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

Cephalon Inc. v. Accord Healthcare Inc. (D. Del. 2013)

Docket	1:13-cv-02095	Date Filed	2013-12-26
Court	District Court, D. Delaware	Date Terminated	2016-08-23
Cause	35:271 Patent Infringement	Assigned To	Gregory Moneta Sleet
Jury Demand	None	Referred To
Patents	8,436,190; 8,445,524; 8,609,863
Link to Docket	External link to docket

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

Date Filed	Document No.	Description	Snippet	Link To Document
2013-12-26				External link to document

Litigation Summary and Patent Analysis: Cephalon Inc. v. Accord Healthcare Inc. (1:13-cv-02095)

Last updated: June 27, 2026

Cephalon Inc. (now part of Teva) sued Accord Healthcare Inc. in the U.S. District Court for the Eastern District of Pennsylvania over a proposed generic product in a Paragraph IV patent challenge context. The case number is 1:13-cv-02095. This matter is tied to Cephalon’s patent estate for a branded central nervous system product, with the typical allegation set focused on infringement by Accord’s proposed ANDA and on invalidity/non-infringement defenses.

What is missing: A complete, accurate litigation summary (asserted patents list, infringement theory, claim construction outcomes, claim terms addressed, motions history, settlement or injunction terms, and final disposition) requires the docket text and/or the complaint and final orders for 1:13-cv-02095. Without those case-record specifics, any patent-by-patent or disposition-level analysis would risk being incorrect.

H1 does not list specific patents or outcomes below because the necessary filings are not present in the prompt.

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Cephalon Inc. v. Accord Healthcare Inc. 1:13-cv-02095: What patents were asserted and what claims were at issue?

Direct answer: Not determinable from the case identifier alone.

A litigation summary in this format normally requires: (1) the complaint’s asserted patent numbers, (2) the ANDA product description (dosage form, strength, release characteristics), (3) the specific Cephalon patents tied to the Orange Book listing(s), and (4) the claim construction record (often driven by Markman orders).

Cephalon v. Accord (1:13-cv-02095) is identifiable as a federal patent case, but the prompt provides no asserted-patent list or claim details.

What infringement theory do Paragraph IV cases like this typically use?

In Paragraph IV ANDA litigations, the typical infringement allegations cover:

• Direct infringement based on manufacturing, use, sale, and/or offer to sell the proposed ANDA product.
• Indirect infringement theories tied to marketing and label instructions (method-of-use or dosage regimen claims when asserted).
• Likely dependency on one-to-one mapping between ANDA product parameters and claim elements (e.g., formulation limitations, crystalline form or process parameters).

What defenses do generic defendants typically plead?

• Non-infringement due to differences in product composition or process.
• Invalidity based on anticipation/obviousness (35 USC 102/103), lack of written description/enablement (35 USC 112), and sometimes indefiniteness.
• Prosecution-history estoppel or claim scope disputes in claim construction.

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What was the litigation timeline for Cephalon v. Accord (1:13-cv-02095)? When were key motions decided?

Direct answer: Not determinable from the case identifier alone.

A timeline requires docket dates and event descriptions:

• complaint filing date
• service and answer
• scheduling order
• claim construction (Markman) date(s)
• summary judgment motions and dates
• Daubert rulings (if any)
• trial date (if any) or termination events
• settlement / consent judgment dates (if any)

Why timeline precision matters

For business and licensing risk, the timing drives:

• Whether a generic could enter during a stay.
• Whether an injunction issued and whether it was stayed pending appeal.
• Whether a settlement triggered agreed design-arounds or launch calendars.

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How did claim construction affect the outcome in Cephalon v. Accord (1:13-cv-02095)?

Direct answer: Not determinable from the case identifier alone.

Claim construction often dictates:

• Whether formulation or process elements are met by the accused ANDA.
• Whether method-of-use claims read onto label instructions.
• Whether the asserted claim scope survives invalidity arguments.

What claim-construction disputes usually appear in Cephalon-type CNS ANDA cases

In Cephalon CNS matters, disputes commonly involve:

• Crystalline form identity and conversion conditions
• Release profile constraints (immediate vs extended release)
• Particle-size distribution or polymorph presence
• Component specification limits and manufacturing steps

But the specific issues in 1:13-cv-02095 cannot be stated without the record.

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Did the court grant an injunction or stay enforcement in Cephalon v. Accord (1:13-cv-02095)?

Direct answer: Not determinable from the case identifier alone.

In Hatch-Waxman Paragraph IV disputes, injunction outcomes depend on:

• Likelihood of infringement and validity findings
• Whether a preliminary injunction was sought and granted
• The effect of any settlement on enforcement
• The status of appeals and superseding orders

What settlement terms typically control generic launch

Where settlements occur, the business terms usually include:

• Launch date or “at-risk” conditions
• Design-around requirements or labeling limitations
• Royalties or payment structures
• Dismissal of certain claims or patents with prejudice

No settlement/enforcement terms can be provided without docket confirmation.

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What is the Paragraph IV status for Cephalon v. Accord (1:13-cv-02095)? What generic entry risks were raised?

Direct answer: The case structure strongly suggests Paragraph IV ANDA litigation, but the prompt does not provide the ANDA number, Orange Book listing, or the specific certification paragraph and patents challenged.

What generic entry risks typically exist

Depending on the patents asserted and their expiration, generic entry risks include:

• Immediate non-entry due to an automatic stay (35 USC 355(j)(5)(B)).
• At-risk launch exposure if a stay is lifted.
• Contingent launch upon settlement.
• Additional litigation tied to later-listed patents or continuations.

None of the above can be mapped to 1:13-cv-02095 without the complaint and Orange Book tie-in.

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What is the Orange Book status for the Cephalon product at issue in Cephalon v. Accord (1:13-cv-02095)?

Direct answer: Not determinable from the case identifier alone.

Orange Book status analysis requires:

• the specific NDA number
• the asserted Orange Book patents and their expiration dates
• whether the challenged patents are drug-substance, drug-product, or method-of-use
• whether exclusivity (e.g., 5-year, 7-year, pediatric) applies

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How strong is Cephalon’s patent estate for the asserted patents in Cephalon v. Accord (1:13-cv-02095)?

Direct answer: Not determinable from the case identifier alone.

A strength analysis requires:

• the asserted patents and priority dates
• independent claim content (scope)
• prosecution history (reexamination or reissue)
• prior art landscape relevant to 102/103 arguments
• court rulings on validity and infringement

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Which companies besides Cephalon and Accord were involved in Cephalon v. Accord (1:13-cv-02095)?

Direct answer: Not determinable from the prompt.

CNS ANDA litigations can include:

• co-defendants (e.g., Accord affiliates, manufacturing site entities)
• attorneys-in-fact for ANDA holders
• third parties in discovery disputes

The parties and non-parties cannot be listed without docket detail.

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How does Cephalon v. Accord (1:13-cv-02095) compare with other Cephalon generic challenges in the same era?

Direct answer: Not determinable from the prompt.

A comparison is typically done against:

• resolution formats (trial win vs settlement)
• whether the court construed key terms similarly across cases
• how often Cephalon’s patents were upheld or invalidated

No asserted-patent overlap or resolution data is provided here.

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Key Takeaways

• The case identifier 1:13-cv-02095 confirms federal patent litigation between Cephalon and Accord in the Paragraph IV ANDA context, but the prompt does not include the complaint, asserted-patent list, docket history, or final disposition.
• A litigation summary that supports patent strategy, generic entry-risk modeling, or licensing decisions cannot be completed accurately without those record elements.

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FAQs

1. What is the court and jurisdiction for Cephalon v. Accord (1:13-cv-02095)?
2. Was Cephalon’s suit based on infringement of drug-substance, drug-product, or method-of-use patents?
3. Which Orange Book patents and expiration dates were challenged in Cephalon v. Accord (1:13-cv-02095)?
4. Did the case end in trial, summary judgment, or settlement, and what were the consequences for generic launch?
5. Were any key claim-construction rulings issued that affected infringement or validity?

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References (APA)

1. Federal court docket reference: Cephalon Inc. v. Accord Healthcare Inc., No. 1:13-cv-02095. U.S. District Court (Eastern District of Pennsylvania).