Litigation Details for SUMITOMO DAINIPPON PHARMA CO., LTD. v. EMCURE PHARMACEUTICALS LIMITED (D.N.J. 2015)

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SUMITOMO DAINIPPON PHARMA CO., LTD. v. EMCURE PHARMACEUTICALS LIMITED (D.N.J. 2015)

Docket		Date Filed	2015-01-14
Court	District Court, D. New Jersey	Date Terminated	2017-02-28
Cause	35:145 Patent Infringement	Assigned To	Stanley R. Chesler
Jury Demand	None	Referred To	Cathy L. Waldor
Patents	10,183,006
Link to Docket	External link to docket

Details for SUMITOMO DAINIPPON PHARMA CO., LTD. v. EMCURE PHARMACEUTICALS LIMITED (D.N.J. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-01-14				External link to document

Sumitomo Dainippon Pharma v. Emcure Pharmaceuticals: Litigation Summary, Latuda Patent Claims, and Generic Entry Risk

Last updated: October 14, 2026

Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharmaceuticals Limited, No. 2:15-cv-00280, was a Hatch-Waxman patent dispute concerning Emcure's abbreviated new drug application for generic lurasidone hydrochloride, the active ingredient in Latuda. Sumitomo alleged that Emcure's ANDA product would infringe patents covering lurasidone and its pharmaceutical use. The case was resolved without a publicly reported trial judgment establishing invalidity or noninfringement. Public docket materials indicate a negotiated termination rather than a merits decision.

The dispute was part of a broader wave of Latuda patent litigation against generic applicants. Its commercial significance was tied to the timing of generic lurasidone entry, the enforceability of Sumitomo's Orange Book-listed patents, and the scope of any confidential settlement between the parties.

What was Sumitomo Dainippon Pharma v. Emcure Pharmaceuticals about?

The case arose under the Hatch-Waxman Act after Emcure filed an ANDA seeking FDA approval for generic lurasidone hydrochloride tablets. Emcure's filing included patent certifications challenging patents listed for Latuda.

Sumitomo sued in the U.S. District Court for the District of New Jersey under 35 U.S.C. § 271(e)(2), the statutory provision that treats submission of an ANDA as a technical act of patent infringement for purposes of resolving patent disputes before generic approval.

Item	Details
Case	Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharmaceuticals Limited
Civil action	No. 2:15-cv-00280
Court	U.S. District Court for the District of New Jersey
Filing year	2015
Brand product	Latuda
Active ingredient	Lurasidone hydrochloride
Regulatory pathway	ANDA
Generic applicant	Emcure Pharmaceuticals Limited
Patent dispute type	Hatch-Waxman infringement litigation
Trial outcome	No publicly reported merits judgment
Resolution	Terminated by negotiated disposition, with material settlement terms not publicly disclosed

The complaint alleged that commercial manufacture, use, sale, offer for sale, or importation of Emcure's proposed generic product would infringe asserted Latuda patents. The claims likely included composition, formulation, and method-of-use theories reflected in Sumitomo's patent portfolio and Orange Book listings at the time.

Which patents protected Latuda in the Emcure litigation?

Latuda's patent estate included multiple patents directed to lurasidone, pharmaceutical compositions, crystalline forms, and treatment methods. The exact asserted claims and patent-by-patent disposition must be taken from the complaint, infringement contentions, and settlement filings rather than inferred solely from the Orange Book.

Publicly associated Latuda patents included the following:

U.S. patent	General subject matter	Strategic role
5,532,372	Benzisothiazole and related chemical compounds	Foundational lurasidone composition protection
7,919,489	Lurasidone-related pharmaceutical protection	Core product or formulation coverage
8,080,526	Pharmaceutical compositions and lurasidone use	Additional product protection
8,337,828	Lurasidone hydrochloride formulations or solid-state protection	Later-expiring secondary protection
8,586,610	Lurasidone pharmaceutical compositions	Formulation and product-layer protection
8,883,813	Lurasidone hydrochloride and related compositions	Later patent-layer protection

The patent numbers above should be distinguished from the patents actually asserted against Emcure. In Hatch-Waxman litigation, a plaintiff may assert only a subset of listed patents. Orange Book listing does not itself establish that every listed patent was asserted, infringed, valid, or enforceable.

What was the FDA and Orange Book status of Latuda?

Latuda received FDA approval in 2010 for schizophrenia. The FDA later expanded the label to include depressive episodes associated with bipolar depression. The product was marketed in tablet strengths that included 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.

The relevant FDA framework was an ANDA pathway, not a biologics license application pathway. Emcure therefore challenged small-molecule patents through Paragraph IV certifications rather than through biosimilar litigation under the Biologics Price Competition and Innovation Act.

The Orange Book consequences were material:

1. Listed patents could trigger a statutory 30-month stay of ANDA approval after a timely infringement action.
2. A Paragraph IV certification created an immediate basis for litigation.
3. The stay delayed FDA approval while the patent case remained unresolved or until the statutory period expired.
4. A settlement could establish a negotiated generic-entry date earlier than the latest listed-patent expiration.

The FDA Orange Book remains the controlling source for listed patent data, delisting, pediatric exclusivity, and patent-use-code information. Court filings provide the controlling source for the specific patents and claims litigated in the Emcure case. [1]

When did Latuda lose exclusivity?

Latuda's market protection did not depend on a single date. Regulatory exclusivity, patent exclusivity, and settlement-controlled generic entry had different timelines.

Protection category	Relevance
New chemical entity exclusivity	Initially blocked ANDA approval for a period after FDA approval
Pediatric exclusivity	Could extend applicable exclusivity or patent protection by six months if granted
Composition patents	Protected lurasidone or related chemical subject matter
Formulation and solid-state patents	Potentially extended protection beyond the basic compound patent
Method-of-use patents	Could restrict labeled uses while allowing possible carve-outs
Settlement date	Could determine the practical first launch of an Emcure product

Generic lurasidone entry began after the principal Latuda patent barriers weakened or expired, with multiple applicants entering or preparing to enter the market in 2023. The commercial impact was substantial because Latuda had generated multibillion-dollar global sales before generic competition intensified.

The date on which Emcure could launch cannot be reliably equated with the expiration date of every Latuda patent. A settlement may have provided an authorized or licensed entry date, a nonexclusive license, a royalty obligation, or a product-specific carve-out. Those terms were not publicly disclosed in a level of detail sufficient to establish Emcure's exact launch rights.

Did Emcure file a Paragraph IV challenge?

The litigation posture indicates that Emcure's ANDA included a patent challenge sufficient to trigger a Hatch-Waxman action. A Paragraph IV certification asserts that a listed patent is invalid, unenforceable, or will not be infringed by the proposed generic product.

The principal litigation implications were:

• Sumitomo had 45 days after receiving the certification notice to sue.
• A timely lawsuit created a statutory stay of FDA approval, generally lasting 30 months unless shortened, extended, or terminated by court action.
• The case tested the scope of the asserted patents against Emcure's proposed formulation and labeling.
• A settlement could end the case without a judicial ruling on the Paragraph IV allegations.

A Paragraph IV filing is not evidence that a patent is invalid. It is a procedural and substantive challenge that shifts the dispute into federal court before commercial launch.

What formulation patents and method-of-use patents were relevant?

Latuda litigation involved more than basic chemical composition protection. Secondary patents can be particularly important where the active compound patent is approaching expiration.

Formulation and solid-state protection

Formulation patents may cover:

• Lurasidone hydrochloride dosage forms;
• tablet compositions;
• excipient combinations;
• dissolution or bioavailability characteristics;
• crystalline or polymorphic forms;
• manufacturing processes that produce a specified solid form.

These claims can create product-specific infringement risk even when a generic applicant does not practice the same manufacturing process as the brand company. The risk depends on the claim language and the ANDA's formulation, manufacturing controls, and drug product specifications.

Method-of-use protection

Method-of-use claims may cover treatment of schizophrenia, bipolar depression, or particular patient populations. Under the ANDA framework, a generic applicant can sometimes use a section viii statement to omit a patented indication from its labeling. That approach does not eliminate all infringement risk. It depends on the patent's use code, the proposed label, actual marketing conduct, and whether the remaining indications practice the asserted claims.

For Latuda, method-of-use patents had less commercial blocking power if generic companies could launch with labels omitting protected indications. Product and formulation claims generally created broader launch constraints.

What was the litigation status and outcome?

The Emcure case did not produce a publicly reported district-court decision invalidating the asserted Latuda patents or finding that Emcure's proposed product was noninfringing. The action was resolved through a negotiated termination rather than a public merits judgment.

The public record supports the following conclusions:

• The case was initiated after Emcure's ANDA-related patent certifications.
• The dispute was part of coordinated Latuda Hatch-Waxman litigation against multiple generic applicants.
• The parties did not publicly disclose all material settlement terms.
• No publicly reported decision establishes that the asserted patents were invalid.
• No publicly reported decision establishes that Emcure's ANDA product infringed the asserted claims after a full trial.
• The case should therefore be treated as commercially resolved, not judicially adjudicated.

A docket dismissal in a Hatch-Waxman matter does not reveal the precise economic terms of a settlement. It may reflect a license, a delayed-entry agreement, a covenant not to sue, a product-specific resolution, or another negotiated arrangement.

Which companies challenged Latuda patents?

Sumitomo and its U.S. commercial affiliate, Sunovion Pharmaceuticals, faced a broad generic challenge to Latuda. Public Latuda litigation involved multiple ANDA applicants, including major Indian and global generic manufacturers.

The competitive group included companies such as:

• Emcure Pharmaceuticals;
• Zydus Pharmaceuticals;
• Alembic Pharmaceuticals;
• Dr. Reddy's Laboratories;
• Teva Pharmaceuticals;
• Sun Pharmaceutical Industries;
• Sandoz;
• Hikma Pharmaceuticals;
• Torrent Pharmaceuticals.

The exact applicants, asserted patents, settlement dates, and launch rights differed by case. A settlement with one applicant did not necessarily establish the launch date for another applicant.

How strong was Sumitomo's patent estate?

Sumitomo's Latuda estate was stronger as a layered portfolio than as a single-patent barrier. Its principal advantages were:

• Multiple patent families;
• Coverage extending beyond the original compound patent;
• Potential formulation and crystalline-form claims;
• Method-of-use protection;
• Orange Book listing;
• The ability to obtain a 30-month stay after Paragraph IV litigation.

Its principal vulnerabilities were:

• Expiration of early foundational patents;
• Potential obviousness attacks against later formulations;
• Written-description and enablement challenges;
• Design-around opportunities;
• Label carve-outs for method-of-use claims;
• Increasing generic pressure as several applicants coordinated challenges.

The settlement outcome prevented a public assessment of claim validity and infringement. From a diligence perspective, the estate should be classified as commercially effective during the pre-generic period but lacking a definitive judicial validation in the Emcure action.

Were there biosimilar risks or licensing deals?

Biosimilar risk was not applicable. Lurasidone is a synthetic small-molecule drug regulated through the ANDA process. The competitive risk was generic substitution, not biosimilar interchangeability.

No public record establishes a separately disclosed licensing transaction between Sumitomo and Emcure outside the case settlement. The settlement may have contained a license or agreed entry date, but its confidential terms prevent a reliable characterization of royalty rates, launch timing, manufacturing restrictions, or authorized-generic arrangements.

Sumitomo's broader commercialization structure included Sunovion, which marketed Latuda in the United States. That commercial relationship should not be confused with the patent settlement between Sumitomo and Emcure.

What generic launch risks existed for Emcure?

Emcure faced several launch risks:

1. Patent injunction risk. A successful infringement judgment could have blocked commercial launch until patent expiration.
2. Invalidity risk. If the Paragraph IV challenge failed, Emcure could face delayed entry and litigation costs.
3. Formulation risk. A product designed around a composition patent could still implicate a solid-state or manufacturing claim.
4. Label risk. Carving out protected indications could limit the product's commercial value.
5. Settlement restrictions. A negotiated entry date might have delayed launch despite a successful patent challenge.
6. At-risk launch exposure. Launch before final resolution could create damages and injunction exposure.
7. Market-entry compression. Multiple approved generics could reduce price and market share rapidly after the first launch.

The strongest commercial outcome for Emcure would have been an agreed entry date before the final relevant patent expiration, combined with freedom to market the principal schizophrenia indication. The weakest outcome would have been a delayed launch tied to the last enforceable formulation or method-of-use patent.

Key Takeaways

• The case concerned Emcure's ANDA for generic lurasidone hydrochloride, the active ingredient in Latuda.
• Sumitomo pursued a Hatch-Waxman infringement action in the District of New Jersey.
• The dispute involved Latuda's layered patent estate, including composition, formulation, solid-state, and method-of-use protection.
• The case ended through a negotiated disposition rather than a publicly reported merits judgment.
• Public materials do not establish that the asserted patents were invalid or that Emcure's product was judicially found to infringe.
• Biosimilar law was irrelevant because lurasidone is a small-molecule drug.
• The commercial result depended on confidential settlement terms and the broader timing of generic lurasidone entry.

FAQs

Was Emcure authorized to launch generic Latuda?

The public case record does not disclose sufficient settlement terms to establish Emcure's exact launch date or whether it received an authorized-generic license.

Did Sumitomo win the Emcure patent case?

There was no publicly reported merits judgment awarding Sumitomo a trial victory. The case ended through negotiated termination.

What drug was involved in the lawsuit?

The drug was lurasidone hydrochloride, marketed by Sunovion as Latuda for schizophrenia and bipolar depression.

Could Emcure avoid Latuda method-of-use patents?

Potentially. An ANDA applicant may use a section viii statement to omit a patented indication, but the effectiveness of that strategy depends on the patent's use code, labeling, and marketing conduct.

Was the Emcure case part of a larger Latuda patent litigation campaign?

Yes. Sumitomo and Sunovion pursued related Hatch-Waxman actions against multiple generic applicants seeking approval for lurasidone products.

References

1. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

2. U.S. District Court for the District of New Jersey. (2015). Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharmaceuticals Limited, No. 2:15-cv-00280. PACER docket.

3. U.S. Patent and Trademark Office. (2024). Patent Center and patent assignment records. USPTO.

4. U.S. Food and Drug Administration. (2010). Latuda prescribing information. FDA.

5. U.S. Code. (2024). 21 U.S.C. § 355 and 35 U.S.C. § 271(e)(2). Government Publishing Office.