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Otsuka Pharmaceutical v. Lupin | Patent Lawsuit 24-2297

Otsuka Pharmaceutical Co., Ltd. v. Lupin Limited

24-2297 Fed. Cir. Closed 3 patents
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Infringement action filed 10 Sep 2024 in the United States Court of Appeals for the Federal Circuit and closed 21 May 2026, with 3 patents asserted. Recorded basis of termination: appeal dismissed.

Case recordPatsnap Litigation Data·

Case record

Case no.
24-2297
Verdict cause
Infringement action
Court
Fed. Cir.
Court level
Court of Appeals
Case region
District of Columbia
Chief judge
None recorded
Trial level
Appeal
Filed – Closed
10 Sep 2024 – 21 May 2026
Duration
618 days
Basis of termination
Appeal Dismissed
Products & marks
JYNARQUE® tolvaptan tablets in 15, 30, 45, 60, and 90 mg dosage · JYNARQUE® tolvaptan tablets
Source: Patsnap Litigation Data. Case 24-2297, United States Court of Appeals for the Federal Circuit. Open this record in Eureka
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Patent at issue
US10905694B2 Active App. US12/665642

Pharmaceutical solid preparation comprising benzazepines and production method thereof

The subject invention provides a novel pharmaceutical solid preparation that has superior disintegration properties and excellent solubility, leading to sufficient absorbability of active ingredients through the gastrointestinal tract. The pharmaceutical solid preparation of the present invention comprises:

    • (a) 7-chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoylamino)benzoyl]-2,3,4,5-tetrahydro-1H-benzoazepine and/or salt thereof;
    • (b) hydroxypropylcellulose containing a hydroxypropoxyl group in an amount of 50% or greater; and
    • (c) at least one member selected from the group consisting of carmellose, sodium carboxy methyl starch, crospovidone, and low substituted hydroxypropylcellulose with an average particle diameter of 30 to 70 μm, and a 90% cumulative particle diameter of 100 to 200 μm.

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Patent standing
Legal status
Active
Granted
2 Feb 2021
Earliest priority
21 Jun 2007
Est. expiry
7 Apr 2030
Validity challenges
None recorded
Licences recorded
None recorded
Classification
A61K31/55A61K9/20A61K9/16
Prosecution counsel
SUGHRUE MION, PLLC
Examiner
LUNDGREN, JEFFREY S
US8273735B2 Active App. US12/064178

Process for preparing benzazepine compounds or salts thereof

This invention provides a process for preparing benzazepine compounds of the formula (1): wherein X1 is a halogen atom, R1 and R2 are a lower alkyl group, or salts thereof as well as intermediate benzoic acid compounds in high yield and high purity on industrial scale, which are useful as an intermediate for preparing a pharmaceutically active 2,3,4,5-tetrahydro-1H-1-benzazepine compound having vasopressin antagonistic activity.

Read claims and description in Eureka
Patent standing
Legal status
Active
Granted
25 Sep 2012
Earliest priority
2 Sep 2005
Est. expiry
14 Aug 2028
Validity challenges
None recorded
Licences recorded
None recorded
Classification
C07D223/16
Examiner
KIFLE, BRUCK

Also asserted in this case

1 more

The docket lists 3 asserted patents. Full bibliographic detail, drawings and prosecution history for the remaining asserted patent are one query away in Eureka.

Source: Patsnap patent data + case record. Bibliographic fields and drawings reproduced from the published patent document. Break down the claims
Parties & counsel

Parties of record

Counsel of record

Source: case record + Patsnap company data. Attorney names appear as recorded in the docket. Compare both portfolios
Outcome

Basis of termination

From the record · verbatim

“THIS CAUSE having been considered, it is ORDERED AND ADJUDGED: AFFIRMED”

Case 24-2297 · Fed. Cir. · closed 21 May 2026
Source: case record, verbatim. The quoted paragraph is the basis-of-termination text as filed.

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Three questions this record usually leads to. Each one runs against the full litigation and patent corpus, and cites what it finds.

FAQ

Frequently asked questions

What is case 24-2297?

24-2297 is a patent infringement action brought by Otsuka Pharmaceutical Co., Ltd. against Lupin Limited, filed on 10 Sep 2024 in the United States Court of Appeals for the Federal Circuit. The case closed on 21 May 2026.

Which patents were asserted in 24-2297?

US10905694B2 (“Pharmaceutical solid preparation comprising benzazepines and production method thereof”), assigned to OTSUKA PHARMACEUTICAL CO., LTD., currently active; US8273735B2 (“Process for preparing benzazepine compounds or salts thereof”), assigned to OTSUKA PHARMACEUTICAL CO., LTD., currently active; US8501730B2 (“Process for preparing benzazepine compounds or salts thereof”), assigned to OTSUKA PHARMACEUTICAL CO., LTD.. The record also lists JYNARQUE® tolvaptan tablets in 15, 30, 45, 60, and 90 mg dosage and JYNARQUE® tolvaptan tablets.

How was case 24-2297 terminated?

The recorded basis of termination is appeal dismissed. The termination text reads: “THIS CAUSE having been considered, it is ORDERED AND ADJUDGED: AFFIRMED”

How long did case 24-2297 take?

618 calendar days, from filing on 10 Sep 2024 to closure on 21 May 2026.

Who were the attorneys and the judge in 24-2297?

Alicia Alexandra Rose Russo, John D. Murnane, Joshua Rothman, Megan S. Woodworth and Zachary L. Garrett are recorded as counsel for plaintiff Otsuka Pharmaceutical. Carol Pitzel Cruz, Jared C. Bunker and William R. Zimmerman appear for defendant Lupin.

Answers reproduce fields from the case record for 24-2297 and do not constitute legal advice. Ask your own question

Disclaimer. This page reproduces publicly available court docket data for case 24-2297 and is provided for general information and reference only. It is not legal advice and must not be relied upon as such.

Docket data has limits. Records are drawn from a snapshot and may lag the live docket. Sealed filings, amended complaints, counterclaims and post-closure motions may not be reflected. Party names, attorney names and firm affiliations are reproduced as recorded and may contain omissions. Where a field is absent from the record, this page marks it as not recorded rather than inferring a value.

No characterisation of the parties or the outcome. This page reports what the record contains. Nothing here should be read as an assertion that any party infringed, that any patent is valid or invalid, that any settlement occurred, or that any party prevailed.

No FTO or validity opinion. Nothing on this page constitutes a freedom-to-operate, novelty, validity or infringement opinion. Any decision touching a live patent dispute should be verified independently and reviewed with qualified patent counsel.

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