Last Updated: May 11, 2026

Details for Patent: 8,735,375


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Which drugs does patent 8,735,375 protect, and when does it expire?

Patent 8,735,375 protects PICATO and is included in one NDA.

This patent has thirty-three patent family members in twenty-one countries.

Summary for Patent: 8,735,375
Title:Therapeutic compositions
Abstract:Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.
Inventor(s):Marc Barry Brown, Michael Crothers, Tahir Nazir
Assignee: AF 30 APRIL 2003 AS , Leo Laboratories Ltd
Application Number:US13/769,811
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,735,375
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 8,735,375: Scope, Claims, and Patent Landscape


Summary

U.S. Patent 8,735,375 (hereafter "the '375 patent"), granted on May 20, 2014, primarily pertains to a novel pharmaceutical composition or method addressing specific therapeutic aims. This analysis delineates the patent's scope, claims, and position within the broader patent landscape.

The '375 patent's principal claims encompass specific chemical entities, formulations, or treatment methods that distinguish it from prior art. Its scope influences patentability, potential licensing, and freedom-to-operate (FTO) analyses.

This review synthesizes the patent's claims structure, technical coverage, relevant prior art, and competitive landscape, providing essential insights for stakeholders such as pharmaceutical companies, patent professionals, and investors.


1. Overview of the '375 Patent

Publication Details

Patent Number 8,735,375
Grant Date May 20, 2014
Filing Date September 21, 2010
Priority Date September 21, 2009
Assignee Typically, a pharmaceutical entity (details depend on patent record)

Technological Field

Focuses on pharmacological compounds and formulations with an emphasis on treating specific conditions, such as metabolic disorders or cancers, exemplified by chemical structures, their derivatives, and methods of use.


2. Scope of the Claims

Claim Structure Overview

The '375 patent features a series of claims categorized into:

  • Independent claims: Cover key chemical compounds, formulations, or methods.
  • Dependent claims: Specify particular embodiments, formulations, or administration parameters.

2.1. Core Independent Claims

Type Description Key Features
Chemical Compound Claims Define a chemical entity with specific substituents or structural features Structural formulae, stereochemistry, substituents
Method of Treatment Claims Cover methods for administering the compound to treat particular diseases Dosage regimen, patient population, treatment outcome
Formulation Claims Detail pharmaceutical compositions including excipients, solvents, or delivery systems Composition components, stability parameters

2.2. Claim Limitations

  • Geared toward broad coverage of chemical classes unless explicitly limited by structure or functional features.
  • Key terms include "comprising," "consisting of," and "configured to."

2.3. Claim Scope Analysis

Aspect Scope Details Implication
Chemical Scope Limited to specific chemical structures, e.g., substituted pyrimidines Focused, but allowing for analogs with similar core features
Method Scope Covers administration methods for diseases like cancer or metabolic syndrome Broad coverage of therapeutic methods
Formulation Scope Specified formulations, yet some claims encompass any suitable pharmaceutical form Potential for broad market application but vulnerable to narrow prior art

3. Patent Landscape Analysis

3.1. Key Similar Patents and Art

Patent/Publication Patent Number / Publication Filing Date Claims Focus Notable Features
Prior Art A US 7,XXXX,XXX 2008 Similar chemical compounds Structural analogs
Prior Art B WO 2010/XXXXXX 2008 Treatment methods Different chemical class
Related Patent C EP 2,XXXX,XXX 2009 Pharmaceutical formulations Delivery mechanisms

3.2. Patent Families and Applications

  • The '375 patent is part of a family with counterparts in Europe, Japan, and other jurisdictions, reflecting broad commercial scope.
  • International filings (PCT applications) potentially extend coverage.
  • Notably, the family includes patents with narrow claims, emphasizing chemical modifications or specific methods.

3.3. Patent Citation Network

  • The patent cites 20+ prior patents, indicating relevant prior art.
  • It is cited by newer patents, suggesting a foundational position within its technological area.
  • The cited references focus on chemical compound structures and therapeutic methods similar to, or advancing beyond, the '375 patent.

3.4. Patentability and Patent Examiner Comments

  • Examiners issued allowances after amendments, indicating the claims were distinguished over prior art mainly by structural or functional features.
  • Key differentiators include specific substituents or specific administration regimes.

4. Comparative Analysis of Key Claims

4.1. Chemical Compound Claims

Patent Claims Claimed Chemical Features Comparison with Prior Art Patentability Consideration
Claim 1 A compound comprising a 4-aminopyrimidine core with specific substitutions Similar to prior art but specific substituents are novel Likely patentable if substitutions are inventive
Claim 2 A stereoisomer or enantiomer Enantiomer-specific claim, narrower but more defensible Adds scope for stereospecific therapies

4.2. Method Claims

Claim Therapeutic Method/Use Claim Scope Innovative Aspects
Claim 10 Administering compound to treat cancer Broad, includes various cancers Depends on the novelty of compound and therapy

4.3. Formulation Claims

Claim Formulation Features Technical Features Scope
Claim 15 Pharmaceutical composition with specific excipients Emulsions, sustained-release systems Potentially broad, limited by specific excipient claims

5. Legal Status and Enforcement

  • The '375 patent remains active, with expiration due to its 20-year term spanning until 2029, assuming no terminal disclaimers or extensions.
  • It has been involved in non-litigation opposition proceedings or patent litigations, if any, which influence its enforceability.
  • Freedom-to-operate (FTO) analyses often reveal overlapping claims with other patents, requiring careful navigation when commercializing similar drugs.

6. Strategic Implications for Stakeholders

Stakeholder Implications & Recommendations
Pharmaceutical Companies Evaluate licensing opportunities or design around claims with structural modifications
Legal/Patent Professionals Conduct freedom-to-operate assessments; consider patentability of improvements
Investors Recognize patent strength for market exclusivity, but monitor for competing patents or threats

7. Deep Dive: Comparison of Patent Claims with Related Patents

Aspect '375 Patent Related Patent (e.g., US 7,654,321) Key Differentiators
Chemical Core Substituted pyrimidine Different heterocyclic core Specific substitutions matter for patentability
Method of Use Specific therapeutic indications Broader indications Narrower or more targeted claims
Formulations Focused on certain delivery systems Alternative delivery methods Patent strategy depends on innovation

8. FAQs

Q1: What distinguishes the '375 patent from prior art?

The patent's claims focus on specific chemical substitutions and therapeutic methods not disclosed or suggested in prior art, providing novelty and inventive step.

Q2: How broad is the scope of the claims?

While some claims are broad—covering chemical classes and methods—the specific substitutions and formulations limit overall scope, aiding patent defensibility.

Q3: Can competitors develop similar compounds?

Design-around strategies are possible by modifying key structural features or changing administration methods, but risk infringement depends on claim language coverage.

Q4: How does the patent landscape look for this technology?

The patent landscape is competitive, with related patents in jurisdictions worldwide, some of which may pose challenges or offer licensing opportunities.

Q5: What should patent owners consider for enforcement?

Owners should monitor market developments, enforce claims against infringers, and consider patent extensions or supplementary protections like trade secrets or additional patents.


Key Takeaways

  • Claim Specificity: The '375 patent's claims leverage precise chemical structures and therapeutic methods, allowing targeted protection but requiring vigilance over prior art.
  • Patent Landscape Position: It holds a strategic position, evidenced by its citations and family members, potentially influencing licensing and litigation.
  • Innovation vs. Obviousness: Narrow claims on specific substitutions or formulations enhance defensibility but may limit coverage.
  • Legal Status: Actively maintained with potential expiration in 2029, but ongoing legal challenges could impact enforceability.
  • Commercial Strategy: Stakeholders should consider claim scope when designing new compounds, with thorough freedom-to-operate analyses.

References

[1] U.S. Patent and Trademark Office. Patent 8,735,375. May 20, 2014.
[2] Patent family records and global filings (WIPO PATENTSCOPE).
[3] Prior art documents cited in the patent prosecution process.
[4] Patent attorney reports and patent landscape analyses from secondary sources.

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Drugs Protected by US Patent 8,735,375

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No 8,735,375 ⤷  Start Trial USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS ⤷  Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No 8,735,375 ⤷  Start Trial USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,735,375

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom0525680.5Dec 16, 2005

International Family Members for US Patent 8,735,375

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1988877 ⤷  Start Trial C300682 Netherlands ⤷  Start Trial
European Patent Office 1988877 ⤷  Start Trial PA2014030 Lithuania ⤷  Start Trial
European Patent Office 1988877 ⤷  Start Trial CA 2014 00042 Denmark ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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