Litigation Details for Pfizer Inc. v. Accord Healthcare Inc.USA (D. Del. 2013)

Pfizer Inc. v. Accord Healthcare Inc.USA (D. Del. 2013)

Docket		Date Filed	2013-06-28
Court	District Court, D. Delaware	Date Terminated	2016-04-21
Cause	35:271 Patent Infringement	Assigned To	Gregory Moneta Sleet
Jury Demand	None	Referred To
Patents	6,858,650; 7,384,980; 7,855,230; 7,985,772; 8,338,478
Link to Docket	External link to docket

Details for Pfizer Inc. v. Accord Healthcare Inc.USA (D. Del. 2013)

Date Filed	Document No.	Description	Snippet	Link To Document
2013-06-28				External link to document

Pfizer Inc. v. Accord Healthcare Inc. (1:13-cv-01155): Litigation Summary, Patent Issues, and Case Outlook

Last updated: July 16, 2026

Executive summary: Pfizer Inc. v. Accord Healthcare Inc. (U.S. District Court, Case No. 1:13-cv-01155) is a Hatch-Waxman patent infringement dispute tied to Pfizer’s branded product and Accord’s proposed FDA-marketed generic. The case centers on asserted Orange Book-listed patents and the legal effect of Accord’s ANDA Paragraph IV certification, with the core litigation question focused on whether Accord’s generic acts as an infringer and whether the asserted claims are valid and enforceable.

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What patents were asserted in Pfizer v. Accord Healthcare Inc. (1:13-cv-01155)?

A complete patent-by-patent claim-and-hold summary cannot be produced from the case caption alone. Case number and party names do not identify (i) the specific Pfizer product at issue, (ii) which Orange Book patents were listed as asserted, or (iii) the particular asserted claims and theories (infringement and invalidity grounds). Without the docket record identifying the asserted patents and claim sets, any listing would be guesswork.

What is typically at issue in this type of Hatch-Waxman case?

In Pfizer-versus-ANDA Paragraph IV cases, courts usually address:

• Claim construction disputes for the asserted claims
• Direct infringement vs. induced or contributory infringement theories (often tied to label instructions and proposed manufacturing)
• Non-infringement defenses tied to composition, manufacturing, or process steps
• Invalidity defenses including anticipation, obviousness, lack of written description or enablement, and indefiniteness
• Enforceability defenses such as inequitable conduct (if pleaded)

Because the asserted patent list and claim numbers are not provided, the factual and legal scope of 1:13-cv-01155 cannot be mapped to a specific portfolio.

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What does the complaint allege Accord challenged under Paragraph IV in 1:13-cv-01155?

The complaint’s allegation set in Paragraph IV cases typically includes:

• Accord filed an ANDA referencing Pfizer’s approved drug
• Accord certified that the asserted patents are invalid, unenforceable, or will not be infringed
• Pfizer alleges infringement under 35 U.S.C. § 271(e)(2) based on the ANDA submission

But the ANDA and patent certifications at issue in 1:13-cv-01155 are not identified by the case number alone. A precise litigation narrative requires the complaint’s Paragraph IV paragraph(s), the specific “H” and “F” certifications referenced, and the asserted patent numbers.

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What infringement and validity arguments were decided by the court in Pfizer v. Accord (1:13-cv-01155)?

Courts usually resolve Hatch-Waxman patent cases through one or more of:

• Summary judgment on infringement (often after claim construction)
• Summary judgment or trial outcomes on invalidity (anticipation/obviousness)
• A final judgment on infringement and validity for each asserted claim
• A separate procedural record on injunction and bond (if applicable)
• Post-judgment motions (Rule 50/59)

However, without the docket’s substantive orders, the actual determinations for 1:13-cv-01155 cannot be stated accurately.

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How did claim construction affect the outcome in Pfizer v. Accord Healthcare (1:13-cv-01155)?

Claim construction can be outcome-determinative in method, formulation, and use-patent cases. Typical inflection points include:

• Whether a “comprising” limitation is met
• Whether a viscosity, particle size, polymorph, or dissolution profile requirement is met
• Whether an epidemiology or patient-selection “patient group” limitation is satisfied for method-of-use patents
• Whether process steps in a manufacturing method claim are actually performed

In 1:13-cv-01155, the asserted claim types are unknown from the provided information. Without the claim terms and the Markman order, the role of claim construction cannot be summarized.

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Did Pfizer obtain an injunction, and when did it matter for Accord’s generic entry?

In Hatch-Waxman:

• A merits win by the NDA holder can lead to a permanent injunction against the generic’s commercial launch until patent expiry.
• If the court finds non-infringement or invalidity, the generic can launch once FDA approval issues and any exclusivity windows run.
• Even with an adverse merits finding, procedural stays and appellate timelines can delay market entry.

Whether an injunction was granted or stayed in 1:13-cv-01155 depends on the final judgment and any post-judgment appellate disposition. The case materials are not provided here, so injunction status cannot be stated.

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What settlement or licensing terms resolved Pfizer v. Accord (1:13-cv-01155)?

A settlement in Hatch-Waxman can include:

• A covenant not to sue for specific products or dosages
• A date-based entry schedule
• Licensing terms for certain patents
• Dismissal with or without prejudice
• Confidential manufacturing and supply terms

Settlement outcomes are not inferable from the case caption. Without the docket entries or settlement order, a terms-and-timeline analysis cannot be produced without fabrication.

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What is the appeal posture for 1:13-cv-01155 (Federal Circuit or district court only)?

Hatch-Waxman patent judgments are commonly appealed to the U.S. Court of Appeals for the Federal Circuit. The appeal posture impacts:

• Whether the generic launch was stayed pending appeal
• Whether the merits ruling was affirmed, reversed, or remanded
• Whether claim construction was revised

No appeal information is provided beyond the case identifier, so the appellate outcome cannot be stated.

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How does this case compare with other Pfizer vs. Accord Hatch-Waxman disputes?

Comparison requires at least:

• The Pfizer product and patent portfolio
• Whether Accord’s ANDA was a filing for the same strength/form or a different formulation
• The procedural posture and whether the outcome was infringement, invalidity, or settlement

These inputs are not present, so a credible comparison cannot be made.

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What is the Orange Book status and what patents were at risk in 1:13-cv-01155?

Orange Book risk analysis requires:

• The Orange Book NDA listing
• Each patent number, type (drug substance, drug product, method-of-use)
• Expiration dates and listed periods
• Any licensing or co-ownership structure

No NDA identifier, Orange Book listing, or patent list is included in the prompt. A targeted “what patents were at risk” analysis would require docket-linked patent numbers.

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Key Takeaways

• Pfizer Inc. v. Accord Healthcare Inc. (1:13-cv-01155) is a Hatch-Waxman Paragraph IV patent infringement dispute framework, but the asserted patents, claim types, claim construction, and merits outcomes cannot be accurately summarized from the case caption and docket number alone.
• Without the docket record (complaint, claim chart, Markman order, summary judgment/trial orders, final judgment, and any settlement/appeal entries), any patent and outcome mapping would be speculative.

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FAQs

1. What product and ANDA were involved in Pfizer v. Accord (1:13-cv-01155)?
   The case caption alone does not identify the drug product or the specific ANDA filing.

2. Which Orange Book patents did Pfizer assert in 1:13-cv-01155?
   The asserted patent numbers and claim sets are not identified by the case caption.

3. Did Accord’s Paragraph IV certification lead to trial, summary judgment, or settlement in this case?
   The resolution type and procedural milestones are not available from the provided identifier.

4. Was there an injunction or stay affecting Accord’s generic launch after the district court ruling?
   Injunction/stay status depends on orders and judgment entries not included here.

5. What was the appeal outcome, if any, for 1:13-cv-01155?
   Appeal posture and Federal Circuit disposition are not identifiable from the prompt.

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References (APA)

No sources were provided in the prompt, and no case docket documents, orders, or patent lists were supplied to cite.