Details for Patent: 6,423,722

Summary for Patent: 6,423,722

Title:	Crystalline macrolides and process for their preparation
Abstract:	33-Epichloro-33-desoxyascomycin of formula I ##STR1## and various tautomeric or forms thereof, in crystalline form, such as Form A and Form B. Their preparation involves appropriately converting amorphous compound of formula I, or compound of formula I in other than Form A, or compound of formula I in other than Form B, respectively, from a solution thereof under crystallization-inducing conditions or conditions inducing preferential crystallization of Form A or B, respectively. Such crystals are particularly indicated for use in the preparation of topical galenical forms of the compound for pharmaceutical use, e.g. creams, emulsions and ointments.
Inventor(s):	Dosenbach; Cornelia (Efringen-Kirchen, DE), Grassberger; Maximilian (Vienna, AT), Hartmann; Otto (Basel, CH), Horvath; Amarylla (Vienna, AT), Mutz; Jean-Paul (Blotzheim, FR), Penn; Gerhard (Oberwil, CH), Pfeffer; Sabine (Weil, DE), Wieckhusen; Dierk (Binzen, DE)
Assignee:	Novartis AG (Basel, CH)
Application Number:	09/690,404
Patent Claim Types: see list of patent claims	Compound; Process; Composition; Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent No. 6,423,722

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Introduction

U.S. Patent No. 6,423,722 (the ‘722 patent), issued on July 23, 2002, represents a significant intellectual property asset within the pharmaceutical landscape. This patent pertains to a novel chemical compound or pharmaceutical composition, typically associated with therapeutic use, and exemplifies innovations aimed at treatment modalities or drug delivery systems. Analyzing the scope, claims, and overall patent landscape of the ‘722 patent provides critical insights for patent holders, competitors, and investment stakeholders within the biotech and pharmaceutical sectors.

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Scope of the Patent

The ‘722 patent encompasses a defined scope centered on specific chemical compounds, their pharmaceutical formulations, or methods of treatment that leverage the novel compounds’ therapeutic properties. The scope extends to:

• Chemical Structure and Composition: The patent delineates chemical entities with particular molecular frameworks, substitutions, stereochemistry, or functional groups designed to optimize efficacy or pharmacokinetics. The claims specify the molecular configurations that distinguish the invention from prior art.

• Method of Use: The patent claims often encompass methods of administering the compound for particular indications—such as neurological, oncological, or infectious diseases—effectively securing control over specific therapeutic applications.

• Pharmaceutical Formulations: The patent covers various formulations, including salts, solvates, or delivery systems that improve stability or bioavailability.

• Method of Synthesis: While less common, some claims may extend to proprietary synthesis routes, emphasizing inventive steps in manufacturing.

This broad yet precise scope enables patent protection both over the compound itself and its practical use, establishing a firm legal boundary around the core invention.

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Claims Analysis

The ‘722 patent’s claims structurally define the legal boundaries of its protection. Critical elements include:

• Independent Claims: These typically cover the chemical compound with specific structural features or particular therapeutic uses. For instance, a claim might specify a compound characterized by a core structure with certain substituents that confer activity.

• Dependent Claims: These refine the independent claims, adding nuances such as specific substituents, stereochemical configurations, or formulations, thereby expanding protection breadth.

• Method Claims: Claiming novel therapeutic or synthesis methods, these often integrate steps for preparation, administration, or treatment, establishing patent rights beyond the chemical entity.

Specificity of claims influences enforceability and licensing scope. For example, narrow claims on a particular compound enable precise enforcement but limit coverage if structural variations are introduced. Conversely, broad claims encompassing classes of compounds or methods can offer extensive protection but risk invalidation if challenged by prior art or obviousness.

Key aspects include:

• Structural Limitations: The claims define precise structural parameters, such as molecular weight, specific functional groups, or stereochemistry, aimed at distinguishing from prior art.

• Therapeutic Scope: Claims specify targeted diseases or conditions, aligning patent rights with particular therapeutic claims rather than broad chemical classes.

• Use and Composition Claims: These provide a layered protection strategy, covering the compound, its pharmaceutical compositions, and methods of use.

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Patent Landscape and Prior Art Context

The patent landscape surrounding the ‘722 patent involves a trove of prior art, including:

• Pre-existing Chemical Entities: Earlier patents or publications disclose similar chemical scaffolds, necessitating the ‘722 patent to demonstrate novelty—either through specific substitutions or unique stereochemistry.

• Therapeutic Use Prior Art: Existing drugs or clinical studies prior to the patent’s filing date may encompass similar indications, prompting the patent to carve out novel mechanisms of action or targeted disease states to maintain distinctiveness.

• Synthetic Methodologies: Innovations claimed in synthesis must demonstrate an inventive step over standard or known routes, which is pivotal for patent validity.

• Evolution of the Patent Family: The lifecycle of related patents, such as continuation applications or foreign counterparts, shapes the patent family landscape, enabling broader territorial rights or extended exclusivity.

From a strategic perspective, patent landscape analysis reveals the following:

• The patent likely resides within a network of patents covering the class of compounds or therapeutic niche, with potential for licensing or litigation.

• Due to the intense competition within pharmaceutical development, claims involve proactive strategies to preempt generic challenges and carve out market exclusivity.

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Critical Analysis of the Patent’s Validity and Enforceability

Given the patent’s age and chemical specificity, questions arise about its robustness against validity challenges:

• Novelty: The patent appears to meet novelty thresholds if the claims carve out a unique structural variant or therapeutic use not previously disclosed.

• Non-Obviousness: The inventive step hinges on the unique combination of chemical features and therapeutic application, which may be patentable if sufficiently non-obvious over prior art.

• Adequate Disclosure: Sufficient chemical and biological data must support utility, enabling others skilled in the arts to reproduce the invention, thus satisfying enablement and written description requirements.

• Claims Construction: Precision in claims mitigates the risk of invalidation and delineates enforceable rights, especially against competitors’ similar compounds.

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Implications for Stakeholders

Industry participants should consider the following implications:

• Patent Holders: Secure licensing rights and monitor for potential infringers within the scope of the patent claims. Exploiting or licensing the patent’s claims could secure market exclusivity for the therapeutic compounds.

• Competitors: Analyze claims to identify potential infringement risks or designaround opportunities—especially if claims are narrowly tailored.

• Legal Strategists: Evaluate potential challenges based on prior art references and consider patent lifecycle management strategies, including patent term adjustments or supplementary protection certificates.

• Research & Development: Use the patent’s disclosures to identify gaps or opportunities for novel derivatives or alternative methods that avoid infringement.

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Conclusion

U.S. Patent No. 6,423,722 embodies a comprehensive protection strategy for specific chemical compounds, their formulations, and therapeutic methods. Its scope is strategically designed to secure exclusive rights in a competitive pharmaceutical landscape. The claims’ structure balances broad protection with precision to withstand legal scrutiny, anchored by a carefully curated patent landscape. As pharmaceutical innovation progresses, the patent’s enforceability and strategic value hinge upon diligent monitoring of prior art developments and ongoing R&D activity.

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Key Takeaways

• The ‘722 patent’s scope includes both chemical compounds and associated therapeutic methods, emphasizing a dual protection strategy.

• Precise claims define the patent’s enforceable boundaries, requiring keen understanding of chemical structures and therapeutic indications.

• Effective patent landscape analysis is vital for identifying potential licensing, infringement, or designaround opportunities within competitive biotech and pharma markets.

• Validity hinges on novelty, non-obviousness, and sufficient disclosure; regular legal audits are recommended to maintain enforceability.

• Stakeholders should leverage the patent’s disclosures for R&D direction, while simultaneously strategizing against potential challenges from prior art.

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FAQs

1. What is the main focus of U.S. Patent No. 6,423,722?
   The patent primarily protects specific chemical compounds, their pharmaceutical formulations, and methods of treating particular diseases using these compounds.

2. How broad are the claims in the ‘722 patent?
   The claims are structured to cover specific structural variants of compounds and their therapeutic uses, with dependent claims adding narrower coverage details.

3. What challenges could threaten the validity of this patent?
   Prior art disclosures of similar compounds or methods, obviousness of the modifications, or insufficient detail in disclosures could potentially challenge validity.

4. How does this patent fit into the broader patent landscape?
   It likely resides within a network of patents covering related chemical classes, indicating strategic positioning within a competitive innovation space.

5. What strategic actions should patent holders consider?
   Monitoring competitor developments, enforcing claims, and managing patent portfolios to extend market exclusivity are critical actions.

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References

1. U.S. Patent No. 6,423,722.
2. [Pharmaceutical Patent Reference Literature]
3. [Analysis of Patent Law in Chemical & Pharmaceutical Domains]
4. [Market Reports on Competitive Patent Landscape]
5. [Legal Case Studies Related to Patent Validity Challenges]

Drugs Protected by US Patent 6,423,722

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: 6,423,722

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	9713730	Jun 30, 1997

International Family Members for US Patent 6,423,722

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	017754
Austria	287410
Australia	739211
Australia	8540998
Brazil	9810956
Canada	2290412