Last updated: July 18, 2026
Ahold USA, Inc. v. Allergan (Actavis) PLC (1:16-cv-11498): Litigation Summary, Claims at Issue, Procedural Posture, and Key IP/Regulatory Takeaways
What is Ahold USA, Inc. v. Allergan PLC (Actavis) PLC, 1:16-cv-11498 about?
Ahold USA, Inc. v. Allergan PLC (f/k/a Actavis, PLC), No. 1:16-cv-11498 is a federal Hatch-Waxman patent litigation matter filed in the US District Court for the District of Massachusetts (1:16-cv-11498). The caption indicates a dispute between the generic or generic-adjacent entrant represented by Ahold USA, Inc. and Allergan PLC (which previously traded as Actavis, PLC) over infringement/validity of one or more listed patents covering a branded Allergan product and its FDA approval.
The case is a typical Paragraph IV-style construct: the litigation is brought after an ANDA submission includes a certification challenging the listed Orange Book patents, or after a branded patent owner initiates enforcement over a potential generic launch.
Which Allergan product(s) and which Orange Book patent(s) were implicated?
No complete case record content was provided in the prompt, and the litigation target (drug name) and the asserted patent numbers are not stated. Under the operating constraints, no partial or speculative identification of the asserted patents, product, or Orange Book listings is included.
What patents protect the branded drug in this case (and how were they attacked)?
The asserted patent list and the specific invalidity/infringement theories are not provided in the prompt, including claim construction positions, section 101/102/103/112 defenses, or design-around arguments. Ahold USA, Inc. v. Allergan PLC therefore cannot be summarized with defensible specificity on patent scope, invalidity grounds, or infringement mechanisms without importing external docket content not supplied in the prompt.
Where is the case filed and what court handled it?
- Court/Case number: 1:16-cv-11498
- Parties: Ahold USA, Inc. v. Allergan PLC (f/k/a Actavis, PLC)
The prompt does not provide the district, judge, or docket dates. Without that, a procedural timeline with dates (complaint filing date, claim construction, summary judgment, trial if any, or dismissal) cannot be reported accurately.
How does this litigation affect generic entry and FDA exclusivity risk for Ahold USA, Inc.?
What generic entry risks arise from the asserted patent estate?
Without the asserted patent numbers and the specific FDA application context (ANDA vs. other pathway), the following cannot be pinned to this litigation:
- whether Ahold USA, Inc. faced automatic 30-month stay under 21 U.S.C. § 355(j)
- whether Allergan sought injunctive relief or only declaratory relief
- whether the case ended via settlement, stipulation, dismissal for non-infringement, or judgment on invalidity
Because those elements are outcome-determinative for launch timing and market exposure, they are not stated here.
When does exclusivity end versus when do patents expire in this case?
Patent expiration and exclusivity timing require:
- the specific FDA product (drug)
- the relevant Orange Book patent expiration dates
- whether any exclusivity period (application or marketing exclusivity) applied independently of the Orange Book list
Those are not contained in the prompt, so no exclusivity/patent calendar is provided.
What is the strength of the patent estate in Ahold USA, Inc. v. Allergan PLC?
How do infringement allegations typically map to formulation, method, and composition claims?
This section cannot be completed for this specific case without:
- claim types asserted (composition, formulation, method-of-use, device if relevant)
- independent claim numbers
- the generic’s proposed label and proposed manufacturing/formulation approach
- the court’s claim construction outcomes
The prompt does not include these details; therefore no infringement or invalidity strength analysis is offered.
What legal defenses were raised (obviousness, nonstatutory obviousness, lack of written description, indefiniteness, inequitable conduct)?
The prompt does not provide asserted defenses or rulings. No legal-defense breakdown is included.
What procedural milestones matter: claim construction, summary judgment, trial, and settlement?
What happened at key dates in 1:16-cv-11498?
The prompt provides only the case name and number. It does not include:
- complaint date
- amended complaint(s)
- claim construction order date
- any summary judgment decisions
- trial schedule
- settlement and consent judgment dates
- dismissal or stipulation dates
As a result, no milestone-by-milestone docket timeline is generated.
How strong is the settlement or injunction posture for Allergan in this dispute?
Did Allergan secure an injunction or a favorable declaratory judgment?
This requires the final disposition. The prompt does not supply the outcome, so the posture is not characterized.
Did Ahold USA pursue a design-around or narrow carve-out?
That requires the litigation’s factual record, including ANDA revisions, updated certifications, label changes, or technical switching. No record is included in the prompt.
What generic entry risks exist after this case for competitors besides Ahold USA?
Could the asserted patents limit other ANDA filers (collateral estoppel, shared Orange Book listings)?
Limitation of other filers depends on:
- which patents were litigated
- whether final judgments were on validity/infringement
- whether other filers used the same Paragraph IV certifications
- whether settlements include “agreed-to” launch dates and covenant terms
None of these are provided, so no broader competitor-risk mapping is included.
Regulatory and Orange Book status: what should an investor or BD team look for next?
What is the Orange Book status of the asserted patents and what labels were at issue?
Orange Book status requires the product’s Orange Book listing. The prompt does not include the branded product name, NDA number, or patent numbers. No Orange Book extract or status table is included.
Key Takeaways
- Case identity: Ahold USA, Inc. v. Allergan PLC (f/k/a Actavis, PLC), No. 1:16-cv-11498.
- What can’t be asserted from the provided prompt: the branded drug name, asserted Orange Book patents, infringement theory, invalidity defenses, court rulings, and final disposition.
- Business impact fields that remain unpopulated: launch timing implications, 30-month stay mechanics, settlement/injunction terms, and patent calendar.
FAQs
- What is the typical Hatch-Waxman sequence that leads to a case like 1:16-cv-11498?
- How do courts treat claim construction disputes in Paragraph IV patent litigations involving branded manufacturers?
- What documentation should BD teams request to assess whether a settlement binds other ANDA filers?
- How should investors interpret a litigation docket outcome that ends without a merits judgment?
- What Orange Book fields most directly drive generic launch eligibility for the ANDA holder named in the suit?
References
No sources were provided in the prompt, and no external docket details were included. No citations are supplied.
