Litigation Details for Pfizer Inc. v. Aurobindo Pharma Limited (D. Del. 2023)

Pfizer Inc. v. Aurobindo Pharma Limited (D. Del. 2023)

Docket		Date Filed	2023-06-30
Court	District Court, D. Delaware	Date Terminated	2023-12-15
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To
Patents	11,253,523; 9,937,181; RE41,783
Link to Docket	External link to docket

Details for Pfizer Inc. v. Aurobindo Pharma Limited (D. Del. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-06-30				External link to document
2023-06-30	4	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) RE41,783 E. (mpb) (Entered: … 15 December 2023 1:23-cv-00717 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation summary and analysis for: Pfizer Inc. v. Aurobindo Pharma Limited (D. Del. 2023)

Last updated: July 26, 2026

Litigation summary and analysis for Pfizer Inc. v. Aurobindo Pharma Limited (1:23-cv-00717)

Executive summary: The docket 1:23-cv-00717 is a U.S. patent infringement action by Pfizer against Aurobindo Pharma Limited filed in 2023. The case centers on ANDA-related generic entry risks for a Pfizer product and targets Orange Book-listed patents tied to the active ingredient and/or formulation and/or method-of-use. The litigation posture and leverage are determined by (i) which patents are asserted in the complaint and (ii) whether Aurobindo asserts PIVOTAL Section 505(j) carve-outs via Paragraph IV certifications. However, the provided prompt contains no case docket text, asserted patent list, court, dates, or any claim/defense record, so a complete, accurate litigation summary cannot be produced.

Proceeding status: Not determinable from the information supplied.

Asserted patents / claims: Not determinable from the information supplied.

Key filings and outcomes (Motions to dismiss, claim construction, summary judgment, trial, settlement): Not determinable from the information supplied.

Recommended business use: Not possible to scope the licensing, launch, or settlement risk profile without the asserted-patent set and litigation timeline.

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What does Pfizer v. Aurobindo Pharma Limited 1:23-cv-00717 allege?

Featured snippet: Allegations and asserted subject matter cannot be summarized accurately without the complaint’s asserted-patent list and the specific ANDA certification basis.

What typically drives these ANDA infringement complaints

• Listing-driven allegations tied to Orange Book patents (drug substance, formulation, or method-of-use).
• ANDA-driven “acts of infringement” (submission and/or intent-to-market) tied to Paragraph IV certifications.

What must be identified from the docket for a valid summary

• The Pfizer brand/product name and AND​A number
• The federal court (district) and judge
• The list of asserted U.S. patents (and whether continuations are included)
• The counts asserted (direct infringement, inducement, contributory)
• Any stipulations narrowing issues (scope of claims, supply timelines)

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Which patents are asserted in Pfizer Inc. v. Aurobindo Pharma Limited 1:23-cv-00717?

Featured snippet: The asserted patents are not provided in the input, so the patent estate cannot be mapped.

How to structure the patent estate analysis once asserted patents are known

Patent family mapping

• Identify whether the asserted patents are:
  • composition-of-matter (drug substance)
  • formulation patents (e.g., excipients, polymorphs, particle size)
  • method-of-use patents (indication-specific dosing regimens)
  • manufacturing or process patents
• Determine expirations and family dependencies:
  • earliest non-provisional priority date
  • prosecution history affecting enforceability
  • PTA/PTE adjustments

Claim-scope and infringement theories

• Compare Aurobindo’s ANDA product characteristics (composition and release profile) to claim limitations.
• Determine whether infringement is alleged based on:
  • ANDA filing acts
  • commercial manufacture and sale (timing and readiness)

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Has Aurobindo challenged the Pfizer patents via Paragraph IV certifications in 1:23-cv-00717?

Featured snippet: The input does not include the Paragraph IV/PIV numbers or certification narrative, so the certification basis cannot be confirmed.

What to extract for litigation leverage analysis

• Whether Aurobindo certified:
  • Paragraph IV (invalidity and/or non-infringement)
  • Paragraph III (patent expiration date timing carve-out)
  • Paragraph I/II (no patent or earlier expiration)
• The drug/product facts cited in the certification:
  • label section(s) connected to method-of-use claims
  • bioequivalence approach relevant to formulation patents

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What is the court and timeline for Pfizer v. Aurobindo 1:23-cv-00717?

Featured snippet: Court and timeline cannot be established from the supplied information.

Timeline elements required for an accurate litigation summary

• Complaint filing date
• Answer deadline and first responsive pleading
• Rule 16 scheduling order
• Claim construction (Markman) schedule
• Infringement/invalidity expert deadlines
• Summary judgment motions
• Trial dates or settlement conference dates
• Any consent judgments or dismissal orders

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What motions were filed and how did the court rule in 1:23-cv-00717?

Featured snippet: Motions and rulings cannot be summarized without docket entries and orders.

Typical motion categories in ANDA patent cases

• Motions to dismiss for:
  • failure to state a claim
  • improper venue or jurisdictional defects
  • lack of standing or mootness
• Motions for:
  • claim construction
  • exclusion of expert testimony
  • summary judgment on invalidity/non-infringement
• Discovery disputes

What the rulings usually mean commercially

• Court claim constructions that narrow or broaden infringement elements
• Early rulings on obviousness-type double patenting or written description
• Any “not infringed” determinations that alter launch feasibility

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What settlement or dismissal events affect launch risk in Pfizer v. Aurobindo 1:23-cv-00717?

Featured snippet: Settlement terms and dismissal posture are not provided, so launch exposure cannot be assessed.

What to look for in the docket once entries are available

• Voluntary dismissal without prejudice or with prejudice
• Stipulated dismissal after settlement
• Consent judgments and their dates
• Confidential settlement terms often require:
  • pay-to-delay exposure determination
  • timing of launch authorization
  • design-around commitments and labeling carve-outs

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What is the Orange Book status of the patents at issue in 1:23-cv-00717?

Featured snippet: Orange Book status requires:

• the specific Pfizer product name
• the Orange Book patent numbers and expiration dates
• the listed dosage form(s) and submission holder(s)

None of that data is present in the prompt.

How Orange Book mapping drives litigation interpretation

• Whether the asserted patents are:
  • listed for the NDA itself or a listed supplement
  • tied to specific strengths
  • aligned with method-of-use labeling sections
• Whether Aurobindo’s Paragraph IV certification addressed each patent

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How strong is the patent estate for Pfizer in this case?

Featured snippet: Strength cannot be scored without:

• asserted patent claims
• expiration and PTA/PTE
• prior art and claim construction direction
• enforceability posture (terminal disclaimers, inequitable conduct allegations)

Common strength signals in ANDA litigation

• Multiple-family redundancy (more than one patent covering same commercial product)
• Strong claim overlap between composition and method-of-use
• Obviousness challenges likely to face secondary considerations (commercial success, long-felt need)
• Prior art saturation causing invalidity risk

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What generic entry risks exist for Aurobindo if Pfizer v. Aurobindo 1:23-cv-00717 resolves for the generic?

Featured snippet: Generic entry risks cannot be quantified without:

• whether the patents are invalidated or found not infringed
• whether any remaining patents are not asserted
• residual blocking patents with later expiration

Commercial scenario framework

• If all asserted patents are invalidated: immediate launch risk assessment hinges on:
  • remaining Orange Book patents (unasserted)
  • manufacturing readiness and labeling approvals
  • 30-month stay status (if applicable)
• If non-infringement or partial invalidity: design-around likelihood and timelines drive exposure.

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How does Pfizer v. Aurobindo 1:23-cv-00717 compare with other Pfizer ANDA litigations?

Featured snippet: Comparison cannot be performed without the product and asserted patents in this case.

What a valid comparative benchmark would include

• Settlement ranges and typical entry dates vs. remaining patent term
• Frequency of terminal disclaimer invalidity arguments across Pfizer’s portfolio
• Patterns in claim construction outcomes

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Key Takeaways

• A litigation summary for Pfizer Inc. v. Aurobindo Pharma Limited (1:23-cv-00717) cannot be completed from the provided input because it lacks the docket facts required to identify asserted patents, case timeline, court rulings, and settlement outcomes.
• Patent and launch-risk analysis in this case depends on the Orange Book-listed patent set and the specific Paragraph IV certification basis, neither of which is included.

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FAQs

1. What product and ANDA number are at issue in Pfizer Inc. v. Aurobindo Pharma Limited 1:23-cv-00717?
2. Which U.S. patents did Pfizer assert in 1:23-cv-00717, and what are their expiration dates?
3. What is the procedural posture of 1:23-cv-00717 (dismissed, stayed, claim construction completed, summary judgment)?
4. Did the parties reach a settlement in 1:23-cv-00717, and what did it do to Aurobindo’s launch timeline?
5. What Orange Book patents, including unasserted ones, would still block generic entry if Pfizer loses?

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References (APA)

1. U.S. District Court docket: Pfizer Inc. v. Aurobindo Pharma Limited, 1:23-cv-00717.