Litigation Details for AbbVie Inc. v. Prinston Pharmaceutical Inc. (D. Del. 2023)

AbbVie Inc. v. Prinston Pharmaceutical Inc. (D. Del. 2023)

Docket		Date Filed	2023-04-28
Court	District Court, D. Delaware	Date Terminated	2024-06-20
Cause	35:271 Patent Infringement	Assigned To	Jennifer L. Hall
Jury Demand	None	Referred To
Patents	10,537,572; 10,682,351; 11,344,551; 7,056,927; 7,419,983
Link to Docket	External link to docket

Details for AbbVie Inc. v. Prinston Pharmaceutical Inc. (D. Del. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-04-28				External link to document
2023-04-28	4	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 10,537,572 B2 ;10,682,351 B2.… 28 April 2023 1:23-cv-00470 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation Summary and Analysis: AbbVie Inc. v. Prinston Pharmaceutical Inc. (1:23-cv-00470)

Last updated: July 27, 2026

Executive summary: AbbVie Inc. sued Prinston Pharmaceutical Inc. in the U.S. District Court for the District of Delaware under the Hatch-Waxman Act, asserting patent infringement tied to a Prinston generic-to-be product corresponding to an AbbVie reference drug. The case number is 1:23-cv-00470. No reliable, citable details on the asserted patents, asserted claims, FDA submission type (ANDA vs. 505(b)(2)), Paragraph IV certifications, claim construction positions, or case status (motions, scheduled trial, settlement) are provided in the input record.

H1: AbbVie v. Prinston Pharmaceutical Inc. 1:23-cv-00470 litigation summary and patent analysis

What patents are asserted in AbbVie v. Prinston Pharmaceutical 1:23-cv-00470?

Answer: The asserted patent numbers and the specific claims asserted are not provided in the available input.

Which patent types are typically at issue in AbbVie ANDA suits?

In Hatch-Waxman litigations, AbbVie (as the NDA holder) typically asserts:

• Composition-of-matter patents covering the active pharmaceutical ingredient or salt/form
• Formulation patents covering dosage forms (tablet, capsule) and excipients
• Method-of-use patents tied to dosing regimens or therapeutic effects
• Manufacturing/process patents (less common, but seen in portfolio-heavy estates)

What does the claim target usually look like?

Without the complaint or infringement contentions, the following cannot be stated from the provided record:

• Whether AbbVie asserted “core” composition claims
• Whether AbbVie alleged induced infringement under 35 USC 271(b)
• Whether AbbVie sought declaratory judgments covering commercial manufacture, use, or sale

Is this case an ANDA Paragraph IV challenge, a 505(b)(2, or something else?

Answer: The input does not identify the drug, the FDA application type, or whether the dispute is tied to Paragraph IV certifications.

What to infer from the case caption alone

A caption naming an NDA holder (AbbVie) and an accused generic filer (Prinston) often indicates Hatch-Waxman alignment, but the following cannot be concluded from the record:

• Whether Prinston filed a Paragraph IV ANDA
• Whether AbbVie listed Orange Book patents for the reference product
• Whether the litigation sought 30-month stay, earlier launch enjoinment, or both

What is the procedural posture in AbbVie v. Prinston 1:23-cv-00470?

Answer: No procedural milestones are provided in the input.

Items that drive case value in 1:23-cv-00470

For downstream licensing and generic launch risk, the following are typically decisive but are not present here:

• Whether AbbVie’s complaint was followed by an answer and counterclaims
• Whether the court entered a scheduling order and set Markman dates
• Whether either side filed motions to dismiss, for judgment on the pleadings, or for summary judgment
• Whether there are pending motions tied to site-specific injunction standards or regulatory exclusivity

When does exclusivity end for the AbbVie reference product in this lawsuit?

Answer: The input does not identify the AbbVie reference drug, so exclusivity timelines cannot be calculated.

What timelines usually matter to generic entry

In Hatch-Waxman practice, launch timing depends on:

• Expiration of Orange Book-listed patents (earliest expiration, including pediatric extensions)
• Regulatory exclusivity (NCE, pediatric exclusivity, orphan exclusivity if applicable)
• 30-month stay resulting from a Paragraph IV certification
• Court-ordered injunction scope and duration

What is the Orange Book status of the AbbVie drug at issue?

Answer: Orange Book listings are not provided in the input record.

What “Orange Book status” usually means in litigation

To evaluate market entry risk, analysts typically map:

• Listed patents by type (drug substance, formulation, method)
• Patent expiration dates and any pediatric exclusivity
• Whether the accused ANDA included Paragraph IV certifications to one or more patents
• Whether additional “carve-out” patents were asserted (secondary patents)

How strong is AbbVie’s patent estate in this specific dispute?

Answer: Strength cannot be assessed without:

• The asserted patent numbers and remaining term
• Whether key claims involve composition vs. formulation vs. method-of-use
• Whether prior art or obviousness issues exist for asserted claims
• Whether the court has issued any claim construction or validity rulings

What typically drives outcomes in AbbVie-style patent estates

In multi-patent estates, case results usually turn on:

• Early claim construction alignment between the infringed claims and the generic design-around
• Validity challenges based on prior publications and earlier filings
• Infringement contentions linked to ANDA label and manufacturing descriptions

Which companies are challenging AbbVie patents alongside Prinston (co-defendants, cohorts, settlements)?

Answer: The input provides no companion cases or co-defendants.

Why this matters

Coordinated filings by multiple generics can:

• Increase settlement leverage
• Affect court scheduling and consolidated discovery
• Create cross-pollination of design-around strategies

What claims does Prinston typically contest in infringement actions like 1:23-cv-00470?

Answer: The input does not include Prinston’s defenses or invalidity theories.

Common defense buckets

Generic defendants in this posture often argue:

• Non-infringement (no literal or no equivalents)
• Invalidity under 35 USC 102/103/112 and indefiniteness
• Lack of statutory authority for certain requested injunctions
• Narrowing construction based on specification requirements

What generic entry risks exist for Prinston after AbbVie v. Prinston 1:23-cv-00470?

Answer: Launch risk cannot be assessed without:

• Court rulings affecting infringement or injunction
• Whether the court issued a stay, injunction, or granted summary judgment
• Patent expiration or design-around timing relative to 30-month stay

Risk model components

A practical risk model normally needs:

• Earliest court injunction trigger (asserted patent with remaining term)
• Whether the generic can launch “at risk” before a patent expires
• Whether the generic’s Paragraph IV design can avoid the asserted claim elements
• Whether settlement licenses provide “carve-out” dates or royalty-bearing entry

Did AbbVie and Prinston reach a settlement agreement that licenses or delays entry?

Answer: No settlement information is provided in the input record.

What settlements usually look like in Hatch-Waxman

Settlement outcomes can include:

• License agreements authorizing launch at a specific date
• “No-ATB” or delayed launch commitments
• Covenants not to sue for non-infringing versions
• Revenue-sharing and royalty triggers

How does AbbVie v. Prinston compare with other AbbVie Hatch-Waxman litigations in 2023-2024?

Answer: Comparison is not possible because the input does not provide asserted drug identity, product, or any other litigations.

What an apples-to-apples comparison would require

A meaningful comparison needs:

• Same reference product and patent family
• Same Paragraph IV posture (same certification)
• Same court district and similar scheduling events

FDA regulatory pathway and label risk: what does this case mean for prescribing information?

Answer: The drug identity and filing type are missing from the input, so label and regulatory pathway cannot be tied to litigation.

What analysts usually connect

After Hatch-Waxman filings, the market impact often depends on:

• Whether the generic sought approval to the same indications and dosing
• Whether label changes trigger carve-outs in infringement theories
• Whether an authorized generic was planned or launched

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Key Takeaways

1. The case reference AbbVie Inc. v. Prinston Pharmaceutical Inc., 1:23-cv-00470 is identified, but the input contains no asserted patent list, FDA submission details, or procedural status required for a litigation-specific infringement/validity analysis.
2. Without the complaint, docket events, or infringement contentions, patent strength, exclusivity impact, and generic launch risk cannot be determined from the provided record.
3. Settlement likelihood, injunction scope, and timeline are also not derivable from the supplied information.

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FAQs

1. What does a Delaware Hatch-Waxman case number like 1:23-cv-00470 usually indicate about the asserted FDA application type?
2. How do asserted formulation versus method-of-use patents change the infringement and design-around risk for generics?
3. What court events most strongly predict whether a Paragraph IV case ends in trial versus summary judgment?
4. How do pediatric exclusivity and patent term adjustments affect the earliest possible generic launch date in Hatch-Waxman suits?
5. What role do Orange Book patent expirations play in determining injunction scope when multiple patents are listed?

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References (APA)

1. (No cited sources available from the provided input.)