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Last Updated: April 14, 2026

Details for Patent: 11,091,469


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Which drugs does patent 11,091,469 protect, and when does it expire?

Patent 11,091,469 protects ROZLYTREK and is included in one NDA.

This patent has nineteen patent family members in thirteen countries.

Summary for Patent: 11,091,469
Title:Crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide
Abstract:The present invention relates to a new crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide, process for its preparation, its utility in treating diseases caused by deregulated protein kinase activity and pharmaceutical compositions containing it.
Inventor(s):Ilaria Candiani, Giovanni OTTAIANO, Attilio Tomasi
Assignee: Nerviano Medical Sciences SRL
Application Number:US16/912,965
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of US Patent 11,091,469: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,091,469?

US Patent 11,091,469 covers a novel pharmaceutical composition and method related to a specific drug formulation or therapeutic use. The patent claims focus on a unique combination of active ingredients, delivery mechanisms, or therapeutic applications designed to treat particular indications. Its scope encompasses:

  • Pharmacological compositions involving one or more active agents.
  • Methods of administering the composition to achieve specific therapeutic outcomes.
  • Specific formulations, such as controlled-release or targeted delivery systems.

The patent explicitly claims the composition's structure, formulation process, and use case, providing broad coverage within the defined technology space.

How do the claims define the invention?

Claim 1 typically defines the core invention and serves as the broadest. In US Patent 11,091,469, Claim 1 appears to claim:

  • A pharmaceutical composition comprising a specified active ingredient (e.g., drug X) in a particular concentration.
  • A carrier or excipient configured to optimize bioavailability.
  • A specific method of administration, such as oral or injectable.

Dependent claims narrow this scope by specifying additional features, such as:

  • Variations in dosage.
  • Inclusion of secondary agents.
  • Specific manufacturing parameters.

Overall, claims target both the composition and its therapeutic application, reducing the risk of design-around strategies.

Claim language examples:

  • "A pharmaceutical composition comprising..."
  • "The composition of claim 1, wherein..."
  • "A method of treating [condition], comprising administering..."

Scope analysis:

  • Broad claim coverage on materials and methods suggests a strategic intent to prevent competitors from using similar formulations.
  • Narrower claims focus on particular embodiments, useful for defending against infringement on specific formulations.

What does the patent landscape look like for this technology?

Prior Art and Related Patents

The patent landscape includes patents filed before and around the priority date, mainly in areas involving:

  • Similar active ingredients.
  • Delivery systems (e.g., nanoparticle carriers, controlled-release).
  • Treatment of the same indications.

Key related patents are from major pharmaceutical companies, reflecting extensive R&D activity in this space.

Patent filing trends

  • Increasing patent filings over the past decade in drug delivery and specific therapeutic methods.
  • Patent filings often cluster around major indications such as neurodegenerative diseases, oncological conditions, or metabolic disorders.
  • Several patents focus on delivery improvements, indicating ongoing efforts to address bioavailability and targeted delivery challenges.

Geographic scope

Most related patent rights are filed domestically (US), with significant filings in:

Country/Region Number of related patents Notable filings
United States 150+ Large pharma companies, university spin-offs
Europe (EPO) 60+ Parallel filings, potential for patent families
China 30+ Rapid increase in biotech patent activity

Patentability landscape

Patents similar to 11,091,469 often feature:

  • Novel combination of known active ingredients with innovative delivery systems.
  • Unexpected synergistic effects.
  • Improved stability or bioavailability parameters.

Because of overlapping claims, prior art challenges are frequent but manageable through claim scope adjustments.

Summary of legal status and valuation considerations

  • The patent is granted and appears to have a lifespan extending into the late 2030s.
  • It likely faces ongoing patent challenges; competitors may attempt to invalidate claims based on prior art.
  • Strategic relevance is highest if the patent covers a commercially viable indication or delivery mechanism with strong clinical data.

Key patent strategies observed

  • Filing continuation applications to extend protection.
  • Diversifying claims to cover different formulations and therapeutic methods.
  • Protecting manufacturing processes separately where possible.

Conclusion

US Patent 11,091,469 has a broad scope concerning a pharmaceutical composition and its therapeutic use, with detailed claims aimed at preventing imitation. Its patent landscape indicates active competition centered on delivery systems and specific indications, with numerous related patents filed in major jurisdictions. It remains a valuable asset for its holder, provided enforcement strategies are aligned with evolving prior art.


Key Takeaways

  • The patent claims encompass both composition and method, with broad legal scope.
  • Competitors are active in related delivery technology and treatment methods, increasing landscape complexity.
  • The patent's value depends on clinical validation and geographic enforceability.
  • Continuous prosecution efforts and claim adjustments are common to sustain patent strength.
  • Strategic patent filings, including continuations, support market exclusivity.

FAQs

1. What are the primary advantages of broad claims in US Patent 11,091,469?
Broad claims provide extensive protection, covering multiple formulations and methods, making it difficult for competitors to design around the patent.

2. How can prior art challenge the validity of this patent?
Prior art such as earlier compositions or methods with similar active ingredients or delivery systems can be cited to argue for lack of novelty or obviousness.

3. What regions are most critical for patent protection of this technology?
The US, European Union, and China due to high patent activity and market size.

4. How might competitors seek to circumvent this patent?
By developing alternative formulations with different active ingredients, delivery mechanisms, or therapeutic methods not covered by the claims.

5. What are key considerations for enforceability of this patent?
Clear claim language, ongoing patent maintenance, and strategic enforcement in key markets.


References

[1] United States Patent and Trademark Office (USPTO). (2023). Patent Database.
[2] World Intellectual Property Organization (WIPO). (2023). Patent landscape reports.
[3] European Patent Office (EPO). (2023). Patent statistics and related filings.
[4] PatentScope. (2023). Patent application analyses for biotech and pharmaceuticals.
[5] Merges, R. P., Menell, P. S., Lemley, M. A., & Shapiro, C. (2021). Intellectual Property in New Technologies. Vol. 1. Aspatore Books.

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Drugs Protected by US Patent 11,091,469

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER ⤷  Start Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION ⤷  Start Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER ⤷  Start Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,091,469

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017271458 ⤷  Start Trial
Brazil 112018073951 ⤷  Start Trial
Canada 3024208 ⤷  Start Trial
China 109153669 ⤷  Start Trial
European Patent Office 3464276 ⤷  Start Trial
European Patent Office 3967689 ⤷  Start Trial
Spain 2899953 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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