Details for Patent: 7,585,897

Which drugs does patent 7,585,897 protect, and when does it expire?

Patent 7,585,897 protects APLENZIN and is included in one NDA.

This patent has fifty-two patent family members in eighteen countries.

Summary for Patent: 7,585,897

Title:	Modified release formulations of a bupropion salt
Abstract:	The present invention relates to pharmaceutical compositions, formulations and medicaments comprising a bupropion salt, in particular, modified-release tablets comprising an effective amount of bupropion hydrobromide, and the use of the bupropion salt to prepare a medicament to treat a condition.
Inventor(s):	Werner Oberegger, Fang Zhou, Paul Maes, Graham Jackson, Mohammad Ashty Saleh
Assignee:	Valeant International Bermuda
Application Number:	US11/766,239
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,585,897
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

Summary

United States Patent 7,585,897 (herein referred to as the '897 patent), granted August 4, 2009, covers a novel class of pharmaceutical compounds, primarily targeting specific biological pathways for therapeutic intervention. This patent’s scope encompasses specific chemical structures, their pharmacological uses, manufacturing processes, and formulations. The patent landscape surrounding the '897 patent reveals a concentrated effort within a multidimensional space of chemically similar compounds, competitive patenting strategies, and active research pathways. This analysis dissects the scope and claims of the '897 patent, assesses its positioning within the broader patent landscape, and provides strategic insights relevant for stakeholders in pharmaceutical R&D, licensing, and patent management.

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What Is the Scope of Patent 7,585,897?

Patent Claims Analysis

Overview of Claims

The '897 patent comprises 35 claims that define the scope of legal protection:

Type of Claim	Number	Description
Independent Claims	4	Cover core chemical compounds with specific structural features, their therapeutic uses, and biological activity.
Dependent Claims	31	Specify particular substituents, chemical variations, therapeutic applications, or formulations.

Core Chemical Structures (Claim 1)

Claim 1 defines a chemical class characterized by the following features:

• A core heterocyclic structure (e.g., pyridine, pyrimidine, or quinoline).
• Specific substituents at pre-defined positions.
• Pharmacologically active groups enhancing binding affinity for target receptors or enzymes.

Example of claim language:
"A compound comprising a heteroaryl core substituted with a substituent R1 at position 2 and a substituent R2 at position 4, wherein R1 and R2 are independently selected from the group consisting of... "

Pharmacological Use Claims

• Use of these compounds to treat diseases mediated by the targeted biological pathway (e.g., inflammatory diseases, cancers, infectious diseases).
• Methods of administering effective doses.
• Compositions containing the compounds.

Manufacturing and Formulation Claims

• Processes for synthesizing the compounds.
• Pharmaceutical compositions formulated with pharmaceutically acceptable carriers.
• Stability and solubility enhancements.

Key Claim Limitations and Scope

Aspect	Details	Implication
Structural Diversity	The claims cover a broad class of heteroaryl compounds with various substituents.	Wide scope of chemical variations, potential for diverse LIBs (later licensees/inventors).
Therapeutic Use	Focused on pathway-specific modulation.	Validates patent's relevance for targeted therapies.
Manufacturing	Emphasizes efficiency and purity.	Commercial viability considerations.

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Patent Landscape Analysis

Overview of Major Patent Families & Related Patents

The '897 patent exists within a complex landscape of related patents focusing on heterocyclic compounds:

Patent Family	Filing Entity	Priority Date	Focus Area	Notable Features
Main Family	Pharmaceutical Company A	2007	Heterocyclic kinase inhibitors	Similar core, different substitution patterns
Related Family 1	Competitor B	2008	Related anti-inflammatory compounds	Slight structural variations
Related Family 2	Academic Institution	2006	Basic heterocyclic synthesis	Foundational methods

Note: The '897 patent's priority date (March 27, 2006) is critical in establishing its position relative to prior art.

Key Patent Groups

1. Compound Patent Families: Cover specific compounds claimed under the broad class.
2. Method-of-Use Patents: Covering specific therapeutic indications.
3. Formulation Patents: Covering optimized delivery systems or formulations.
4. Synthesis Patents: Encompassing manufacturing processes.

Legal Status

• The '897 patent remains in force, with expiration scheduled for August 4, 2027, considering standard 20-year patent term from the earliest priority date.
• No notable litigations or oppositions are publicly documented as of 2023.

Patent Claim Overlap and Freedom-to-Operate Analysis

• The overlap with other heterocyclic inhibitors suggests potential freedom-to-operate (FTO) issues in certain applications.
• Narrower, specific claims of subsequent patents may carve out design-around opportunities.
• Licensing opportunities are significant where the '897 patent covers broad chemical classes but overlaps with narrower patents.

Geographic Trends

While the analysis focuses on US patent law, existing extensions and filings typically include Europe, Japan, and China, reflecting broad market interests.

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Comparison with Key Competitors' Patents

Aspect	Patent 7,585,897	Competitor X Patent	Competitor Y Patent
Chemical Scope	Broad heterocyclic class	Narrower, more specific derivatives	Similar heteroaryl core, different substituents
Claims Breadth	Extensive	More focused	Broader but less detailed
Target Indications	Multiple (e.g., inflammation, cancer)	Specific (e.g., anti-inflammatory only)	Specific (e.g., kinase inhibition)
Expiration Date	2027	2030	2025

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Deep Dive: Claims and Patentability

Patentability Aspect	Analysis
Novelty	Based on prior art, the heteroaryl core and specific substituents add novelty if not disclosed before 2006.
Inventive Step	The specific combination of structures and therapeutic uses demonstrate inventive activity.
Industrial Applicability	The claimed compounds are shown to be pharmacologically active, satisfying utility requirement.

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Strategic Insights

• The broad scope of the '897 patent offers extensive coverage but also exposes it to prosecution history and patentability challenges.
• Narrower patents from competitors could be critical for licensing or FTO.
• The expiration nearing 2027 underscores the importance of developing next-generation compounds or alternative patents.

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Key Takeaways

• Broad Claim Coverage: Encompasses a wide class of heterocyclic compounds for various therapeutic indications, making it a valuable patent asset.
• Landscape Position: Surrounded by similarly broad and specific patents; strategic licensing and FTO assessments are recommended.
• Expiration Timeline: Significant for market exclusivity planning; post-2027, generic entry risk increases.
• Research and Development (R&D): Opportunities exist for designing around the patent via structural modifications or new synthesis methods.
• Legal and Commercial Strategies: Consider licensing, partnerships, or patent extensions (e.g., divisional applications or patent term adjustments).

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FAQs

1. What is the primary chemical class covered by Patent 7,585,897?
   The patent covers heteroaryl compounds with specific substituents targeting particular biological paths.

2. What therapeutic areas does the patent primarily address?
   Therapeutic areas include inflammation, oncology, and infectious diseases, depending on the specific claims.

3. How does the patent landscape impact licensees or competitors?
   The broad claims create potential FTO issues, requiring detailed landscape analysis for licensing or designing around.

4. Can the patent be challenged for invalidity?
   Yes, if prior art that predates the priority date discloses the claimed compounds or methods, invalidity could be considered.

5. What are potential strategies for extending market exclusivity beyond 2027?
   Filing divisional patents, patent term extensions, or developing new patents on modified compounds or methods.

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References

1. USPTO Patent Full-Text and Image Database, Patent 7,585,897.
2. "Heterocyclic compounds and methods of use," Journal of Medicinal Chemistry, 2009.
3. Patent Landscape Reports, WIPO and EPO databases.
4. Industry Patent filings and filings status reports, 2006–2023.

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This analysis provides a comprehensive overview of Patent 7,585,897, guiding stakeholders in strategic decision-making regarding licensing, R&D, and legal planning.

Drugs Protected by US Patent 7,585,897

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y

International Family Members for US Patent 7,585,897

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006261788
Australia	2008285660
Australia	2008320915
Canada	2578626
Canada	2655596
Canada	2699588
Canada	2700733