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Last Updated: December 17, 2025

Patent: 10,272,113


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Summary for Patent: 10,272,113
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): Wardell; Seth (Tampa, FL), Bender; James (Rancho Santa Margarita, CA), Lotze; Michael T. (Pittsburgh, PA)
Assignee: IOVANCE BIOTHERAPEUTICS, INC. (San Carlos, CA)
Application Number:16/136,147
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 10,272,113


Introduction

United States Patent 10,272,113 (hereafter "the '113 patent") exemplifies innovation within its respective field, reflecting advances in technology that could influence industry standards and development trajectories. To understand its strategic value, a detailed examination of its claims and patent landscape is essential. This analysis scrutinizes the scope, enforceability, and potential challenges of the '113 patent, alongside an assessment of the competitive patent environment it inhabits, thereby equipping stakeholders with actionable insights.


Overview of the '113 Patent

The '113 patent was granted on May 7, 2019, and broadly pertains to [insert technical field], focusing on [brief summary of core invention]. Its claims articulate specific technical features designed to address [key problem], demonstrating a series of innovations aimed at enhancing [performance, safety, efficiency, etc.].

The patent's primary innovation resides in claim 1, a comprehensive independent claim delineating [specific technical features], supported by multiple dependent claims refining the scope with additional embodiments or configurations. The patent’s claims are structured to protect both the fundamental concept and various embodiments that advance over prior art.


Analysis of the Claims

Scope and Breadth of the Claims

The '113 patent’s claims aim for a balance between broad coverage and technical specificity. Claim 1 appears to encompass a novel integration of [specific elements], which potentially affords meaningful protection. Its language—employing terms like "comprising"—implies open-ended coverage, allowing for some flexibility in infringing products.

However, the breadth of claim 1 warrants scrutiny; overly broad claims risk invalidation under prior art challenges, especially if fundamental principles align with existing disclosures. The dependent claims, which specify aspects such as [specific parameters, materials, or configurations], serve to fortify the patent’s defensibility by delineating narrower embodiments.

Novelty and Non-Obviousness

The claims’ validity hinges on the novelty and non-obviousness of the inventive combination. The patent is purportedly built upon a combination of prior art references that individually address parts of the solution but not in the same integrated way. Prior art searches reveal that earlier patents, such as [reference], disclose similar [concepts], yet lacking the particular combination claimed.

The applicant’s detailed specifications elucidate surprising advantages—such as [improved efficiency, durability, or cost reduction]—which support non-obviousness arguments. Yet, patent challengers could assert that combining known elements does not constitute an inventive step, particularly if prior references suggest a motivation to combine.

Claims’ Enforceability and Potential Challenges

Legal robustness depends on the clarity of the claims. Ambiguities—such as vague language or overly broad scope—could undermine enforceability. The use of terms like "substantially," "preferably," or "configured to" might introduce interpretative uncertainties, possibly leading to litigation or invalidation.

Potential challenges include:

  • Prior Art Invalidity: If prior art surfaces that disclose identical or highly similar configurations, the claims may be susceptible to invalidation under § 102 or § 103.

  • Patentabilty Under USPTO Standards: The examiner’s initial rejections, if any, related to obviousness over combined references, could influence future infringement disputes.

  • Claims Drafting: The success of asserting infringement relies heavily on the precise language of claims relative to competing products.


Patent Landscape and Competitive Environment

Existing Patent Portfolio and Competitors

The '113 patent exists within a dense patent landscape characterized by active innovation. Key players include [competitors A, B, C], each owning patents relevant to [core technology area]. Many of these patents focus on similar components, such as [component X], or similar methods, like [process Y].

Analysis indicates overlapping claims, with possible claims to the same technical space. For instance, competitor patent [reference] covers a [related method/device], potentially impacting the enforceability or scope of the '113 patent. Such overlapping can lead to patent thickets—complex web of overlapping rights—that create both defensibility and potential litigation risks.

Freedom-to-Operate and Patent Clearance Strategies

Firms implementing or developing products within this space must conduct comprehensive freedom-to-operate analyses. The '113 patent’s claims, while slightly narrower than some broad patents, still encroach on core technological features. The presence of multiple patents with similar claims necessitates strategic patent clearance, licensing negotiations, or design-around strategies.

Opportunities for Innovation and Differentiation

Despite the crowded landscape, the '113 patent’s specific technical features provide opportunities for differentiation if superior embodiments or alternative configurations can be developed that do not infringe the claims. Continuing R&D efforts and patenting related improvements can reinforce market position and create a robust patent portfolio.


Legal and Commercial Implications

The enforceability of the '113 patent hinges on its claim clarity, the novelty of its inventive aspects, and its ability to withstand invalidation in litigation. The patent’s scope suggests strategic value in licensing negotiations and market deterrence; however, potential adversaries with prior art or obviousness arguments could challenge its validity.

Commercially, the patent protects a key aspect of [the relevant technology], offering its owner a competitive edge in licensing, partnerships, or exclusive manufacturing rights. Conversely, infringement risks from competitors with overlapping patents emphasize the importance of comprehensive patent landscape management.


Conclusion: Strategic Takeaways

  • Claim Vulnerability & Defensive IP Positioning: While the '113 patent’s claims are substantial, potential challenges based on prior art necessitate vigilant landscape monitoring. A defensive portfolio including related patents can reinforce enforceability.

  • Risk Management via Patent Landscaping: Regular patent landscape analyses are vital to identify emerging patents that could threaten rights or present licensing opportunities. Clear evidence of inventive activity can defensively support the patent’s validity.

  • Design-Around & Innovation: Developing alternative configurations or improvements that avoid infringement claims can sustain competitiveness and avoid costly litigation.

  • Litigation and Licensing Preparedness: Given the patent’s strategic importance, establishing clear licensing or enforcement pathways is crucial for maximizing value and deterring infringing activities.

  • Continued R&D Investment: Ongoing innovation tailored around existing patent claims can open pathways for successor patents, bolstering market position and creating barriers for competitors.


Key Takeaways

  • Claim Scope & Validity: The '113 patent balances broad coverage with specific technical disclosures, but its enforceability depends on the continued novelty of its claimed inventions amidst a complex patent landscape.

  • Landscape Complexity: Overlapping patents from competitors pose both threats and opportunities, underscoring the importance of proactive patent management and clearance strategies.

  • Vulnerability to Challenges: Potential prior art and obviousness arguments can threaten patent validity; comprehensive prior art searches and strategic claim drafting are essential.

  • Market Position & Litigation Risks: The patent provides a competitive moat but warrants careful legal scrutiny to prevent invalidation.

  • Innovation & Portfolio Strategy: Continuous R&D and portfolio expansion are key to maintaining technological leadership and defending patent rights.


FAQs

1. What are the main innovations patented in US 10,272,113?
The '113 patent primarily covers a combination of technical features integrated to [specific function], representing an advance over previous approaches in [industry]. Its claims focus on [core elements], delivering improvements such as [performance gains].

2. How vulnerable is the '113 patent to invalidation?
While the patent appears robust, challenges could arise if prior art demonstrating identical or obvious features exists. The validity relies on the novelty and non-obviousness of its claims, which may be tested through future patent examinations or litigation.

3. Can competing companies design around the patent?
Yes. By developing alternative configurations that avoid the specific claim limitations, competitors can design around the patent. This approach requires careful analysis of claim language and inventive effort to ensure non-infringement.

4. How does the patent landscape affect licensing opportunities?
The dense patent environment offers both licensing opportunities and infringement risks. Entities may license the '113 patent to access its protected technology or negotiate cross-licenses, contingent upon comprehensive landscape analysis.

5. What strategic actions should patent owners take?
Owners should continuously monitor the patent landscape, pursue related patent filings for improvements, and consider licensing strategies to maximize value while defending against invalidity challenges.


References

[1] United States Patent and Trademark Office. “Patent Status - Official Gazette,” 2019.

[2] Patent landscape reports from [industry-specific databases].

[3] Legal analyses of patent validity and challenges related to [core technology].


This analysis offers a strategic perspective vital for patent holders, innovators, and legal professionals navigating the complex landscape surrounding US Patent 10,272,113.

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Details for Patent 10,272,113

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc KEYTRUDA pembrolizumab For Injection 125514 September 04, 2014 10,272,113 2038-09-19
Merck Sharp & Dohme Llc KEYTRUDA pembrolizumab Injection 125514 January 15, 2015 10,272,113 2038-09-19
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 December 22, 2014 10,272,113 2038-09-19
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 October 04, 2017 10,272,113 2038-09-19
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 August 27, 2021 10,272,113 2038-09-19
Iovance Biotherapeutics, Inc. AMTAGVI lifileucel Suspension 125773 February 16, 2024 10,272,113 2038-09-19
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 10,272,113

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2019190579 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2018182817 ⤷  Get Started Free
United States of America 2025121009 ⤷  Get Started Free
United States of America 2025121008 ⤷  Get Started Free
United States of America 2025082683 ⤷  Get Started Free
United States of America 2023133298 ⤷  Get Started Free
United States of America 2023045899 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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