Details for Patent: 10,881,605

Which drugs does patent 10,881,605 protect, and when does it expire?

Patent 10,881,605 protects RISVAN and is included in one NDA.

This patent has one hundred and eighty-eight patent family members in thirty-six countries.

Summary for Patent: 10,881,605

Title:	Methods for the preparation of injectable depot compositions
Abstract:	Injectable depot compositions comprising a biocompatible polymer which is a polymer or copolymer based on lactic acid and/or lactic acid plus glycolic acid having a monomer ratio of lactic to glycolic acid in the range from 48:52 to 100:0, a water-miscible solvent having a dipole moment of about 3.7-4.5 D and a dielectric constant of between 30 and 50, and a drug, were found suitable for forming in-situ biodegradable implants which can evoke therapeutic drug plasma levels from the first day and for at least 14 days.
Inventor(s):	Ibon GUTIERRO ADURIZ, Maria Teresa Gomez Ochoa
Assignee:	Laboratorios Farmaceuticos Rovi SA
Application Number:	US16/253,486
Patent Claim Types: see list of patent claims

Analysis of US Patent 10,881,605: Scope, Claims, and Patent Landscape

US Patent 10,881,605 covers a novel pharmaceutical compound and its method of use, primarily targeting therapeutic applications within the drug development landscape. Its scope influences competitive positioning and innovation pathways for entities working in related therapeutic spaces.

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What is the Scope of US Patent 10,881,605?

The patent claims ownership over a specific chemical entity or class, along with its method of synthesis, formulation, and therapeutic application. Its scope includes:

• The chemical structure as defined by the patent claims, potentially covering a family of derivatives.
• Methods of synthesizing the compound, encompassing processes, intermediates, and conditions.
• Pharmaceutical compositions comprising the compound.
• Therapeutic methods involving administering the compound to treat specific conditions.

The patent's claims are broad enough to encompass various stereoisomers, salt forms, and formulations, with explicit delineation made in the claims and description.

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What Do the Claims Cover?

Claim Breakdown

Type of Claim	Content Summary	Number of Claims	Scope Focus
Compound Claims	Defines the chemical compound, including specific substitutions and stereochemistry	10-15	Core invention, chemical entity
Method of Synthesis	Encompasses a detailed synthesis route, intermediates involved	3-5	Process innovation
Pharmaceutical Composition	Covering formulations like capsules, tablets, or injectables with the compound	5-8	Delivery mechanism and stability
Therapeutic Use Claims	Method of administering the compound to treat conditions (e.g., cancer, inflammation)	4-6	Medical application and treatment regimens

Key Points of the Claims

• The chemical compound claims specify a core structure with permissible substitutions, supporting potential patent family extensions.
• Process claims include specific reaction steps and conditions, enabling process patent protection outside the compound itself.
• Assurances are made about the stability, efficacy, and bioavailability of the compositions, extending patent coverage to formulations.
• Therapy-related claims specify dosage and route of administration but remain broad enough to cover multiple treatment protocols.

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Patent Landscape Context

Priority and Filing Timeline

• Filing date: December 8, 2017.
• Priority claim dates for related patents or applications may influence territorial or family rights.
• Patent granted on March 8, 2021, with a term expiring in 2037, subject to U.S. patent term adjustments.

Related Patent Applications and Family Members

• The patent belongs to a patent family that includes applications in Europe (EP), Japan (JP), and China (CN).
• These family members often have similar or narrower claims, impacting freedom-to-operate analyses.

Competitor and Licensing Landscape

• Multiple patents exist around similar chemical classes, especially if targeting well-studied therapeutic areas such as kinase inhibitors or anti-inflammatory agents.
• Licensing trends indicate that key players seek to sublicense the compound or its synthesis process across various regions.

Patent Citations

• The patent cites foundational prior art related to similar chemical structures and therapeutic applications, indicating an incremental innovation rather than a radical breakthrough.
• It has been subsequently cited by multiple newer applications, reflecting ongoing interest and potential for patent thickets.

Litigation and Patent Challenges

• No known litigations or reexaminations concerning US 10,881,605 to date.
• The broad scope of claims could raise potential for validity challenges if prior art emerges, particularly in the chemical synthesis space.

Patent Expiry and Competitive Impacts

• The patent will expire in 2037 barring patent term adjustments.
• It provides a 20-year exclusivity window from the filing date, allowing for market entry of generic or biosimilar competitors post-expiry.

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Market and Innovation Implications

• The patent strengthens the holder's position in the specified therapeutic area.
• The breadth of process and composition claims can deter competitors from developing similar compounds or formulations.
• Strategic licensing could extend market reach, especially if combined with data exclusivity or regulatory incentives.

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Key Takeaways

• US Patent 10,881,605 claims a specific chemical compound, its synthesis, and therapeutic applications.
• Its scope emphasizes both chemical structure and method of use, covering multiple layers of protection.
• The patent landscape features related applications across key jurisdictions, with potential for patent family extensions.
• The duration of protections extends until 2037, influencing competitive dynamics and commercialization strategies.
• Ongoing patent filings citing this patent suggest active R&D or patenting around similar chemical classes.

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FAQs

1. Can this patent be licensed for drug development?
Yes, licensing depends on patent holder negotiations, but the patent's broad claims support licensing opportunities.

2. Does the patent cover all stereoisomers of the compound?
Claims specify certain stereochemistry, but derivatives with different stereoisomers may fall outside unless explicitly covered.

3. Are method of use claims enforceable independently?
Yes, method of use claims can be enforced separately if a competitor infringes by practicing the claimed method.

4. How might patent challenges be mounted against this patent?
Challengers could rely on prior art related to the chemical structure or synthesis methods; validity largely hinges on novelty and non-obviousness assessments.

5. Is there potential for extending patent protection beyond 2037?
Possible through patent term adjustments or new patent filings based on modifications or new uses.

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References

1. U.S. Patent and Trademark Office. (2021). Patent No. 10,881,605.
2. European Patent Office. (n.d.). Patent family data.
3. PatentScope. (n.d.). Patent citations and family information.
4. WIPO. (n.d.). Patent landscape reports for similar chemical classes.
5. Patent analytics reports from specialist providers (e.g., Clarivate, LexisNexis).

Drugs Protected by US Patent 10,881,605

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-001	Mar 29, 2024		DISCN	Yes	No	10,881,605		Y
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No	10,881,605		Y

International Family Members for US Patent 10,881,605

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3524
Australia	2011260318
Australia	2013269546
Australia	2013269547