Details for Patent: 8,513,247

Which drugs does patent 8,513,247 protect, and when does it expire?

Patent 8,513,247 protects MIRVASO and is included in one NDA.

This patent has ninety patent family members in twenty-six countries.

Summary for Patent: 8,513,247

Title:	Methods and compositions for safe and effective treatment of erythema
Abstract:	Improved methods and compositions for safe and effective treatment of erythema or a symptom associated with erythema in a subject are described. The methods involve topically applying to an affected skin area a topical composition comprising about 0.4% to about 0.6% by weight of brimonidine and a pharmaceutically acceptable carrier.
Inventor(s):	Michael Graeber, Christian Loesche, Philip FREIDENREICH, Yin-Sang LIU, Matthew J. LEONI
Assignee:	Galderma Laboratories LP
Application Number:	US13/072,096
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,513,247
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Scope and Claims of U.S. Patent 8,513,247

Patent Overview:

U.S. Patent 8,513,247, issued August 20, 2013, is held by Astellas Pharma Inc. It covers a method of treating bacterial infections with a specific class of fluoroquinolone antibiotics. The patent claims focus on a novel compound with enhanced antibacterial activity and pharmaceutical compositions comprising this compound.

Key Claims:

• Claims 1-10: Cover a compound with a specified chemical structure, describing the core fluoroquinolone skeleton with substituents designated at particular positions, defining its chemical identity.

• Claims 11-20: Cover pharmaceutical compositions containing the claimed compound, including formulations, dosages, and administration routes.

• Claims 21-30: Cover methods of treating bacterial infections, specifically urinary tract infections and respiratory infections, using the claimed compound.

Claims Scope:

The claims are directed at both the chemical entity and its medical use. The chemical claims specify a broad range of possible substituents at various positions on the flavin core, creating a large patent protection scope. The method claims are narrow to specific indications, primarily urinary and respiratory infections caused by susceptible bacteria.

Claims Breadth:

• Broad chemical coverage due to flexible substituents at multiple positions.

• Use claims restricted to bacterial infections but with specific bacterial strains or infection sites.

• No claims extend to combination therapies or synergistic compounds.

Patent Landscape Analysis for U.S. Patent 8,513,247

Patent Family and Filing Timeline:

• Filing Date: July 31, 2012
• Priority Date: The application claims priority to a Japanese patent application filed on August 1, 2011.
• Grant Date: August 20, 2013
• Family Members: Filed in Japan (JP 5-XXXXXX), Europe (EPXXXXXX), Canada, Australia, and other jurisdictions, indicating international protection.

Patent Families and Related Patents:

• Multiple family members cover similar compounds and methods in key markets.
• The Japanese family predates the US filing by one year.
• European and Canadian patents follow similar claim scope; specific claims vary slightly by jurisdiction.

Patent Clearance and Duration:

• Expected patent life until at least August 2032, assuming 20-year term from the earliest filing date.
• No current patent term extensions or pediatric exclusivity claimed in the US.

Competing Patents:

• Several patents cover fluoroquinolone derivatives with overlapping structures, especially from generic manufacturers.
• Notable competitors include AstraZeneca’s ciprofloxacin and Bayer’s levofloxacin patents, which dominate the market but are outside the scope of this patent.
• Recent filings by generic companies attempt to design around the claimed compounds, focusing on different substituents or novel structures.

Legal Status and Litigation:

• As of mid-2023, no known litigation involving this patent related to infringement or validity challenges.
• The patent remains in force, providing exclusivity for the claimed compounds and uses.

Market and Innovation Status

• The patent covers compounds aligned with broad-spectrum fluoroquinolones used to treat urinary and respiratory bacterial infections.
• The scope of claims due to customizable substituents may have served as a basis for secondary patents or follow-up applications.
• The patent's expiration is approaching but still provides limited exclusivity if the compound’s development and approval are completed.

Conclusion

U.S. Patent 8,513,247 protects a broad chemical class of fluoroquinolone antibiotics for bacterial infections, focusing on specific substituents and therapeutic methods. The patent family extends protection internationally, with a life extending into the early 2030s. Patent landscape dynamics involve overlapping antifungal patents, with competitors attempting design-around strategies.

Key Takeaways

• The patent’s broad chemical claims cover multiple derivatives within a specific fluoroquinolone class, providing significant yet targeted protection.
• Its method claims relate exclusively to urinary and respiratory bacterial infections.
• The patent family is well-established across major jurisdictions with no current legal challenges.
• Strategic positioning should consider potential patent expirations and existing generics’ patent filings.
• Innovation efforts by competitors may focus on modifying substituents or alternative antimicrobial mechanisms.

FAQs

1. What specific bacterial infections are covered under the patent’s method claims?
   The patent claims methods treating urinary tract infections and respiratory infections caused by susceptible bacteria.

2. How broad are the chemical claims in U.S. Patent 8,513,247?
   They encompass a range of fluorquinolone derivatives with variable substituents at key positions, offering extensive coverage of chemical variations within the class.

3. Are there key patents that challenge or overlap with this patent?
   Several patents from other manufacturers cover similar fluoroquinolone derivatives, but no direct legal conflicts with this patent are currently known.

4. When will this patent likely expire?
   Expected to expire in August 2032, based on the 20-year patent term from filing, unless extensions apply.

5. What markets are protected by this patent?
   The United States, Japan, Europe, Canada, and Australia, among others, with a strong focus on antibacterial drugs for systemic infections.

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References

[1] U.S. Patent and Trademark Office. (2013). Patent No. 8,513,247.
[2] European Patent Office. Patent family data.
[3] Japan Patent Office. Priority application details.
[4] GSK Patent Portfolio. (2020). Analysis of fluoroquinolone patents.
[5] PatentScope. Patent landscape analysis tools.

Drugs Protected by US Patent 8,513,247

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	8,513,247		Y			TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

International Family Members for US Patent 8,513,247

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1631293		CR 2014 00031	Denmark
European Patent Office	1631293		C300683	Netherlands
European Patent Office	1631293		1490049-2	Sweden
European Patent Office	1631293		C20140022 00150	Estonia
European Patent Office	1631293		92462	Luxembourg