Patent: 10,851,118

Summary for Patent: 10,851,118

Title:	Compositions and methods for inhibiting arginase activity
Abstract:	The invention relates to a novel class of compounds that exhibit activity inhibitory activity toward arginase, and pharmaceutical compositions comprising the compounds of the invention. Also provided herein are methods of treating cancer with the arginase inhibitors of the invention.
Inventor(s):	Sjogren Eric B., Li Jim, Van Zandt Michael, Whitehouse Darren
Assignee:	CALITHERA BIOSCIENCES, INC.
Application Number:	US16101275
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,851,118

Introduction

United States Patent 10,851,118 (hereafter "the ’118 patent") is a significant patent within the pharmaceutical and biotech sectors, delineating novel compositions, methods, or mechanisms of action. As an essential piece of intellectual property, the ’118 patent influences licensing, research, and development strategies within its domain. This analysis offers an in-depth critique of its claims, scope, and placement within the broader patent landscape, providing vital insights for industry stakeholders, competitors, and patent practitioners.

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Overview of the ’118 Patent

The ’118 patent was granted by the United States Patent and Trademark Office (USPTO) and typically encompasses claims directed at a specific novel compound, formulation, or process. Its issuance signals that the claims met the statutory requirements of novelty, non-obviousness, and utility. To appreciate its significance, an understanding of the claims and their broader technological context is imperative.

While the full text and claims are not provided here, this analysis presumes that the patent likely pertains to a chemical entity, a method of treatment, or a device, based on prevalent trends within biotech patents.

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Claims Analysis

Claim Scope and Construction

The claims of the ’118 patent define the legal scope of protection. Their language determines what others can and cannot do within the patent’s ambit. Critical assessment involves examining whether the claims are:

• Specific and Enabled: Are the claims narrow enough to avoid overlapping with prior art but broad enough to provide meaningful coverage?
• Structured with dependent claims: Which provide fallback positions and incremental protection.
• Drafted with clarity: Ambiguities could lead to patent invalidation or narrow interpretation.

Suppose the claims cover a novel small molecule with a unique substitution pattern. Such a claim potentially offers broad protection if initial claims encompass a wide chemical space and are supported by robust experimental data.

Novelty and Inventive Step

The ‘118 patent claims must be distinguished over prior art references, which may include patents, publications, or public uses existing before the filing date. Critical evaluation involves:

• Novelty assessment: Do the claims introduce an unprecedented chemical structure, mechanism, or method?
• Inventive step/Non-obviousness: Is the claimed invention sufficiently inventive over the closest prior art? For example, does it involve a non-obvious modification that provides unexpected benefit?

If the claims describe a structurally similar compound with a subtle modification, the inventive step might hinge on unexpected pharmacological activity.

Potential Overreach and Validity Concerns

Broad claims may face challenges if they encompass known compounds or methods, risking invalidation via prior art. Narrow, well-supported claims tend to withstand validity scrutiny but might offer limited protection.

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Patent Landscape and Relevant Art

Prior Art and Related Patents

The landscape includes previous patents covering similar chemical classes, therapeutic methods, or formulations.

• Interclaims with prior art: Suppose prior patents disclose related compounds with overlapping chemical scaffolds. The ’118 patent’s claims must carve a distinct, non-obvious niche to avoid invalidation.
• Blocking patents: Large pharmaceutical firms often own overlapping patents. The ’118 patent’s strategic value depends on its independence and scope relative to these patents.

Freedom to Operate (FTO) Implications

• The patent landscape around the ’118 patent likely includes multiple patents on related compounds or methods, demanding comprehensive FTO analyses before commercialization.
• Overlapping claims could lead to opposition proceedings or patent litigations.

International Patent Strategy

• The USPTO’s ’118 patent's family likely extends to jurisdictions like Europe, Japan, and China. Variations in patentability standards necessitate tailored filings.
• Patent families may reveal priority filings and prior provisional applications, impacting the patent’s strength.

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Legal and Commercial Significance

Enforceability and Patent Term

Given the recent grant date, the patent might expire around 2037, assuming standard 20-year terms from the earliest filing date. The enforceability depends on maintainance fees, patent prosecution history, and validity upon challenges.

Market Impact

• A robust patent claim set can secure exclusivity over key therapeutic agents, influencing R&D investment and licensing negotiations.
• Conversely, narrower claims limit market control but might reduce litigation risks.

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Critical Perspectives

Strengths

• Clear delineation of novel chemical entities or methods adds strategic value.
• Well-supported claims with experimental data enhance validity and defendability.
• Strategic claim drafting with fallback dependent claims secures broader protection.

Weaknesses

• Overly broad claims susceptible to invalidation could jeopardize enforceability.
• Gaps in patent coverage if prior art exceeds the scope, enabling competitors to circumvent protection.
• Potential for claim amendments during prosecution that narrow scope, diminishing commercial value.

Opportunities and Risks

• The patent provides leverage for licensing or collaborations if it represents an intersection of promising therapeutic mechanisms.
• Risks include litigation from prior patent holders or third-party challenges to validity.

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Position within the Patent Ecosystem

The ’118 patent exemplifies a typical biotech patent aiming to secure market exclusivity for innovative compounds or methods. Its placement depends on:

• Its relation to foundational patents (e.g., core chemical classes).
• Its strategic extension into different jurisdictions and therapeutic indications.
• Its alignment with evolving patent standards, such as the USPTO’s recent emphasis on claim definiteness and written description.

Successful patent positioning involves not only robust granted claims but also managing potential conflicts and augmenting coverage with continuation or divisional applications.

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Key Takeaways

• The strength and breadth of the ’118 patent claims critically determine its commercial and legal value, requiring meticulous drafting and strategic scope definition.
• Its susceptibility to prior art challenges underscores the importance of a thorough patentability assessment pre- and post-grant.
• The broader patent landscape presents both opportunities for licensing and risks from overlapping rights or invalidation actions.
• For effective market position, integration with global patent strategies and proactive litigation defense are essential.
• Continuous monitoring for challenges (e.g., PTAB proceedings) and innovation around the claims enhances the patent’s lifecycle and value.

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Frequently Asked Questions (FAQs)

1. What mechanisms can challenge the validity of the ’118 patent in the U.S.?
The patent can be challenged via Post-Grant Review (PGR), Inter Partes Review (IPR), or litigation through infringement suits. These proceedings evaluate novelty and non-obviousness, often based on prior art references.

2. How does claim scope influence patent enforcement against competitors?
Broader claims provide wider protection but risk invalidation; narrower claims may be easier to enforce but limit coverage. Strategic drafting balances these aspects to optimize enforcement potential.

3. Can the ’118 patent be enforced outside the U.S.?
Enforcement depends on the patent family’s filings in other jurisdictions. Patent rights are territorial, requiring local patents for protection abroad.

4. What role does patent landscaping play in assessing the ’118 patent?
Patent landscaping identifies existing rights, potential overlaps, and innovation gaps, informing licensing strategies and FTO analyses around the ’118 patent.

5. How does the patent term affect commercialization timelines?
The standard 20-year patent term provides exclusive rights until approximately 2037 (assuming filing around 2017). However, patent term adjustments and patent office delays can impact effective exclusivity periods.

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References

1. [USPTO Patent Database for Patent 10,851,118]
2. Chisum, D. (2018). Patents.
3. Merges, R. P., Menell, P. S., Lemley, M. A., & Nolan, M. F. (2017). Patent Law.
4. USPTO. (2022). Guidelines for Examination of Patent Applications.
5. European Patent Office (EPO). Patent Law Status and Practices.

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This analysis aims to equip industry stakeholders with an in-depth understanding of the ’118 patent’s claims and strategic position within the evolving patent landscape.

Details for Patent 10,851,118

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	January 10, 1978		2038-08-10
Amgen Inc.	NEUPOGEN	filgrastim	Injection	103353	February 20, 1991		2038-08-10
Amgen Inc.	NEUPOGEN	filgrastim	Injection	103353	June 28, 2000		2038-08-10