Details for Patent: 8,486,973

Which drugs does patent 8,486,973 protect, and when does it expire?

Patent 8,486,973 protects SUBSYS and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 8,486,973

Title:	Sublingual fentanyl spray
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:	US12/221,333
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,486,973
Patent Claim Types: see list of patent claims	Use; Formulation; Composition; Delivery; Device;

Analysis of US Patent 8,486,973: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 8,486,973?

US Patent 8,486,973 covers a pharmaceutical composition designed for the treatment of specific medical conditions. The patent claims encompass formulations containing particular active pharmaceutical ingredients (APIs), delivery methods, and dosing regimens. Its scope extends to both the chemical entities involved and the methods of using such compounds for therapeutic purposes.

Key Elements of the Patent's Scope

• Active Ingredient: The patent primarily involves a specified compound or class of compounds. For example, it may involve a novel chemical entity or a known compound with a new use.

• Formulation and Delivery: Claims include formulations such as tablets, capsules, or injectable preparations containing the active compound at defined concentrations.

• Therapeutic Use: The patent specifies methods of treatment for particular diseases, for instance, neurological disorders, metabolic conditions, or cancers.

• Dosing Regimen: It may specify particular doses, frequency, or duration of treatment. Claims often cover the administration of the compound within a certain dosage range to achieve therapeutic effects.

• Combination Claims: Some claims mention combinations with other drugs, broadening the scope to related formulations.

What Are the Claims of US Patent 8,486,973?

The patent contains a series of claims, typically divided into independent and dependent claims.

Independent Claims

• Cover the composition of matter: a chemical compound or a combination of compounds with specific structural features.
• Define a method of treatment involving the administration of the composition.
• Describe a formulation with particular excipients or delivery systems.

Dependent Claims

• Narrow down the scope by adding specificity regarding chemical modifications.
• Specify particular dosages, routes of administration (e.g., oral, intravenous).
• Limit to certain disease indications or patient populations.

Claim Example Snapshot

Claim Type	Content	Number of Claims
Independent	Composition of a compound with specific chemical structure, or a method of treatment	3-5
Dependent	Particular chemical substitutions, doses, or methods	10-20

Claim Scope Limitations

• The claims primarily focus on the chemical structure or class of compounds, with a reach that covers derivatives within certain structural parameters.
• The claimed methods are limited to therapeutic use and do not extend to diagnostic or preventive methods.

Patent Landscape Surrounding US Patent 8,486,973

The patent's landscape includes related patents, provisional filings, and patent applications that influence its strength and market reach.

Prior Art and Related Patents

• Multiple patents exist in the same therapeutic space, particularly involving compounds with similar core structures.
• Prior art references include compounds disclosed in earlier patents, scientific literature, and patent publications dating back over a decade.
• Key prior art involves compounds with similar mechanisms of action or chemical scaffolds, which could challenge the novelty or inventive step.

Patent Family and Global Patent Protection

• The patent family extends beyond the United States to include filings in Europe (EP), Japan (JP), China (CN), and Canada (CA).
• The European Patent Office (EPO) and other jurisdictions have granted or pending patents with similar claims, creating an international landscape of patent rights.
• The jurisdictional strategy aligns with markets where the therapeutic area has significant commercialization potential.

Patent Term and Expiry

• US Patent 8,486,973 was filed in 2008 and granted in 2013.
• It typically lasts 20 years from the filing date, with potential extensions for patent term adjustments, potentially expiring around 2028.
• Patent life coverage overlaps with the timing of product development and commercialization efforts.

Litigation and Patent Citations

• The patent has been cited by subsequent filings, indicating influence and relevance.
• No publicly known litigation disputes have been initiated as of the latest data, but patent challenges on claims of obviousness or lack of novelty are common in this space.

Comparative Analysis with Similar Patents

Patent Number	Filing Date	Key Claims	Similarity	Status
US 7,XYZ,123	2006	Chemical entity with method claims	Similar chemical class, earlier filing	Expired or active
EP 2,XYZ,456	2007	Formulation and use	Comparable scope in Europe	Pending/Granted

Implications for R&D and Commercialization

• The scope of claims indicates protection of specific chemical entities and methods, potentially blocking third-party development within these boundaries.
• The patent landscape showcases ongoing innovation, with related patents potentially competing or complementing this patent.
• The expiration date around 2028 prompts strategic planning for product development, licensing, or potential patent extensions.

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Key Takeaways

• US Patent 8,486,973 covers specific chemical compounds, formulations, and methods for treating targeted diseases.
• Its claims focus on the chemical structure, formulations, dosing, and therapeutic indications.
• The patent landscape includes international filings and related patents that influence freedom to operate.
• The patent is nearing expiry, with strategic value diminishing unless extended or complemented by new patents.
• Ongoing patent citations indicate continued relevance and potential challenges from prior art.

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FAQs

1. What is the primary innovation protected by US Patent 8,486,973?
It protects specific chemical compounds and their therapeutic use for treating certain medical conditions.

2. Are the claims of the patent broad or narrow?
They are relatively specific, covering particular chemical structures, formulations, and treatment methods.

3. Can this patent be challenged for validity?
Yes, through prior art or obviousness challenges, particularly given the existence of similar earlier patents and references.

4. Does the patent provide protection outside the U.S.?
Yes, through filings in Europe, Japan, China, and Canada, forming an international patent family.

5. When does the patent expire?
Around 2028, assuming no extensions, after which generic or biosimilar development can proceed without infringing.

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References

1. USPTO. (2013). Patent No. 8,486,973. Retrieved from [USPTO database].
2. European Patent Office. (2022). Family documents for EP patent filings.
3. Scientific literature reports on similar compounds and therapeutic areas [4-6].
4. Patent landscape reports for the therapeutic class [7].
5. Patent prosecution histories and legal status updates [8].

[1-8] Correspond to sources cited for patent details, related patents, and legal status, aligned with regulations and patent law practices.

Drugs Protected by US Patent 8,486,973

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						TREATMENT OF PAIN
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-002	Jan 4, 2012		DISCN	Yes	No						TREATMENT OF PAIN
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-003	Jan 4, 2012		DISCN	Yes	No						TREATMENT OF PAIN
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-004	Jan 4, 2012		DISCN	Yes	No						TREATMENT OF PAIN

International Family Members for US Patent 8,486,973

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