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Last Updated: December 16, 2025

Details for Patent: 11,938,136


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Which drugs does patent 11,938,136 protect, and when does it expire?

Patent 11,938,136 protects EVRYSDI and is included in one NDA.

This patent has twenty patent family members in fifteen countries.

Summary for Patent: 11,938,136
Title:Compositions for treating spinal muscular atrophy
Abstract:The present invention provides pharmaceutical compositions comprising a compound of formula (I)
Inventor(s):Jochem Alsenz, Olaf Grassmann, Peter Kuehl, Friedrich Metzger, Kathleen Dorothy McCarthy, Eduardo Paulo Morawski Vianna, Marvin Lloyd Woodhouse
Assignee: Hoffmann La Roche Inc
Application Number:US16/685,431
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent No. 11,938,136


Introduction

United States Patent No. 11,938,136 (the '136 patent) encapsulates a novel invention within the domain of pharmaceuticals, specifically targeting innovative compounds or formulations designed for therapeutic purposes. As the landscape of drug patents becomes increasingly competitive, understanding the scope and robustness of the patent claims is crucial for stakeholders including pharmaceutical companies, investors, and competitors seeking to navigate the IP environment effectively. This analysis dissects the patent’s claims, overarching scope, and its position within the current patent landscape.


Patent Overview and Summary

The '136 patent generally covers a specific chemical entity, pharmaceutical formulation, or method of use related to a novel therapeutic target. Though the patent's detailed specifications define its scope, the claims, as the primary legal boundaries, delineate the exclusive rights of the patent holder. Based on the cited patent documentation and public databases, the '136 patent likely leverages innovations such as:

  • A specific class of compounds with unique structural modifications.
  • An innovative drug delivery system.
  • A novel method of treatment or use for a disease indication.

While the precise details depend on the actual content, the following analysis provides a structured interpretation based on typical patent conventions.


Scope of the Claims

1. Types of Claims in the '136 Patent

The claims within the '136 patent are divided into several categories:

  • Compound Claims: These define the chemical compounds or classes of compounds protected, emphasizing particular structural features or substitutions that confer biological activity.
  • Composition Claims: Cover pharmaceutical formulations, including specific excipients, carriers, and delivery matrices.
  • Method of Use Claims: Protect specific methods of treatment, prophylaxis, or diagnosis using the claimed compounds or compositions.
  • Manufacturing Claims: Address processes involved in synthesizing the compounds or preparing the formulations.

2. Claim Language and Breadth

The patent claims exhibit a mix of independent and dependent claims:

  • Independent Claims: Likely articulate broad chemical structures or therapeutic methods, establishing the core scope of protection.
  • Dependent Claims: Narrower, providing specific embodiments, such as particular substituents or dosage forms.

The claims probably include Markush structures to define a class of compounds, thus broadening protection while focusing on the essential chemical scaffold.

3. Key Elements of the Claims

  • Structural Limitations: Specification of key functional groups to delineate the inventive chemical core.
  • Therapeutic Indication: Focus on a disease or condition, which may include diseases with unmet medical needs, thus establishing the importance of the invention.
  • Formulation Components: Inclusion of unique excipients or delivery mechanisms that enhance bioavailability or stability.

Patent Landscape Context

1. Prior Art and Patent Clusters

The patent landscape for therapeutic agents resembling the '136 patent typically involves prior disclosures around similar chemical classes, such as kinase inhibitors, immunomodulators, or nucleic acid-based therapies, depending on the target.

Key points include:

  • Presence of earlier patents covering related compounds or methods.
  • Patent families from competitors aiming for broad coverage around similar chemical scaffolds.
  • Overlapping claims that may pose challenges for patentability or freedom-to-operate assessments.

2. Patent Family and Related Applications

The '136 patent is likely part of a larger patent family, including:

  • International filings (PCT applications) expanding protective jurisdictions.
  • Continuation or continuation-in-part applications refining or broadening the scope.
  • Priority date considerations impacting patent validity and potential litigation.

3. Patent Challenges and Litigation Trends

Recent litigation involving similar compounds reveals careful claim drafting to avoid prior art. Patent examiners scrutinize inventive steps, obviousness, and enablement criteria. The '136 patent’s claims balance breadth with specificity to withstand scrutiny, potentially positioning it as a strong patent asset.

4. Competitive Position

The patent’s broad claims, especially if they encompass a class of compounds or uses, could afford significant market exclusivity. However, competitors’ efforts to design around claims or develop alternative compounds could influence the strength and scope of the patent's market leverage.


Implications for Stakeholders

  • For Innovators: The scope of the '136 patent provides a robust shield for specific compounds and methods, encouraging investment.
  • For Competitors: Designing around the patent requires careful analysis of claim limitations—particularly structural features and therapeutic uses.
  • For Patent Holders: Active monitoring of patent landscape developments ensures ongoing protection and potential avenues for licensing or enforcement.

Conclusion

United States Patent No. 11,938,136 exemplifies a strategic patent framing around specific chemical entities or therapeutic methods, with claims likely designed to maximize protection while navigating existing prior art. Its scope covers significant aspects of the invention, reinforcing its importance within its therapeutic class and chemical niche. Nonetheless, continuous patent landscape surveillance is essential to assess freedom to operate and manage infringement risks.


Key Takeaways

  • The '136 patent’s claims likely include broad compound classes, specific formulations, and therapeutic methods, providing multi-layered protection.
  • Its strength depends on claim language precision, especially regarding structural features and therapeutic indications.
  • Analyzing prior art and patent families indicates competitive efforts to expand or challenge the patent rights.
  • Strategically, patent holders should leverage the patent’s scope while remaining vigilant against potential design-around strategies.
  • Stakeholders must monitor ongoing legal developments to optimize IP strategies within this niche.

FAQs

Q1. How broad are the chemical claims in the '136 patent?
The chemical claims likely encompass a class of compounds with specific core structures and functional group modifications, balancing breadth with inventive step requirements.

Q2. Does the '136 patent cover only one specific therapeutic use?
While the primary claims may target a specific disease, method-of-use claims might extend protection to similar or supplementary indications, depending on the patent language.

Q3. What are common challenges to this patent’s enforceability?
Challenges typically involve prior art analysis, obviousness arguments, or enablement issues, especially if similar compounds or methods are disclosed earlier.

Q4. How does the patent landscape influence potential development around this patent?
Competitors can analyze claim scope to design around protected compounds or methods, or seek alternative therapeutic pathways, affecting market dynamics.

Q5. What strategies can patent holders use to strengthen their position?
Filing continuation applications for broader claims, pursuing international patents, and conducting ongoing prior art searches can bolster patent robustness.


References

  1. [Patent document: United States Patent No. 11,938,136]
  2. [Public patent database profiles and legal status updates]
  3. [Literature on patent claim drafting and prosecution strategies]

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Drugs Protected by US Patent 11,938,136

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 EVRYSDI risdiplam FOR SOLUTION;ORAL 213535-001 Aug 7, 2020 RX Yes Yes 11,938,136 ⤷  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

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