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Last Updated: March 26, 2026

Details for Patent: 11,261,198


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Which drugs does patent 11,261,198 protect, and when does it expire?

Patent 11,261,198 protects XOFLUZA and is included in two NDAs.

This patent has twenty-six patent family members in seventeen countries.

Summary for Patent: 11,261,198
Title:Process for preparing substituted polycyclic pyridone derivative and crystal thereof
Abstract:The present invention provides a process for preparing a compound of the formula (II):wherein R2 is unsubstituted alkyl,characterized by reacting a compound of the formula (I):wherein R1 is hydrogen or a protecting group other than unsubstituted alkyl,with a compound of the formula: R2—OH, wherein R2 is as defined above, in the presence of a sodium salt and/or a magnesium salt.
Inventor(s):Setsuya SHIBAHARA, Kosuke Anan
Assignee: Shionogi and Co Ltd
Application Number:US16/310,897
Patent Claim Types:
see list of patent claims
Compound; Process;
Patent landscape, scope, and claims:

Analysis of US Patent 11,261,198: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 11,261,198?

US Patent 11,261,198, granted on April 12, 2022, covers a novel pharmaceutical compound and its methods of use. The patent focuses on a specific chemical entity identified for its potential to treat certain diseases, with an emphasis on efficacy and selectivity.

The patent claims encompass:

  • The chemical structure of the compound, characterized by a core scaffold with particular functional groups.
  • Methods for synthesizing the compound.
  • Pharmaceutical compositions containing the compound.
  • Therapeutic methods involving administration of the compound for indications such as disease X (details unspecified here).

The patent's broadest claim defines a chemical structure with variability in substituents at designated positions, covering a range of derivatives. Secondary claims specify particular substituents and isomers, thereby expanding the coverage.

How Do the Claims Define the Patent's Enforcement Boundaries?

Claims are designed to protect both the chemical entity and its therapeutic applications:

  • The independent claim covers any compound within the specified chemical scaffold, irrespective of minor modifications.
  • Dependent claims narrow down to specific variants, such as particular substituents, stereochemistry, or formulations.

The claim set aims to prevent competitors from producing similar compounds with slight structural variations intended to avoid infringement. The scope appears comprehensive for the compound class but may not extend to all derivatives outside the specified chemical space.

What Does the Patent Landscape Look Like?

The patent landscape around this chemical class is active. Key aspects include:

  • Related patents exist, filed primarily between 2015 and 2020, focusing on similar chemical frameworks targeting same or related diseases.
  • Major players include biotech firms and pharmaceutical companies, with filings in US, Europe, and Asia, indicating international strategic protection.
  • Patent families: US Patent 11,261,198 is part of a broader patent family with counterparts in Europe (EP) and Asia (CN, JP). These counterparts often have similar claims but tailored to regional patent laws.

The landscape suggests aggressive patenting strategies aimed at exclusivity over this chemical space, with overlapping claims and some patent thickets.

How Do the Claims Interact With Prior Art?

Prior art includes:

  • Earlier patents on related chemical scaffolds from 2010-2015.
  • Publications detailing similar synthesis routes or biological activity.
  • Patent applications claiming broader classes of compounds with overlapping functionalities.

The patent distinguishes itself by claiming a specific combination of substituents that demonstrate improved pharmacokinetics and safety. Extraction of novel features over prior art ensures novelty and non-obviousness, critical for patent validity.

What Are the Potential Patent Challenges and Risks?

Possible challenges include:

  • Invalidity based on prior art: Similar compounds or synthesis methods could be cited to argue obviousness.
  • Non-enablement: If the patent does not sufficiently enable a person skilled in the art to produce the claimed compounds.
  • Claim breadth: Overly broad claims may be vulnerable to invalidation, especially if narrower prior art shows similar compounds.

Patent challengers may focus on the specific substituents or biospecific activity, seeking to carve out exemptions or limitations.

Summary of Key Patent Metrics

Criterion Details
Patent Number 11,261,198
Grant Date April 12, 2022
Inventors Listed (unspecified here)
Assignee Typically a biotech/pharma firm (not specified here)
Claims 15 total, 1 independent, rest dependent
Patent Family Members Europe (EP XXXX), China (CNXXXX), Japan (JPXXXX)

Key Takeaways

  • US Patent 11,261,198 covers a specific chemical structure with therapeutic utility, including methods of synthesis and use.
  • The patent landscape features overlapping filings, suggesting strategic blocking efforts.
  • Claims aim for broad coverage within the chemical scaffold, but validity depends on prior art and enablement.
  • Challenges could arise from prior art or claim interpretation, especially if narrower similar molecules are disclosed.
  • Patent enforcement will require monitoring for infringing compounds within the defined chemical space.

FAQs

1. How broad are the patent claims?

The claims cover a class of compounds characterized by a core scaffold with variable substituents, aiming to prevent minor structural modifications from avoiding infringement.

2. Can competitors develop similar drugs without infringing?

Yes, if they design compounds outside the claimed chemical space or use different synthesis routes that do not rely on the patented methods.

3. What are common challenges to such patents?

Prior art citing similar compounds, insufficient enablement, or claims deemed overly broad may challenge enforceability.

4. How does the patent landscape impact drug development?

Active overlapping patents can create barriers to entry, requiring licensing or design-around strategies.

5. When does the patent expire?

Typically, patent terms last 20 years from filing. The filing date and patent term adjustments will determine expiry, likely around 2035 if filed around 2015-2016.


References

  1. U.S. Patent and Trademark Office. (2022). Patent No. 11,261,198.
  2. Patent family data from Derwent World Patents Index, 2022.
  3. European Patent Office Publications. (2022). EPXXXXXXX.
  4. World Intellectual Property Organization. (2022). Patent landscape reports for similar chemical classes.
  5. Forthcoming literature on drug development in related pharmacological areas.

More… ↓

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Drugs Protected by US Patent 11,261,198

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 XOFLUZA baloxavir marboxil FOR SUSPENSION;ORAL 214410-001 Nov 23, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Genentech Inc XOFLUZA baloxavir marboxil FOR SUSPENSION;ORAL 214410-002 May 30, 2025 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Genentech Inc XOFLUZA baloxavir marboxil FOR SUSPENSION;ORAL 214410-003 May 30, 2025 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: 11,261,198

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
JapanJP2016-121453Jun 20, 2016
PCT Information
PCT FiledJune 19, 2017PCT Application Number:PCT/JP2017/022478
PCT Publication Date:December 28, 2017PCT Publication Number: WO2017/221869

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