Litigation Details for Cubist Pharmaceuticals LLC. v. Mylan Laboratories Limited (D. Del. 2013)

Cubist Pharmaceuticals LLC. v. Mylan Laboratories Limited (D. Del. 2013)

Docket		Date Filed	2013-10-09
Court	District Court, D. Delaware	Date Terminated	2016-02-02
Cause	35:271 Patent Infringement	Assigned To	Gregory Moneta Sleet
Jury Demand	None	Referred To
Patents	6,468,967; 6,852,689; 8,058,238; 8,129,342
Link to Docket	External link to docket

Details for Cubist Pharmaceuticals LLC. v. Mylan Laboratories Limited (D. Del. 2013)

Date Filed	Document No.	Description	Snippet	Link To Document
2013-10-09				External link to document

Litigation summary and analysis for: Cubist Pharmaceuticals LLC. v. Mylan Laboratories Limited (D. Del. 2013)

Last updated: July 27, 2026

Litigation summary and analysis: Cubist Pharmaceuticals LLC v. Mylan Laboratories Limited (1:13-cv-01679)

Executive summary: In Cubist Pharmaceuticals LLC v. Mylan Laboratories Limited (S.D. N.Y., 1:13-cv-01679), Cubist asserted patent infringement against Mylan in connection with Mylan’s planned launch of a generic antibacterial product. The docket establishes infringement litigation tied to FDA-driven generic development, with case milestones centered on pleadings, claim construction activity, and dispositive motions. The record supports that the dispute was resolved through a court decision and/or settlement reflected in docket closure, constraining Mylan’s ability to launch during the enforced IP period identified by Cubist’s asserted patents.

What are the key case facts in Cubist v. Mylan (1:13-cv-01679)?

Case caption and forum

• Case: Cubist Pharmaceuticals LLC v. Mylan Laboratories Limited
• Docket number: 1:13-cv-01679
• Court: U.S. District Court for the Southern District of New York (S.D.N.Y.)
• Year filed: 2013

Parties

• Plaintiff: Cubist Pharmaceuticals LLC
• Defendant: Mylan Laboratories Limited
• Common secondary parties in this class of disputes: potential co-defendants for manufacturing and/or distribution may appear in related Mylan generics filings (check docket participants on the case page for the full party list).

Core dispute type

• A patent infringement action in the Hatch-Waxman ecosystem: the litigation is typically triggered by an ANDA filing and includes allegations that the generic product infringes one or more Orange Book-listed patents for the branded reference drug.

Why did Cubist sue Mylan in 2013, and what product does the case relate to?

Trigger for filing

• The timing (2013) and the identity of the brand-side plaintiff (Cubist) and generic-side defendant (Mylan) align with antibacterial patent challenges commonly filed after ANDA notices.

What Cubist was trying to block

• Cubist’s litigation posture in this docket is consistent with blocking generic entry until expiration of:
  • the asserted composition and/or formulation patents, and
  • any applicable regulatory exclusivities attached to the reference product’s Orange Book patent listings.

How litigation maps to Orange Book risk

• If the asserted patents are Orange Book-listed, Mylan’s exposure usually depends on whether the ANDA included a Paragraph IV certification for one or more patents and whether Cubist sued within the statutory window.

What patents did Cubist assert, and how did claim scope shape Mylan’s risk?

Answer required by your request

• A complete and accurate litigation analysis requires the specific asserted patent numbers and asserted claims from the docket (complaint and infringement contentions) and the court’s claim construction outcomes.

Hard-data requirement

• This response cannot produce a complete patent-level summary (patent numbers, asserted claims, infringement theory, and post-Markman holdings) because those data are not present in the prompt provided here.

What procedural milestones appeared on the docket in 1:13-cv-01679?

Milestone categories that typically appear in this docket type

• Complaint filing and service
• Answer and affirmative defenses
• Motions to dismiss (often jurisdiction, venue, pleadings sufficiency)
• Claim construction (Markman) scheduling
• Dispositive motions (summary judgment on infringement or invalidity)
• Trial or, in many Hatch-Waxman cases, settlement/consent judgment without trial
• Final judgment and docket closure

Hard-data requirement

• The docket-specific dates, motion numbers, briefing outcomes, and the final judgment disposition are not contained in the prompt. Producing them would require the underlying docket text.

How did the court handle claim construction and validity/infringement in this case?

What analysis depends on

• In Hatch-Waxman patent cases, the key value driver is the claim construction outcome:
  • Narrowed claim terms can reduce infringement likelihood for a generic formulation/process.
  • Broad constructions can force a non-infringement position into a validity attack.

Validity/infringement frameworks

• Common invalidity routes in this litigation profile:
  • anticipation or obviousness
  • indefiniteness
  • written description / enablement
  • non-infringement based on generic manufacturing and composition parameters

Hard-data requirement

• The court’s construed terms and the ruling disposition are not included in the prompt, preventing a claim-level or holding-level analysis.

What was the outcome: did Mylan launch, and when?

Outcome types

• Judgment after trial
• Consent judgment reflecting settlement
• Dismissal pursuant to settlement or withdrawn claims
• Stipulated entry of judgment

Hard-data requirement

• The prompt does not include the docket’s disposition entry or settlement/consent judgment terms, including any:
  • launch date carve-outs
  • stipulated injunction scope
  • at-risk launch permissions
  • payment or royalty structures (if settlement occurred)

What does the case imply for exclusivity timelines and generic entry risk?

Business implication framework (generic entry risk)

• Generic entry risk is highest if:

  • the asserted patents survive claim construction and dispositive motion practice; or
  • the final judgment includes an injunction covering the ANDA product.

• Risk decreases if:

  • the court narrows the claim scope or finds non-infringement; or
  • the court holds key claims invalid or unenforceable.

Hard-data requirement

• Without the patents asserted, their status, and the court’s final disposition, the exclusivity and entry-risk timeline cannot be stated accurately for this specific case.

How does this Cubist v. Mylan litigation compare with other Cubist-Hatch-Waxman disputes?

Comparison variables

• Asserted patent families (composition vs. method-of-use vs. formulation)
• Claim construction outcomes
• Whether the case resolved by early settlement or full adjudication
• Whether the generic product launched “at risk” after a stay lifted or after a settlement carve-out

Hard-data requirement

• Comparative analysis requires at least one additional complete case record or the asserted patent families from this docket. Those are not provided.

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Key Takeaways

• Cubist Pharmaceuticals LLC v. Mylan Laboratories Limited (1:13-cv-01679) is a 2013 S.D.N.Y. Hatch-Waxman patent infringement dispute tied to generic entry risk for an antibacterial product.
• Litigation significance is driven by the asserted Orange Book patents and the court’s claim construction and disposition.
• This prompt does not include the asserted patent numbers, the claim terms, or the docket’s final disposition. Without those, a patent-level infringement/validity and exclusivity timeline analysis cannot be stated accurately.

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FAQs

1. What court and docket details define Cubist Pharmaceuticals LLC v. Mylan Laboratories Limited (1:13-cv-01679)?
2. How do Paragraph IV certifications typically connect to Cubist’s patent infringement suits against ANDA filers like Mylan?
3. What procedural steps (Markman, summary judgment, injunction) most often determine generic launch timing in Cubist-type Hatch-Waxman cases?
4. What settlement structures are common when S.D.N.Y. Hatch-Waxman cases resolve before trial?
5. How do claim construction outcomes usually shift the non-infringement versus invalidity balance in generic antibacterial patent cases?

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References

1. U.S. District Court for the Southern District of New York, Cubist Pharmaceuticals LLC v. Mylan Laboratories Limited, No. 1:13-cv-01679 (case docket).