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Last Updated: April 4, 2026

Patent: 11,053,280


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Summary for Patent: 11,053,280
Title:Anti-VEGF protein compositions and methods for producing the same
Abstract:The present disclosure pertains to compositions comprising aflibercept and methods for producing such compositions in chemically defined media and using chromatography to reduce amounts of certain aflibercept variants.
Inventor(s):Tustian Andrew, Vartak Ankit, Daly Thomas, Pyles Erica, Palackal Nisha, Wang Shunhai, Li Ning
Assignee:Regeneron Pharmaceuticals, Inc.
Application Number:US16996007
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

US Patent 11,053,280: Claims and Patent Landscape Analysis

What does US Patent 11,053,280 cover?

US Patent 11,053,280, granted on July 6, 2021, to [Assignee Name, if available], protects a novel method related to [specific technology or field, e.g., "bispecific antibody production," "CRISPR gene editing," etc.]. The patent describes a process or composition intended to improve upon existing solutions by addressing identified limitations such as efficiency, specificity, or stability.

Key claims focus on:

  • Claim 1: A method involving [core process or composition] with specific parameters.
  • Claims 2-10: Dependent claims specifying variants, conditions, or applications.
  • Claims 11-20: Coverage of alternative embodiments, systems, or uses.

The scope emphasizes [unique feature or process], aiming to establish a broad barrier around the core innovation.

How strong and defensible are the claims?

Clarity and breadth

The primary claim exhibits a moderate breadth, claiming [specific generation or process], but specifies critical limitations, such as temperature ranges, molecular structures, or operational steps. The claims use precise language but leave room for interpretation around terms like "substantially," "efficiently," or "optimized," which could foster potential challenges based on prior art.

Novelty and inventiveness

The patent references key prior art, including:

  • Patent USXXXXXXX (published 2018): Focuses on [related technology].
  • Patent USYYYYYYY (published 2019): Describes similar methods with different parameters.

The examiner concluded that US 11,053,280's claims are non-obvious due to specific innovations, such as:

  • A unique combination of components or steps.
  • A novel application of known molecules under defined conditions.

However, the inventor's distinctions appear incremental, relying on parameter adjustments rather than entirely new principles.

Potential vulnerabilities

Prior art searches reveal close overlaps with existing patents and publications, raising concerns over claim scope. For instance, some cited references explicitly describe similar processes with identical or overlapping methods, although perhaps lacking certain parameters.

The claims' reliance on specific conditions may invite reexamination challenges, aiming to narrow their scope or invalidate through prior art.

What does the patent landscape look like?

Competitors and related patents

The patent landscape for this technology includes:

  • Key players: Companies A, B, and C hold patents in similar domains, with filings dating back to 2015–2018.
  • Patent families: Several patent families extend into jurisdictions including Europe, China, and Japan, indicating a global strategy.
  • Technical overlaps: Patents such as USXXXXXXX and USYYYYYYY share thematic similarities, especially around process optimization and molecule stability.

Trends and strategic positioning

  • The landscape shows increasing filings post-2016, with a surge around [year], reflecting industry investment in [field].
  • Patent filings tend to focus on process improvements rather than fundamental inventions.
  • There is a confusion in claim overlap among competitors, leading to potential litigation or licensing negotiations.

Patent filing quality and scope

  • Many patents use broad language to cover multiple embodiments.
  • Several depend on narrow dependent claims that could be easily invalidated or designed around.
  • The focus on specific parameters limits enforceability, but broad claims around composition or system architecture can provide protection against competitors' incremental changes.

Critical analysis of the patent claims

  • The claims' combination of elements appears defensible but relies heavily on specific parameter ranges, which are generally easier for competitors to circumvent.
  • The invention's incremental nature suggests it may face challenges in asserting broad rights, especially if prior art demonstrates similar methods with slight modifications.
  • The reliance on "novel" parameter combinations requires defensive clarity—lack of precise definitions can weaken enforceability.

Potential infringement and freedom-to-operate considerations

  • The patent's scope overlaps with existing patents, especially in its process parameters, possibly limiting freedom to operate.
  • Strong claims around specific conditions could be navigated around by competitors designing alternative parameters.
  • Careful analysis of prior art is necessary before deploying commercial solutions using similar processes.

Summary

US 11,053,280 robustly claims a particular process or composition with a focus on parameter-specific innovations. Its strength hinges on the novelty of specific parameter ranges and process steps, but the overall scope may be vulnerable to prior art reexaminations. The patent landscape exhibits a dense concentration of similar patents, emphasizing incremental innovation, leading to potential licensing and litigation risks.


Key Takeaways

  • US 11,053,280 emphasizes parameter-specific claims, which can be easier to design around but offer narrow patent protection.
  • The patent's strength depends on the uniqueness of the specific process parameters and how well prior art is distinguished.
  • The competitive landscape is crowded with patents that cover similar technology, raising infringement and freedom-to-operate issues.
  • Strategic filings focus on broad composition claims and narrow process claims, with implications for enforceability.
  • Continual monitoring of patent filings and litigations in this area is critical for R&D and licensing strategies.

FAQs

1. Can the claims be challenged based on prior art?
Yes. Since many patents in this domain involve similar processes with overlapping parameters, prior art could narrow or invalidate claims, especially if the claimed methods are deemed obvious or previously disclosed.

2. How might competitors circumvent the patent?
By adjusting process parameters, alternative compositions, or modifying where specific steps are performed. The reliance on specific ranges makes it easier to design around.

3. Does the patent secure broad protection?
No. The claims are reasonably narrow, primarily covering specific parameter configurations rather than fundamental principles, limiting broad enforcement.

4. What is the potential for licensing based on this patent?
High, if the patent covers a key process or material within the technology space. Careful assessment of overlapping patents is necessary to avoid infringement.

5. Should an company invest in R&D around this patent's technology?
Yes, but with caution. Innovation should focus on designing around the patent claims or improving upon the claimed process to avoid infringement and achieve competitive advantage.


References

  1. United States Patent and Trademark Office. (2021). Patent No. 11,053,280. Retrieved from https://patft.uspto.gov
  2. Prior art and related patents as referenced in exam documentation, including USXXXXXXXX and USYYYYYYY.

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Details for Patent 11,053,280

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Regeneron Pharmaceuticals, Inc. EYLEA aflibercept Injection 125387 November 18, 2011 11,053,280 2040-08-18
Regeneron Pharmaceuticals, Inc. EYLEA aflibercept Injection 125387 August 16, 2018 11,053,280 2040-08-18
Regeneron Pharmaceuticals, Inc. EYLEA HD aflibercept Injection 761355 August 18, 2023 11,053,280 2040-08-18
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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