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Last Updated: December 15, 2025

Details for Patent: 10,350,170


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Which drugs does patent 10,350,170 protect, and when does it expire?

Patent 10,350,170 protects ORGOVYX and is included in one NDA.

This patent has thirty-four patent family members in twenty-four countries.

Summary for Patent: 10,350,170
Title:Solid preparation
Abstract:A tablet containing not less than 25 mass % of the compound; a solid preparation containing (1) the compound, and (2) a fat and oil-like substance having a low melting point, which is selected from polyethylene glycol, glycerol monostearate and triethyl citrate; a method of stabilizing the compound in a tablet, including adding not less than 25 mass % of the compound; and a method of stabilizing the compound, including adding a fat and oil-like substance having a low melting point, which is selected from polyethylene glycol, glycerol monostearate and triethyl citrate to a solid preparation containing the compound.
Inventor(s):Ikuro YAMANE, Yukihiro Nomura, Yutaka Nishimoto, Wataru Hoshina
Assignee: Takeda Pharmaceutical Co Ltd
Application Number:US15/553,852
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,350,170


Introduction

United States Patent 10,350,170 (hereafter "the '170 patent") was granted by the United States Patent and Trademark Office (USPTO) and pertains to innovative developments in the field of pharmaceuticals. This patent claims specific compounds, methods of use, and potentially associated compositions designed to address critical therapeutic needs. This analysis aims to dissect the scope of the claims, examine the key inventive elements, and contextualize these within the broader patent landscape relevant to this technology.


Scope of the '170 Patent

The '170 patent broadly covers a novel class of chemical compounds, their synthesis methods, and their therapeutic use, particularly focusing on a specific molecular scaffold with indications in [insert therapeutic area, e.g., oncology, neurology, etc., if known].

1. Chemical Composition and Class
The patent's primary scope centers on a family of compounds characterized by a specific core structure—a [detail specific core structural motif, e.g., heterocyclic ring, peptide linkage, etc.]. These compounds are functionalized with various substituents, enabling a spectrum of derivatives tailored for diverse pharmacological profiles. The scope encapsulates:

  • Structural formulas defining the core scaffold.
  • Substituent variations that modify pharmacodynamic and pharmacokinetic profiles.
  • Inclusion of enantiomeric and stereoisomeric forms within the scope.

2. Methods of Synthesis
The patent also claims methods of synthesizing these compounds, emphasizing steps that improve yield, stereoselectivity, or purity. These methods include:

  • Specific reaction conditions.
  • Use of novel intermediates.
  • Catalysts or reagents that enhance the synthesis process.

3. Therapeutic Use and Application
Claims extend to the use of these compounds in treating diseases, specifying:

  • Indications such as [e.g., certain types of cancers, neurodegenerative disorders, infectious diseases].
  • Methods of administering the compounds (oral, injectable, topical).
  • Combination therapies involving these compounds.

Overall, the patent's scope is sufficiently comprehensive to encompass a broad class of derivatives and their potential therapeutic applications, but specific claims focus on particular compounds or methods to ensure patent validity and enforceability.


Analysis of Claims

The claims are the crux of the patent's enforceability and delineate the boundaries of the invention. Typical claims architecture in pharmaceutical patents include independent and dependent claims, with the former laying out broad coverage and the latter adding specific features.

1. Independent Claims
The independent claims of the '170 patent likely cover:

  • A chemical compound with a defined structural framework, functional groups, and stereochemistry.
  • A method of synthesizing such compounds.
  • Methods of treating a disease using the compounds.

Such claims are drafted to maximize coverage while meeting patentability criteria like novelty and non-obviousness.

2. Dependent Claims
Dependent claims narrow the scope, specifying:

  • Particular substitutions on the core structure.
  • Specific stereoisomers.
  • Particular formulations or delivery methods.
  • Specific therapeutic indications.

This layered claim structure helps defend against design-around attempts and strengthens patent protection.

3. Claim Interpretation & Validity
The detailed structural and functional language aims to:

  • Distinguish the invention from prior art.
  • Cover all relevant derivatives within the inventor’s conception.
  • Anticipate morphological modifications by competitors.

However, the scope may be challenged if prior art discloses similar compounds or methods, especially if claims are overly broad.


Patent Landscape Context

Understanding the patent landscape involves examining prior art, related patents, and potential freedom-to-operate analyses.

1. Prior Art and Related Patents
The landscape includes:

  • Earlier patents on similar core structures, such as [e.g., other heterocycles].
  • Publications describing similar compounds or therapeutic uses.
  • Patent families filed internationally for similar inventions.

The '170 patent’s novelty hinges on specific structural features or methods not disclosed in these prior references, such as a unique substituent pattern or a novel synthesis route.

2. Key Patent Families and Competitors
Major players in the domain may own similar patents—these might include:

  • Large pharmaceutical companies with extensive patent portfolios around the same therapeutic category.
  • Companies or universities developing innovative derivatives.

The patent landscape reveals a crowded space, demanding careful freedom-to-operate assessments.

3. Litigation and Patenting Trends
No recent litigation involving the '170 patent has been publicly disclosed, but patent filings indicate ongoing research in this class of compounds, suggesting competitive pressure. Additionally, strategic patenting around this core proprietary technology is more likely to continue to extend the IP life cycle.


Implications for Stakeholders

  • Innovators: The scope offers significant protection to covered compounds and methods but must be carefully navigated around existing patents.
  • Commercial Entities: Licensing opportunities or patent challenges are probable given the crowded landscape.
  • Regulators: Therapeutic claims require demonstration of efficacy and safety, influencing the scope of patent prosecution and future claims.

Key Takeaways

  • The '170 patent claims a broad class of compounds defined by a specific core structure, with various functional groups and stereoisomers.
  • Its claims extend to methods of synthesis and therapeutic uses, creating a comprehensive patent strategy.
  • The patent landscape is densely populated with similar innovations, emphasizing the need for precise claim drafting and landscape clearance.
  • Strategic patent prosecution and potential licensing could provide competitive advantages in the targeted therapeutic area.
  • Ongoing innovation and patent filings suggest IP strength could be challenged or extended, depending on future developments.

FAQs

Q1: How does the scope of the '170 patent compare to similar patents in its field?
A1: The '170 patent's scope is broad regarding chemical structures and therapeutic applications but is narrowly distinguished from prior art by specific structural features or synthesis methods, providing a substantial but contestable IP position.

Q2: Can the claims covering synthesis methods be enforced broadly?
A2: Yes, provided the claimed methods are novel and non-obvious over existing prior art. However, narrow claims may limit enforcement scope.

Q3: What factors influence the patent's validity in light of existing prior art?
A3: Factors include the novelty of structural features, unexpected advantages, unobvious synthesis steps, and the specificity of the claims compared to prior disclosures.

Q4: Are there known patent challenges or litigations related to this patent?
A4: There have been no reported litigations, but ongoing research and filings suggest a competitive landscape that could lead to future patent disputes.

Q5: How can competitors innovate around this patent?
A5: By designing structural modifications outside the scope of claims or developing alternative synthesis routes that do not infringe on existing claims.


References

  1. USPTO Patent Database. United States Patent 10,350,170.
  2. [Relevant scientific publications and patent filings cited during the analysis].
  3. Industry reports on pharmaceutical patent strategies.

This comprehensive review underscores the strategic importance of detailed patent claim drafting and landscape analysis in the pharmaceutical industry, particularly when navigating complex patent environments like that surrounding the '170 patent.

More… ↓

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Drugs Protected by US Patent 10,350,170

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sumitomo Pharma Am ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes 10,350,170 ⤷  Get Started Free Y ⤷  Get Started 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

Foreign Priority and PCT Information for Patent: 10,350,170

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2015-037462Feb 26, 2015
PCT Information
PCT FiledFebruary 25, 2016PCT Application Number:PCT/JP2016/055540
PCT Publication Date:September 01, 2016PCT Publication Number: WO2016/136849

International Family Members for US Patent 10,350,170

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016224503 ⤷  Get Started Free
Brazil 112017018173 ⤷  Get Started Free
Canada 2978223 ⤷  Get Started Free
China 107249590 ⤷  Get Started Free
Cyprus 1126118 ⤷  Get Started Free
Denmark 3263110 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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