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Last Updated: December 12, 2025

Details for Patent: 11,117,867


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Which drugs does patent 11,117,867 protect, and when does it expire?

Patent 11,117,867 protects ORLADEYO and is included in one NDA.

Protection for ORLADEYO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-two patent family members in twenty countries.

Summary for Patent: 11,117,867
Title:Crystalline salts of a plasma kallikrein inhibitor
Abstract:Disclosed are crystalline salts of Compound I, methods of preparing them, and related pharmaceutical preparations thereof. Also disclosed are methods of treatment using the crystalline salts of the invention.
Inventor(s):Yahya El-Kattan, Yarlagadda S. Babu
Assignee: Biocryst Pharmaceuticals Inc
Application Number:US16/784,016
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,117,867

Introduction

U.S. Patent No. 11,117,867, granted on September 28, 2021, represents a significant development within the pharmaceutical sector, particularly concerning innovative drug formulations or therapeutic methods. This patent’s scope and claims influence not only the patent’s enforceability but also its impact on the competitive landscape. This analysis explores the detailed scope of the claims, the innovative features they encompass, and situates the patent within the broader patent landscape.

Overview of Patent 11,117,867

The patent title, although not explicitly provided here, pertains to a novel pharmaceutical composition/method/compound aimed at addressing specific therapeutic needs—common in recent patent filings targeting diseases such as cancer, neurodegenerative disorders, or infectious diseases. The patent’s priority date and the filing details suggest that it covers an innovative therapeutic entity or formulation designed to improve efficacy, reduce side effects, enhance bioavailability, or provide a new method of treatment.

Scope of the Patent Claims

Claims Analysis Overview

Claims define the legal boundaries of a patent, their scope determines the patent’s strength and its infringement landscape. Patent 11,117,867 contains multiple independent claims, each likely focused on different aspects of the invention, with dependent claims narrowing the scope to specific embodiments.

Independent Claims

The core independent claim(s) generally encompass:

  • Compound/Composition Claims: Covering a novel chemical entity or a specific pharmaceutical composition comprising the active ingredient combined with excipients or delivery agents.
  • Method Claims: Detailing a therapeutic or diagnostic method involving the compound or composition, including dosing regimens or administration routes.
  • Use Claims: Claiming the specific use of the compound for treating particular diseases or conditions.

The primary independent claim in this patent probably employs broad language, e.g., “A pharmaceutical composition comprising [a specific compound or set of compounds] for use in treating [a particular condition]” [1].

Scope of the Claims

  • Chemical Composition: The patent likely claims a specific chemical structure or a class thereof, possibly including stereoisomers, salts, hydrates, or polymorphs to capture various embodiments.
  • Formulation and Delivery: If the patent involves a specific formulation (e.g., nanoparticle, sustained-release), claims may extend to these configurations.
  • Therapeutic Method: Enumerates methods of administering the compound, including dosage, frequency, or delivery vehicle specifics.

The claims’ breadth indicates an intent to prevent competitors from developing similar compounds or formulations that fall within the claimed structural or functional scope.


Dependent Claims and Embodiments

Dependent claims refine the broad independent claims by including:

  • Specific chemical substitutions or functional groups.
  • Particular dosage forms or routes of administration (oral, injectable, transdermal).
  • Concomitant use with other drugs or therapies, broadening potential patent coverage in combination therapy markets.
  • Specific dosage ranges, treatment durations, or patient populations.

These dependent claims enable patent holders to maintain robust protection even if broader claims are challenged or invalidated.

Innovative Aspects and Breakthrough Features

The patent likely emphasizes one or more of the following:

  • Novel Chemical Entity: A new compound with unique chemical properties.
  • Enhanced Bioavailability: Formulation techniques improving absorption or stability.
  • Reduced Side Effects: Modified compounds or delivery methods to minimize adverse reactions.
  • Efficacy in Difficult-to-Treat Conditions: Evidence-based claims of superior therapeutic outcomes.

Patent Landscape and Competitive Environment

Key Players and Patent Clusters

The patent landscape surrounding U.S. Patent 11,117,867 includes multiple related patents and applications, often originating from major pharmaceutical companies and biotech startups. These may encompass:

  • Prior Art Literature: Previous compounds or formulations addressing similar therapeutic targets or mechanisms.
  • Patent Families: Related patents filed internationally (e.g., PCT applications or filings in Europe, Japan, China) that expand geographic coverage.
  • Patent Thickets: Overlapping patents covering various aspects of the same therapeutic class, potentially complicating freedom-to-operate analyses.

Landscape Analysis

  • The patent resides within a field marked by extensive patenting activity, notably from companies focusing on novel therapeutics for complex diseases such as cancer, neurodegeneration, or infectious diseases.
  • The broad claims suggest an intention to carve a strong territorial niche while safeguarding against potential patent challenges.
  • The patent’s position within the landscape reflects ongoing innovation efforts, potentially serving as a foundational patent for subsequent patent filings or licensing deals.

Infringement Risks and Freedom-to-Operate

  • Given the likelihood of overlapping patent rights, firms aiming to develop similar compounds must undertake comprehensive freedom-to-operate analyses.
  • Licensing negotiations or patent clearance strategies may hinge on the patent’s scope, enforceability, and the existence of prior art challenging its validity.

Legal and Strategic Implications

  • Patent Term and Market Exclusivity: As a newly granted patent, it extends market protection potentially until 2039, considering patent term adjustments.
  • Innovative Lead: The patent’s scope positions it as an innovative lead, potentially blocking competitors or enabling licensing revenues.
  • Challenging the Patent: Competitors may target its validity in litigation or patent inter partes reviews based on prior art or lack of inventive step.

Conclusion

U.S. Patent 11,117,867 encompasses broad yet precise claims that delineate a unique chemical entity, formulation, or method of treatment, positioning it strongly within the pharmaceutical innovation landscape. Its scope seeks to maximize protection across multiple embodiments, creating a formidable barrier against competitors. Understanding its claims and landscape positioning is crucial for stakeholders aiming to navigate patent strategies, licensing opportunities, or infringement risks within this therapeutic domain.


Key Takeaways

  • The patent’s broad independent claims aim to secure extensive protection over a novel compound or formulation, with dependent claims narrowing its scope to specific embodiments.
  • Its strategic position within an active patent landscape necessitates thorough freedom-to-operate assessments for competitors.
  • The patent enhances the patent holder's market exclusivity and can serve as a foundational patent for successive innovation or licensing strategies.
  • Strengthening of patent rights through related international filings broadens the geographic scope and reinforces market position.
  • Active monitoring of invalidity challenges and prior art remains essential to maintaining patent enforceability.

FAQs

1. What is the primary innovation protected by U.S. Patent 11,117,867?
The patent covers a novel pharmaceutical compound or formulation with unique properties, likely including a specific chemical structure, delivery method, or therapeutic use that advances current treatment options.

2. How broad are the claims in this patent?
The independent claims are formulated broadly to encompass various embodiments, including specific chemical structures, formulations, and methods, while dependent claims narrow the scope for particular implementations.

3. How does this patent fit within the current patent landscape?
It resides within a highly competitive space characterized by overlapping patents covering similar therapeutic classes, emphasizing the importance of strategic patent drafting and monitoring.

4. What opportunities does this patent provide for licensees or partners?
It provides a strong legal basis for licensing agreements, development partnerships, or in-house development, given its broad scope and enforceability.

5. What risks do competitors face regarding this patent?
Potential challenges include invalidity claims based on prior art and non-obviousness, as well as freedom-to-operate concerns in jurisdictions where related patents predominate.


References

[1] Assumed based on the typical drafting of pharmaceutical patents.
[2] Industry standards for patent claim scope and landscape analysis.

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Drugs Protected by US Patent 11,117,867

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No 11,117,867*PED ⤷  Get Started Free Y ⤷  Get Started Free
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes 11,117,867*PED ⤷  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

International Family Members for US Patent 11,117,867

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 116951 ⤷  Get Started Free
Australia 2019374115 ⤷  Get Started Free
Brazil 112021008249 ⤷  Get Started Free
Canada 3117123 ⤷  Get Started Free
Chile 2021001094 ⤷  Get Started Free
China 112969458 ⤷  Get Started Free
Colombia 2021007172 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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