Last Updated: June 19, 2026

Litigation Details for TAKEDA PHARMACEUTICALS AMERICA, INC. v. APOTEX, INC. (D.N.J. 2021)


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TAKEDA PHARMACEUTICALS AMERICA, INC. v. APOTEX, INC. (D.N.J. 2021)

Docket 2:21-cv-12998-KM-AME Date Filed 2021-06-25
Court District Court, D. New Jersey Date Terminated
Cause 35:271 Patent Infringement Assigned To Kevin McNulty
Jury Demand None Referred To
Patents 8,114,874; 9,493,470
Link to Docket External link to docket
Small Molecule Drugs cited in TAKEDA PHARMACEUTICALS AMERICA, INC. v. APOTEX, INC.
The small molecule drug covered by the patents cited in this case is ⤷  Start Trial .

Details for TAKEDA PHARMACEUTICALS AMERICA, INC. v. APOTEX, INC. (D.N.J. 2021)

Date Filed Document No. Description Snippet Link To Document
2021-06-25 119 Opinion include nonhuman 12 Zou et al., U.S. Patent No. 8,114,874 (DE 64-5). …The patents-in-suit are Patent Nos. 9,493,470 (the “’470 patent”), 11,192,895 (the “’895 patent”), 11,192,897… 63) ’470 Patent = Patent No. 9,493,470 (DE 63-2) ’895 Patent = Patent No. 11,192,895 (DE…,192,897 (the “’897 patent”), and 11,384,086 (the “’086 patent”).1 These patents are directed to crystalline…, and ’897 patents—was consolidated with Civil Action No. 1:22-cv-06151, a parallel patent infringement External link to document
>Date Filed >Document No. >Description >Snippet >Link To Document

Litigation summary and analysis for: TAKEDA PHARMACEUTICALS AMERICA, INC. v. APOTEX, INC. (D.N.J. 2021)

Last updated: April 24, 2026

What happened in Takeda Pharmaceuticals America, Inc. v. Apotex, Inc. (2:21-cv-12998-KM-AME)?

What is the case and what issues did the court address?

The user-provided docket identifier “2:21-cv-12998-KM-AME” corresponds to a U.S. federal case in the District of New Jersey, styled Takeda Pharmaceuticals America, Inc. v. Apotex, Inc.. However, the message provides no operative facts (asserted patents, brand/generic drug, claims at issue, procedural posture, judgment dates, or the court’s decision text). With no case record content, a complete litigation summary and patent-validity/infringement analysis cannot be produced without fabricating details.

What relief was sought and how did the dispute progress?

No information is provided about:

  • asserted patents (numbers, filing/issue dates)
  • the accused product (NDC, drug name, formulation, dosage)
  • the theory of infringement (direct, induced, contributory; product-by-process)
  • the legal framework (e.g., Hatch-Waxman 21 U.S.C. § 355(j), 35 U.S.C. §§ 271, 282)
  • claim construction outcomes
  • expert findings or claim-to-spec mapping
  • motions (dismissal, summary judgment, preliminary injunction)
  • final judgment or settlement terms

Without these inputs, any “summary and analysis” would be non-verifiable.

What patents were asserted and what claims were litigated?

No asserted patent list or claim set is provided. Patent litigation analysis requires at minimum:

  • patent numbers and relevant independent claims
  • relevant claim terms construed by the court
  • infringement elements and accused features
  • defenses (invalidity grounds, § 102/§ 103/§ 112, inequitable conduct if any)

None of that is included in the request.

What was the court’s outcome?

No disposition is provided (dismissal, injunction, permanent injunction, summary judgment, trial verdict, or consent judgment). Without the decision or docket event list, there is no accurate basis to state the outcome.


Litigation summary

No case record content was included beyond the case caption and docket number. A litigation summary requires the court’s rulings, the asserted patent(s), and the accused product and infringement/invalidity positions. Those elements are absent.


Patent analysis (infringement, validity, remedies)

A substantive patent analysis cannot be generated because the request does not provide:

  • patent numbers and claim text
  • court claim constructions
  • technical claim charts or equivalent disclosures
  • prior art references relied on for anticipation/obviousness
  • how the accused product is made and what it contains

Producing this analysis without those facts would require inventing specifics, which is not appropriate.


Key Takeaways

  1. The request contains insufficient record details to produce a complete, accurate litigation summary.
  2. A defensible infringement and validity analysis requires asserted patent claims, court constructions, and accused product specifics, none of which are provided.
  3. No outcome, remedies, or procedural milestones are included, so the case cannot be characterized reliably.

FAQs

1) Is the case a Hatch-Waxman patent dispute?

Not determinable from the provided information.

2) Which Takeda drug and which Apotex product were involved?

Not determinable from the provided information.

3) What patents were asserted in the complaint?

Not provided in the request.

4) Did the court issue an injunction or summary judgment?

Not provided in the request.

5) What grounds were used for invalidity (anticipation, obviousness, enablement, indefiniteness)?

Not provided in the request.


References

[1] No external sources were provided in the prompt, and no case text or docket event details were included to cite.

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