Last updated: August 1, 2026
Executive summary
- Case: Stiefel Laboratories Inc. v. Cobrek Pharmaceuticals Inc., 1:09-cv-00167 (federal court; docket number provided).
- Procedural and substantive details (claims asserted, patent(s) at issue, parties other than Stiefel and Cobrek, court, dates, outcome, settlement terms, and any associated ANDA/Orange Book linkage) are not present in the input.
- Without those case-specific facts, a complete and accurate litigation summary cannot be produced.
H1: Stiefel v. Cobrek Pharmaceuticals Inc. (1:09-cv-00167) Litigation Summary, Parties, Patents, and Outcome
What claims and patents did Stiefel assert in Stiefel Laboratories Inc. v. Cobrek Pharmaceuticals Inc. 1:09-cv-00167?
A litigation summary requires the asserted patent numbers and claim theories. The docket number alone does not identify:
- which patent(s) Stiefel listed as “patents-in-suit,”
- whether the suit was brought under 35 U.S.C. § 271(e)(2) for an Abbreviated New Drug Application,
- whether the dispute involved validity, non-infringement, or both,
- whether multiple Orange Book listings were targeted.
What court and jurisdiction governed 1:09-cv-00167, and what procedural posture mattered?
A business-grade analysis must anchor on:
- the court (district and judge),
- key motion practice (dismissal, claim construction, summary judgment),
- scheduling events (Markman/claim construction, trial dates),
- whether the case ended by final judgment, stipulation, consent judgment, or settlement.
Those facts are not provided.
When did the case file and how did the timeline affect exclusivity or generic entry?
For Hatch-Waxman litigation, stakeholders need:
- filing date relative to ANDA submission and FDA approval timing,
- any automatic stay under 21 U.S.C. § 355(j) tied to the first Paragraph IV notice,
- whether the litigation triggered a 30-month stay, and when it expired,
- whether any later amendments, dismissals, or settlements altered launch timing.
The input does not include filing dates, notice dates, or FDA pathway context.
What Orange Book patents were at issue, and what is the Orange Book status of the drug tied to 1:09-cv-00167?
To map patent exposure, an Orange Book crosswalk is required:
- drug product name(s),
- NDA holder and ANDA applicant names,
- patent numbers listed for each strength/route/dosage form,
- patent expiration dates (including periods adjusted under 35 U.S.C. § 154),
- regulatory exclusivities (NCE, pediatric exclusivity, 505(b)(2) exclusivity where relevant).
None of this linkage is included.
Did Cobrek file a Paragraph IV certification, and what certifications were challenged?
A correct analysis needs:
- the ANDA’s Paragraph IV certifications (to which patents),
- the exact “to the extent that” scope,
- whether Cobrek also made Section viii statements (bioequivalence or labeling changes),
- whether Stiefel alleged the ANDA was “medically significant” for method-of-use or carve-out labels.
The input provides no ANDA/P-IV details.
How strong was the patent estate for the asserted patents in Stiefel v. Cobrek?
Strength requires actual patent IDs and at least:
- claim chart elements,
- novelty/obviousness posture,
- prosecution history, reexamination, terminal disclaimers,
- prior art categories relevant to the asserted claims.
Without patent numbers and asserted claim themes, strength scoring cannot be produced.
What infringement theories did Stiefel use against Cobrek’s proposed product?
A meaningful infringement analysis depends on:
- dosage form and formulation (active ingredient, strengths, excipients if relevant),
- manufacturing method if method-of-use or process claims were asserted,
- labeling and instructions if method-of-use claims were asserted,
- whether the case involved inducement/contributory theories.
No product/formulation identifiers are provided.
What defenses did Cobrek raise (non-infringement, invalidity, unenforceability)?
A complete litigation analysis requires:
- invalidity grounds (35 U.S.C. §§ 102/103/112, subject matter eligibility where relevant),
- enforceability defenses (inequitable conduct, prosecution laches, patent misuse),
- claim construction disputes.
None of these details are included.
Did the case end in settlement, consent judgment, or final merits judgment?
Stakeholders typically need:
- the effective settlement date,
- the agreed launch date or design-around features,
- any covenant not to sue scope,
- payment-for-delay considerations where applicable,
- whether any injunction issued or was vacated.
No outcome information is provided.
Were there related cases, counterclaims, or appeals connected to 1:09-cv-00167?
Patent estate and launch risk often turn on:
- parallel litigations involving other ANDA filers,
- appellate outcomes impacting claim construction or validity,
- related ITC or state actions.
No related-case data is included.
How did this litigation affect generic or branded market entry in practice?
To quantify commercial impact, analysis requires:
- ANDA approval date(s),
- tentative launch dates and whether entry occurred,
- design-around changes required by settlement,
- prescribing and market-share shifts tied to entry.
None of that is present.
What is the expected generic entry risk profile if 1:09-cv-00167 resolved by settlement?
Risk analysis requires the settlement mechanics:
- which patents were excluded/included,
- whether settlement included a “designed for approval” carve-out,
- whether any remaining patents still bar entry,
- whether any subsequent continuation patents exist.
No settlement terms are provided.
Which jurisdictions and jurisdictions-by-patent matter for Stiefel v. Cobrek?
For business decisions, it matters whether:
- only the U.S. district court was involved,
- there were international filings affecting manufacturing/exports,
- any injunctive relief was sought beyond U.S. entry.
No jurisdictional scope beyond the docket number is provided.
Key Takeaways
- A litigation summary and analysis for Stiefel Laboratories Inc. v. Cobrek Pharmaceuticals Inc. (1:09-cv-00167) cannot be completed from the docket number alone.
- Missing case-specific facts required for a high-stakes patent and regulatory assessment include asserted patents, Orange Book linkage, procedural milestones, and the case outcome.
FAQs
- What patents were “in suit” in Stiefel Laboratories Inc. v. Cobrek Pharmaceuticals Inc. (1:09-cv-00167)?
- Did 1:09-cv-00167 involve an ANDA Paragraph IV notice and 30-month stay?
- Was the case resolved by settlement, consent judgment, dismissal, or final judgment?
- What court and judge handled claim construction or summary judgment in 1:09-cv-00167?
- How did the outcome of 1:09-cv-00167 affect Cobrek’s ability to launch the generic product?
References
- (No citable sources were provided in the prompt.)
