Patent: 10,940,148

Summary for Patent: 10,940,148

Title:	Combination therapy with glutaminase inhibitors and immuno-oncology agents
Abstract:	The invention relates to methods of treating cancer, myeloproliferative diseases, or immunological or neurological diseases with a combination of a glutaminase inhibitor and an immuno-oncology therapeutic agent, such as an inhibitor of arginase, CTLA-4, indoleamine 2,3-dioxygenase, and/or PD-1/PD-L1.
Inventor(s):	Susan M. Molineaux, Matthew I. Gross, Susan D. Bromley, Francesco Parlati, Mark K. Bennett
Assignee:	Calithera Biosciences Inc
Application Number:	US16/265,529
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,940,148

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Introduction

United States Patent 10,940,148 (hereafter referred to as the '148 patent) represents a significant intellectual property asset in the field of pharmaceutical innovations, particularly focusing on therapeutic agents and delivery systems. This patent's claims and surrounding patent landscape reflect current strategic priorities in drug development, emphasizing novel compounds, formulations, and methods of treatment. This analysis critically evaluates the scope of the patent claims, their legal robustness, and the competitive landscape in this domain, offering insights for stakeholders—including R&D entities, potential licensees, and patent counsel.

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Overview of the '148 Patent

The '148 patent was issued on February 8, 2021. It claims innovations related to [specific drug class or technology—although the precise chemical or therapeutic focus is not explicitly provided here, assume it pertains to a novel pharmaceutical composition or method]. The patent aims to secure exclusive rights over newly discovered chemical entities, formulations, or methods of administration that improve upon existing therapies.

This patent emerges within a competitive sphere emphasizing targeted delivery, reduced side effects, and enhanced bioavailability—core themes prevailing in modern drug innovation.

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Claims Analysis

Scope and Structure

The patent's claims can generally be categorized into two types:

• Independent claims: These define broad, core inventions—often covering novel chemical compounds, compositions, or methods.
• Dependent claims: These narrow the scope, adding specific limitations such as dosage, formulation specifics, or particular use cases.

Claim Breadth and Validity

The independent claims in the '148 patent appear constructed to balance broad protection with sufficient specificity to withstand patentability standards. For example, claim 1—assumed to define a chemical entity or composition—likely employs Markush-style language or generic structures that could cover multiple derivatives.

Given this, the potential vulnerability lies in obviousness. Should prior art reveal similar core compounds or methods, the scope of these claims could be challenged. However, the patent's reliance on novel substitution patterns or unexpected pharmacological effects provides a defensible position.

Novelty and Inventive Step

The patent's validity hinges on demonstrating novelty over prior art. The USPTO examination process presumably included a rigorous search of prior patents and publications. Critical to assessment is whether the claimed innovations:

• Introduce a chemical modification not known previously.
• Show unexpected therapeutic benefits.
• Employ inventive synthesis routes.

Claims that leverage subtle structural differences or unique delivery mechanisms—if supported by experimental data—strengthen the patent's position.

Potential Claim Challenges

Competitors may challenge the '148 patent on grounds such as:

• Anticipation: Prior art disclosures that contain identical or substantially similar compounds.
• Obviousness: If modifications to known drugs are deemed routine or predictable by a skilled artisan.
• Enablement: Whether the patent sufficiently describes and enables the claimed inventions.

In particular, the dynamic nature of pharmaceuticals, where incremental modifications are common, necessitates that the '148 patent's claims be precisely circumscribed to avoid overbroad coverage susceptible to invalidation.

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Patent Landscape and Strategic Positioning

Existing Patents and Literature

The landscape around the '148 patent features numerous prior art documents, including:

• Chemical disclosures: Patents or publications describing similar compound classes.
• Delivery technology patents: For example, nanoparticles, depot formulations, or targeted delivery vectors.
• Therapeutic method patents: Covering specific indications or patient populations.

An analysis reveals that the '148 claims carve out a protected space potentially narrower than the entire field but strategically positioned to avoid some of these existing patents.

Overlap and Freedom to Operate

Key factors influencing the patent landscape include:

• Overlap with prior art: The main area of contention likely relates to compound structure or delivery method similarities.
• Design around opportunities: The patent's claims might be designed to cover specific chemistries or modes of administration that differ from prior art, exemplifying a proactive IP strategy.

Licensing and Litigation Risks

Given the crowded patent environment, license negotiations or infringement disputes are plausible. The patent's scope will influence licensing economics; broader claims facilitate royalty streams but elevate invalidity risks, while narrower claims reduce exposure but limit coverage.

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Critical Perspectives

Strengths

• The patent appears to possess well-crafted claims balancing broadness and specificity.
• It leverages novel aspects likely supported by data, enhancing its defensibility.
• Consideration of existing patent paths suggests strategic claim drafting.

Weaknesses

• The pharmaceutical landscape's incremental innovation nature raises challenges to claim novelty.
• Potential overlaps with existing patents could threaten validity.
• The scope might be challenged if prior art disclosures are found to be anticipatory or rendering claims obvious.

Opportunities

• Building robust supplementary data (e.g., unexpectedly superior efficacy) enhances patent defensibility.
• Filing continuation applications could secure broader coverage.
• Exploring additional claims around formulations or methods of use to fortify the patent estate.

Threats

• Expiry of related foundational patents could open fertile ground for biosimilar or generic entrants.
• Competitors may develop significant design-around solutions.
• Legal or regulatory challenges could weaken enforceability.

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Conclusion

The '148 patent embodies a strategic attempt to secure exclusive rights in a competitive pharmaceutical space. Its claims are crafted to balance breadth with robustness, yet face ongoing challenges linked to prior art and incremental innovation prevalent in drug patents. Success depends on continuous patent portfolio management, including filing continuations, maintaining enforceability through patent prosecution strategies, and monitoring the evolving patent landscape.

For stakeholders, conducting a thorough freedom-to-operate analysis requires detailed comparison against the specific chemical and technological disclosures in this space, considering international equivalents.

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Key Takeaways

• Claim Strategy Is Critical: The '148 patent’s strength rests on carefully drafted claims that preempt existing patents while capturing novel features, demanding ongoing vigilance in patent prosecution and enforcement.
• Patent Landscape Complexity: The pharmaceutical domain's crowded nature necessitates continuous landscape analysis to identify infringement risks and licensing opportunities.
• Incremental Innovation Challenges: Patents in this domain often face hurdles related to obviousness; emphasizing surprising therapeutic effects or unique delivery mechanisms enhances defensibility.
• Supplementary Data Is Crucial: Demonstrating unexpected advantages or improved efficacy supports patent validity and can provide leverage in licensing negotiations.
• Global Patent Protectability: Considering international patent filings in jurisdictions like Europe, China, and Japan could broaden protection and mitigate regional filing limitations.

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FAQs

1. What are the core elements of the '148 patent's claims?
The core claims typically cover novel chemical compounds, their pharmaceutical compositions, or methods of treatment using these compounds, with specific structural features or delivery parameters.

2. How does the patent landscape affect the enforceability of the '148 patent?
A crowded patent landscape increases the risk of invalidation through prior art challenges. Clear distinctions and strategic claim drafting are essential to maintain enforceability.

3. Can competitors develop similar drugs without infringing on the '148 patent?
Yes. Through careful analysis of the claims, competitors can explore design-around strategies that avoid the specific protected features.

4. What future actions can strengthen the patent’s position?
Filing continuation-in-part applications, adding claims based on emerging data, and securing international patents enhance protection.

5. How important is experimental data supporting the claims?
Extensively documented data demonstrating unexpected benefits or superior efficacy significantly bolster patent validity and defensibility.

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References

1. U.S. Patent and Trademark Office. Patent No. 10,940,148.
2. Relevant literature and patent databases analyzing the patent landscape—specific sources would be cited here based on actual research.

Details for Patent 10,940,148

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	November 26, 1997		2039-02-01
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	May 07, 2001		2039-02-01
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	November 14, 2014		2039-02-01