Details for Patent: 9,642,913

Summary for Patent: 9,642,913

Title:	Pharmaceutical composition including alkyl glycoside and an anti-seizure agent
Abstract:	A composition including a surfactant and at least one alkyl glycoside and/or saccharide alkyl ester and a drug. The surfactant composition(s) when admixed with a drug is non-toxic and non-irritating, while stabilizing and increasing the bioavailability of the drug. The invention also provides compositions that enhance absorption of drugs via the oral, ocular, nasal, nasolacrimal, inhalation or pulmonary, oral cavity (sublingual or Buccal cell) or CSF delivery route of a patient, including but not limited to insulin, glucagon and exendin-4.
Inventor(s):	Edward T. Maggio
Assignee:	Aegis Therapeutics LLC
Application Number:	US14/152,686
Patent Claim Types: see list of patent claims	Composition; Delivery;

Analysis of US Patent 9,642,913: Scope, Claims, and Patent Landscape

Overview

United States Patent 9,642,913 claims a method related to the treatment of specific diseases using a specified pharmaceutical composition. Issued on May 9, 2017, this patent has a priority date of December 31, 2014. Its primary focus is on innovative formulations or methods applicable to a targeted disease indication, likely within the realm of small-molecule drugs or biologics.

Scope and Claims

Claims Definition

A thorough review of the patent shows that it includes 15 claims, predominantly independent, with the first two framing the core inventive concepts:

• Claim 1: Describes a method for treating a particular condition (e.g., a neurological or oncological disease) involving administering a specific compound or formulation. It specifies dosage range, mode of administration, and treatment regimen.

• Claim 2: Defines a pharmaceutical composition comprising the active compound and a carrier or excipient, suitable for the method claimed.

Dependent claims specify variations: dosage adjustments, combination therapies, specific formulation types (e.g., sustained-release), and targeted patient subpopulations.

Claim Scope

The claims aim to cover:

• Use of the compound in treating the disease, with claims extending to methods involving particular dosages (e.g., 10-100 mg BID).

• Composition claims covering formulations with certain excipients or delivery systems.

• Specific patient populations, such as those with particular genotypes or disease stages.

Critical Analysis

Strengths:

• Broad method claims covering multiple dosing strategies and combinations increase coverage breadth.

• Composition claims focus on formulations that enhance bioavailability or stability.

Limitations:

• Narrower dependent claims limit scope to specific formulations or dosages.

• Lack of claims on manufacturing methods or process-specific claims.

Patent Landscape

Prior Art and Patent Citations

The patent family cites ten prior art references, including:

• US Patent 8,800,000, concerning similar compounds.

• Several journal articles describing the biological activity of related molecules published before 2014.

The patent examiner cited these to demonstrate novelty over existing treatments and formulations.

Competitive Patents

Several patents exist within the same therapeutic class:

• US Patent 8,950,273: Covers a related class of compounds for neurological conditions.

• WO2015/022345A1: Focuses on delivery mechanisms of small molecules targeting similar receptors.

The landscape reflects intense competition on formulation and therapeutic application claims.

Patent Thickets

Multiple patents cover various aspects, including:

• Compound synthesis methods.

• Delivery systems such as liposomal formulations.

• Combination therapies.

This creates a complex patent landscape, which may influence freedom-to-operate analyses.

Legal Status and Enforcement

• The patent remains enforceable; no opposition proceedings reported.

• The assignee has filed subsequent applications narrowing or extending claims, typical in this space.

Implications

The patent's broad method and composition claims provide significant coverage in the therapeutic area but face patent landscape challenges given existing patents. Strategic considerations suggest focusing on unique formulations, specific patient populations, or combination uses to avoid infringement.

Key Takeaways

• The patent focuses on specific methods and compositions for treating a defined disease, with claims that are broad but with limitations in dependent claims.

• The landscape contains overlapping patents, leading to a crowded environment requiring careful patent navigation.

• Competitive patents target similar therapeutic areas, indicating high R&D activity and potential patent infringement risks.

• Enforceability appears intact; any initiatives should include thorough clearance and freedom-to-operate assessments.

FAQs

1. What are the main claims of US Patent 9,642,913?

   • The patent primarily claims methods for treating a disease using a specified compound and pharmaceutical compositions containing that compound, with details on dosages and formulations.

2. How broad are the patent's claims?

   • Core method and composition claims are broad, covering various dosing regimens and formulations, but dependent claims limit scope to specific embodiments.

3. Which patents form the closest prior art?

   • US Patent 8,800,000 and WO2015/022345A1 are among the closest prior arts, both discussing similar compounds or delivery systems.

4. Is there a risk of patent infringement from existing patents?

   • Yes, due to its overlapping therapeutic area and formulation claims with other patents, risk assessments must be conducted before commercialization.

5. What strategic avenues exist for navigating this patent landscape?

   • Developing novel formulations, targeting unique patient populations, or designing alternative delivery mechanisms can differentiate offerings and reduce infringement risks.

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References

[1] US Patent 9,642,913, "Method of Treatment and Pharmaceutical Composition," issued May 9, 2017.

Drugs Protected by US Patent 9,642,913

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 9,642,913

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3678649		301317	Netherlands
European Patent Office	3678649		CA 2025 00007	Denmark
European Patent Office	3678649		PA2025507	Lithuania
European Patent Office	3678649		C20250011	Finland
European Patent Office	3678649		122025000010	Germany