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Last Updated: May 16, 2025

Details for Patent: 11,253,515


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Which drugs does patent 11,253,515 protect, and when does it expire?

Patent 11,253,515 protects ROZLYTREK and is included in one NDA.

This patent has thirteen patent family members in ten countries.

Summary for Patent: 11,253,515
Title:Pharmaceutical compositions and dosage forms
Abstract: Disclosed herein are pharmaceutical compositions and dosage forms including N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazi- n-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide that are useful in the treatment of subjects having cancer. The present disclosure also provides methods for preparing these pharmaceutical compositions and dosage forms, and methods of treating subjects having cancer utilizing the pharmaceutical compositions and dosage forms provided herein.
Inventor(s): Codallos, Jr.; Daniel (San Diego, CA), Orr; Robert (San Clemente, CA), Li; Ching-Yuan (San Diego, CA), Start; Valerie Denise (San Diego, CA)
Assignee: Ignyta, Inc. (South San Francisco, CA)
Application Number:16/746,644
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 11,253,515

Introduction

United States Patent 11,253,515, titled "Pharmaceutical compositions and dosage forms," is a patent that delves into the development of specific pharmaceutical compositions and their corresponding dosage forms. To analyze this patent, it is crucial to understand its scope, claims, and the broader patent landscape it operates within.

Patent Overview

Publication Number and Authority The patent, numbered US11,253,515B2, was issued by the United States Patent and Trademark Office (USPTO)[4].

Inventorship and Ownership

Determining True and Only Inventors In the context of US patent law, it is essential to identify the "true and only" inventors of the patentable subject matter. This involves determining who conceived the idea or subject matter of the patent claims. For a patent like US11,253,515, the inventors would have had to conceive the definite and permanent idea of the complete and operative invention, which in this case involves specific pharmaceutical compositions and dosage forms[2].

Patent Claims

Scope and Breadth of Claims The scope of a patent is often measured by the breadth and clarity of its claims. For US11,253,515, the claims would detail the specific pharmaceutical compositions, including the chemical compounds and their formulations. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process, indicating that the claims in this patent are likely well-defined and specific[3].

Independent Claim Length and Count

The independent claim length and count are metrics used to measure patent scope. A patent with fewer but more detailed independent claims may indicate a narrower and more focused scope, which can be beneficial for enforcement and litigation purposes. The claims in US11,253,515 would need to be analyzed for their length and count to understand the patent's overall scope[3].

Pharmaceutical Compositions

Chemical Compounds and Dosage Forms The patent describes pharmaceutical compositions that include specific chemical compounds such as difluorobenzyl, indazol, and piperazin derivatives. These compounds are formulated into various dosage forms, which are detailed in the patent's claims and descriptions. For example, the patent mentions n-[5-[(3,5-difluorophenyl)methyl]-1H-indazol-3-yl]-4-(4-methylpiperazin-1-yl)-2-(oxan-4-ylamino)benzamide, a complex chemical compound with potential therapeutic applications[4].

Therapeutic Applications

Diseases and Conditions The pharmaceutical compositions described in the patent are intended for various therapeutic applications, including the treatment of diseases such as non-small cell lung carcinoma, colon cancer, and neuroblastoma. The patent details the effects of these compositions on these conditions, highlighting their potential as antineoplastic agents[4].

Prior Art and Citations

Common Citation Document (CCD) To understand the novelty and non-obviousness of the inventions in US11,253,515, it is important to review the prior art cited by the patent office. The Common Citation Document (CCD) consolidates prior art citations from participating IP offices, providing a comprehensive view of the existing knowledge in the field[1].

Patent Examination Process

Patent Examination Data System (PEDS) The Patent Examination Data System (PEDS) allows public users to search, view, and download bibliographic data for all publicly available patent applications. This system can provide insights into the examination process of US11,253,515, including any office actions, amendments, and the overall duration of the examination[1].

Legal and Policy Considerations

Small Claims Patent Court In the broader patent landscape, there are ongoing discussions about the feasibility of a small claims patent court. This initiative aims to address issues related to patent litigation costs and complexity, which could impact the enforcement and validity of patents like US11,253,515. The Administrative Conference of the United States (ACUS) has conducted studies on this topic, engaging with various stakeholders to understand the legal, policy, and practical considerations[5].

Key Takeaways

  • Inventorship: The patent must list the true and only inventors who conceived the idea of the pharmaceutical compositions.
  • Claims: The scope of the patent is defined by its claims, which should be specific and well-defined to ensure enforceability.
  • Pharmaceutical Compositions: The patent details specific chemical compounds and their formulations for therapeutic applications.
  • Therapeutic Applications: The compositions are intended for treating various diseases, including non-small cell lung carcinoma and colon cancer.
  • Prior Art: The CCD helps in understanding the prior art and the novelty of the inventions.
  • Examination Process: PEDS provides insights into the examination process and any office actions related to the patent.

FAQs

  1. Who are the inventors listed in US Patent 11,253,515? The inventors listed in the patent are those who conceived the idea of the specific pharmaceutical compositions and dosage forms. Their names are typically found in the patent document.

  2. What are the key chemical compounds described in the patent? The patent describes compounds such as difluorobenzyl, indazol, and piperazin derivatives, which are formulated into various dosage forms.

  3. What diseases are the pharmaceutical compositions intended to treat? The compositions are intended for treating diseases such as non-small cell lung carcinoma, colon cancer, and neuroblastoma.

  4. How can one access the prior art citations for this patent? The Common Citation Document (CCD) provides a single point access to prior art citations from participating IP offices.

  5. What is the significance of the Patent Examination Data System (PEDS) in relation to this patent? PEDS allows users to search, view, and download bibliographic data for all publicly available patent applications, providing insights into the examination process of US11,253,515.

Sources

  1. USPTO - Search for patents https://www.uspto.gov/patents/search
  2. Determining Inventorship for US Patent Applications https://agsci.oregonstate.edu/sites/agsci/files/main/research/vrc_release_inventorship-gattari.pdf
  3. Patent Claims and Patent Scope - Search eLibrary :: SSRN https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
  4. US11253515B2 - Pharmaceutical compositions and dosage forms - Google Patents https://patents.google.com/patent/US11253515B2/en
  5. U.S. Patent Small Claims Court https://www.acus.gov/research-projects/us-patent-small-claims-court

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Drugs Protected by US Patent 11,253,515

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 11,253,515 ⤷  Try for Free Y ⤷  Try for Free
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes 11,253,515 ⤷  Try for Free Y ⤷  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

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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.