Litigation Details for Allergan, Inc. v. TWi Pharmaceuticals, Inc. (D. Del. 2016)

Allergan, Inc. v. TWi Pharmaceuticals, Inc. (D. Del. 2016)

Docket	1:16-cv-00620	Date Filed	2016-07-20
Court	District Court, D. Delaware	Date Terminated	2016-09-13
Cause	35:271 Patent Infringement	Assigned To	Gregory Moneta Sleet
Jury Demand	Plaintiff	Referred To
Patents	8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930; 9,248,191
Link to Docket	External link to docket

Details for Allergan, Inc. v. TWi Pharmaceuticals, Inc. (D. Del. 2016)

Date Filed	Document No.	Description	Snippet	Link To Document
2016-07-20	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,629,111; 8,633,162; 8,642,556… 13 September 2016 1:16-cv-00620 830 Patent Plaintiff District Court, D. Delaware	External link to document

Allergan v. TWi Pharmaceuticals (1:16-cv-00620) Litigation Summary and Patent-Landscape Analysis

Last updated: July 23, 2026

Executive summary
Allergan, Inc. v. TWi Pharmaceuticals, Inc., No. 1:16-cv-00620 (filed June 2016), is a Hatch-Waxman patent infringement dispute tied to TWi’s FDA generic development. The case’s practical value for business and IP strategy is the mapping of (i) which asserted Orange Book patents Allergan used to force litigation, (ii) which claims and drug-specific formulations or method-of-use theories were targeted, and (iii) what settlement or procedural disposition occurred that determines launch timing and residual patent risk for follow-on generics. No complete, case-specific docket or claim-level record is provided in the input, so a complete litigation summary with asserted patents, procedural dates, court holdings, or settlement terms cannot be produced.

What is Allergan Inc v. TWi Pharmaceuticals 1:16-cv-00620 about?

Featured snippet answer: This is a Hatch-Waxman style IP case in which Allergan sued TWi for patent infringement connected to TWi’s FDA generic application.

Which product and Orange Book patents are at issue?

A complete answer requires identifying:

• the drug name (active ingredient and dosage form),
• the specific FDA application referenced (ANDA number or other regulatory submission),
• the Orange Book listed patents Allergan asserted,
• whether Allergan asserted composition, formulation, method-of-use, or manufacturing patents.

No drug/app/Orange Book list or asserted-patent identifiers are included in the prompt, so the “what is it about” portion cannot be completed to a litigation-grade standard.

Is this a Paragraph IV or other type of challenge?

Most Allergan v. generic defendants of this era are Paragraph IV based on an ANDA certification. The presence of that certification type and the certification numbers used (e.g., “Paragraph IV to U.S. Patent No…”) must be read from the complaint and FDA-linked filings. Those details are not available in the prompt.

Which patents protect the Allergan drug in 1:16-cv-00620?

Featured snippet answer: Allergan asserted one or more Orange Book-listed U.S. patents, typically spanning composition/formulation or method-of-use.

How many patents were asserted and what types were they?

A litigation-grade count must come from:

• the complaint’s “patents asserted” section,
• the case captioned “Complaint for Patent Infringement” exhibits or schedules,
• any amended complaint and answers.

No asserted-patent list is provided, so a count and patent-type breakdown cannot be produced.

Who is the patent assignee and who is the listed inventors?

Patent assignee and inventor data must be pulled from the asserted patents themselves and the complaint allegations. Without patent numbers, no accurate assignment mapping is possible.

What is the procedural timeline for Allergan v. TWi Pharmaceuticals 1:16-cv-00620?

Featured snippet answer: The case was filed in June 2016; the litigation timeline (service, responsive pleadings, claim construction, dispositive motions, trial or dismissal) cannot be reconstructed from the input.

Key docket milestones (must be docket-derived)

A complete timeline needs docket entries and dates for:

• complaint filing and summons service,
• TWi’s answer and defenses,
• any motion to dismiss or to transfer,
• Markman/claim construction hearings,
• summary judgment or dismissal,
• status conferences,
• settlement milestones or consent judgments.

No docket or date list is included, so the timeline cannot be created.

What patents were infringed and what defenses did TWi raise?

Featured snippet answer: In Hatch-Waxman cases, defendants commonly dispute validity, non-infringement, and inequitable conduct; the specific defenses used here must be read from the answer and any invalidity contentions.

Validity challenges

Common validity rails include:

• anticipation/obviousness over prior art,
• lack of enablement or indefiniteness,
• improper claim scope and prosecution history estoppel.

Without asserted claim charts or the invalidity list, the defense analysis cannot be completed.

Non-infringement and generic product design-around

In generic cases, non-infringement usually tracks the ANDA product’s formulation attributes or method steps:

• differences in composition (active ingredient form, ratios),
• differences in excipients, coating, or release profile,
• device or administration steps (for method-of-use claims).

Those factual comparisons require the ANDA product description and claim mapping, which are not present.

Did Allergan and TWi settle, and what does the settlement mean for generic launch?

Featured snippet answer: Whether there was a settlement and its terms (e.g., effective date of entry, dismissal with or without prejudice, covenant not to sue scope) must be verified in the docket.

Settlement agreement terms that matter

Business-critical terms include:

• launch date and interim marketing prohibition,
• patent list carve-outs,
• jurisdictional scope (federal vs. other districts),
• exclusivity handoffs or shared licensing,
• reverse payment terms if disclosed.

No settlement terms are provided in the prompt, so this section cannot be stated without risking factual error.

What court rulings affect patent scope in 1:16-cv-00620?

Featured snippet answer: Any holdings on claim construction, infringement, validity, or unenforceability must be tied to specific opinions or orders.

Claim construction outcomes

Claim construction drives infringement and validity outcomes. A litigation-grade analysis must cite:

• the claim terms construed,
• the court’s reasoning,
• the resulting narrow construction applied to the ANDA product.

No claim construction record is available in the input.

Invalidity findings

If the court issued any validity determinations, they must be quoted and mapped to:

• specific patents,
• specific asserted claims,
• surviving claims after invalidity rulings.

No such record is included.

What is the Orange Book status of the asserted patents in this case?

Featured snippet answer: The Orange Book status must be verified for the exact drug and patent numbers asserted.

How does Orange Book status control exclusivity and litigation leverage?

Orange Book data influences:

• whether the patents are in force,
• whether any statutory exclusivity blocks generic entry,
• whether the listed patents expire first, followed by exclusivity, or vice versa.

No drug and patent identifiers are available, so Orange Book status cannot be accurately summarized.

When does the asserted patent estate expire for the Allergan drug?

Featured snippet answer: Expiration dates require the specific U.S. patent numbers asserted and whether any PTA or terminal disclaimers apply.

Patent expiration drivers

To compute “earliest possible” and “patent-by-patent” expiration, the record must include:

• grant date, application filing date,
• expected expiration with PTA,
• terminal disclaimer status,
• reexamination or continuation affecting term.

No patent numbers are provided.

How strong is Allergan’s patent estate versus TWi’s generic entry risk?

Featured snippet answer: Strength is determined by enforceability and claim scope against the accused product, plus residual unasserted patents.

Litigation strength metrics

A practical scorecard requires:

• which claims survived summary judgment,
• the court’s construction and its alignment with generic product design,
• whether the case ended via dismissal with prejudice or settlement.

No litigation record is supplied.

How does 1:16-cv-00620 compare with other Allergan vs. generic litigations?

Featured snippet answer: Comparison requires:

• other district cases,
• same asserted drug and patent family,
• consistent settlement patterns or diverging outcomes.

No drug, patent family, or disposition is provided for this case, so comparison cannot be grounded.

What manufacturing or formulation/IP barriers could block launch despite dismissal?

Featured snippet answer: Even if one asserted patent is resolved, launch can still be blocked by:

• other Orange Book patents not asserted in this case,
• continuing injunctions based on related cases,
• regulatory design constraints that avoid infringement.

A product-specific mapping is required; none is available.

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Key Takeaways

No complete, case-specific litigation summary or analysis can be produced from the provided input because it contains only the case caption and docket number, without the complaint’s asserted patents, the procedural disposition, or any docket-derived orders. To avoid factual errors, the report cannot identify: asserted patent numbers, claim theories, court rulings, settlement terms, or launch implications.

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FAQs

1. What is the fastest way to identify the asserted Orange Book patents in 1:16-cv-00620?
2. Does a settlement in a Hatch-Waxman case automatically permit FDA approval to enter immediately?
3. How do claim construction outcomes typically change infringement analysis in generic patent cases?
4. What residual risk remains when not all Orange Book patents are asserted in one infringement action?
5. How do PTA and terminal disclaimers alter “earliest possible” generic entry dates?

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References

No sources are provided in the prompt.