You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 7, 2025

Details for Patent: 11,091,469


✉ Email this page to a colleague

« Back to Dashboard


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 eighteen 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
Patent landscape, scope, and claims:

United States Patent 11,091,469: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 11,091,469, titled "Crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]," is a patent that has significant implications in the field of pharmaceuticals, particularly in the development of kinase inhibitors. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

The patent in question pertains to a crystalline form of a compound with the formula N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl], which is identified as an active kinase inhibitor. Specifically, it inhibits ALK, ROS1, TrkA, TrkB, and TrkC kinases, making it a valuable asset in the treatment of various cancers and other diseases associated with these kinases[1].

Scope of the Patent

Kinase Inhibition

The scope of the patent is centered around the crystalline form of the specified compound and its application as a kinase inhibitor. Kinase inhibitors are crucial in cancer therapy as they can target specific kinases involved in tumor growth and progression. The patent's focus on a crystalline form indicates the importance of the compound's physical properties in its efficacy and stability.

Pharmaceutical Applications

The patent's scope extends to the pharmaceutical applications of the compound, including its use in treating diseases where the targeted kinases play a significant role. This includes various types of cancer and potentially other conditions where kinase activity is aberrant.

Claims of the Patent

Independent Claims

The patent includes independent claims that define the crystalline form of the compound, its method of preparation, and its use in therapeutic applications. These claims are critical as they outline the specific aspects of the invention that are protected by the patent.

Dependent Claims

Dependent claims further specify the details of the independent claims, such as the particular crystalline forms, methods of synthesis, and specific therapeutic uses. These claims help to narrow down the scope and ensure that the patent protection is not overly broad.

Patent Landscape

Strategic Patenting

The patent landscape in the pharmaceutical sector is complex and often involves strategic patenting. Companies may seek patents not only for commercialization but also to block competitors, negotiate with them, or build "thickets" of patents to impede others' research and development activities[4].

Intellectual Property Protection

The USPTO plays a crucial role in granting patents and ensuring that intellectual property rights are protected. Patents like US 11,091,469 are part of a larger strategy where companies seek to protect their inventions to gain economic benefits in exchange for disclosing technical information[2].

Technological Fields

The patent falls under the broader category of chemistry and health, which is one of the significant technological fields in patenting. This category includes medical technology and pharmaceuticals, areas where the USPTO grants a substantial number of patents annually[4].

Metrics for Measuring Patent Scope

Claim Language

The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. Narrower claims, like those in US 11,091,469, are often associated with a higher probability of grant and a shorter examination process[3].

Industry Impact

R&D and Innovation

Patents in the pharmaceutical sector are crucial for R&D-performing firms. They help in securing financing and protecting intellectual property, which is essential for the development and commercialization of new drugs. The high-technology manufacturing and commercial knowledge-intensive services industries are particularly active in this area[4].

Legal and Regulatory Aspects

Patent Litigation

Patents can be subject to litigation, especially in the competitive pharmaceutical industry. Cases like Arbutus Biopharma Corporation v. Moderna Therapeutics, Inc. highlight the complexities and challenges involved in patent disputes, including inter partes review and the determination of prior art[5].

Economic Benefits

Licensing and Commercialization

The economic benefits of a patent like US 11,091,469 include licensing opportunities and commercialization of the drug. Companies can monetize their patents through licensing agreements, which can be a significant revenue stream.

Conclusion

The United States Patent 11,091,469 is a significant invention in the field of kinase inhibitors, with a clear scope and well-defined claims. Understanding the patent landscape, including strategic patenting, intellectual property protection, and the metrics for measuring patent scope, is crucial for navigating the complex world of pharmaceutical patents.

Key Takeaways

  • Kinase Inhibition: The patent is centered around a crystalline form of a compound that inhibits specific kinases.
  • Pharmaceutical Applications: The compound has therapeutic applications in treating diseases associated with the targeted kinases.
  • Strategic Patenting: The patent is part of a broader strategy to protect intellectual property and block competitors.
  • Intellectual Property Protection: The USPTO plays a key role in granting and protecting patents.
  • Industry Impact: Patents are crucial for R&D-performing firms in the pharmaceutical sector.
  • Legal and Regulatory Aspects: Patents can be subject to litigation, including inter partes review.

FAQs

  1. What is the main subject of United States Patent 11,091,469?

    • The main subject is a crystalline form of a compound that acts as a kinase inhibitor.
  2. Which kinases does the compound in the patent inhibit?

    • The compound inhibits ALK, ROS1, TrkA, TrkB, and TrkC kinases.
  3. Why is the crystalline form of the compound important?

    • The crystalline form is important for the compound's efficacy and stability in pharmaceutical applications.
  4. How do companies use patents strategically in the pharmaceutical sector?

    • Companies use patents to block competitors, negotiate, or build "thickets" of patents to impede others' R&D activities.
  5. What metrics are used to measure the scope of a patent?

    • Metrics such as independent claim length and independent claim count are used to measure the scope of a patent.

Sources

  1. Google Patents: US11091469B2 - Crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl].
  2. USA.gov: U.S. Patent and Trademark Office (USPTO).
  3. SSRN: Patent Claims and Patent Scope.
  4. NSF: Chapter 8 - Invention, Knowledge Transfer, and Innovation.
  5. CAFC: ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.

More… ↓

⤷  Try for Free


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 11,091,469 ⤷  Try for Free TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER ⤷  Try for Free
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No 11,091,469 ⤷  Try for Free TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION ⤷  Try for Free
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes 11,091,469 ⤷  Try for Free TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER ⤷  Try for Free
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes 11,091,469 ⤷  Try for Free TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.