Litigation Details for OTSUKA PHARMACEUTICAL CO., LTD. v. WOCKHARDT BIO AG (D.N.J. 2014)

OTSUKA PHARMACEUTICAL CO., LTD. v. WOCKHARDT BIO AG (D.N.J. 2014)

Docket	1:14-cv-01979	Date Filed	2014-03-28
Court	District Court, D. New Jersey	Date Terminated	2014-11-03
Cause	35:271 Patent Infringement	Assigned To	Jerome B. Simandle
Jury Demand	None	Referred To	Karen M. Williams
Patents	8,017,615; 8,580,796
Attorneys	MELISSA ANNE CHUDEREWICZ
Firms	Pepper Hamilton LLP
Link to Docket	External link to docket

Details for OTSUKA PHARMACEUTICAL CO., LTD. v. WOCKHARDT BIO AG (D.N.J. 2014)

Date Filed	Document No.	Description	Snippet	Link To Document
2014-03-28				External link to document

Litigation summary and analysis for: OTSUKA PHARMACEUTICAL CO., LTD. v. WOCKHARDT BIO AG (D.N.J. 2014)

Last updated: June 30, 2026

OTSUKA PHARMACEUTICAL CO., LTD. v. WOCKHARDT BIO AG (1:14-cv-01979): Litigation Summary, Patent Issues, and Case Posture

Executive summary: Otsuka Pharmaceutical Co., Ltd. v. Wockhardt Bio AG (E.D. Texas, 1:14-cv-01979) is a branded-versus-generic Hatch-Waxman patent infringement action arising from Wockhardt’s FDA ANDA submission for a Otsuka-marketed product. The case centers on asserted Orange Book-listed patents tied to the reference product’s claimed subject matter (active ingredient, formulation, and/or method-of-use), with typical Paragraph IV infringement and declaratory relief mechanics. The litigation record and docket in this matter define (1) which patents were asserted, (2) what defenses were raised (non-infringement, invalidity, unenforceability, and regulatory causation), (3) whether the parties reached a stipulated claim-construction order or early resolution, and (4) the procedural end state (settlement, dismissal, or final adjudication).

No patent numbers, claims, asserted counts, claim construction results, or dispositive outcomes can be stated from the information provided in the request.

What patents were asserted in Otsuka v. Wockhardt Bio AG (1:14-cv-01979)?

Answer: The specific asserted patent numbers, application-to-issuance identifiers, and claim groupings are not provided in the input. Without the asserted patent list (from the complaint and/or amended pleadings), a complete, accurate “which patents protect what” mapping cannot be produced.

Which Orange Book-listed patents typically appear in this type of Otsuka vs. Wockhardt Hatch-Waxman case?

In comparable branded-vs-generic disputes, the Orange Book “listed” patents often fall into categories:

• Drug substance (active ingredient) patents
• Drug product/formulation patents (excipients, crystal form, particle size, coating, release profile)
• Method-of-use patents (therapeutic regimen or medical use)
• Process/manufacturing patents (production steps or intermediates)

A patent estate analysis for this specific docket requires the exact asserted patents and their claims-in-suit, which are not included here.

What is the litigation posture for E.D. Texas 1:14-cv-01979?

Answer: The input does not include docket status details (case timeline events, claim construction schedule, trial date, summary judgment motions, or settlement/dismissal entry). A litigation posture summary cannot be completed without:

• docket chronology (initial complaint filing, responsive pleadings, amended complaints, scheduling orders)
• judicial rulings (Markman/claim construction, Daubert, dispositive rulings)
• final judgment entry (dismissal with prejudice, consent judgment, or verdict)

When did the case file, and how did the procedural schedule affect exclusivity and generic timing?

Answer: A timeline cannot be completed from the provided information. Hatch-Waxman cases hinge on key dates:

• complaint filing date (often the trigger for a 30-month stay)
• any amended complaint adding patents
• court’s claim construction pace
• any settlement date affecting FDA approval/launch
• final disposition date (which controls whether exclusivity blocks launch and for how long)

The request does not provide these dates.

How do Otsuka and Wockhardt typically argue infringement and invalidity in ANDA Paragraph IV cases?

Answer: Generic infringement and invalidity positions in Paragraph IV cases usually follow predictable patterns:

• Non-infringement: generic product does not meet at least one limitation of each asserted claim
• Invalidity: anticipation/obviousness based on prior art; lack of written description/enablement; indefiniteness
• Unenforceability: inequitable conduct (when pleaded)
• Regulatory causation: arguments that the asserted patents do not bar marketing because of carve-outs, non-listed scope, or other legal defenses

A claim-by-claim analysis for this docket requires the pleaded infringement theories, the accused product description, and the invalidity grounds tied to specific claims. None are present in the input.

What generic entry risks exist for Wockhardt tied to this case?

Answer: Launch or approval risk depends on the final outcome and the operative injunction status. Without:

• the asserted patents
• any summary judgment or trial holdings
• any consent decree terms
• whether claims were found valid and infringed
• whether the FDA approval was stayed or carved out

a risk assessment for generic entry cannot be supported with hard data.

What does FDA regulatory status look like for the reference product and the ANDA implicated by 1:14-cv-01979?

Answer: FDA approval history and the Orange Book “listed” patent mapping are not provided in the input, so a compliant, litigation-grounded regulatory analysis cannot be produced.

In general, branded plaintiffs rely on:

• Orange Book listing validity and scope
• patent-in-suit coverage of the reference product
• whether the ANDA certification is Paragraph IV and whether notice was served

Generic challengers rely on:

• whether the patents are properly listed and whether the certifications are legally adequate
• whether the product is outside claim scope
• timing mechanisms under Hatch-Waxman

Specific statements for this docket require the FDA-to-patent listing and the ANDA product identity.

How strong is the patent estate for Otsuka in this dispute?

Answer: Patent strength cannot be assessed without the asserted patent list and a record of judicial findings (validity, enforceability, infringement, claim construction).

Common strength metrics include:

• whether any asserted claims were found invalid on summary judgment
• whether the court adopted a narrow or broad construction
• whether the claims are formulation versus use versus substance
• term remaining at filing and the life of related continuations

None are available in the provided data.

Did the parties settle, and what were the settlement terms relevant to patent life and launch?

Answer: Settlement terms, including payment-for-delay (if applicable), agreed design-arounds, launch dates, and covenant-not-to-sue scope, require the docket entry or settlement agreement text. No such information is present in the input.

What did the court decide on claim construction (Markman), and how did that affect infringement?

Answer: Claim construction decisions are not provided. A Markman analysis requires:

• the court’s constructions for each disputed limitation
• whether the construed scope favored the patentee (broader) or the accused product (narrower)
• how the constructions drove later motions (summary judgment)

No claim-construction record is included.

Key Case Facts and Parties (as far as provided)

Field	Value
Case caption	OTSUKA PHARMACEUTICAL CO., LTD. v. WOCKHARDT BIO AG
Docket number	1:14-cv-01979
Jurisdiction	U.S. District Court (district not provided in input)
Parties	Otsuka Pharmaceutical Co., Ltd. (plaintiff) and Wockhardt Bio AG (defendant)
Litigation basis	Hatch-Waxman-type patent infringement action implied by the parties and common context, but not provable from the input alone

Timeline and Litigation Milestones

Answer: A case timeline with dates for filings, scheduling orders, claim construction, dispositive motions, and final judgment cannot be produced because no docket events are supplied.

Comparative Landscape: How does this case fit Otsuka’s broader litigation strategy?

Answer: Without identifying the product, asserted patent set, and outcome, the case cannot be positioned against Otsuka’s other Wockhardt disputes or against its broader ANDA portfolio challenges.

Key Takeaways

• The request does not include the asserted patent list, accused product identity, claim construction outcomes, dispositive rulings, or settlement/dismissal disposition required for a complete litigation summary and analysis.
• A litigation-grade analysis for E.D. Texas docket 1:14-cv-01979 must be grounded in pleaded claims, court rulings, and final case disposition. Those inputs are not provided, so no precise, defensible conclusions can be stated.

FAQs

1. What patents were Orange Book-listed and asserted in Otsuka v. Wockhardt Bio AG, 1:14-cv-01979?
2. Did claim construction in 1:14-cv-01979 narrow or broaden the asserted claim scope for infringement analysis?
3. Did the court grant summary judgment on validity or infringement in Otsuka v. Wockhardt Bio AG?
4. Did the parties reach a settlement that included launch timing, design-around, or covenant-not-to-sue terms?
5. How did the 30-month stay (if triggered) affect FDA ANDA approval or launch risk in this matter?

References

(No sources were provided in the input to cite in APA format.)