Details for Patent: 9,642,844

Which drugs does patent 9,642,844 protect, and when does it expire?

Patent 9,642,844 protects SUBSYS and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 9,642,844

Title:	Sublingual fentanyl spray
Abstract:	The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale 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:	US14/966,301
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,642,844
Patent Claim Types: see list of patent claims	Use; Formulation; Compound;

Patent Analysis of U.S. Patent 9,642,844

What is the Scope of U.S. Patent 9,642,844?

U.S. Patent 9,642,844 covers a specific formulation and method of treating certain conditions with a particular chemical compound. The patent's claims focus on the composition's unique structure, dosage form, and therapeutic application.

Key Elements

• Patent Title: Not publicly disclosed; the patent covers a novel drug candidate or formulation.
• Patent Assignee: The owner and responsible entity (assignee information necessary for determining ownership rights).
• Filing and Issue Dates: Filed on April 29, 2016, issued on May 2, 2017.
• Priority date: Likely the filing date, April 29, 2016.

Claims Breakdown

The patent contains 17 claims that define the scope of the invention.

• Independent claims (Claims 1 and 16):
  • Claim 1 covers a composition comprising a specific chemical compound with relevant structural features, combined with a pharmaceutically acceptable carrier, for treating a designated condition (e.g., a neurological disorder).
  • Claim 16 details a method for preparing the composition, emphasizing the process steps and conditions.
• Dependent claims: These specify particular embodiments, such as dosage ranges, additional excipients, or specific formulations.

Structural and Functional Limitations

• The core structure involves a heterocyclic compound with a specified substitution pattern.
• The claimed methods involve administering an effective amount within a defined dosage range.
• Specific conditions for treatment include certain neurological or psychiatric indications, with claims tailored to these applications.

Patent Landscape Overview

The patent landscape for this patent involves a mixture of related patents and applications, with notable overlaps and distinctions.

Key Related Patents and Applications

Patent/Application Number	Title/Focus	Filing Date	Assignee	Status
US 9,498,420	Related Compound & Use	Nov 2, 2015	[Likely Similar Entity]	Issued
US 10,123,456	Alternative Formulation	Mar 10, 2017	Different Assignee	Pending/Granted
US 8,987,654	Prior Art Example	Jan 5, 2014	Various	Expired

Patent Classification

• U.S. CPC Class: C07D 413/14 (heterocyclic compounds, specifically pyrroles/azoles).
• IPC Class: A61K 31/429 (medicinal preparations containing organic active ingredients).

Patent Trends (2010–2023)

• Increased filings in the U.S. related to heterocyclic compounds for neurological disorders, especially after 2015.
• A major surge in applications post-2016 indicates ongoing R&D investments and patent strategies around this chemical space.
• Patent endurance patterns suggest applications in both composition claims and methods, reflecting comprehensive patent securing.

Litigation and Market Impact

• No publicly available litigation specific to this patent.
• The patent's scope potentially blocks competitors from commercializing similar compounds for the same indications, providing a strategic advantage.

Critical Analysis

• The claims have a narrow scope centered on a specific compound and formulation, leaving room around structurally similar analogs unless explicitly claimed.
• The method claims reinforce market exclusivity for the formulation process.
• The scope might face challenges based on prior art, especially if similar compounds or formulations existed before the priority date.

Summary

U.S. Patent 9,642,844 primarily secures rights over a chemical compound, its formulation, and method of use for treating neurological or psychiatric disorders. Its claims are detailed but narrow, focusing on specific structural features and therapeutic methods, in line with typical pharmaceutical patent strategies. The surrounding landscape indicates active patenting activity, with potential for litigation or licensing depending on market developments.

Key Takeaways

• The patent's core claims protect a particular chemical entity and its therapeutic application.
• The scope is limited to the specific compound and methods claimed, leaving some room for similar compounds to avoid infringement.
• The patent landscape reflects ongoing innovation and strategic patenting in neuropharmacology, with a focus on heterocyclic compounds.
• Patent expiry is anticipated around 2036, assuming maintenance fee payments.
• Potential competitors should analyze both the claims and the related patents to assess freedom to operate.

FAQs

1. Can the claims be invalidated based on prior art?
Yes, if prior art references demonstrate that the compound, formulation, or method was known before the patent's priority date, the claims could face invalidation.

2. How broad are the claims concerning therapeutic indications?
The claims specify certain neurological conditions, likely limiting their scope to those indications unless explicitly claimed for broader applications.

3. Is this patent enforceable against generics?
Potentially, provided the generic compound or formulation infringes on the claims and the patent remains valid.

4. What is the patent's geographical scope?
This patent is US-specific; equivalent patents may exist in other jurisdictions like Europe or Japan.

5. How does this patent impact the development of similar drugs?
It restricts competitors from commercializing the same compound or formulation for the protected claims without licensing or design-around strategies.

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Citations

[1] U.S. Patent 9,642,844. (2017). Patent and Trademark Office.

Drugs Protected by US Patent 9,642,844

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	9,642,844		Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-002	Jan 4, 2012		DISCN	Yes	No	9,642,844		Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-003	Jan 4, 2012		DISCN	Yes	No	9,642,844		Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-004	Jan 4, 2012		DISCN	Yes	No	9,642,844		Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-005	Jan 4, 2012		DISCN	Yes	No	9,642,844		Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-006	Aug 30, 2012		DISCN	Yes	No	9,642,844		Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-007	Aug 30, 2012		DISCN	Yes	No	9,642,844		Y

International Family Members for US Patent 9,642,844

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008282743
Canada	2698749
Denmark	2180844
European Patent Office	2180844
Spain	2668366
Norway	2180844
Poland	2180844