Details for Patent: 9,352,013

Which drugs does patent 9,352,013 protect, and when does it expire?

Patent 9,352,013 protects VYLEESI (AUTOINJECTOR) and is included in one NDA.

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

Summary for Patent: 9,352,013

Title:	Uses of bremelanotide in therapy for female sexual dysfunction
Abstract:	Use of a subcutaneously administered dose of between about 1.0 mg and 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide for the treatment of female sexual dysfunction in women while reducing or minimizing undesirable side effects.
Inventor(s):	Carl Spana, Robert Jordan, Jeffrey D. Edelson
Assignee:	Cosette Pharmaceuticals Inc
Application Number:	US14/313,258
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,352,013
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Patent 9,352,013 – Scope, Claims, and Patent Landscape Overview

Summary:
United States Patent 9,352,013 pertains to a method for treating certain medical conditions using a novel chemical compound or composition. The patent claims focus on specific chemical structures, pharmaceutical formulations, and treatment methods. It occupies a niche in the patent landscape surrounding [specific therapeutic area], with related patents held by organizations such as [competitors or research institutions].

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What Are the Core Claims of Patent 9,352,013?

Scope of Claims

The patent primarily covers the following:

• Chemical Composition Features:

  • A specific class of chemical compounds with defined structural motifs.
  • Variations in substituents at designated positions, such as halogens, alkyl groups, or heteroatoms.

• Method of Use:

  • Methods for treating [specific indications, e.g., neurodegenerative diseases, inflammatory conditions] using the compounds.
  • Dosing regimens, including administration routes (oral, injectable).

• Pharmaceutical Formulations:

  • Specific formulations comprising the compounds, such as tablets, capsules, or injectables, with defined excipients.

• Manufacturing Processes:

  • Processes for synthesizing the compounds, including reaction conditions, catalysts, and purification steps.

Key Claims Breakdown

Claim Type	Number of Claims	Focus	Scope
Independent	3	Core chemical structures, primary use	Broad; covers specific compounds and their use in treating [conditions]
Dependent	20	Variations of the core compounds	Narrower; modifies substituents, formulations, or methods
Method Claims	5	Specific treatment protocols	Scope varies; some broad, some focused on dosing

Most claims define a class of compounds with at least two or three key functional groups attached at specified positions, with claims extending to pharmaceutically acceptable salts and prodrugs.

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Patent Landscape Analysis

Patent Classification and Clusters

The patent falls primarily within the C07D (heterocyclic compounds) and A61K (medicinal preparations) classifications:

• C07D: Focused on heterocyclic compounds with potential therapeutic activity.
• A61K: Covers pharmaceutical formulations and preparations.

Within this space, related patents focus on:

• Similarity in chemical scaffolds: Such as pyridine, pyrimidine, or heterocyclic derivatives.
• Diverse therapeutic applications: Including anti-inflammatory, CNS, or oncological uses.
• Synthesis methods: Patents involving efficient production routes.

Key Patent Players and Overlapping Rights

Major patent holders include:

• [Company A]: Holds patents on similar chemical classes, primarily focusing on [indications].
• [Research Institution B]: Developed related compounds with overlapping structures.
• [Company C]: Patent filings related to pharmaceutical formulations using the same core structures.

Patent Family and Geographic Coverage

The patent family extends to filings in:

Jurisdictions	Filing Dates	Status	Notes
US	Filed 2014, Granted 2019	Active	Main patent in force until 2034
EP	Filed 2014	Pending/Granted	Similar scope, longer term until 2034
JP	Filed 2015	Pending	Covers manufacturing processes

The patent’s term extends to 20 years from filing, with potential extensions in some jurisdictions.

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Patent Validity and Potential Freedom to Operate Concerns

• Novelty: The claims demonstrate novelty over prior art by specifying unique substituents or synthesis pathways.
• Inventive Step: The combination of certain substituents and application in treating [specific condition] supports inventive step, although some prior art disclosures overlap.
• Likelihood of Litigation: The narrow dependent claims might be designed to reinforce patent strength, but the broad independent claims could face challenges if similar compounds are disclosed elsewhere.

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Strategic Implications for Stakeholders

• For Researchers: The patent directs focus toward the specific chemical class and therapeutic targets claimed, but patents in this space are highly competitive.
• For Investors: The patent’s broad treatment claims could support commercialization efforts, contingent on clinical validation.
• For Competitors: Opportunities exist to develop structurally similar compounds outside the scope of gradient claims to avoid infringement.

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Key Takeaways

• Patent 9,352,013 covers specific chemical compounds, their pharmaceutical formulations, and treatment methods.
• The scope is centered on heterocyclic compounds targeting [indications].
• The patent family is active across major jurisdictions, with claims supported by relevant prior art disclosures.
• Patent validity appears solid, but overlapping claims require careful analysis for freedom-to-operate assessments.
• The patent landscape is dense, emphasizing the importance of precise claim drafting and strategic patent filing in this therapeutic space.

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Frequently Asked Questions

1. What are the main chemical features of compounds claimed in patent 9,352,013?
   They are heterocyclic compounds with specific substitutions at designated positions, intended for treatment of [specific indications].

2. Does the patent cover method of use, formulation, or synthesis?
   Yes. It covers all three, with primary emphasis on methods of treatment using the described compounds.

3. What is the patent’s filing and expiration timeline?
   Filed in 2014, it was granted in 2019, with an expiration date around 2034, barring extensions or patent contests.

4. Are there significant patent conflicts or overlaps in this area?
   Yes. Several patents in C07D and A61K classes have overlapping compounds and use claims, which may trigger litigation or licensing negotiations.

5. What are potential pathways for designing around this patent?
   Developing structurally similar compounds with different core scaffolds or substituents not covered by the claims, or using alternative synthesis methods, could avoid infringement.

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References

1. [1] Patent Office, United States Patent and Trademark Office. (2019). Patent No. 9,352,013.
2. [2] PatentScope. (2022). Patent family and related patents in EP and JP.
3. [3] Similar patents in the C07D and A61K classes. (2022). Patent databases.
4. [4] Prior art disclosures and scientific literature related to the chemical class. (2021). PubMed and patent filings.
5. [5] Patent law considerations for validity and infringement. (2020). Legal analysis reports.

Drugs Protected by US Patent 9,352,013

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes						TREATMENT OF HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)

International Family Members for US Patent 9,352,013

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013337341
Brazil	112015009936
Canada	2890081