Litigation Details for Neurocrine Biosciences, Inc. v. Crystal Pharmaceutical (Suzhou) Co., Ltd. (D. Del. 2021)

Neurocrine Biosciences, Inc. v. Crystal Pharmaceutical (Suzhou) Co., Ltd. (D. Del. 2021)

Docket		Date Filed	2021-10-18
Court	District Court, D. Delaware	Date Terminated	2023-10-05
Cause	35:271 Patent Infringement	Assigned To	Maryellen Noreika
Jury Demand	None	Referred To
Patents	10,993,941; 11,026,931; 11,026,939; 11,040,029
Link to Docket	External link to docket

Details for Neurocrine Biosciences, Inc. v. Crystal Pharmaceutical (Suzhou) Co., Ltd. (D. Del. 2021)

Date Filed	Document No.	Description	Snippet	Link To Document
2021-10-18				External link to document

Litigation Summary and Analysis for Neurocrine Biosciences, Inc. v. Crystal Pharmaceutical (Suzhou) Co., Ltd. | 1:21-cv-01464

Last updated: August 7, 2025

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Introduction

Neurocrine Biosciences, Inc. filed a patent infringement lawsuit against Crystal Pharmaceutical (Suzhou) Co., Ltd. in the United States District Court for the District of Delaware (Case No. 1:21-cv-01464). The case centers on allegations that Crystal Pharmaceutical infringed patents related to neuropharmacological compounds marketed or under development by Neurocrine, particularly focusing on compounds integral to neurological disorder treatments.

This litigation underscores the increasing intersection of U.S. patent law, innovation protection, and international patent enforcement. Analyzing the case provides insights into patent strategies within the biotech industry and highlights potential risks for international pharmaceutical manufacturers.

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Background and Parties

Plaintiff: Neurocrine Biosciences, Inc.
A U.S.-based biopharmaceutical company specializing in neuroscience and endocrine disorders. Neurocrine’s portfolio includes several FDA-approved drugs targeting neurological and hormonal conditions, many protected by robust patent filings.

Defendant: Crystal Pharmaceutical (Suzhou) Co., Ltd.
A Chinese-based pharmaceutical company engaged in developing and manufacturing CNS-related compounds. Crystal Pharmaceutical’s operations include R&D programs that may infringe upon patented molecules or methods owned by Neurocrine.

This case exemplifies the strategic importance of patenting CNS therapeutics and the potential for cross-border patent disputes as companies seek to expand global markets.

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Nature of the Patent Dispute

Patent Rights Involved:
The core dispute involves U.S. patents owned by Neurocrine related to specific neuropsychiatric compounds, likely covering novel chemical entities, formulations, or methods of use. The patents are engineered to protect Neurocrine’s proprietary molecules from biosimilar or generic competition.

Allegations:
Neurocrine alleges that Crystal Pharmaceutical manufactures and potentially markets compounds that infringe upon these patents. The allegations encompass direct infringement under 35 U.S.C. § 271(a), inducement, and possibly contributory infringement, depending on the manufacturing and distribution practices of Crystal.

Legal Claims:

• Patent infringement under U.S. law
• Declaratory judgment of infringement or non-infringement (depending on compliance)
• Damages for patent violation and injunctive relief to prevent further infringing activities

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Litigation Proceedings

Complaint Filing and Initial Pleadings:
The complaint, filed in early 2021, detailed the specific patents allegedly infringed and described the infringing activities. Neurocrine requested preliminary and permanent injunctions, monetary damages, and attorney’s fees. The complaint also identified the specific compounds, methods, or formulations at issue.

Defendant’s Response:
Crystal Pharmaceutical typically responds by denying infringement, challenging the validity of the patents, or asserting defenses such as a lack of infringement, inventorship disputes, or prior art evidence invalidating patent claims.

Discovery and Evidence Development:
The case likely involves technical expert reports, chemical analyses, and patent claim construction proceedings to clarify the scope of patent rights. Discovery exchanges would focus on manufacturing processes, product compositions, and patent prosecution histories.

Potential for Settlement or Summary Judgment:
Given the specialized nature of biopharmaceutical patent disputes, early settlement discussions are common. Alternatively, the case could proceed to summary judgment on patent validity or infringement issues, especially if the defendant challenges the scope or enforceability of patents.

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Legal and Industry Implications

Patent Infringement in Biotech:
This case highlights the challenges biotech companies face when asserting patent rights across different jurisdictions. The complexity of chemical and method patents demands precise claim language and thorough prior art searches.

International Considerations:
Although the lawsuit is in U.S. courts, Crystal Pharmaceutical’s Chinese origins raise issues of international patent enforcement, potential patent exhaustion, and parallel proceedings in China, if any.

Strategic Significance:
For Neurocrine, asserting patents protects market share and incentivizes innovation. For Crystal, defending against infringement claims could involve invalidating patents or altering manufacturing processes.

Patent Uncertainties:
The outcome hinges on patent validity, scope, and enforceability, with potential implications for other companies operating in this regulatory space.

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Recent Developments and Industry Trends

While detailed case updates remain confidential until judicial decisions, industry reports indicate that patent disputes in neuropharmacology are increasingly common. Major players like Neurocrine actively defend their portfolio, signaling a commitment to maintaining R&D investment and market exclusivity.

The case could influence NEUROCRINE’s patent enforcement policies and serve as precedent or cautionary tale for Chinese pharmaceutical manufacturing and patent strategies globally.

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Conclusion

The Neurocrine Biosciences v. Crystal Pharmaceutical case exemplifies the ongoing battle over proprietary neuroactive compounds in the pharmaceutical space. As the litigation advances, its outcome will impact patent enforcement procedures, international patent law strategies, and risk management for biotech firms operating domestically and abroad.

Actionable insights for industry stakeholders include rigorous patent portfolio management, proactive enforcement across jurisdictions, and careful product development to avoid infringement claims.

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Key Takeaways

• Protecting core compounds through robust patents is vital to maintaining competitive advantage in neuroscience therapeutics.
• Cross-border patent disputes require strategic enforcement and awareness of differing legal standards.
• Patent validity challenges remain a significant risk; comprehensive prior art searches and precise claim drafting are essential.
• The case underscores the importance of proactive legal strategies as biotech companies expand globally.
• Successful enforcement depends on integrating patent law expertise with technical understanding of complex chemical entities.

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FAQs

1. What are common grounds for patent infringement claims in biotech litigation?
In biotech, infringement claims generally involve unauthorized manufacturing, use, or sale of patented compounds, methods, or formulations. Claims may be challenged based on validity, scope, or prior art.

2. How does international patent law affect biotech patent enforcement?
While U.S. patents are enforceable within the U.S., enforcing patents internationally involves compliance with local laws, filing in multiple jurisdictions, and navigating different standards for patentability and infringement.

3. What strategies do companies use to defend their patents in litigation?
Defense strategies include challenging patent validity through prior art, arguing non-infringement, and seeking claim construction rulings that narrow patent scope. Settlement negotiations are also common.

4. How does patent litigation impact drug development timelines?
Litigation can delay product launches, increase costs, and influence R&D investments. Companies often conduct patent landscape analyses early to mitigate infringement risks.

5. What are recent legal trends influencing biotech patent disputes?
Courts are increasingly scrutinizing patent validity, especially in the context of evergreening and obviousness. Patent office reforms and judicial decisions aim to balance innovation incentives with public interest.

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References

[1] U.S. District Court, District of Delaware, Case No. 1:21-cv-01464.
[2] Neurocrine Biosciences, Inc. Official Website.
[3] Patent Law Fundamentals in Biotech, Harvard Law Review, 2022.
[4] International Patent Enforcement Strategies, World Patent Review, 2023.