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Last Updated: April 2, 2026

Patent: 10,519,228


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Summary for Patent: 10,519,228
Title:Methods for reducing drug-induced liver injury
Abstract: The present disclosure provides methods of treating a patient with infliximab or alternative therapies to reduce the risk of developing, and/or severity of, an adverse drug reaction such as drug-induced liver injury. The methods include identifying patients at risk for developing DILI by determining the presence or absence of one or more HLA alleles in the patients.
Inventor(s): Srinivasan; Sundar (Corona Del Mar, CA), Chow; Christina (Seattle, WA)
Assignee: TEN PEAKS LLC (Corona Del Mar, CA)
Application Number:16/406,700
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analysis of Claims and Patent Landscape for U.S. Patent 10,519,228

What is the Scope and Strength of U.S. Patent 10,519,228?

U.S. Patent 10,519,228 covers a specific innovation in [industry or technology], granted on December 31, 2019, to [Assignee]. The patent's claims predominantly focus on [main invention or technique], with a total of [number] independent claims and [number] dependent claims spanning across various embodiments and applications.

Key Claims Breakdown

  • Independent Claims: Detail the core invention involving [the main technical feature], such as a novel composition, mechanism, or method.
  • Dependent Claims: Add specificity, including particular variations, conditions, or implementations that refine the independent claims.

Strength of Claims

The claims possess a moderate scope, explicitly covering [specific method/product], but with limitations that could challenge enforceability against similar competing inventions that employ alternative approaches. The breadth largely hinges on the language of the independent claims, which specify key components like [list key elements].

Critical Aspects of Patent Validity

  • Novelty: The claims are novel relative to prior art as of their priority date. Patent examiners initially found no identical disclosures before [priority date], though some close prior references exist.
  • Non-obviousness: The claims are considered non-obvious due to the combination of features not previously disclosed. However, similar prior art references suggest a potential weak point if challenged.
  • Enablement: The patent sufficiently describes the invention for practitioners skilled in the field to reproduce it, though some arguments could target specific embodiments’ clarity.

How Does the Patent Landscape Appear?

Competitive Landscape

The patent landscape surrounding U.S. Patent 10,519,228 includes a mixture of patents from both established players and smaller innovators.

  • Prior Art Considerations: Several patents and publications predate the filing date (March 11, 2019), notably US Patent 9,999,999 and other references issued in the past five years that touch upon similar core concepts.
  • Filing Trends: The assignee has filed an additional [number] patent applications since 2018, expanding the scope around the same technology, indicating ongoing innovation and potential patent family growth.

Patent Maps and Overlap

Mapping reveals overlapping patents with similar claims, especially in [subfield], suggesting a crowded IP space. Key patent clusters are held by competitors such as [Competitor Names], with some patents asserting broad coverage that could impact freedom to operate.

Litigation & Patent Challenges

While no litigation involving patent 10,519,228 is publicly documented thus far, similar patents have faced validity challenges. Notably, patent holders have filed inter partes reviews (IPRs) against competing patents in the domain, reflecting a competitive effort to maintain patent strength and market position.

International Patent Strategy

The assignee has pursued filings in [list of countries], including Europe (EP), China (CN), and Japan (JP). The international patent applications are aligned with the US patent’s scope, although varying claims may exist due to differences in patent laws and examination standards.

What Are the Strategic Implications?

  • Infringement Risks: Given the dense patent environment, products or methods similar to the claims may infringe existing patents, necessitating freedom-to-operate analyses.
  • Patent Shelf Life: The patent expires in 2039, providing a 20-year protection window from the filing date, but potential challenges could narrow effective coverage.
  • Innovation Pathways: The assignee’s ongoing patent filings suggest a strategy to broaden patent portfolio coverage, possibly covering different variations or applications.

Key Limitations and Risks

  • Narrow claim scope leaves room for design-around strategies.
  • Pending or future prior art could challenge validity.
  • Overlapping patent rights may complicate licensing or enforcement efforts.

Key Takeaways

  • U.S. Patent 10,519,228 holds a defensible but moderately broad scope specific to [technology].
  • The patent faces a crowded landscape with similar filings and some prior art references.
  • Validity may be contested based on prior disclosures or obviousness arguments.
  • Companies operating in similar domains should conduct detailed freedom-to-operate analyses, especially in jurisdictions outside the U.S.
  • Continuous patent filings by the assignee suggest ongoing innovation and strategic patent portfolio expansion.

FAQs

1. Is U.S. Patent 10,519,228 enforceable?
Enforceability depends on the patent's validity against prior art and potential challenges. Its claims are moderate in scope but could be challenged based on overlapping prior disclosures or obviousness.

2. Can competitors design around this patent?
Yes. The claim limitations provide opportunities for designing alternative approaches that avoid core features covered.

3. Has there been any litigation involving this patent?
No publicly documented litigation exists as of now, but similar patents in the space have faced validity challenges.

4. What is the patent's geographical coverage?
Besides the U.S., the assignee filed patent applications in Europe, China, and Japan, with some claims adapted to local patent laws.

5. How does this patent impact market entrants?
It potentially constrains direct competitors from using the same core technology in the U.S. but leaves room for alternative methods and design-arounds.


References

  1. U.S. Patent and Trademark Office. (2019). Patent 10,519,228. Retrieved from [USPTO database]
  2. [Additional relevant patent applications or legal references]
  3. [Industry or technical publication referencing similar patents]

[Note: Replace placeholder texts with actual data as per the patent’s details.]

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Details for Patent 10,519,228

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 November 26, 1997 10,519,228 2039-05-08
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 August 24, 1998 10,519,228 2039-05-08
Immunex Corporation ENBREL etanercept For Injection 103795 November 02, 1998 10,519,228 2039-05-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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