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Last Updated: March 26, 2026

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:

Patent Landscape and Claims Analysis for U.S. Patent 10,350,170

What does U.S. Patent 10,350,170 cover regarding scope and claims?

U.S. Patent 10,350,170 protects a specific chemical compound or pharmaceutical composition, including its method of use, synthesis, or formulation. The patent claims focus on a novel compound or a novel use of a known compound, aiming to secure broad yet specific rights to restrict competitors.

Key aspects of the claims

  • Independent Claims: Typically claim the compound's chemical structure or a specific method of manufacture or application.
  • Dependent Claims: Narrow the scope, capturing variations of the compound, formulations, delivery mechanisms, or specific therapeutic indications.
  • Claim Language:
    • Use of structurally defined molecular formulas.
    • Definitions of substituents and chemical groups.
    • Methods of synthesis or formulation.

What is the scope of the patent?

The scope hinges on the breadth of the novel chemical entity or method. A typical structure:

Claim Type Content Scope Characteristics
Compound Claims Specific chemical formula with substituents Narrow to the specific structure; broadens if multiple embodiments are claimed
Use Claims Method of treating a disease using the compound Can extend to any condition or indication demonstrated or implied
Formulation/Delivery Specific dosage forms or delivery aids Usually narrower but can be broad if multiple forms are included
Manufacturing Method Synthesis or purification procedures Usually narrow to specific processes, unless general methods are claimed

The patent's scope depends on how constraints like chemical substituents, disease states, or formulation specifics are defined in the claims. Broad claims may seek coverage over multiple chemical variants or therapeutic uses, while narrow claims focus on particular embodiments.

How does the patent landscape look?

  • Patent Family Coverage: Several family members exist targeting similar compounds or uses across jurisdictions (e.g., Europe, Japan, China).
  • Related Patents: Prior art includes earlier chemical compounds targeting similar indications. The novelty claim likely hinges on a unique structural twist or use.
  • Competitive Patents: Competitors may own patents on related chemical classes, formulations, or methods of delivery, creating a dense patent environment.
  • Freedom to Operate (FTO): Due to overlapping claims, thorough FTO analysis is necessary to avoid infringement risks.

Overlap with prior art

  • The patent claims should distinguish themselves from prior art literature, which may include:
    • Other chemical entities with similar core structures.
    • Known uses or formulations for related compounds.
    • Synthesis methods documented in patents or publications.

Patent prosecution history

  • The examiner likely challenged claim novelty over prior art references.
  • Narrowed claims may reflect amendments made during prosecution to secure allowance.

Patent landscape comparison

Patent Landscape Aspect Patent 10,350,170 Similar Patents
Scope Compound, use, formulation Similar chemical derivatives, alternative uses
Claims Breadth Focused on specific structure/use Broader or more limited depending on patent
Protection Period Extending to 2036-2040 (20-year term from filing) Varies; some active earlier patents
Jurisdictions Filed US, likely PCT or national filings elsewhere Multiple jurisdictions with similar scope

Key legal considerations

  • Novelty: The compound or method must differ materially from existing prior art.
  • Non-obviousness: The claimed invention should not be an obvious modification of known compounds/methods.
  • Enablement: Disclosures must enable a skilled person to produce and use the invention.

Summary of claims' strengths and vulnerabilities

  • Strengths:

    • Precisely defined chemical structures.
    • Specific therapeutic or formulation details.
    • Embodying a novel chemical scaffold.
  • Vulnerabilities:

    • Inherent narrowness if claims rely heavily on specific substituents.
    • Potential overlap with prior art on similar derivatives.
    • Limited scope for broad use claims if narrowly drafted.

Key takeaways

  • The patent secures rights primarily over a specific chemical entity and its uses.
  • Its strength depends on how well it differentiates from prior art, especially in structural features.
  • A dense patent landscape indicates the need for ongoing freedom to operate assessments.
  • Broad claims could face validity challenges if prior art discloses similar compounds or methods.
  • Narrow claims risk limited commercial scope but may be easier to defend.

FAQ

Q1: Can the patent claims be challenged based on prior art?
Yes. If similar compounds or methods are disclosed before the patent’s priority date, the claims may be invalidated for lack of novelty or obviousness.

Q2: Is the scope of the patent likely to cover all therapeutic uses of the compound?
No. Use claims are typically limited to specific indications, unless broad use claims are explicitly filed.

Q3: How does formulation patenting impact the patent landscape?
Formulation patents can extend protection, especially if they improve stability, delivery, or bioavailability, but they are often narrower than compound claims.

Q4: What are the challenges in patenting chemical compounds?
Ensuring novelty with respect to prior art, defining sufficient structural scope, and balancing breadth with defensibility.

Q5: How does this patent interact with existing patents in the same class?
It may overlap with or challenge existing patents. Conducting a freedom-to-operate analysis is crucial before commercialization.


References

[1] United States Patent and Trademark Office. (2023). Patent No. 10,350,170.
[2] WIPO. (2022). Patent landscape report for pharmaceutical compounds.
[3] USPTO. (2022). Patent examination guidelines for chemical inventions.

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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 ⤷  Start Trial ⤷  Start Trial Y ⤷  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

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

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