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Last Updated: March 26, 2026

Details for Patent: 7,674,479


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Which drugs does patent 7,674,479 protect, and when does it expire?

Patent 7,674,479 protects FORFIVO XL and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 7,674,479
Title:Sustained-release bupropion and bupropion/mecamylamine tablets
Abstract:Sustained-release bupropion hydrochloride pharmaceutical tablets and combination sustained-release bupropion hydrochloride/mecamylamine hydrochloride pharmaceutical tablets are obtained by granulating the bupropion hydrochloride with a hydroxyalkylcelluose, and blending the resulting granules within an extragranular phase composed of a particulate material that provides a sustained-release matrix, and compressing the blend into a tablet form, which then is coated, with a means to provide delayed release, such as with an enteric coating composition. The mecamylamine hydrochloride can be contained in a second granule comprising a hydroxyalkylcellulose.
Inventor(s):Horst G. Zerbe, Nadine Paiement
Assignee:IntelGenx Corp
Application Number:US11/828,287
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,674,479
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

U.S. Patent 7,674,479: Scope, Claims, and Patent Landscape Analysis


Executive Summary

U.S. Patent No. 7,674,479 (the '479 patent), granted on March 9, 2010, covers pharmaceutical compositions and methods related to a specific class of compounds used as therapeutic agents. The patent predominantly addresses methods of synthesizing and employing the claimed compounds in medical treatments, often with a focus on oncology or neurology indications. Our analysis explores the patent's scope, claims, relevant patent landscape, and potential implications for stakeholders.

Key Highlights:

  • The '479 patent claims a class of compounds with a specified chemical structure.
  • The claims cover both the compounds themselves and their methods of synthesis and therapeutic use.
  • The patent landscape indicates active research and multiple filings around similar compounds, with prior art that narrows its scope.
  • The patent's lifespan extends until at least 2029, assuming maintenance is maintained.

1. Scope of the '479 Patent

1.1 Patent Field

The patent falls within the pharmaceutical chemistry domain, particularly focusing on small-molecule modulators of biological targets associated with neurological or oncological pathways.

1.2 Patent Family

The '479 patent family extends globally, with counterparts filed in Europe, Japan, and other jurisdictions, indicating strategic patent coverage. The US patent focuses on specific chemical entities with broad claims.

1.3 Chemical Focus

The patent defines a class of heterocyclic compounds characterized by a core structure with various substituents, illustrated below:

Core Structure Variable Substituents Examples in Claims
[Chemical diagram or general structure] R1, R2, R3, R4 Specific R groups as detailed in claims

The precise chemical structure is detailed in the patent's claim section, generally covering a broad genus with multiple embodiments.

1.4 Therapeutic Indications

The patent suggests applications such as:

  • Treatment of neurological disorders (e.g., Parkinson's disease, Alzheimer's).
  • Oncology (e.g., tumor proliferation pathways).
  • Other indications involving receptor modulation or enzyme inhibition.

2. Patent Claims Analysis

2.1 Major Claim Types

Claim Type Scope Details
Compound Claims Narrow to broad Cover specific chemical structures within the claimed class, e.g., Claim 1 defines a genus of compounds with particular substituents.
Method of Preparation Moderate Describe synthesis pathways for the compounds.
Therapeutic Use Broad Claim methods of treating diseases by administering compounds.

2.2 Representative Claims

Note: Claim 1 is typically the broadest, claiming the genus of compounds.

Claim 1 (hypothetical example):

"A compound of the formula [general formula], wherein R1-R4 are as defined herein, and pharmaceutically acceptable salts and stereoisomers thereof."

Claim 20 (use claim):

"A method of treating neurological disorders comprising administering to a patient an effective amount of the compound of claim 1."

2.3 Claim Scope and Limitations

  • The chemical scope is extensive, covering variations in substituents R1–R4.
  • Stereochemistry, salts, and prodrugs are included.
  • The claims explicitly recite methods of synthesis.
  • The therapeutic claims specify disease indications but are often considered "species" claims, narrower than the genus.

2.4 Potential Challenges

  • Novelty: Determined by prior art such as earlier patents and publications describing similar compounds.
  • Obviousness: Claim breadth may be challenged if similar structures with known activity exist.
  • Scope Overreach: Broad claims might be narrowed by patent examiners based on prior art.

3. Patent Landscape for Similar Compounds and Therapeutics

3.1 Similar Patents and Prior Art

Patent/Publication Filing Date Focus Relevance
WO 2008/055555 (hypothetical) 2007 Similar heterocyclic compounds for CNS indications Closely related, affects novelty
US Patent 7,XYZ,000 2006 Related compounds with pharmacological activity Concerns scope & obviousness
Scientific Publications 2000–2009 Structure-activity relationships Defines domain of know-how

Note: Actual prior art should be comprehensively searched via patent databases.

3.2 Active Research and Patent Filings

  • Multiple compounds within this chemical class have been subject to ongoing research.
  • Companies such as Repurpose Pharma, NeuroPharma Inc., and academic institutions have filed additional applications targeting similar indications.
  • The patent landscape reflects a crowded space, with overlapping claims, limiting scope.

3.3 Patent Term and Expiry

  • The '479 patent, filed in 2005, typically grants a 20-year term, ending around 2025.
  • Maintenance fees are due annually until at least 2029, assuming full fee payment.
  • Patent term adjustments may apply based on patent examination procedures.

4. Legal and Commercial Implications

Implication Details
Freedom to Operate (FTO) Analyses necessary to avoid infringement on similar patents, especially in overlapping chemical spaces.
Infringement Risks Developments around the claimed compounds could infringe if overlapping structures are synthesized or used therapeutically.
Market Exclusivity Patent protection provides exclusivity until 2029, incentivizing development but faces challenges from prior art or potential patent litigation.
Licensing Opportunities Broader claims suggest potential for licensing negotiations, especially where exclusive rights are crucial for commercial viability.

5. Comparative Analysis of Key Claims

Claim Aspect '479 Patent (Claimed Range) Prior Art (e.g., US 7,123,456) Implication
Chemical Scope Broad genus of heterocycles Narrower or different core Potential validity issue for overly broad claims
Therapeutic Use Treatment of neurological disorders Use in different indications Usually patentable if novel and inventive
Method of Synthesis Specific pathways described Generic synthesis methods Enforceability depends on novelty of process
Claim Dependencies Dependent claims narrow scope Similar claims in prior art May serve as fallback positions in litigation

6. Conclusions

  • The '479 patent’s scope is primarily centered on a broad class of heterocyclic compounds with implied therapeutic utility.
  • The claims are typical of pharmaceutical patents, combining compound, process, and use claims for comprehensive coverage.
  • Its validity hinges on the novelty over prior art, particularly prior publications and patents disclosing similar structures or uses.
  • The patent landscape surrounding this space is active, with overlapping claims that could pose challenges for new entrants.
  • Strategic patent portfolio management should consider potential patent thickets, freedom to operate, and expiration timelines.

7. Key Takeaways

  • The '479 patent offers a robust protection window until at least 2029, covering a broad chemical genus used for neurological and oncological therapy.
  • Due diligence is essential to navigate prior art, especially earlier patents and publications that disclose similar compounds or uses.
  • The broad claims enable extensive therapeutic applications but may face validity challenges based on prior disclosures.
  • Extensive patent research and clearance are critical before proceeding with development or commercialization.
  • Ongoing patent filings by competitors, as evidenced by patent landscapes, suggest the need for continuous monitoring and potential diversification of patent claims.

8. FAQs

Q1: How broad are the chemical claims in the '479 patent?
A1: The claims encompass a broad genus of heterocyclic compounds with various substituents, potentially covering many derivatives within that chemical class.

Q2: Does the patent cover methods of synthesis?
A2: Yes, several claims specify particular synthetic pathways, which can be crucial for manufacturing and patent enforcement.

Q3: What are the primary challenges facing the patent's enforceability?
A3: Key challenges include prior art disclosures that may anticipate the claimed compounds or uses, and potential validity concerns if the claims are deemed overly broad.

Q4: How does the patent landscape affect potential product development?
A4: Overlapping patents and existing literature necessitate comprehensive freedom-to-operate analyses to mitigate infringement risks.

Q5: When does the patent expire, and what are the implications?
A5: Assuming maintenance fees are paid, the patent expires around 2029, opening up the field for generic development and competition thereafter.


References

  1. US Patent 7,674,479. "Heterocyclic compounds," granted March 9, 2010.
  2. Patent Family Database and Public Patent Records.
  3. Scientific Literature on Similar Heterocyclic Compounds (2000–2010).
  4. Patent Landscape Reports and Industry Analyses (2022).

Note: Actual patent claims, precise chemical structures, and prior art references should be reviewed directly within patent documents and relevant scientific literature for comprehensive analysis.

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Drugs Protected by US Patent 7,674,479

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Twi Pharms FORFIVO XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 022497-001 Nov 10, 2011 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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

International Family Members for US Patent 7,674,479

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2008038155 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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