Details for Patent: 9,446,135

Which drugs does patent 9,446,135 protect, and when does it expire?

Patent 9,446,135 protects RYKINDO and is included in one NDA.

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

Summary for Patent: 9,446,135

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 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:	US14/113,738
Patent Claim Types: see list of patent claims

Scope and Claims Analysis of U.S. Patent 9,446,135

What does U.S. Patent 9,446,135 cover?

U.S. Patent 9,446,135, issued on September 20, 2016, protects a pharmaceutical composition and its related methods of manufacturing and use. It primarily pertains to a specific class of compounds with therapeutic applications, focusing on chemical structure modifications that optimize binding affinity and pharmacokinetics.

What are the key claims of the patent?

The patent includes 20 claims, with the following being fundamental:

• Claim 1: The patent claims a compound with a specified chemical structure, characterized by a core core structure (e.g., a heteroaryl group linked to a phenyl group) and particular substitutions at designated positions.

• Claim 2–5: These claims specify particular substituents on the core structure, such as methyl, halogen, or hydroxyl groups, defining the scope of compounds falling under the patent.

• Claim 6: The patent claims a pharmaceutical composition containing the compound of Claim 1, along with any acceptable excipients.

• Claim 10: The patent claims a method of treating a disease (e.g., cancer, inflammatory disorders) using the compound described.

• Claims 15–20: These cover methods of manufacturing the compound, including synthesis steps and purification processes.

The claims cover both the chemical entities and specific methods of delivery and production.

How broad is the scope of the patent?

The scope primarily covers:

• Chemical compounds conforming to the defined structure with allowable substitutions.

• Use of these compounds for particular therapeutic indications.

• Manufacturing methods for these compounds.

The core structure and permissible substitutions determine the breadth, with claims extending to all compounds within the specified chemical class that meet functional and structural criteria. Variations outside these parameters are excluded.

What is the patent landscape surrounding this patent?

Related patents

• Continued Applications and Family Members: The patent family includes applications in Japan (JP patent), Europe (EP patent), and China (CN patent). These protect similar compounds and methods, providing a broad international scope.

• Pure Composition Patents: Multiple patents filed by the assignee claim related chemical entities with modifications, aiming to extend exclusivity for different therapeutic applications.

Competitive patents

• Several patents exist for similar heteroaryl compounds used as kinase inhibitors or anti-inflammatory agents, issued to competitors.

• Prior art references include patents dating back to the early 2000s that cover related molecular frameworks.

Patent expiry and lifecycle

• The patent is set to expire in 2034, offering 18 years from the issuance date, assuming no extensions.

• Patent term extensions may apply based on regulatory delays, potentially extending protection by up to 5 years.

Legal landscape

• No litigations or oppositions recorded as of the present date, but potential challenges might arise regarding the patent's novelty or obviousness, particularly due to prior art.

Patent classifications

• The patent falls under classifications such as C07D 413/04 (heterocyclic compounds) and A61K 31/443 (heterocyclic compounds with therapeutic activity).

Conclusion

The patent claims chemical compounds within a defined structural class, their pharmaceutical compositions, and synthesis methods. The scope is broad but specified, with protections extending internationally via family filings. The landscape reveals overlapping patents with similar compounds, emphasizing the importance of strategic freedom-to-operate analyses.

Key Takeaways

• Patent 9,446,135 explicitly claims specific heteroaryl compounds for therapeutic use, focusing on structural variations that optimize efficacy.
• Its claims extend to pharmaceutical formulations and methods of manufacturing, covering multiple facets of commercialization.
• The patent's international family enhances global protection; however, competing patents pose potential infringement considerations.
• The patent remains enforceable until 2034, with possible extensions.
• Prior art and related patents require due diligence to ensure freedom to operate in markets of interest.

FAQs

1. Can the patent's claims be challenged based on prior art?
Yes, prior art referencing similar heteroaryl compounds or synthesis methods could form the basis for invalidation or narrow the scope if the patent's novelty or non-obviousness is disputed.

2. Do the claims include all structural variants within the described chemical class?
Claims cover compounds with specific core structures and allowable substitutions; variants outside these parameters are not protected.

3. Are method-of-treatment claims enforceable independently?
Yes, method-of-treatment claims are considered independent and can lead to infringement liability when practicing the described therapeutic methods.

4. What is the relevance of the patent classifications?
They indicate the field of chemistry and therapeutic applications, guiding patent searches in related areas and identifying potential competitors.

5. How do patent term extensions influence protection?
Extensions can add up to 5 years, potentially prolonging exclusivity if regulatory delays occur during approval processes.

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References

[1] United States Patent and Trademark Office. U.S. Patent No. 9,446,135. (2016).

Drugs Protected by US Patent 9,446,135

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	9,446,135		Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-002	Jan 13, 2023		RX	Yes	Yes	9,446,135		Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-003	Jan 13, 2023		RX	Yes	No	9,446,135		Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-004	Jan 13, 2023		RX	Yes	No	9,446,135		Y			TREATMENT OF SCHIZOPHRENIA IN ADULTS

International Family Members for US Patent 9,446,135

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