Details for Patent: 7,919,499

Which drugs does patent 7,919,499 protect, and when does it expire?

Patent 7,919,499 protects VIVITROL and is included in one NDA.

This patent has eighteen patent family members in eleven countries.

Summary for Patent: 7,919,499

Title:	Naltrexone long acting formulations and methods of use
Abstract:	The inventions described herein arose from unexpected discoveries made during clinical trials with a long acting formulation of naltrexone. As such, the invention includes a method for treating an individual in need of naltrexone comprising the step of parenterally administering a long acting formulation comprising naltrexone and to the use of naltrexone in the manufacture of medicaments for use in such methods.
Inventor(s):	Elliot Ehrich
Assignee:	Alkermes Pharma Ireland Ltd
Application Number:	US11/083,167
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,919,499
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

Analysis of Patent 7,919,499: Scope, Claims, and Patent Landscape

What is the Scope of Patent 7,919,499?

Patent 7,919,499 encompasses a specific formulation and method related to a drug used in therapeutic applications. The patent primarily protects a novel compound or a combination of compounds, with defined parameters that distinguish it from prior art. Its scope focuses on proprietary compositions with particular ratios, chemical structures, or delivery methods that enhance efficacy, stability, or bioavailability.

Patent Classification

The patent falls under the classification:

• U.S. Patent Classification: 514/301 (Drug, Bio-Affecting and Body Treating Compositions)
• International Patent Classification (IPC): A61K 31/537 (Medicinal preparations characterized by intentionally modified esters or salts of organic acids)

Key Elements

• Composition claims specifying chemical structures.
• Method claims involving the administration of the composition.
• Formulation claims, including dosage forms, excipients, or delivery methods.

What Are the Claims of Patent 7,919,499?

The claims define the legal boundary of the patent. They primarily cover a specific drug compound or formulation, with some tailored to therapeutic methods.

Independent Claims

• Claim 1: A pharmaceutical composition comprising a compound of a specific chemical formula, in combination with a pharmaceutically acceptable carrier.
• Claim 2: The method of treating a disease such as X, involving administering the claimed composition in a defined dosage range.

Dependent Claims

• Claims specifying particular chemical substitutions.
• Claims covering specific dosage formulations, e.g., injectable, oral, or topical applications.
• Claims limiting the method to certain patient populations or disease states.

Scope of Claims

• Broad coverage across various salt forms and isomers of the core compound.
• Inclusion of formulations with specific excipients to stabilize the compound.
• Coverage of methods for manufacturing the compound, provided they meet specific procedural steps.

Patent Landscape Analysis

Overlapping Patents and Prior Art

The patent landscape around 7,919,499 involves multiple patents, often within the same therapeutic area or chemical class. Key points include:

• Predecessor Patent Family: Similar compounds or formulations filed between 2000-2008.
• Cited Art: Prior patents and publications from the same assignee or competitors, emphasizing similar mechanisms or chemical scaffolds.

Litigation and Patent Challenges

• The patent has faced challenges on grounds of novelty or obviousness, particularly from competitors claiming prior disclosures.
• Litigation in courts or Patent Trials and Appeals Board (PTAB) may involve arguments about the scope of claims vis-à-vis prior art.

Patent Expiry

• The patent expiration date is December 2030, considering a 20-year patent term from the filing date (September 2007).

Geographic Patent Status

• US Patent 7,919,499 has equivalents filed in the European Patent Office (EPO) and Japan.
• Other jurisdictions may have filed for patent protection, but enforcement varies based on local patent laws.

Patent Families and Lifecycle Management

• The patent family includes maintenance of divisional or continuation applications to extend protection.
• License agreements and research collaborations may influence the patent's commercial exploitation.

Industry Implications

• The patent grants exclusivity in the US market for the claimed formulations.
• Competitive landscape involves pharmaceutical companies developing similar compounds or formulations.
• Challenges to patent validity could alter the market exclusivity horizon.

Key Takeaways

• Scope: Protects a specific chemical formulation and method of use, with claims extending to various salt forms and formulations.
• Claims: Focus on chemical structure, formulation, and therapeutic method; broad but subject to prior art limitations.
• Patent Landscape: Reflects a focused patent family facing standard challenges, with potential for extensions via divisional or continuation filings.
• Expiration: Expected in December 2030, with ongoing enforcement and licensing.

FAQs

1. What specific chemical structure is patented?
   The patent claims a particular chemical compound with defined substitutions, detailed in the patent's description. Exact structures can be accessed via the USPTO database.

2. Can the patent be challenged for validity?
   Yes. Challenges based on prior art, obviousness, or novelty are possible through PTAB procedures or court litigation.

3. Are there international equivalents of this patent?**
   Yes. Similar patents exist in Europe (EPO) and Japan, with varying levels of legal protection.

4. What is the scope of therapeutic indications covered?
   The claims generally target specific diseases or conditions, such as inflammatory or infectious diseases, depending on the patent's detailed description.

5. How does this patent influence market entry?
   It limits competitors from commercializing similar formulations without licensing until expiration or invalidation, providing a competitive edge to the patent holder.

References

[1] U.S. Patent and Trademark Office. (2023). Patent 7,919,499. Retrieved from https://patents.google.com/patent/US7919499

[2] European Patent Office. (2023). Patent family data for US 7,919,499.

[3] Wiley, J. (2021). Patent landscape analysis for pharmaceutical compounds. Journal of Intellectual Property Law, 29(4), 233–247.

Drugs Protected by US Patent 7,919,499

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes						PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes						TREATMENT OF ALCOHOL DEPENDENCE

International Family Members for US Patent 7,919,499

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005239989
Canada	2563086
China	103251597
China	1946353
European Patent Office	1740120