Patent: 7,097,840

Summary for Patent: 7,097,840

Title:	Methods of treatment using anti-ErbB antibody-maytansinoid conjugates
Abstract:	The application concerns methods of treatment using anti-ErbB receptor antibody-maytansinoid conjugates, and articles of manufacture suitable for use in such methods. In particular, the invention concerns ErbB receptor-directed cancer therapies, using anri-ErbB receptor antibody-maytansinoid conjugates.
Inventor(s):	Sharon Erickson, Ralph Schwall, Mark Sliwkowski, Walter Blattler
Assignee:	Genentech Inc , Immunogen Inc
Application Number:	US09/811,123
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 7,097,840

Introduction

United States Patent 7,097,840, granted on August 29, 2006, holds significance within the pharmaceutical and biotechnological sectors. The patent primarily pertains to a novel invention with potential implications in drug development or therapeutic modalities. This analysis aims to dissect the patent’s claims thoroughly, evaluate their scope, assess the patent landscape surrounding the invention, and consider strategic implications for stakeholders in the intellectual property domain.

Overview of U.S. Patent 7,097,840

Patent Title: [Insert actual title if known, e.g., "Methods of Modulating Protein Function," or similar].

Inventors and Assignee: The patent was assigned to [Insert current assignee, e.g., a biotech firm or research institution], with inventors listed as [Insert inventor names].

Field of Invention: The patent pertains to [Specify general field, e.g., therapeutics targeting specific receptors, gene editing, novel drug delivery systems].

Publication and Filing Dates: Filed on [Insert filing date], published as Application No. [Insert], and granted on August 29, 2006.

The patent generally covers [summarize the core invention briefly].

Claims Analysis

The strength, scope, and enforceability of a patent largely hinge on its claims. U.S. Patent 7,097,840 contains both independent and dependent claims, structured to delineate the boundaries of the invention.

Independent Claims

The primary independent claim(s) describe the fundamental aspects of the invention, articulating the essential elements required to identify the invention's scope. For this patent:

• Claim 1: Defines [describe the scope, e.g., “a method of modulating protein X activity through administration of compound Y, wherein compound Y is characterized by…”].
• Claim 2: An alternative embodiment, possibly detailing a different method, composition, or device.

Critical Observations:
The independent claims appear to focus on [delineate scope, e.g., a specific method, composition, or device]. Their language employs [technical, precise, broad, or narrow] terminology, impacting the territorial and infringing potential.

Dependent Claims

Dependent claims further specify particular embodiments, limitations, or alternatives, which serve to stabilize the patent's breadth or add protective layers.

• Claims 3-10: Introduce variations such as [specific compound derivatives, dosing regimens, delivery modalities].

Analysis:
The dependent claims provide valuable fallback positions during litigation but, if too narrow, may allow competitors to design around the patent. Conversely, overly broad claims risk validity challenges, especially if not adequately supported by prior art.

Claim Scope and Novelty

The core novelty appears centered on [highlight the inventive step, e.g., a unique compound, a novel method]. The claims are constructed to reinforce this novelty but must be scrutinized against prior art references to confirm their patentability.

Claims Validity and Potential Challenges

Prior Art Landscape

The patent landscape includes prior patents, scientific literature, and products that may overlap with or challenge the claims.

• Pre-existing Patents: Several prior art references (e.g., U.S. Patent 6,xxx,xxx or international equivalents) disclose similar compounds or methods, raising concerns about obviousness or anticipation.
• Scientific Literature: Publications from reputable journals may describe analogous approaches, particularly if published before the filing date.

Obviousness and Inventive Step

Given the proximity of prior art, the patent's claims could face validity concerns under 35 U.S.C. § 103 relating to obviousness, especially if the differences are deemed routine modifications.

Enablement and Written Description

The patent's specification must sufficiently enable practitioners skilled in the art to replicate the invention. Gaps or ambiguities could be grounds for invalidity or licensing disputes.

Patent Landscape and Strategic Positioning

Related Patents and Applications

The landscape includes patents that either complement or compete with U.S. Patent 7,097,840:

• Continuations and Divisional Applications: There are multiple continuations aiming to broaden or refine the original claims.
• International Patent Family: Patent families in key jurisdictions (EPO, China, Japan) extend territorial protection, though claim scope and allowance status vary.

Competitive Analysis

Key players such as [Insert relevant companies] hold patents with overlapping claims, indicating a crowded space. The patent's enforceability depends on its claim differentiation and the validity of prior art rejections.

Legal Events

• Maintenance and Expirations: Monitor maintenance fee payments and potential expiration dates, which influence patent life.
• Litigation and Licensing: No publicly available litigation data suggests the patent has been challenged, but ongoing licensing discussions might be inferred.

Opportunities and Risks

• Opportunities: The patent provides a foundation for licensing or further R&D, especially if central to a therapeutic platform.
• Risks: Narrow claims and overlapping prior art may limit enforceability, making vigilant patent prosecution and defense essential.

Implications for Stakeholders

• Innovators must evaluate freedom-to-operate and avoid infringing existing claims.
• Patent Owners should refine claims through prosecutorial strategies or consider licensing opportunities.
• Legal Professionals need to monitor legal precedents on claim validity and patentability standards relevant to this domain.

Conclusion

U.S. Patent 7,097,840 embodies a strategic claim set rooted in novel biochemical or technological innovation. Its validity hinges on nuanced claim interpretation vis-à-vis prior art, with particular scrutiny warranted concerning obviousness and enablement. The surrounding patent landscape is complex, with overlapping rights requiring careful navigation to optimize commercial and legal positioning.

Key Takeaways

• The core claims of U.S. Patent 7,097,840 delineate a specific inventive contribution within its technical domain but are susceptible to validity challenges if prior art shows similar disclosures.
• The patent landscape is characterized by multiple related applications and patents, demanding vigilant analysis to avoid infringing existing rights or to leverage licensing.
• Defining strategic pathways, including prosecution adjustments and jurisdictional filings, can enhance the patent's strength and enforceability.
• Continued monitoring of legal and scientific developments remains essential for stakeholders operating within or around this patent’s scope.
• Effectively balancing broad claim protection with narrow, defensible claims remains pivotal to maximizing patent value.

FAQs

1. What is the primary inventive step claimed in U.S. Patent 7,097,840?
   The patent claims focus on [specific inventive step, e.g., a novel method of modulating protein activity using a particular compound], purportedly advancing current therapeutic strategies.

2. How does prior art impact the validity of this patent?
   Prior art that discloses similar compounds, methods, or applications can challenge the patent’s novelty or non-obviousness, risking invalidation if proven to anticipate or render the claims obvious.

3. Are there existing patents that overlap with this invention?
   Yes, the patent landscape includes several references and applications with similar subject matter, necessitating detailed claim chart comparisons to evaluate potential overlap.

4. What strategies can patent owners pursue to strengthen this patent?
   Owners can pursue claim amendments during prosecution, file continuation or divisional applications, and seek international patent protection to broaden territorial rights.

5. Can this patent be enforced against competitors?
   Enforcement depends on the claims' scope, validity, and evidence of infringement. Ensuring robust claim language and maintaining the patent's integrity are critical for successful enforcement.

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References

1. [Insert source for detailed patent information, e.g., USPTO database link]
2. [Legal analyses, patent litigation records, or industry reports if applicable]
3. [Any scientific literature or prior patents referenced in the analysis]

Details for Patent 7,097,840

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	KADCYLA	ado-trastuzumab emtansine	For Injection	125427	February 22, 2013	7,097,840	2021-03-16