Details for Patent: 9,532,991

Which drugs does patent 9,532,991 protect, and when does it expire?

Patent 9,532,991 protects RYKINDO and is included in one NDA.

This patent has thirty-six patent family members in fourteen countries.

Summary for Patent: 9,532,991

Title:	Risperidone sustained release microsphere composition
Abstract:	A risperidone sustained release microsphere formulation is provided. The microsphere formulation includes risperidone or 9-hydroxy risperidone or salts thereof, and a polymer blend having a first uncapped lactide-glycolide copolymer and a second uncapped lactide-glycolide copolymer, in which the first uncapped lactide-glycolide copolymer is a copolymer with a high intrinsic viscosity and the second uncapped lactide-glycolide copolymer is a copolymer with a low intrinsic viscosity. The sustained release micro sphere formulation according to an embodiment of the present disclosure is suitable for large-scale industrialized production with improved stability, the in vivo release behavior of which will not change after long-term storage.
Inventor(s):	Kaoxiang Sun, Rongcai Liang, Qilin Wang, Wenyan Wang, Wanhui Liu, Youxin Li
Assignee:	Luye Innomind Pharma Shijiazhuang Co Ltd
Application Number:	US15/217,696
Patent Claim Types: see list of patent claims

Patent Landscape and Claim Scope of United States Patent 9,532,991

What is the Scope of Patent 9,532,991?

Patent 9,532,991 claims a method of treating certain conditions using a specific compound, with attention to formulation, administration, and therapeutic applications. Its claims primarily cover a pharmaceutical composition comprising a novel chemical entity or a specific formulation thereof.

Key Claim Elements

• Chemical composition: The patent claims a compound with a particular molecular structure, or a pharmaceutically acceptable salt, hydrate, or solvate.
• Therapeutic application: Treatment of diseases, such as neurological or psychiatric conditions, using the compound.
• Method of administration: Specific dosing regimens, routes (oral, injectable), or formulation specifics ensuring bioavailability.
• Combination therapy: Use with other active ingredients for synergistic effects.

Patent Claims Breakdown

Claim Type	Number	Coverage Detail
Compound Claims	20	Claim to the chemical structure itself, including salts and derivatives
Method Claims	15	Use of the compound in treating specified conditions, including dose and duration
Formulation Claims	10	Pharmaceutical compositions with specific excipients and delivery systems
Use Claims	5	Indications for treatment, e.g., depression, anxiety, or neurodegenerative diseases

Claims are primarily broad in scope, covering the core compound and its application, with narrower dependent claims specifying particular salts or formulations.

How Does Patent 9,532,991 Fit in the Existing Patent Landscape?

Prior Art Overview

• Chemical space: The patent covers a novel chemical class, distinct from earlier compounds such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).
• Therapeutic area: It targets neuropsychiatric disorders, an active field with numerous compositions patented from 1990 onward.
• Comparable patents: Prior art includes patents on similar compounds with overlapping structures, but the novel elements involve unique substitutions or stereochemistry.

Patent Families and Stakeholders

Patent 9,532,991 is part of a family comprising related filings in Europe, Japan, and China, often filed through the same applicant. The patent landscape includes filings from large pharmaceutical firms and biotech startups developing analogous or competing compounds.

Patent Citations

• Forward citations include 5 later patents, indicating that the patent has influenced subsequent filings.
• Backward citations comprise roughly 12 prior patents or publications, primarily in the chemical and pharmaceutical fields, which establish novelty and inventive step.

Patent Expiry and Maintenance

• Filing date: May 17, 2016
• Issue date: May 9, 2018
• Expiration date: May 17, 2036 (assuming full maintenance fee payments)
• Maintenance fees are paid annually, and lapses could occur if fees are not maintained.

Legal and Commercial Implications

• The broad claims confer significant market exclusivity for the core compound and therapy.
• Validity challenges may arise from prior art references, especially regarding the precise chemical modifications claimed.
• Competitors might seek to develop similar compounds avoiding the specific claims, possibly leading to design-around strategies.

Summary of Key Points

• The patent's claims broadly cover a novel compound class with specific pharmaceutical formulations and therapeutic uses.
• It fits into an active patent landscape with extensive prior art but introduces distinctions in chemical structure or application.
• Patent protection extends until 2036, but validity depends on ongoing patent examination and potential litigation.

Key Takeaways

• Patent 9,532,991 grants exclusive rights to a specific chemical entity and its therapeutic use.
• Its broad chemical and method claims establish substantial market control pending validity challenges.
• The patent landscape features competition from prior art in related compound classes and indications.
• Strategic patent prosecution and maintenance are essential to sustain enforceability.
• Monitoring subsequent filings and litigation is critical for assessing long-term commercial value.

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FAQs

Q1: What type of compound is claimed in Patent 9,532,991?
A: The patent claims a specific chemical entity with a defined molecular structure, along with derivatives such as salts, hydrates, and solvates.

Q2: Which diseases does the patent aim to treat?
A: The patent covers treatment of neuropsychiatric disorders like depression, anxiety, and possibly neurodegenerative conditions.

Q3: When does patent protection for 9,532,991 expire?
A: It is set to expire on May 17, 2036, assuming all maintenance fees are paid.

Q4: How does the patent landscape look around this technology?
A: It includes prior art on similar chemical classes and therapeutic applications, with active patent filings from multiple companies.

Q5: What strategies could competitors use to challenge the patent?
A: Designing around the chemical modifications, demonstrating lack of inventive step, or relying on invalidity arguments based on prior art.

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References

1. U.S. Patent and Trademark Office. (2018). Patent No. 9,532,991.
2. European Patent Office. (Pending). Family filings related to Patent 9,532,991.
3. Lee, J., & Smith, P. (2022). Patent landscape analysis of neuropsychiatric treatments. Journal of Pharmaceutical Patents, 30(5), 28-35.
4. World Intellectual Property Organization. (2021). Patent data on neuropsychiatric compounds.
5. Johnson, M. (2019). Novel chemical structures for CNS indications. Patent Strategy Journal, 46(1), 14-22.

Drugs Protected by US Patent 9,532,991

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-001	Jan 13, 2023		DISCN	Yes	No	9,532,991		Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-002	Jan 13, 2023		RX	Yes	Yes	9,532,991		Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-003	Jan 13, 2023		RX	Yes	No	9,532,991		Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-004	Jan 13, 2023		RX	Yes	No	9,532,991		Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS

International Family Members for US Patent 9,532,991

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012248038
Brazil	112013027235
Canada	2832663
China	103338752
China	104127385
European Patent Office	2701687