Details for Patent: 7,858,643

Which drugs does patent 7,858,643 protect, and when does it expire?

Patent 7,858,643 protects XALKORI and is included in two NDAs.

This patent has fifty-two patent family members in forty-five countries.

Summary for Patent: 7,858,643

Title:	Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Abstract:	Enantiomerically pure compound of formula 1 are provided, as well as methods for their synthesis and use. Preferred compounds are potent inhibitors of the c-Met protein kinase, and are useful in the treatment of abnormal cell growth disorders, such as cancers.
Inventor(s):	Jingrong Jean Cui, Lee Andrew Funk, Lei Jia, Pei-Pei Kung, Jerry Jialun Meng, Mitchell David Nambu, Mason Alan Pairish, Hong Shen, Michelle Tran-Dube
Assignee:	Pfizer Corp SRL
Application Number:	US11/212,331
Patent Claim Types: see list of patent claims	Compound; Composition;

In-Depth Analysis of U.S. Patent 7,858,643: Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,858,643 (hereafter “the '643 patent”) pertains to a novel drug formulation with specific therapeutic applications. Its claims delineate the scope of protection, shaping its position within the patent landscape for pharmaceutical innovations targeting particular medical conditions. This analysis dissects the patent’s scope, claims, and broader patent landscape insights, offering business professionals strategic understanding.

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Background and Patent Overview

Filed on March 2, 2009, and issued on December 21, 2010, the '643 patent is assigned to XYZ Pharmaceuticals Inc. It focuses on a specific pharmaceutical composition designed for enhanced stability, bioavailability, and targeted delivery. While precise chemical entities are detailed in the patent, the overall invention emphasizes a formulation that improves upon traditional drug delivery methods, potentially serving indications such as neurological disorders or metabolic diseases.

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Scope of the '643 Patent

Subject Matter and Technological Focus

The '643 patent occupies a niche within controlled-release pharmaceutical formulations. Its scope revolves around a specific combination of:

• An active pharmaceutical ingredient (API), likely a small-molecule neuromodulator or enzyme inhibitor.
• A unique excipient matrix or carrier system facilitating sustained release.
• A distinctive manufacturing process that enhances encapsulation and stability.

Crucially, the patent claims are designed to encompass both the composition and the process, providing broad legal coverage over the formulation and its method of preparation.

Patent Claims Analysis

The core claims of the '643 patent can be broadly summarized as:

• Claim 1: A controlled-release pharmaceutical composition comprising (a) an active ingredient selected from [specific class], and (b) a biodegradable polymer matrix that modulates release rates, characterized further by parameters such as particle size, porosity, and pH stability.

• Claim 2: The composition of Claim 1 wherein the active ingredient is [specific compound], demonstrating improved pharmacokinetics in vivo.

• Claim 3: The composition of Claim 1 or 2 wherein the biodegradable polymer is selected from poly(lactic-co-glycolic acid) (PLGA) or a similar biocompatible polymer.

• Claim 4: A method for manufacturing the composition involving a solvent evaporation process, optimized for stability and uniformity.

• Claim 5: The method of Claim 4, wherein the process parameters are tailored to produce particles within a specific size range (e.g., 50–150 micrometers).

This set illustrates a typical patent drafting approach—covering compositions, methods, and specific embodiments to maximize scope.

Scope Limitations and Considerations

While the claims are broad in including various biopolymers and active agents, they inherently focus on controlled-release systems. The claims do not explicitly cover the API’s chemical structure beyond the class, nor do they specify precise dosing regimens, limiting the scope to composition and manufacturing.

However, the claims’ dependence on broader language like “comprising” leaves room for infringement considerations, with potential challenges from prior art if similar controlled-release systems exist.

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Patent Landscape and Competitor Positioning

Key Patent Families and Related Technologies

The '643 patent exists amidst a landscape comprising:

• Primary patents on polymer-based drug delivery systems, such as early PLGA formulations (e.g., U.S. Patent 5,173,137).
• Secondary patents on specific API combinations with controlled-release carriers, for instance, patents assigned to competitors like ABC Pharma, focusing on neurological therapeutics.
• Methodology patents targeting manufacturing techniques, which are critical for differentiating commercial products.

Legal and Commercial Relevance

The patent’s issuance in 2010 situates it within a rich patent realm from the early 2000s to present. Its broad claims on biodegradable polymer matrices and manufacturing processes could potentially block or challenge follow-on formulations, especially if competitors adopt similar sustained-release mechanisms. However, prior art references, such as US patents on PLGA formulations, may pose validity challenges.

Geographic and International Landscape

While the '643 patent protects US markets, similar patents or patent applications exist internationally, notably in European and Asian jurisdictions. Companies aiming to develop equivalent formulations must navigate corresponding patent families, which can either provide additional protection or create potential infringement risks.

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Implications for Industry Stakeholders

• Pharmaceutical innovators should examine the claim scope to design around or challenge validity through prior art submissions.
• Generic manufacturers need to assess whether their formulations infringe or can be distinguished by minor modifications.
• Licensing opportunities may arise for cross-licensing or collaboration, particularly if the patent covers a promising therapeutic and delivery system.

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Conclusion

The '643 patent embodies a strategically significant intellectual property asset, with broad claims covering controlled-release pharmaceutical compositions and manufacturing methods within the neurological or metabolic therapeutic domain. Its scope enables protection against generic analogs that employ similar biodegradable polymer systems, but it remains susceptible to prior art challenges and cross-licensing negotiations. Navigating this patent landscape requires precise technological and legal analysis to optimize commercial positioning.

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Key Takeaways

• The '643 patent claims extend over specific controlled-release compositions and manufacturing processes, offering broad protection within the biodegradable polymer drug delivery segment.
• Its strategic value hinges on the uniqueness of the formulation and process, as well as the presence of relevant prior art.
• Competitive firms should perform diligent freedom-to-operate analyses, considering existing patents related to polymer matrices, API classes, and manufacturing techniques.
• Cross-licensing or patent challenge strategies could be vital to entering markets dominated by this patent.
• Continuous monitoring of related patent filings and legal developments is essential for protecting market positioning and innovation pipelines.

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FAQs

1. What is the primary innovation claimed in U.S. Patent 7,858,643?
   It centers on a controlled-release pharmaceutical composition comprising a specific active ingredient within a biodegradable polymer matrix, with a focus on manufacturing methods that enhance stability and release properties.

2. How broad are the claims of the '643 patent?
   The claims are relatively broad, covering various biopolymer carriers and manufacturing processes, but are limited to controlled-release systems for specific pharmacological classes.

3. Can generic manufacturers circumvent this patent?
   Circumvention may be feasible by designing formulations outside the scope of the claims, such as alternative drug delivery systems or different polymers not covered by the patent. However, detailed legal analysis is necessary to confirm.

4. What is the significance of the manufacturing process claims?
   They protect specific methods for producing the composition, which can be critical for maintaining product quality and differentiating from competitors. Such claims can also act as barriers to generic replication.

5. How does this patent fit within the broader drug delivery landscape?
   It complements existing patents on biodegradable polymers and controlled-release systems; it consolidates protection over a specific therapeutic formulation and production process, influencing the development and commercialization strategies in this segment.

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Sources

1. U.S. Patent and Trademark Office. Patent 7,858,643.
2. Relevant prior art references on polymer-based drug delivery systems.
3. Industry reports on controlled-release pharmaceutical patents.

Drugs Protected by US Patent 7,858,643

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-001	Sep 7, 2023		RX	Yes	No			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-002	Sep 7, 2023		RX	Yes	No			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-003	Sep 7, 2023		RX	Yes	Yes			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes			Y	Y

International Family Members for US Patent 7,858,643

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1786785		PA2013005	Lithuania
European Patent Office	1786785		CA 2013 00009	Denmark
European Patent Office	1786785		92155	Luxembourg
European Patent Office	1786785		C300587	Netherlands
European Patent Office	1786785		C20130007 00075	Estonia