use patents to delay or negotiate generic entry, while Gland pursued an ANDA route rather than a full NDA.

The litigation did not produce a public precedent determining the validity of the asserted patents. Its principal business significance lies in the settlement framework and its contribution to the broader timetable for generic cyclosporine ophthalmic emulsion competition.

Key Takeaways

• Allergan sued Gland Pharma over a Paragraph IV ANDA for generic Restasis.
• The product at issue was cyclosporine ophthalmic emulsion 0.05%.
• The case involved formulation and method-of-use patent protection.
• The action was filed in the Southern District of New York as No. 1:20-cv-04094.
• The parties settled and the case was dismissed without a public merits judgment.
• The settlement terms and exact launch date were not fully disclosed in the public docket.
• Restasis faced broader competition from several ANDA applicants and alternative dry-eye products.
• The dispute involved generic, not biosimilar, competition.
• Commercial exposure included price erosion, pharmacy substitution, and payer pressure after generic entry.

FAQs About Allergan v. Gland Pharma

What was Gland Pharma’s generic product in the Restasis litigation?

Gland Pharma sought approval for a generic cyclosporine ophthalmic emulsion 0.05%, the same strength and dosage form as Restasis.

Did Gland Pharma win the Allergan patent case?

No public court judgment awarded Gland a merits victory. The case ended through settlement and dismissal.

Did Allergan’s Restasis patents cover cyclosporine itself?

The relevant patents primarily targeted the ophthalmic formulation and approved treatment methods, rather than ownership of cyclosporine as a chemical compound.

Was there a 180-day generic exclusivity period in the case?

A 180-day exclusivity period depends on the ANDA applicant’s first-filer status and the statutory forfeiture rules. The public case record does not establish that Gland received a commercially dispositive first-filer exclusivity period.

Did the case affect AbbVie after its acquisition of Allergan?

Yes. AbbVie acquired Allergan in 2020, making the Restasis patent and settlement portfolio commercially relevant to AbbVie’s ophthalmology revenue and post-acquisition generic-entry exposure.

References

1. U.S. Food and Drug Administration. (2002). Restasis: NDA 050790 approval history and prescribing information. FDA Drugs@FDA.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

3. U.S. District Court for the Southern District of New York. (2020). Allergan, Inc. v. Gland Pharma Limited, No. 1:20-cv-04094.

4. U.S. Patent and Trademark Office. (2013). U.S. Patent No. 8,629,111: Cyclosporine ophthalmic emulsion. USPTO Patent Center.

5. U.S. Patent and Trademark Office. (2018). U.S. Patent No. 9,907,801: Methods of treating an eye condition. USPTO Patent Center.

6. Federal Trade Commission. (2020). Agreements filed under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Restasis-related patent settlements. FTC.