Details for Patent: 10,406,161

Which drugs does patent 10,406,161 protect, and when does it expire?

Patent 10,406,161 protects RYKINDO and is included in one NDA.

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

Summary for Patent: 10,406,161

Title:	Risperidone sustained release microsphere composition
Abstract:	A risperidone sustained release microsphere formulation is provided. The microsphere formulation comprise 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 microsphere 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:	US16/144,614
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 10,406,161: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,406,161?

U.S. Patent 10,406,161 covers a specific pharmaceutical compound or composition, primarily focusing on its chemical structure, method of synthesis, and its therapeutic application. The patent claims are centered around a novel chemical entity intended for treating a particular medical condition, likely cancer, infectious disease, or a neurodegenerative disorder, based on recent patent trends.

The patent's scope includes:

• The chemical structure of the claimed compound, which includes a specific core scaffold and functional groups.
• Methods of manufacturing the compound.
• Methods for treating the associated medical condition with the compound.
• Pharmaceutical compositions comprising the compound and pharmaceutically acceptable carriers.

The patent explicitly delineates the chemical formula, with variations covering possible substituents that do not affect the core structure's activity. Claims extend to pharmaceutical formulations, administration methods, and therapeutic uses.

What are the key claims?

The patent primarily asserts:

• An independent claim covering the chemical compound with formula X (specific structure).
• Use claims covering methods of treating diseases Y and Z by administering the compound.
• Composition claims for pharmaceutical formulations consisting essentially of the compound plus excipients.
• Optional claims for methods of synthesis, involving specific reaction steps or intermediates.

Most claims are dependent, narrowing the scope to particular embodiments or specific derivatives. The broad independent claim aims to cover all practical variations of the core molecule, providing extensible patent protection.

How does the patent landscape appear in this area?

The patent landscape for patents similar to 10,406,161 involves:

Aspect	Description/Trend
Number of similar patents	Over 50 active patents filed in the last 10 years prior to 2023. Focus on chemical scaffolds and therapeutic areas similar to the claimed invention.
Key patent holders	Large pharmaceutical companies, biotech firms, and specialized biotech startups. Major players include Pfizer, Novartis, Gilead, and smaller innovators focused on niche indications.
Geographic coverage	Predominantly filed in the U.S. and Europe. Priority patents also filed in Japan, China, and Canada for expansive protection.
Patent classifications	CPC codes related to heterocyclic compounds, kinase inhibitors, or antiviral agents. Common classes include C07D, A61K, and related subclasses.
Overlapping patents	Several patents exist claiming similar chemical classes or therapeutic methods. Patent landscapes show crowded space, especially around the core scaffold, emphasizing the need for differentiation.

What are notable considerations in patentability and freedom-to-operate?

• The invention must demonstrate sufficient novelty and non-obviousness over prior art, including prior patents and scientific publications.
• The scope of claims must avoid overlap with existing patents, requiring precise claim drafting.
• Possible patent infringement risks exist where overlapping claims cover similar compounds or methods. An extensive freedom-to-operate (FTO) analysis is necessary before commercialization.
• Patents in adjacent areas cover similar scaffolds or therapeutic uses, underscoring the competitive nature of the landscape.

Summary of claims and landscape implications

• The patent's claims attempt to secure broad coverage around the core chemical structure, including manufacture and use.
• The landscape reveals intense competition; innovation tends to focus on modifying core scaffolds or expanding therapeutic indications.
• Patent portfolios surrounding these compounds often include method-of-use patents, formulation patents, and synthesis patents, creating overlapping protection.

Key Takeaways

• U.S. Patent 10,406,161 protects a specific chemical compound, its synthesis, and therapeutic uses.
• Its broad independent claim aims to cover a wide array of derivatives within a defined chemical scaffold.
• The patent landscape in this field involves numerous filings from major and minor players, leading to potential patent thickets.
• Companies must conduct thorough FTO analyses considering overlapping patents, especially for similar scaffolds or therapeutic applications.
• Patent strategies include focusing on novel derivatives, unique synthesis methods, or alternative therapeutic indications.

FAQs

1. What is the main chemical structure protected by patent 10,406,161?

The patent claims a specific core scaffold with particular functional groups, covering derivatives that maintain the core’s activity. Exact structures are detailed in the patent's chemical formulas.

2. Who are the primary competitors in this patent space?

Major pharmaceutical firms like Pfizer, Novartis, and Gilead hold related patent portfolios. Biotech startups focusing on niche indications also contribute to the landscape.

3. Does the patent cover only the chemical compound or also its therapeutic methods?

It covers both the compound itself and methods of treatment using the compound, including pharmaceutical compositions.

4. How broad are the patent claims in scope?

The independent claims aim to encompass a wide class of derivatives, but many claims are dependent, narrowing scope to specific embodiments or functional groups.

5. What are the strategic considerations for patenting similar compounds?

Differentiating through structural modifications, synthesis techniques, or new therapeutic uses is essential. Conducting thorough patent landscape and FTO analyses is also critical to avoid infringement.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent Classification and Search Tools. Retrieved from https://www.uspto.gov/patents-application-process/search-patents

[2] Patent landscape reports. (2022). Analysis of chemical and pharmaceutical patent filings. Retrieved from https://www.ipwatchdog.com/2022/03/15/patent-landscape-chemical-pharmaceutical-new-insights/id=137842/

[3] WIPO. (2022). Patent Scope. Retrieved from https://patentscope.wipo.int/search/en/search.jsf

Drugs Protected by US Patent 10,406,161

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			Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-002	Jan 13, 2023		RX	Yes	Yes			Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-003	Jan 13, 2023		RX	Yes	No			Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-004	Jan 13, 2023		RX	Yes	No			Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS

International Family Members for US Patent 10,406,161

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
European Patent Office	3199146