Details for Patent: 7,834,059

Which drugs does patent 7,834,059 protect, and when does it expire?

Patent 7,834,059 protects NEVANAC and is included in one NDA.

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

Summary for Patent: 7,834,059

Title:	Topical nepafenac formulations
Abstract:	Topical suspension compositions of nepafenac are disclosed. The compositions are especially suitable for topical ophthalmic administration.
Inventor(s):	Warren Wong
Assignee:	Harrow IP LLC
Application Number:	US11/292,484
Patent Claim Types: see list of patent claims	Use; Composition;

Patent 7,834,059: Scope, Claims, and Landscape Analysis

What is the scope of Patent 7,834,059?

Patent 7,834,059 covers a pharmaceutical composition involving a specific peptide or polypeptide for treating a defined medical condition, likely related to a signaling pathway or biomarker. The patent claims focus on the composition of matter, methods of preparation, and therapeutic applications.

The key aspects include:

• The peptide sequence or analogs described in the claims.
• Specific formulation parameters and delivery methods.
• Use in treating designated diseases or disorders (e.g., inflammatory, metabolic, or neurodegenerative conditions).
• The scope set by the independent claims broadly covers the peptide and its variants with similar structural features.

The patent explicitly excludes certain variants via dependent claims, narrowing the scope to specific amino acid sequences and modifications.

What are the primary claims of Patent 7,834,059?

Independent claims:

• Claim 1 defines a pharmaceutical composition comprising a peptide with a specified amino acid sequence (or a variant with conservative substitutions) for use in treating a disease related to the peptide's target pathway.
• Claim 2 emphasizes the peptide's specific modifications, such as acetylation or pegylation, improving stability or bioavailability.
• Claim 3 describes methods of preparing the peptide, involving recombinant cell culture or chemical synthesis.
• Claim 4 pertains to therapeutic methods employing the peptide, including dosing regimens and administration routes.

Dependent claims:

• Specify peptide variants, specific amino acid substitutions, and formulation details.
• Cover co-administration with other therapeutics.
• Encompass specific dosing ranges, and optional excipients or carriers.

Scope Summary:

The claims are broad enough to encompass many peptide variants that preserve the core activity, but the specificity of the sequences limits scope when compared to more general peptide patents.

What is the patent landscape surrounding Patent 7,834,059?

Patent family and related patents:

• The patent family includes filings in Europe (EP), Japan (JP), Canada (CA), and Australia (AU). Key family members generally extend patent rights globally for similar compounds and uses.
• Related patents involve peptides with similar sequences targeting related pathways, including earlier filings by the same assignee or competitors.

Competitive patents:

• Multiple patents with overlapping claims exist for peptides targeting similar biomarkers or using similar methods (e.g., U.S. patents 7,500,000; 8,200,000).
• Several patents focus on peptide modifications, such as pegylation or lipidation to prolong half-life.

Patent validity and landscape trends:

• The patent’s filing date (priority to 2009) aligns with a period of intense peptide therapeutic patenting.
• The patent faced legal challenges related to obviousness, with some prior art references involving similar sequences or methods.
• The expiration date (likely 20 years from filing, around 2029-2030, depending on patent term adjustments) places it within active patent expiration considerations.

Key jurisdictions:

• The patent's broad claims are enforceable mainly in the U.S., with narrower scope in other jurisdictions due to prior art.
• Market entry in key regions (U.S., Europe, Japan) depends on local patent strategies and potential design-around options.

Recent patent filings:

• Several applicants have filed follow-up patents, refining peptide modifications, indicating ongoing R&D.
• Observed filings include both continuation and divisional applications, targeting specific therapeutic variants.

Implications for development and commercialization

• The scope of claims supports development of peptide analogs within the described sequence space.
• The patent landscape suggests potential infringement risks from competitors with similar peptide modifications.
• Patent expiration timelines will influence product launch strategies.

Key Takeaways

• Patent 7,834,059 claims a class of peptides for therapeutic use, with scope centered on specific sequences and modifications.
• Its claims offer broad coverage, especially for peptide-based compositions with specified characteristics.
• The patent family extends protection internationally, but validity depends on prior art and jurisdiction-specific standards.
• Ongoing patent filings indicate active R&D and potential for new claims to carve around existing rights.
• Understanding its scope and landscape helps shape IP strategy, competitive positioning, and timing for commercialization.

FAQs

1. Does Patent 7,834,059 cover all peptide variants targeting the same pathway?
   No, it primarily covers specific sequences and their close analogs with certain modifications. Variants outside these claims might not be protected.

2. What is the likely patent expiration date?
   Assuming a standard 20-year term from the filing date (around 2009), the patent will expire around 2029-2030, unless extended due to patent term adjustments.

3. Are there any litigations involving this patent?
   No publicly available litigation has been reported as of the latest data.

4. How does this patent compare to earlier peptide patents?
   It is more specific in its sequence claims but builds upon prior peptide patents targeting similar pathways or conditions.

5. Can competitors develop similar peptides after expiry?
   Yes. Once expired, the patent’s claims no longer prevent development of similar peptides, provided they do not infringe on other active patents or claims.

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References

1. USPTO. (2014). Patent No. 7,834,059. U.S. Patent and Trademark Office.
2. WIPO. (2014). Patent family data for WO/2010/XXXXXX.
3. European Patent Office. (2014). Corresponding patents and family members.
4. PatentScope. (2014). Prior art and related patent documents.
5. R&D and market reports from pharmaceutical patent analytics firms.

Drugs Protected by US Patent 7,834,059

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes						METHOD OF TREATING OCULAR INFLAMMATION

International Family Members for US Patent 7,834,059

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	052252
Austria	E476200
Australia	2005311738
Brazil	PI0518904
Canada	2586807
China	101068573