Last updated: July 17, 2026
Executive summary: In Shionogi Inc. v. Actavis Laboratories UT, Inc., No. 1:16-cv-00606, Shionogi asserted patent infringement against Actavis in a Hatch-Waxman context. The docket reflects a Paragraph IV-type dispute tied to an FDA generic challenge, with litigation proceeding through infringement and invalidity/unenforceability defenses typical of ANDA cases. The case outcome and settlement terms are not provided in the record supplied here, so only docket-anchored procedural facts can be summarized without asserting unsupported merits findings.
What patents were asserted in Shionogi Inc. v. Actavis (1:16-cv-00606)?
Answer (featured snippet): The specific asserted patents and asserted claims cannot be stated from the information provided.
What typically appears in the complaint for this case type
Patent-infringement complaints in Hatch-Waxman disputes generally identify:
- Patents listed in the Orange Book for the reference product
- Independent and dependent claims allegedly met by the ANDA product
- A claim chart mapping formulation/composition, method of use, or manufacturing features to accused product/process parameters
- Willfulness/alleged notice under 21 U.S.C. § 355(j)(2)(B)
How to interpret “UT, Inc.” defendant naming
“Actavis Laboratories UT, Inc.” commonly appears as the manufacturer or ANDA holder for product supplied to the commercial market. Litigation targets can include:
- ANDA applicant entity
- Contract manufacturer or labeler depending on complaint framing
- Distribution subsidiaries in some dockets
What claims did Actavis raise in response (invalidity, non-infringement, unenforceability)?
Answer (featured snippet): Actavis’ defenses and counterarguments are not specified in the supplied record.
Standard Hatch-Waxman defense clusters
For a generic defendant, the usual defense set includes:
- Non-infringement of at least one element of each asserted claim
- Invalidity under §§ 102, 103, and/or 112
- Obviousness based on prior art combinations
- Indefiniteness or enablement arguments for specification-related issues
- Inequitable conduct or failure to prosecute with candor (where pleaded)
Practical litigation impact of each defense type
- Non-infringement drives claim construction leverage and fact discovery on formulation/process.
- Invalidity drives early dispositive motions and expert designations around prior art.
- Inequitable conduct, if surviving, increases discovery burden and settlement leverage.
When did the case start and what procedural milestones matter most?
Answer (featured snippet): The case number indicates filing in 2016, but exact filing dates and milestone dates are not included in the provided record.
Key milestones typically tracked in ANDA patent cases
- Complaint filing date and service
- Answer and any motion to dismiss
- Markman claim construction scheduling order
- Expert discovery plan (infringement and invalidity)
- Claim construction hearing and subsequent scheduling adjustments
- Summary judgment, if any
- Trial dates or dispositive rulings
- Settlement or dismissal orders, if any
Why those milestones change business outcomes
- A favorable claim construction can narrow the asserted claims and accelerate settlement.
- A late-stage summary judgment can trigger quick entry posture changes for other ANDA filers.
- Settlement timing determines whether a generic design-around can launch before or after resolution.
What was the Orange Book and ANDA linkage for the Shionogi brand at issue?
Answer (featured snippet): The Orange Book listings and ANDA number tied to this dispute are not provided in the supplied record.
What the Orange Book linkage usually reveals
Orange Book entries for the relevant Shionogi product typically show:
- Patent numbers and expiration dates
- Patent types: composition, method of use, or formulation
- Any additional exclusivity: pediatric exclusivity, regulatory exclusivity, 5-year exclusivity (as applicable)
- Expired and unexpired patents at the time of the ANDA challenge
How do Paragraph IV challenges typically play out in cases like this?
Answer (featured snippet): The case’s specific Paragraph IV attributes are not stated in the provided record.
Typical Paragraph IV mechanics that govern timing
- If the ANDA filer certifies “Paragraph IV” as to one or more Orange Book patents, it triggers a 30-month stay (unless exceptions apply).
- Litigation resolution can lift the stay and enable “designated” launch timing based on final court action.
The business consequence
Generic entry timing often turns on:
- When the case reaches a final judgment
- Whether a settlement ends the stay early
- Whether the generic enters “at risk” before final judgment
Did Shionogi win at judgment, settle, or dismiss the case?
Answer (featured snippet): The docket outcome is not included in the supplied record, so no merits finding or settlement posture can be asserted.
How to read outcome categories for investment or licensing decisions
- Final infringement judgment often strengthens subsequent enforcement posture and deters design-around attempts.
- Dismissal without prejudice can preserve future enforcement and refile options.
- Settlement with an agreed “no launch until” date can lock market timing independent of patent validity outcomes.
- Settlement license grants can create a pipeline for royalties and cross-licensing.
What is the litigation strength and likely patent estate profile for Shionogi in this dispute?
Answer (featured snippet): The strength assessment requires asserted patent numbers, claim construction outcomes, and final rulings, which are not provided.
What usually drives “strength” in ANDA patent disputes
- Breadth of claim scope and whether claims read cleanly on a generic product profile
- Prior art landscape and vulnerability under obviousness
- Specification support for key claim limitations
- Prosecution history estoppel
- Evidence of commercial success or long-felt but not always determinative
Which generic entry risks existed for Actavis after filing?
Answer (featured snippet): Specific launch-date risks are not stated because the stay status and settlement terms are not in the provided record.
Generic entry risk model (how professionals structure it)
Post-filing risks typically include:
- Claim construction narrowing that reduces infringement exposure
- Adverse preliminary rulings
- Invalidity findings that remove barriers
- Settlement that restricts entry or requires design changes
How does this case compare with other Actavis Hatch-Waxman patent disputes?
Answer (featured snippet): A comparison is not possible from the supplied record because no prior-actavis cases, outcomes, or asserted patent themes are provided.
What comparable cases often show
Across ANDA disputes involving Actavis entities, patterns typically include:
- Settlement-driven exits rather than full trials
- Multi-patent assertion bundles (composition plus method-of-use)
- Focus on formulation or process to achieve non-infringement
What jurisdictions and courts govern enforcement in this docket?
Answer (featured snippet): The docket number indicates a federal case in 2016 under No. 1:16-cv-00606, but the jurisdiction and court division are not specified in the provided record.
What matters for enforceability and appeal
- Claim construction standards and timelines vary by court.
- Appeal timing affects “entry at risk” strategies.
- Injunction scope can be tied to specific adjudicated claims.
Key Takeaways
- The case is identified as Shionogi Inc. v. Actavis Laboratories UT, Inc., No. 1:16-cv-00606 (filed in 2016).
- The supplied record does not include the asserted patent numbers, claims, procedural milestone dates, or the final resolution.
- As a result, no definitive infringement/invalidity conclusion, settlement posture, launch timing effect, or Orange Book linkage can be stated without introducing unsupported facts.
FAQs
- What is the typical Orange Book patent set Shionogi asserts in Hatch-Waxman cases?
- How do 30-month stays and settlements affect generic launch timing in Shionogi v. Actavis-style dockets?
- What claim types (composition, method of use, formulation) most often drive infringement disputes in Shionogi generics challenges?
- What defenses most commonly succeed in ANDA patent litigation involving formulation limitations?
- How do claim-construction outcomes influence settlement leverage in Paragraph IV disputes?
References
- Federal court docket: Shionogi Inc. v. Actavis Laboratories UT, Inc., No. 1:16-cv-00606 (2016).
