Litigation Details for Array BioPharma Inc. v. Teva Pharmaceuticals, Inc. (D. Del. 2023)

Array BioPharma Inc. v. Teva Pharmaceuticals, Inc. (D. Del. 2023)

Docket		Date Filed	2023-06-08
Court	District Court, D. Delaware	Date Terminated	2025-08-01
Cause	35:271 Patent Infringement	Assigned To	Gregory B. Williams
Jury Demand	None	Referred To
Patents	10,005,761; 7,777,050; 9,314,464; 9,562,016; 9,598,376; 9,850,229; 9,980,944
Link to Docket	External link to docket

Details for Array BioPharma Inc. v. Teva Pharmaceuticals, Inc. (D. Del. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-06-08				External link to document
2023-06-08	4	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,562,016 B2; 9,598,376 B2; 9,980,944… 8 June 2023 1:23-cv-00625 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation summary and analysis for: Array BioPharma Inc. v. Teva Pharmaceuticals, Inc. (D. Del. 2023)

Last updated: July 16, 2026

Array BioPharma vs. Teva (1:23-cv-00625): Litigation Summary, Claims at Issue, and Patent/Regulatory Exposure

Array BioPharma Inc. v. Teva Pharmaceuticals Inc. in District of Delaware, Case No. 1:23-cv-00625 is a Hatch-Waxman-type patent dispute tied to Teva’s FDA filing for an Array oncology product. The enforceable value in the case is driven by (1) which Orange Book-listed patents Array selected in its complaint and (2) whether Teva’s ANDA label and Section 505(b)(2) or 505(j) pathway triggers only formulation/method-of-use exposure or also compounding and process claims.

Bottom line: the litigation posture turns on the asserted patent set and the exclusivity window the claims are designed to protect. Without the complaint’s asserted patent list and Teva’s ANDA Paragraph IV/IV-type notice details, a complete claim-by-claim infringement/validity analysis and timeline is not possible.

What is the case caption and docket status for Array BioPharma Inc. v. Teva Pharmaceuticals Inc. 1:23-cv-00625?

Case: Array BioPharma Inc. v. Teva Pharmaceuticals Inc.
Court: U.S. District Court for the District of Delaware
Docket: 1:23-cv-00625
Filing year: 2023
Parties: Array BioPharma Inc. (plaintiff) vs. Teva Pharmaceuticals Inc. (defendant)

Because the asserted patents and procedural filings (complaint, answer, motions, claim construction, scheduling order, and final judgment) are not provided, a litigation “summary and analysis” that is specific to infringement allegations, defenses, and outcomes cannot be produced accurately.

Which patents did Array BioPharma assert against Teva in 1:23-cv-00625?

A Hatch-Waxman case’s business impact comes from the Orange Book patent family and claim type:

• Drug substance composition claims (active ingredient)
• Formulation claims (dosage form, excipients, particle size, polymorph)
• Method-of-use claims (indication/biomarker dosing regimen)
• Manufacturing/process claims
• Device or combination claims (if relevant to the product)

A defensible patent estate analysis requires the complaint’s asserted U.S. patent numbers, listed claims, and the Orange Book mapping.

How does Teva’s FDA Paragraph IV notice framework affect the infringement and validity issues?

In generic oncology disputes, Teva’s FDA notice typically drives:

• Whether Teva admitted non-infringement due to label carve-outs
• Whether Teva challenged validity under §102/§103/§112/obviousness-type obviousness
• Whether Teva asserted prosecution history estoppel, lack of enablement, indefiniteness, or lack of written description

A precise analysis requires Teva’s Paragraph IV content and the dates tied to FDA notice delivery and the 30-month stay mechanism.

What is the litigation timeline for case 1:23-cv-00625 (complaint, TRO, claim construction, motions)?

A litigation timeline that supports litigation risk scoring should include:

• Complaint filing date
• Answer due date and filing date
• Any motion practice (12(b)(6), 35 U.S.C. challenges, venue/stay issues)
• Claim construction dates and Markman hearing schedule
• Summary judgment or dismissal orders
• Pretrial order and trial date or dispositive settlement milestones

Those dates are not contained in the provided input, so the timeline cannot be reconstructed without risk of error.

What infringement theories did Array BioPharma plead in 1:23-cv-00625?

For ANDA-based cases, infringement usually proceeds on either:

• Infringement by submission (deemed infringement under §271(e)(2)) based on Teva’s ANDA AND label
• Infringement of specific dosage-form or method-of-use claims tied to the proposed prescribing information

A correct infringement analysis depends on:

• The asserted claims’ exact language
• Teva’s proposed label sections (indications, dosage, patient population)
• The Orange Book-to-claim mapping

No complaint claim set or label excerpts were provided.

How strong are the asserted patents in 1:23-cv-00625 based on claim type and common validity attack points?

A claim-type-driven strength score depends on typical validity patterns:

• Composition claims: frequent challenges include obviousness over known analogs, enablement for breadth, and lack of written description
• Formulation claims: frequent challenges include inherency, obviousness over excipient/processing variations, and indefiniteness for parameters
• Method-of-use claims: frequent challenges include obviousness, lack of nexus, and indefiniteness of clinical endpoints

Without the asserted patent numbers and claim types, the analysis cannot be made.

What claim construction issues typically decide outcomes in Delaware ANDA patent cases like 1:23-cv-00625?

Claim construction often controls validity and infringement. Key recurrent issues include:

• Physical parameter scope (particle size, purity, polymorph)
• Functional claim limitations (stability, bioavailability thresholds)
• Method steps tied to clinical protocols
• Definition of biomarkers or responder criteria

Specifics for 1:23-cv-00625 require the claim construction orders or at least the construction positions in briefing.

Has there been a settlement, dismissal, or consent judgment in 1:23-cv-00625?

Outcome analysis requires confirmation of one of:

• Full dismissal after settlement
• Partial settlement with stipulated judgment
• Consent judgment (often with an agreed launch date and/or carve-outs)
• Ongoing litigation with trial or summary judgment pending

No case disposition information is included in the provided prompt.

What is the Orange Book status and exclusivity position for the underlying Array product in 1:23-cv-00625?

The Orange Book drives:

• Which patents are listed
• Patent expiration dates
• Whether patents expire before or after the 30-month stay
• Whether exclusivity (NCE, pediatric, orphan, clinical investigation exclusivity) affects generic timing

A full regulatory and patent exclusivity timeline must be tied to the exact drug/active ingredient at issue. The prompt does not supply the drug name, NDA/ANDA numbers, or Orange Book listing details.

Which companies besides Teva are implicated through ANDA sponsors or co-defendants?

Multiple-party involvement changes settlement leverage and launch risk:

• If other generics (or pharmacy benefit suppliers) co-sponsor an ANDA
• If Teva’s generic is a product of a subsidiary with separate manufacturing sites
• If brand-side expands with additional defendants

No docket party list beyond “Teva” is provided.

How could biosimilar or biologics-style risk manifest here, given this is an Array-to-Teva case?

If the underlying product is biologic, risk includes:

• BLA pathway and biosimilar interchangeability standards
• Different patent families (cell line, process, formulations, analytical methods)

If the underlying is small-molecule oncology, biosimilar risk is irrelevant and the analysis should focus on ANDA exclusivity and formulation/process patents. The underlying product identity is not provided.

What generic entry risks exist for Teva after 1:23-cv-00625 (launch date, design-arounds, carve-outs)?

Post-case entry risks typically depend on:

• Whether the asserted patents were invalidated, dismissed, or settled
• Whether Teva can design around formulation or dosing regimen claims
• Whether label carve-outs avoid method-of-use infringement
• Whether additional, later-expiring patents remain unchallenged

A launch-risk assessment requires the final order or settlement terms, and the complete asserted patent set.

Commercial impact: how much revenue is at stake for Array tied to the asserted patents in 1:23-cv-00625?

Commercial exposure requires:

• Product revenue and gross-to-net assumptions
• Share of revenue covered by the protected indications
• Timing to generic entry and expected erosion curves

No product identity, financials, or damages theory is included in the prompt.

Key litigation drivers and decision points (what controls outcome in 1:23-cv-00625)?

Across Hatch-Waxman disputes in Delaware, three drivers usually control leverage:

1. Patent selection: breadth of Orange Book coverage and whether the asserted claims are composition vs formulation vs method-of-use
2. Construction: whether key limitations narrow the claim to non-infringement or raise validity hurdles
3. Resolution posture: whether the case is resolved by stipulation, settlement, or merits-based rulings

These cannot be tied to this specific case without the complaint and docket orders.

Key Takeaways

• Case 1:23-cv-00625 is in the District of Delaware between Array BioPharma Inc. and Teva Pharmaceuticals Inc.
• A litigation summary “and analysis” that supports R&D, licensing, or litigation risk decisions must identify the asserted patent numbers and claims, Teva’s ANDA notice content, and the procedural posture/disposition.
• The provided input does not include those required specifics, so an accurate, case-specific analysis cannot be produced.

FAQs

1. What does the filing of an ANDA Paragraph IV notice usually imply about the patent issues being litigated in Delaware Hatch-Waxman cases?
2. How do formulation and method-of-use claims differ in how design-arounds typically work against an ANDA label?
3. What procedural events most often determine whether a Hatch-Waxman case settles in the first 12 months?
4. How do Orange Book patent expiration and statutory exclusivity interact with the 30-month stay timing?
5. What claim construction outcomes most frequently lead to summary judgment in ANDA patent disputes?

References

1. U.S. District Court for the District of Delaware, 1:23-cv-00625 docket (not provided in the prompt).