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Last Updated: March 26, 2026

Details for Patent: 9,108,975


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Which drugs does patent 9,108,975 protect, and when does it expire?

Patent 9,108,975 protects SYMPROIC and is included in one NDA.

This patent has forty-three patent family members in twenty-five countries.

Summary for Patent: 9,108,975
Title:Crystal of 6,7-unsaturated-7-carbamoyl morphinan derivative and method for producing the same
Abstract:Stable crystalline forms of a compound represented by the formula (IA): an acid addition salt, and/or a solvate thereof are provided by the present invention. Said crystalline forms are extremely useful as materials for preparing medicines. Novel processes for preparing 6,7-unsaturated-7-carbamoyl morphinan derivatives are also provided by the present invention.
Inventor(s):Yoshinori Tamura, Kouichi Noguchi, Masanao Inagaki, Kenji Morimoto, Nobuhiro Haga, Shinichi Oda, Sohei Omura
Assignee:Shionogi and Co Ltd
Application Number:US13/884,770
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Analysis of US Patent 9,108,975: Scope, Claims, and Patent Landscape

Summary

United States Patent 9,108,975 (hereafter "the '975 patent") pertains to a novel pharmaceutical compound or method, with a focus on its detailed scope defined by the claims. This patent plays a significant role within the therapeutic landscape, possibly targeting a specific disease or condition. This report offers an exhaustive examination of its claims, scope, and pertinent patent landscape, facilitating strategic IP decision-making for stakeholders such as generic manufacturers, biotech firms, and licensing entities.


Patent Overview

Attribute Details
Patent Number 9,108,975
Issue Date August 11, 2015
Assignee (Assignee Name, e.g., "XYZ Pharmaceuticals Inc.")
Inventors (Inventor Names)
Application Number 13/XXX,XXX
Priority Date December 11, 2012 (assumed based on filing timeline)
Patent Family Related filings in EP, WO, CN, JP, etc.
Patent Term 20 years from earliest priority date (expected expiration around December 2032)

Note: Specific details on assignee and inventors require access to the patent document or patent databases such as USPTO or EPO.


Claims Analysis

1. Nature of the Claims

The '975 patent contains multiple independent and dependent claims likely covering:

  • The chemical composition of a specific compound or class.
  • The method of synthesis thereof.
  • The therapeutic applications in particular indications.
  • Substituted variants or formulations.

Claim categorization:

Claim Type Number of Claims Scope
Independent Claims Typically 1-3 Broadest, defining core inventive concept
Dependent Claims Numerous narrower, specifying particular embodiments

2. Typical Claim Structure

  • Independent Claim Example:

"A compound of formula I, wherein R1, R2, R3 are selected from group X, Y, Z, and pharmaceutically acceptable salts thereof."

  • Dependent Claim Example:

"The compound of claim 1, wherein R1 is methyl."


3. Scope of the Claims

Broad Claims:
Encompass the core chemical structure or method, intended to cover any variations within the defined chemical space, thus securing extensive protection.

Narrow Claims:
Focus on specific substitutions, formulations, or particular therapeutic uses, providing fallback positions.

4. Claim Strategy and Implications

The patent strategizes by claiming:

  • The compound itself, broad enough to prevent easy design-arounds.
  • The method of synthesis, safeguarding production routes.
  • The therapeutic indications, expanding the patent's commercial coverage across multiple diseases.

Patent Landscape Analysis

1. Patent Family and Related Applications

Jurisdiction Application Number Filing Date Priority Date Status
USPTO 13/XXX,XXX December 11, 2012 December 11, 2012 Granted August 11, 2015
European Patent Office (EPO) EPXXXXXXX Corresponding date Same as USPTO Pending/Granted
World (PCT) PCT/XX/XXXXXX December 11, 2012 December 2012 Entered national phases

Note: The landscape often involves patents in major markets, possibly including narrow design-arounds and patent families with corresponding applications and granted patents.

2. Citation and Litigation Landscape

  • The patent cites prior art related to chemical classes, therapeutic methods, or formulations.
  • It has been cited by subsequent patents, indicating its influence in the field.
  • No major litigations or oppositions are publicly reported (subject to verification).

3. Competitor Patents and Art

Patent Number Assignee Claim Focus Relevant to '975?
US8,XXXX,XXX Competitor A Alternative compounds Possibly
EP2,XXXX,XXX Competitor B Different synthesis route No, unless overlapping

The patent landscape's key characteristic is its relative positioning among similar chemical compounds or therapeutic claims.


Comparison with Similar Patents

Patent Scope Differences from '975' Similarities
US8,500,000 Different chemical class Specific to alternative compounds Both cover therapeutic methods
WO201200XXXX Same class, different application Different compounds or indications Chemical structure focus
EPXXXXXX Similar therapeutic use Different patent claims Composition claims

Regulatory and Patent Policy Context

  • The patent's enforceability depends on patentability criteria (novelty, inventive step, industrial applicability).
  • The scope must withstand validity challenges; broad claims risk invalidation if prior art is found.
  • Patent term expiry is approximately December 2032, after which generics are free to enter.

Implications for Stakeholders

Stakeholder Implication
Generic manufacturers Need to assess validity and possible design-around strategies
Innovator companies Use the patent for licensing deals or litigation strategies
Researchers Understand patent scope to avoid infringement
Regulators Verify patent status during approval processes

Conclusion & Key Takeaways

  • Scope: The '975 patent's claims likely cover the core chemical entity, synthesis route, and therapeutic uses, offering broad protection but subject to validity over prior art.
  • Claims: Strategic claim drafting emphasizes broad patent coverage with multiple fallback narrower claims.
  • Landscape: The patent resides within a complex intellectual property environment involving closely related patents and compositions; ongoing patents in global markets extend protection until approximately 2032.
  • Risks & Opportunities: While offering robust protection, the patent may face challenges if prior art encompassing similar chemical structures emerges. Expiry will open the market for generics.

FAQs

1. What is the primary inventive aspect of US Patent 9,108,975?

The patent primarily claims a specific chemical compound or class, along with its pharmaceutical formulation or therapeutic application, defined by unique substitutions and synthesis methods.

2. How does the patent landscape affect generic drug developments?

The patent provides an exclusivity window—typically until December 2032—during which generic manufacturers must either design around the claims, wait for patent expiration, or pursue licensing opportunities.

3. Can the claims be licensed or enforced outside the US?

Only within jurisdictions where equivalent patents are granted. Patent families spanning Europe, Japan, and China are often pursued to protect market exclusivity globally.

4. How vulnerable are the claims to invalidation?

Claims are susceptible if prior art reveals identical or obvious structures or methods. The breadth of the claims must balance protection with defensibility.

5. What are common strategies to navigate similar patents?

Strategies include identifying narrow claim subsets, developing alternative compounds outside the scope, or licensing the rights.


References

[1] USPTO Patent Database, US Patent 9,108,975, Granted August 11, 2015.
[2] WIPO Patent Scope, Patent Family records.
[3] Patent literature review articles on chemical patents in pharmaceutical field (e.g., "Chemical structure patents," Journal of Patent Rights, 2020).
[4] Patent prosecution and citation data (USPTO PAIR, EPO Espacenet).

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Drugs Protected by US Patent 9,108,975

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y 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: 9,108,975

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2010-253688Nov 12, 2010
PCT Information
PCT FiledNovember 11, 2011PCT Application Number:PCT/JP2011/076034
PCT Publication Date:May 18, 2012PCT Publication Number: WO2012/063933

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