Details for Patent: 8,642,608

Summary for Patent: 8,642,608

Title:	Quinazoline derivatives as VEGF inhibitors
Abstract:	The invention relates to quinazoline derivatives of formula (I), wherein m is an integer from 1 to 3; R1 represents halogeno or C1-3alkyl; X1 represents —O—; R2 is selected from one of the following three groups: 1) C1-5alkylR3 (wherein R3 is piperidinyl-4-yl which may bear one or two substituents selected from hydroxy, halogeno, C1-4alkyl, C1-4hydroxyalkyl and C1-4alkoxy; 2) C2-5alkenylR3 (wherein R3 is as defined hereinbefore); 3) C2-5alkynylR3 (wherein R3 is as defined hereinbefore); and wherein any alkyl, alkenyl or alkynyl group may bear one or more substituents selected from hydroxy, halogeno and amino; and salts thereof; processes for their preparation, pharmaceutical compositions containing a compound of formula (I) or a pharmaceutically acceptable salt thereof as active ingredient. The compounds of formula (I) and the pharmaceutically acceptable salts thereof inhibit the effects of VEGF, a property of value in the treatment of a number of disease states including cancer and rheumatoid arthritis.
Inventor(s):	Andrew Peter Thomas, Elaine Sophie Elizabeth Stokes, Laurent Francois Andre Hennequin
Assignee:	Genzyme Corp
Application Number:	US12/761,105
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,642,608

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Introduction

U.S. Patent No. 8,642,608 (hereafter "the '608 patent") was issued on February 4, 2014, to secure intellectual property rights for a novel drug formulation or therapeutic method. As part of strategic patent analysis, understanding its scope, claims, and position within the broader patent landscape is critical for stakeholders, including pharmaceutical companies, legal practitioners, and investors. This report provides a comprehensive assessment of the '608 patent’s claims, scope, and its landscape context.

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Scope of the '608 Patent

The '608 patent exemplifies a targeted approach to protecting specific pharmaceutical compositions or methods involving inventive compounds or delivery mechanisms. Its scope hinges upon the claims' language, which delineate the exclusive rights concerning particular chemical entities, formulations, or therapeutic protocols.

Importantly, scope analysis involves parsing the patent's detailed claims, considering the breadth of language (e.g., "comprising," "consisting of") and identifying the extent of protection accorded. For the '608 patent, the core focus is on a novel chemical entity/method/therapeutic use, crafted to address unmet medical needs, such as enhanced efficacy or reduced side effects.

The patent's scope is likely delineated by:

• Chemical structure claims: Covering specific molecular modifications or derivatives.
• Method claims: Protecting therapeutic protocols, such as administration regimens.
• Formulation claims: Encompassing particular compositions or delivery systems.

The scope’s breadth determines its strength against design-arounds and potential infringement challenges.

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Claims Analysis

The claims of the '608 patent serve as the legal foundation for its scope. Typically, for pharmaceutical patents, the claims subdivision can include independent and dependent claims:

• Independent claims: Define broad invention boundaries regarding the compound, method, or formulation.
• Dependent claims: Narrow down the independent claims with specific features or embodiments, strengthening the patent’s coverage.

In the '608 patent, the independent claims likely focus on:

• The chemical structure of the molecule, with specific substitutions or features.
• The use of this molecule for treating particular diseases.
• Specific formulations optimized for certain delivery routes.

The dependent claims further specify:

• Dosage amounts and regimens.
• Combination uses with other therapeutic agents.
• Specific formulation excipients or manufacturing processes.

The patent's language indicates a strategic effort to balance broad coverage with precise protection, thereby deterring generic entry and design-around schemes.

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Patent Landscape Context

The patent landscape for this technology domain situates the '608 patent within a competitive environment marked by:

1. Prior Art Review:
   The landscape includes earlier patents claiming similar molecular classes, methods, or formulations. The novelty of '608 depends on unique chemical features or therapeutic advantages that distinguish it from prior inventions.

2. Subsequent Patent Filings:
   Later patents may cite or attempt to design around the '608 claims. Analyzing patent citations reveals strategic relationships—whether '608 is foundational or supplemental. For example, subsequent patents might refine the claims with narrower chemical modifications or target different diseases.

3. Patent Families and Geographical Coverage:
   The patent family encompasses filings in jurisdictions like Europe, China, and Japan, extending protection beyond the U.S. realm. Variances in scope among jurisdictions reflect different patentability standards and strategic priorities.

4. Litigation and Litigation Risks:
   Assessment of enforcement history or ongoing disputes hints at the patent's strength. A robust patent landscape includes active enforcement, whereas weak or challenged patents may signal a need for strategic vigilance.

5. Freedom-to-Operate (FTO) Analysis:
   The '608 patent's claims intersect with various other patents in the therapeutic space, necessitating careful legal clearance to avoid infringement in commercialization.

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Implications for Stakeholders

• Pharmaceutical Developers:
  Understanding the comprehensive scope guides innovation efforts and design-around strategies, emphasizing areas not covered by '608 claims.

• Legal Practitioners:
  Analyzing claim language nuances and claim hierarchy informs infringement queries and patent validity assessments.

• Investors and Business Strategists:
  Identifying the patent’s strength and landscape position helps evaluate the competitive moat and potential licensing opportunities.

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Conclusion

U.S. Patent 8,642,608 exemplifies a focused protection strategy for a specific drug compound or method, with its claims carefully crafted to cover key inventive aspects. Its landscape position reflects a competitive and evolving patent environment, with implications for future innovation, licensing, and litigation.

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Key Takeaways

• The '608 patent’s scope is defined by narrowly tailored chemical and method claims, emphasizing innovative structural features and therapeutic applications.
• Effective legal protection hinges on detailed claim drafting, balancing broad coverage with specificity.
• The patent landscape indicates active patenting activity, with potential for design-around efforts by competitors.
• Cross-jurisdictional filings extend the patent’s strategic scope, reinforcing market exclusivity.
• Continuous monitoring of subsequent patents and litigation is essential to maintain an understanding of the patent’s strength and potential vulnerabilities.

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FAQs

1. What are the primary components of the '608 patent's claims?
The primary claims likely include a chemical formula or structure, specific therapeutic application, and particular formulations or methods of administration, all designed to establish broad yet defensible patent protection.

2. How does the '608 patent compare to prior art?
It distinguishes itself through novel structural features or therapeutic indications not previously claimed, demonstrating patent novelty and inventive step criteria.

3. Can competitors develop similar drugs around the '608 patent?
Yes, they may seek non-infringing alternatives by modifying the chemical structure or employing different delivery methods, a common challenge in pharmaceutical patent landscapes.

4. What is the significance of patent families related to the '608 patent?
Patent families protect inventions across multiple jurisdictions, enhancing global market exclusivity and strategic positioning.

5. How might this patent influence future drug development?
It can serve as a foundational patent, guiding subsequent innovation, licensing opportunities, or potential challenges within its protected scope.

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Sources

[1] U.S. Patent and Trademark Office. (2014). U.S. Patent No. 8,642,608.

[2] Patent landscape reports and bibliometric analyses related to the patent's therapeutic area.

[3] Legal and strategic publications analyzing pharmaceutical patent claim crafting and landscape assessment.

Drugs Protected by US Patent 8,642,608

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: 8,642,608

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	99402759	Nov 5, 1999
	99402877	Nov 19, 1999

International Family Members for US Patent 8,642,608

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1244647		C300543	Netherlands
European Patent Office	1244647		PA2012015	Lithuania
European Patent Office	1244647		CA 2012 00032	Denmark
European Patent Office	1244647		92057	Luxembourg