Litigation Details for Abbott Laboratories v. Impax Laboratories Inc. (D. Del. 2010)

Abbott Laboratories v. Impax Laboratories Inc. (D. Del. 2010)

Docket	1:10-cv-01029	Date Filed	2010-11-24
Court	District Court, D. Delaware	Date Terminated	2012-09-11
Cause	35:271 Patent Infringement	Assigned To	Sue Lewis Robinson
Jury Demand	None	Referred To	Mary Pat Thynge
Patents	6,080,428; 6,129,930; 6,406,715; 6,469,035; 6,676,967; 6,746,691; 6,818,229
Link to Docket	External link to docket

Details for Abbott Laboratories v. Impax Laboratories Inc. (D. Del. 2010)

Date Filed	Document No.	Description	Snippet	Link To Document
2010-11-24				External link to document

Litigation Summary and Patent/Regulatory Analysis: Abbott Laboratories v. Impax Laboratories Inc. (1:10-cv-01029)

Last updated: May 21, 2026

What is Abbott Labs v. Impax Labs Inc., 1:10-cv-01029, about?

The docket number 1:10-cv-01029 is an IP/patent infringement case involving Abbott Laboratories as the asserted rights holder and Impax Laboratories as the defendant. The matter is part of the post-Hatch-Waxman enforcement stream where brand companies sue to block or delay FDA approval and market entry of generic products tied to an Orange Book-listed reference drug.

High-level issue in these cases: whether Impax’s proposed generic product infringes one or more Abbott patents (often composition, formulation, method-of-use, or manufacturing patents) and whether patent validity defenses succeed, typically assessed through Markman claim construction and later dispositive motions.

When did Abbott sue Impax in 1:10-cv-01029, and what procedural milestones matter most?

Case number: 1:10-cv-01029
Caption: Abbott Laboratories v. Impax Laboratories Inc.
Court: Federal district court (exact division not provided in the prompt)

Key procedural steps that usually determine outcomes in Abbott v. Impax-type Hatch-Waxman dockets include:

• Complaint filing (triggers the automatic stay when coupled with an ANDA Paragraph IV notice and correct procedural posture).
• Answer and early motions (often including infringement/validity contentions).
• Markman claim construction (shapes infringement outcomes by narrowing claim scope).
• Summary judgment (invalidation, non-infringement, or non-assertion results).
• Trial (less common if settled, but central when litigated).
• Settlement or consent judgment (frequently ends the contest and sets launch dates).

What patents were asserted against Impax in 1:10-cv-01029?

Not provided in the prompt. A complete infringement and validity analysis requires:

• the Orange Book patents-in-suit referenced in the complaint,
• the specific patent numbers, and
• the asserted claims.

No patent identifiers, claim numbers, or an asserted drug name are included in the request, so the asserted estate cannot be enumerated from the information available here.

Which drug product and ANDA link is tied to 1:10-cv-01029?

Not provided in the prompt. Hatch-Waxman litigation is product-specific. A litigation summary that supports regulatory strategy and launch-date modeling needs:

• the reference listed drug (RLD),
• the Impax ANDA number,
• and the Paragraph IV notice date.

These are not present in the prompt, so the ANDA linkage cannot be described accurately.

How do Paragraph IV arguments typically play out in Abbott v. Impax-style cases?

A Paragraph IV infringement suit generally resolves along the following technical and legal fault lines:

• Infringement: claim chart against Impax’s proposed composition or formulation parameters.
• Validity: anticipation and obviousness (often grounded in prior art tables, scientific publications, and earlier patents).
• Best mode/enablement: adequacy of written description and enablement for the asserted claims.
• Indefiniteness: whether claim terms are sufficiently definite.
• Prosecution history estoppel/equivalents: limits on scope if Abbott narrowed during prosecution.

Without the asserted patents and claim set for 1:10-cv-01029, a claim-by-claim analysis cannot be produced.

What is the litigation posture for 1:10-cv-01029 (motions, Markman, schedule, disposition)?

Not provided in the prompt. A litigation summary requires docket events such as:

• Markman order date and outcome,
• summary judgment orders,
• trial dates,
• and final disposition (dismissal, judgment, or settlement).

Those facts are not supplied, so the case cannot be characterized by procedural posture.

Did Abbott and Impax reach a settlement, and what were the launch/entry terms?

Not provided in the prompt. Settlement terms in these cases usually include:

• negotiated design-around terms (formulation or manufacturing changes),
• “trigger” dates tied to FDA actions,
• carve-outs for infringement/non-infringement disputes,
• and sometimes stipulated dismissals with consent judgments.

No settlement agreement terms or disposition date are included, so this cannot be stated.

What is the Orange Book status of the relevant Abbott product, and what patents are listed?

Not provided in the prompt. Orange Book status must be mapped to:

• the RLD,
• the listed patents (including expiration dates),
• and the regulatory exclusivity (NCE, pediatric exclusivity, 5-year exclusivity, and patent-specific 30-month stay effects).

Without the RLD identity, Orange Book listing and expiration modeling cannot be completed.

When does exclusivity expire for the Abbott product in 1:10-cv-01029?

Not provided in the prompt. Exclusivity and patent expiry modeling requires:

• the RLD and ANDA filing context,
• the listed patent expiration dates,
• and the regulatory exclusivities.

The prompt does not contain those identifiers.

How strong is Abbott’s patent estate in 1:10-cv-01029?

Not provided in the prompt. A strength analysis depends on at least:

• which patent classes were asserted (composition, formulation, method-of-use, process),
• their remaining term at filing,
• whether the claims are broad or constrained by prosecution history,
• and the outcome of claim construction.

None of those details are available.

What generic entry risks exist for Impax if Abbott’s patents were invalidated or found non-infringing?

Not provided in the prompt. Generic entry risk assessment depends on:

• which asserted patents were dispositively invalidated or not infringed,
• whether other listed patents remain unchallenged,
• and whether any injunction issued.

No court outcome details are provided.

How does Impax’s litigation position typically map to facility and manufacturing design-arounds?

In Abbott v. Impax-type disputes, manufacturing/process changes can reduce infringement risk if:

• the claims are process-limited (manufacturing method patents),
• the product claims require specific parameters (particle size distributions, polymorph form, dissolution profile, excipient system),
• or the generic can avoid functional limitations.

A design-around analysis needs the asserted claim limitations and Impax’s proposed product attributes. Those are not in the prompt.

Which companies were involved beyond Abbott and Impax in 1:10-cv-01029?

Not provided in the prompt. Co-defendants and licensees are common, including:

• other Impax affiliates,
• ANDA co-filers,
• or Abbott operating company entities.

No additional party information is provided.

Key Takeaways

• The request identifies the matter as Abbott Laboratories v. Impax Laboratories Inc., 1:10-cv-01029, but the prompt contains no asserted drug identity, no patent numbers, no Orange Book listing details, no procedural timeline, and no disposition record.
• A litigation summary at the level expected for litigation, licensing, or investment decisions requires patent- and docket-specific inputs that are not present in the provided text.

FAQs

1. What court events determine whether Abbott can secure an injunction in a Hatch-Waxman suit like 1:10-cv-01029?
2. How do claim construction outcomes (Markman rulings) typically shift infringement risk for generic applicants?
3. What settlement structures are common when Paragraph IV disputes resolve without trial in district court?
4. How is 30-month stay timing tied to Paragraph IV notice and litigation filing in Abbott v. Impax cases?
5. What Orange Book patent categories usually drive the longest delay to generic launch?

References (APA)

1. Abbott Laboratories v. Impax Laboratories Inc., No. 1:10-cv-01029 (court docket).