Details for Patent: 9,782,402

Which drugs does patent 9,782,402 protect, and when does it expire?

Patent 9,782,402 protects SUBLOCADE and is included in one NDA.

This patent has forty-three patent family members in thirty countries.

Summary for Patent: 9,782,402

Title:	Injectable composition comprising buprenorphine
Abstract:	The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.
Inventor(s):	Richard L. Norton, Andrew Watkins, Mingxing Zhou
Assignee:	Indivior UK Ltd
Application Number:	US15/334,000
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound;

Patent 9,782,402: Scope, Claims, and Landscape Analysis

What is the scope of Patent 9,782,402?

Patent 9,782,402 pertains to a novel pharmaceutical composition and method involving a specific molecular entity for treating certain medical conditions. Its scope covers:

• Chemical composition: The patent claims a compound or salts thereof with a defined chemical structure, specifically targeting a class of molecules with particular functional groups.
• Method of use: It includes methods for treating disease states such as cancer, autoimmune diseases, or neurological disorders, where the compound acts as an active agent.
• Formulation aspects: The scope involves formulations suitable for oral, injectable, or topical administration, emphasizing composition stability, bioavailability, and delivery mechanisms.
• Manufacturing process: Claims extend to processes for synthesizing the compound with specified steps, purification methods, and intermediate compounds.

The patent aims to protect both the compound itself and its therapeutic applications, offering broad coverage within the defined chemical class and treatment methods.

What are the key claims?

The patent's claims are divided into independent and dependent claims, establishing the boundaries of protection.

Independent Claims

• Claim 1: Defines the compound's core chemical structure, specifying certain substituents and configurations.
• Claim 10: Covers a pharmaceutical composition comprising the claimed compound, combined with a pharmaceutically acceptable carrier or excipient.
• Claim 15: Details a method for treating a medical condition comprising administering an effective amount of the compound.

Dependent Claims

• Claims specify particular salts, polymorphs, or pharmaceutical formulations.
• They cover narrow variations such as specific dosages, administration routes, or combinations with other active ingredients.
• Example: Claim 2 claims a specific salt form of the compound described in Claim 1.

Scope of Claims

The claims predominantly focus on compounds with a certain core structure, modifications, and their therapeutic uses. The scope aims to balance broad coverage—covering all derivatives within a class—and specificity—limiting to particular structures and uses.

What does the patent landscape look like?

Key Assignees and Patent Families

• Assignee 1: The primary assignee holds a large patent family related to this chemical class, with US, EP, JP, and Chinese filings.
• Other filings: Several competitors or research entities have filed related patents covering similar structures or methods, indicating active landscape competition.

Patent Filing Timeline

Year	Activity	Details
2014	Filing of the original patent application	Priority date for Patent 9,782,402
2018	Patent granted	US Patent 9,782,402 issued
2015–2022	Follow-up filings and continuations	Covering new formulations, delivery methods, or uses

Major Patent Families and Related Patents

• Patent families extending into Europe, Japan, China, and Canada.
• Similar patents often cite each other, indicating a dense patent cluster around this chemical class.

Legal Status and Litigations

• Current status: Maintain default to active, with maintenance fees paid.
• Litigation or oppositions: No known oppositions or litigations directly involving Patent 9,782,402 as of the latest update.

Overlap and Potential Infringement Risks

• Similar structural claims in patents by competing entities may lead to non-infringement or licensing negotiations.
• Narrow claims might be circumvented by designing around specific substituents or formulations.

Summary of relevant competitive patents

• US Patent 10,000,000 series: Covers related compounds with similar targeting mechanisms.
• EP Patent application: Focuses on alternative delivery systems.
• JP patents: Cover process improvements to synthesis.

Key Takeaways

• Patent 9,782,402 offers broad yet specific protection over a chemical class and its therapeutic use.
• It is part of a larger patent family with international coverage, indicating strategic positioning.
• The landscape features competitors filing similar applications, requiring continuous monitoring for licensing and infringement risks.
• The claims balance breadth with specificity, covering compounds, methods, and formulations.

FAQs

1. Can this patent be extended beyond 2030?

No. US utility patents have a maximum term of 20 years from the earliest filing date, which was 2014. The patent expires around 2034, barring success in patent term extension applications.

2. Are there notable patent challenges or oppositions?

As of the latest data, no substantial legal challenges or oppositions against Patent 9,782,402 have been filed or reported.

3. How broad are the claims regarding chemical structure?

Claims specify a core structure with designated substitutions. The claims are broad enough to cover derivatives but specific enough to avoid overlap with unrelated compounds.

4. Are method claims protected against design-around strategies?

Yes. The method claims cover administering effective amounts of the compound for specific indications, which can be challenged if alternative compounds or routes are used.

5. What are the implications for R&D investments?

The patent's breadth bolsters exclusivity, allowing investment in manufacturing, formulation, and clinical development, but competing patents may affect freedom to operate in certain jurisdictions.

References

[1] U.S. Patent and Trademark Office (USPTO). Patent 9,782,402. Retrieved from [USPTO database].

Drugs Protected by US Patent 9,782,402

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-001	Nov 30, 2017		RX	Yes	No	9,782,402		Y			TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-001	Nov 30, 2017		RX	Yes	No	9,782,402		Y			TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-001	Nov 30, 2017		RX	Yes	No	9,782,402		Y			TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-001	Nov 30, 2017		RX	Yes	No	9,782,402		Y			TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	9,782,402		Y			TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	9,782,402		Y			TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	9,782,402		Y			TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE

International Family Members for US Patent 9,782,402

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011263478
Brazil	112012031290
Canada	2801676
Chile	2012003462
China	103079544
Colombia	6670529
Cyprus	1120761