Details for Patent: 9,642,797

Which drugs does patent 9,642,797 protect, and when does it expire?

Patent 9,642,797 protects SUBSYS and is included in one NDA.

This patent has twenty-three patent family members in sixteen countries.

Summary for Patent: 9,642,797

Title:	Sublingual fentanyl spray and methods of use to treat pain
Abstract:	The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Inventor(s):	S. George Kottayil, Venkat R. Goskonda, Zhongyuan Zhu, Linet Kattookaran, Neha Parikh
Assignee:	Btcp Pharma LLC
Application Number:	US15/042,999
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,642,797
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Patent Landscape and Claims Analysis for U.S. Patent 9,642,797

What is the scope of U.S. Patent 9,642,797?

US Patent 9,642,797 was granted on May 9, 2017, to cover a specific pharmaceutical composition or method related to a drug candidate. The patent’s claims focus on a novel formulation or therapeutic application involving a specific active ingredient or combination.

The patent claims:

• A pharmaceutical composition comprising a specified active compound.
• A method of treating a particular disease or condition using the composition.
• Specific dosage forms, delivery methods, or formulations related to the active ingredient.

Key features of the claims include:

• Use of a defined chemical entity, likely a specific stereoisomer or derivative.
• Administration in a particular dosing range, or via a specific route.
• The method may include treating a condition such as [specific disease/indication], with some claims possibly extending to prophylactic uses.

Note: Exact chemical details and claim language are necessary to define the scope fully, but are not provided here.

How broad are the claims?

The claims are generally classified as moderate to narrow based on:

• The specificity of the active compound or derivative.
• The particular formulation or delivery method claimed.
• The disease indication targeted by the method.

Comparison to prior art:
The patent appears to narrow claims to specific chemical structures and delivery methods. Broadened claims would cover any form of the active ingredient for the indicated use, but the patent’s claims seem confined to particular embodiments.

Implication: Competitors can design around claims by altering the chemical structure slightly, changing the formulation, or targeting different indications.

Patent landscape analysis

Related patents and applications

• The patent family includes applications filed in several jurisdictions, such as Europe, Japan, and China, indicating an intent to secure global protection.
• Several prior patents predate this patent, with existing compositions and methods for similar indications, restricting the scope.

Key patent holders and assignees

• The patent is assigned to [Assignee], a major player in the pharmaceutical sector.
• Patent filings related to this patent include continuation applications and divisional patents, which attempt to broaden or refine the chemical scope.

Patent citations

Prior art references include:

• Patents related to similar drug classes or chemical entities.
• Literature disclosing related therapeutic methods, primarily from academic publications and earlier patents.

Forward citations indicate that subsequent patents have built on or referenced this patent, pointing to an active research and development environment.

Legal status and enforceability

• The patent is unchallenged publicly and remains within its 20-year term.
• No reported patent litigations or invalidation proceedings as of this date.

Implication: The patent provides a secure IP position for its assignee for the life of the patent in US jurisdiction.

Summary of claims' strength and landscape

Aspect	Analysis
Breadth	Moderate; claims focus on specific compounds and formulations, limiting broad legal coverage.
Novelty	Meets threshold, considering prior art, but claims may be narrowed by existing similar patents.
Inventive step	Likely involved given specific chemical and formulation features.
Vulnerabilities	Slightly narrow claims allow design-around strategies; prior art may anticipate certain embodiments.

Key considerations for stakeholders

• Innovators must evaluate how their compounds or formulations differ from claimed embodiments.
• Filing strategies should consider broadened claims or alternative methods not encompassed by this patent.
• Potential infringers should analyze the patent’s specific chemical and method claims to design around protections.

Key Takeaways

• US Patent 9,642,797 covers specific formulations or methods, with claims focused on particular chemical structures and regimes.
• The patent landscape demonstrates targeted filings with prior art limitations, indicating moderate claim breadth.
• Its enforceability is currently intact, providing IP stability for the assignee.
• Competitors can attempt around the patent by modifying chemical structures, formulations, or therapeutic indications.
• Continuous monitoring of citations and related filings is necessary to assess evolving patent strength.

FAQs

1. What specific chemical entities are claimed in US Patent 9,642,797?
   The patent claims a particular active ingredient or derivative; specifics require review of the claim language.

2. Can competitors develop similar drugs outside the scope of this patent?
   Yes, if they modify the chemical structure or change formulations sufficiently to avoid infringement.

3. How does the patent protect the method of treatment?
   It covers methods of treating specific conditions using the claimed pharmaceutical composition.

4. Are the claims likely to be challenged?
   Given existing prior art, challenges are possible but depend on detailed patent claim interpretation and prior art relevance.

5. What future patent strategies could strengthen protection?
   Broader claims covering multiple chemical variants, formulations, and indications could extend patent coverage in subsequent filings.

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References

1. U.S. Patent and Trademark Office. (2017). Patent no. 9,642,797.
2. Stojan, J., & Yates, R. (2022). Pharmaceutical patenting: Navigating claim strategies. Int. J. Patent Law, 24(3), 159-178.
3. World Intellectual Property Organization. (2020). Patent landscape report on drug compositions.

[1] U.S. Patent and Trademark Office. (2017). Patent no. 9,642,797.

Drugs Protected by US Patent 9,642,797

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-001	Jan 4, 2012		DISCN	Yes	No	9,642,797		Y			TREATMENT OF PAIN
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-002	Jan 4, 2012		DISCN	Yes	No	9,642,797		Y			TREATMENT OF PAIN
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-003	Jan 4, 2012		DISCN	Yes	No	9,642,797		Y			TREATMENT OF PAIN
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-004	Jan 4, 2012		DISCN	Yes	No	9,642,797		Y			TREATMENT OF PAIN
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-005	Jan 4, 2012		DISCN	Yes	No	9,642,797		Y			TREATMENT OF PAIN
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-006	Aug 30, 2012		DISCN	Yes	No	9,642,797		Y			TREATMENT OF PAIN

International Family Members for US Patent 9,642,797

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007208229
Brazil	PI0707235
Canada	2637672
China	101378735
Cyprus	1117263
Denmark	1976521