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Last Updated: December 17, 2025

Patent: 10,398,734


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Summary for Patent: 10,398,734
Title:Processes for production of tumor infiltrating lymphocytes and uses of same in immunotherapy
Abstract:The present invention provides improved and/or shortened methods for expanding TILs and producing therapeutic populations of TILs, including novel methods for expanding TIL populations in a closed system that lead to improved efficacy, improved phenotype, and increased metabolic health of the TILs in a shorter time period, while allowing for reduced microbial contamination as well as decreased costs. Such TILs find use in therapeutic treatment regimens.
Inventor(s):Seth Wardell, James Bender, Michael T. Lotze
Assignee: Iovance Biotherapeutics Inc
Application Number:US16/201,957
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,398,734


Introduction

United States Patent 10,398,734 (hereafter "the '734 patent") represents a significant innovation within its respective technological domain. As part of the critical landscape assessment, this analysis scrutinizes the patent claims' scope for validity and scope, contextualizes the patent within current research and development trends, and explores its strategic influence across competing entities and the broader patent ecosystem.


Overview of the '734 Patent

The '734 patent, granted on March 26, 2019, appears to cover a novel method, apparatus, or composition—depending on its claims—aimed at enhancing specific functionalities within its field, which may involve pharmaceuticals, biotechnology, electronics, or other high-tech domains. Precise claims are vital for understanding patent strength, as they define the permissible scope of exclusivity.

While the specific field isn't detailed here, the patent document typically encompasses multiple independent claims supported by numerous dependent claims elaborating specific embodiments or improvements. These claims set the boundaries of IP protection and influence strategic patent positioning.


Claim Analysis: Scope and Enforceability

**Claim Construction and Language Clarity

A foundational step in patent analysis involves dissecting the language of the claims. The '734 patent's independent claims likely define core inventive concepts, whereas dependent claims specify particular arrangements or limitations. Important factors include:

  • Discreteness of Elements: Clear delineation of components or steps prevents overly broad interpretations that could lead to invalidation.
  • Use of Standardized Terminology: Vague or ambiguous terms risk indefiniteness, undermining enforceability (per framework established in Nautilus Inc. v. Biosig Instruments, Inc.[1]).
  • Functional Language: Claims relying heavily on functional language are scrutinized for claiming what the invention does rather than what it is, which can threaten patent validity.

Without access to the full claim set, our assessment is hypothetical. Nonetheless, assuming the claims are well-drafted with precise language, they probably delineate a novel approach or composition that distinguishes from prior art.

Potential for Invalidity due to Prior Art

The patent landscape's crux rests on non-obviousness and novelty. Similarities to prior art—whether patents, scientific publications, or industry practices—could impinge upon the claims:

  • Novelty: If the claims encompass features that are already disclosed or well-understood, they risk invalidation.
  • Non-Obviousness: Even novel features might be obvious to those skilled in the art if, for instance, prior art collectively implies the invention.

Prior patent databases such as USPTO and EPO repositories, and scientific literature searches, reveal the degree of overlap. For example, if the '734 patent claims a unique method that improves upon existing processes by combining existing steps in an unexpected way, it exhibits a stronger likelihood of validity.

Claim Breadth and Strategic Value

Broader claims confer extensive protection but are more susceptible to invalidation. Narrow claims limit scope but strengthen enforceability. The strategic choice hinges on balancing innovation disclosure and defensive positioning. Given current standards, claim breadth should be meticulously aligned with inventive step and prior art considerations.


Patent Landscape and Competitive Position

Key Players and Collateral Patents

The patent landscape surrounding the '734 patent includes:

  • Active Patent Families: Similar patents possibly owned by competitors or collaborators that either reinforce or threaten the enforceability of the '734 claims.
  • Litigation and Licensing: Industry history indicates that broad patents often form the basis of licensing negotiations or infringement lawsuits, shaping market dynamics.
  • Patent Thickets: The presence of dense patent clusters around the targeted technological area can impact freedom-to-operate analyses.

For example, if the '734 patent covers a specific technological improvement, companies may have filed alternative or complementary patents that carve out overlapping claims, potentially leading to litigation or settlement strategies.

Impact of Patent Term and Patent Term Adjustments

With the patent granted in 2019, the expiration will likely occur around 2039, subject to maintenance fees and potential patent term adjustments (e.g., for regulatory delays). This timeframe influences strategic planning, especially in fast-evolving sectors like biotech or electronics, where rapid innovation can render patents less valuable over time.

Patent Claim Interplay and Freedom-to-Operate (FTO) Considerations

For commercialization, FTO assessments hinge on the landscape of similar patents. Overlapping claims increase the risk of infringement or patent validity challenges, necessitating detailed patent clearance searches before market entry.


Critical Perspectives

Strengths

  • Innovative Core: Assuming claims are well-drafted, they delineate a novel, non-obvious technical contribution.
  • Strategic Broadness: If claims are sufficiently broad yet defensible, the patent offers substantial competitive advantage.
  • Alignment with Industry Trends: The patent likely addresses current technological gaps and fills market needs, boosting valuation and licensing opportunities.

Weaknesses

  • Potential Overbreadth: Excessively broad claims could invite challenges under Section 112 (111) for indefiniteness or lack of enablement.
  • Prior Art Risks: In a landscape saturated with similar innovations, maintaining claims’ novelty is challenging.
  • Legal Vulnerability: Without detailed specifications and claims, the patent's enforceability remains speculative; ensuring operable claims is critical.

Opportunities and Threats

  • Opportunities: Licensing revenue, blocking competitors, expanding into new markets.
  • Threats: Patent invalidation, litigation costs, alternative competing patents eroding scope, or patent improvements by other entities.

Implications for Stakeholders

Innovators should leverage the '734 patent’s claims to reinforce their portfolio, while ensuring ongoing innovation to prevent obsolescence. Legal strategists must continuously monitor the patent landscape for potential conflicts or infringements. Corporate decision-makers should evaluate licensing, cross-licensing, or R&D investments in the context of this patent’s breadth and enforceability.


Key Takeaways

  • The '734 patent’s value hinges on the clarity of its claims, which must balance broad protection with defensibility against prior art.
  • Robust patent landscape analysis reveals critical overlaps, potential infringement risks, and strategic opportunities.
  • Continual monitoring of legal developments, such as patent invalidation or litigation, is essential for maintaining commercial viability.
  • Strategic patent drafting, including the use of specific language and dependent claims, strengthens enforceability.
  • Effective IP management involves aligning patent assets with ongoing innovation pipelines, market trends, and competitive moves.

FAQs

1. How does claim breadth impact the enforceability of the '734 patent?
Broader claims provide expansive protection but are more vulnerable to invalidation if found to cover prior art or lack sufficient specificity. Narrower claims are easier to defend but offer less market coverage.

2. What are common challenges to the validity of patents like the '734 patent?
Challenges often stem from prior art disclosures that pre-date the patent filing, claims deemed overly broad or vague, or obvious modifications of existing technologies.

3. How can competitors circumvent the '734 patent?
Competitors can develop alternative methods or compositions that fall outside the patent claims' scope, or challenge the patent's validity through post-grant proceedings like inter partes review.

4. What role does patent landscaping play in assessing the '734 patent's strategic value?
Patent landscaping identifies overlapping patents, potential infringement risks, and market opportunities, guiding licensing and R&D strategies to maximize the patent's value.

5. How might future legal decisions affect the scope of the '734 patent?
Court rulings on claim validity, interpretation, and patentability standards could narrow or broaden the scope, influencing enforcement and licensing negotiations.


Conclusions

The '734 patent exemplifies a strategic intellectual property asset poised to influence its technological landscape significantly. Its ultimate value depends on the precision of claim language, resistance to invalidity challenges, and its positioning within a complex patent ecosystem. Continuous patent portfolio management, landscape analysis, and vigilant legal oversight are essential for leveraging its full potential while mitigating risks.


References

[1] Nautilus Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120 (2014).

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Details for Patent 10,398,734

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Iovance Biotherapeutics, Inc. AMTAGVI lifileucel Suspension 125773 February 16, 2024 10,398,734 2038-11-27
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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