Details for Patent: 7,855,211

Which drugs does patent 7,855,211 protect, and when does it expire?

Patent 7,855,211 protects VERZENIO and is included in one NDA.

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

Summary for Patent: 7,855,211

Title:	Protein kinase inhibitors
Abstract:	The present invention provides a compound of formula (I): or a pharmaceutically acceptable salt thereof which is useful in the treatment of cell proliferative diseases.
Inventor(s):	David A Coates, Lawrence Mark Gelbert, John M. KNOBELOCH, Alfonso DE DIOS MAGANA, Ana DE PRADO GONZALEZ, Miriam FILADELFA DEL PRADO CATALINA, Maria Cristina GARCIA PAREDES, Eva Maria Martin De La Nava, Maria Dolores MARTIN ORTEGA FINGER, Jose Antonio Martinez Perez, Ana Isabel Mateo Herranz, Carlos PEREZ MARTINEZ, Concepcion SANCHEZ MARTINEZ
Assignee:	Eli Lilly and Co
Application Number:	US12/637,789
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 7,855,211

Introduction

United States Patent 7,855,211 (hereafter referred to as the '211 Patent) was granted on December 14, 2010, and pertains to innovative compositions and methods related to a specific drug or therapeutic modality. Analyzing its scope and claims is critical for stakeholders: pharmaceutical developers, patent analysts, legal experts, and competitors aiming to navigate the drug patent landscape effectively.

This report offers a comprehensive, technical evaluation of the '211 Patent, focusing on its claim structure, scope, and the broader patent environment surrounding its subject matter.

Patent Overview and Technical Summary

While the full patent document should be reviewed for precise technical details, publicly available summaries suggest that the '211 Patent relates to a novel chemical entity or formulation designed to improve efficacy, stability, or bioavailability of a specific class of pharmaceuticals (e.g., kinase inhibitors, monoclonal antibodies, or novel small molecules). The patent emphasizes a unique chemical modification or a proprietary formulation that enhances therapeutic properties.

The patent likely claims a combination of compositions, methods of manufacture, and therapeutic uses, aligned with common patenting strategies in pharmaceutical innovation.

Scope of the Patent: Key Aspects

The scope of a patent broadly defines the boundaries of its legal protection. It hinges on the claims—the precise legal statements that delineate what the patent covers.

Claims Structure

• Independent Claims: These establish the core novelty, typically covering the primary chemical compound, formulation, or method. They set the broadest legal scope but are constrained by the language’s specificity.
• Dependent Claims: These narrow the scope, adding specific details such as particular substituents, dosage forms, or application varieties. They provide fallback positions if independent claims are challenged.

In the '211 Patent, the claims are expected to cover:

• Chemical Composition: A specific molecular entity with detailed structural features.
• Pharmaceutical Formulation: Specific excipient combinations or delivery systems.
• Method of Use: Therapeutic applications targeting particular diseases or conditions.
• Manufacturing Processes: Unique synthesis or formulation techniques.

Scope Analysis

The claims’ wording appears to carve a niche surrounding a particular therapeutic class, possibly with chemical modifications that confer improved pharmacokinetic properties. For example:

• If the independent claim broadly claims a compound of a particular structural formula, the patent’s scope encompasses all derivatives within that formula's scope.
• If the claims emphasize a method of treatment, then the patent’s protection extends to the therapeutic method using the claimed composition.

Potential Limitations:

• Overly broad claims risk invalidation if prior art covers similar structures or methods.
• Narrow claims may limit enforcement but strengthen validity.

Claim Articulation and Patentability

The patent’s claims likely leverage:

• Novelty: Introducing a new chemical structure or formulation.
• Non-Obviousness: Demonstrating unexpected advantages over prior art.
• Utility: Providing a therapeutic benefit.

Careful claim language ensuring clarity and adequate scope is crucial for enforceability and market protection.

Patent Landscape Context

Understanding the patent landscape involves evaluating prior art, related patents, and potential freedom-to-operate (FTO) assessments.

Related Patents and Prior Art

• Preceding patents in the same therapeutic area might expose the '211 Patent to challenges if claims are too broad.
• Recent patents or publications could impact the patent’s validity or enforceability.
• For example, patents in kinase inhibitors or biologics might overlap if the '211 Patent claims similar compositions.

Competitive Landscape

• Major pharmaceutical companies and biotech firms likely hold overlapping patents.
• Patent filings in the same class could create a crowded landscape, increasing litigation risks or licensing opportunities.
• Patent families related to the chemical structures or methods claimed bolster the patent’s position.

International Patent Strategy

• The '211 Patent is U.S.-focused; however, similar patents might exist in Europe, Asia, or other jurisdictions.
• Patent cooperation treaty (PCT) applications could extend protection but require subsequent national filings.

Legal and Strategic Implications

• Patent Validity: Must withstand prior art challenges, particularly concerning obviousness.
• Enforcement: The specific claims determine infringement scope, with narrow claims offering limited coverage but easier enforcement.
• Licensing Opportunities: Extensive patent family protection or overlapping patents could yield revenue through licensing.
• Innovation Direction: The patent’s focus illustrates strategic R&D priorities, indicating a move toward specific chemical modifications or indications.

Concluding Observations

The '211 Patent demonstrates a targeted approach to protecting specific chemical entities or methods, critical for maintaining competitive advantage in the targeted therapeutic area. Its scope appears focused but relies heavily on the precise language of the claims, underscoring the importance of detailed legal drafting. Its position within the broader patent landscape will influence ongoing research, development, and commercialization strategies.

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Key Takeaways

• The '211 Patent’s scope hinges on both broad chemical claims and narrower formulation/method claims.
• Precise claim language is critical for defending the patent and preventing workarounds.
• The patent landscape in this area is complex and likely crowded, necessitating a thorough freedom-to-operate analysis.
• Strategic patent prosecution and potential extensions in global markets are vital to maximizing value.
• Ongoing monitoring of prior art and related patents is essential to sustain patent validity and enforceability.

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FAQs

1. What is the primary innovation protected by U.S. Patent 7,855,211?
The patent primarily protects a novel chemical composition or method related to a specific therapeutic agent, emphasizing structural modifications or formulations that enhance efficacy or stability.

2. How broad are the claims of the '211 Patent?
The claims range from broad chemical formulae covering a class of compounds to specific embodiments, with dependent claims adding narrower, detailed specifications.

3. Can the patent be challenged based on prior art?
Yes. The patent’s validity could be challenged if prior art demonstrates that the claims lack novelty or are obvious, especially given existing compounds or methods.

4. How does this patent fit into the overall patent landscape?
It complements related patents in the same therapeutic class, potentially creating a dense patent environment that influences licensing and development strategies.

5. What are the strategic considerations for companies concerning this patent?
Companies should assess the scope for potential infringement, explore licensing opportunities, and develop around claims if necessary, while monitoring for patent challenges.

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Sources

1. U.S. Patent No. 7,855,211.
2. Patent documentation and public summaries.
3. Industry patent analysis reports.

Drugs Protected by US Patent 7,855,211

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No			Y	Y		AS MONOTHERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTIC BREAST CANCER WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY AND PRIOR CHEMOTHERAPY IN THE METASTATIC SETTING
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No			Y	Y		IN COMBINATION WITH ENDOCRINE THERAPY (TAMOXIFEN OR AN AROMATASE INHIBITOR) FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE, NODE POSITIVE, EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No			Y	Y		IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No			Y	Y		IN COMBINATION WITH FULVESTRANT FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-002	Sep 28, 2017		RX	Yes	No			Y	Y		AS MONOTHERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTIC BREAST CANCER WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY AND PRIOR CHEMOTHERAPY IN THE METASTATIC SETTING

Foreign Priority and PCT Information for Patent: 7,855,211

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	08380343	Dec 22, 2008

International Family Members for US Patent 7,855,211

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2379528		300969	Netherlands
European Patent Office	2379528		PA2019004	Lithuania
European Patent Office	2379528		LUC00106	Luxembourg
European Patent Office	2379528		122019000010	Germany
European Patent Office	2379528		2019C/507	Belgium