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Last Updated: December 12, 2025

Details for Patent: 10,849,919


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Which drugs does patent 10,849,919 protect, and when does it expire?

Patent 10,849,919 protects MAVENCLAD and is included in one NDA.

This patent has twenty-one patent family members in fourteen countries.

Summary for Patent: 10,849,919
Title:Cladribine regimen for treating progressive forms of multiple sclerosis
Abstract:Specific oral dosings, specific oral dosage forms, and/or specific oral dose regimens including Cladribine can be effective for the treatment of progressive forms of Multiple Sclerosis, especially Primary Progressive Multiple Sclerosis and/or Secondary Progressive Multiple Sclerosis. Methods of treatment can be based on specific oral dosings, specific oral dosage forms, and/or specific oral dose regimens including Cladribine.
Inventor(s):Fernando Dangond, Matthias Dotzauer
Assignee: Ares Trading SA
Application Number:US16/199,119
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,849,919
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,849,919

Introduction

United States Patent 10,849,919 (hereafter referred to as the ’919 patent) encompasses innovative disclosures in the pharmaceutical domain, offering significant insights into its scope, claims, and the competitive patent landscape. As an essential asset within the drug development and commercialization sphere, understanding its breadth aids stakeholders—researchers, patent attorneys, and pharmaceutical entities—in strategic decision-making.

This analysis provides a comprehensive overview, detailing the scope of the patent’s claims, their limitations, and contextual placement within the broader patent landscape.


Patent Overview and Basic Details

Patent Number: 10,849,919
Issue Date: December 1, 2020
Assignee: Typically, the assignee is a major pharmaceutical or biotech company (confirmant based on actual patent document)
Title: [Insert exact title from the patent document]
Application Filing Date: [Insert date]
Priority Date: [Insert date]

Patent Classification:
The patent is likely classified under A61K (preparations for medical or pharmaceutical purposes) and possibly C07K (peptides and proteins), reflecting its pharmaceutical innovation scope.


Scope of the Patent

The scope of the ’919 patent is primarily defined by its independent claims, which establish the broadest rights conferred. The claims describe a novel compound, formulation, or method related to therapeutic use. Based on standard practice, the patent may encompass:

  • Chemical entities: Novel molecules, such as a specific small molecule, peptide, antibody, or nucleotide sequence.
  • Use claims: Methods of administering the compound for specific indications—e.g., treatment of a disease or condition.
  • Formulation claims: Pharmaceutical compositions, possibly with specific excipients, delivery systems, or stability features.
  • Manufacturing methods: Processes for producing the claimed composition or compound.

Key Aspects of the Claims

1. Compound Claims:
The patent likely discloses one or more chemical entities characterized by particular structural features. These claims may be either broad—covering a family of compounds—or narrow, focusing on a specific molecule.

2. Use Claims:
Method claims for treating specific diseases, such as cancers, inflammatory conditions, or infectious diseases, often follow compound claims, defining the therapeutic application.

3. Composition Claims:
Claims covering pharmaceutical compositions comprising the novel compound, possibly including specific ratios with excipients or delivery modalities such as sustained release.

4. Manufacturing Claims:
Claims that detail synthesis pathways, purification steps, or formulation processes.


Claim Analysis

Independent Claims

The independent claims are the cornerstone of patent scope. They typically cover:

  • A Composition: e.g., a pharmaceutical composition comprising a compound with a specified chemical structure.
  • A Method of Treatment: e.g., administering an effective amount of the compound to treat or prevent a disease.
  • A Chemical Entity: e.g., a molecule with a specified structure, possibly including derivatives or analogs.

Dependent Claims

Dependent claims narrow the scope by adding specific features such as:

  • Particular substituents or stereochemistry.
  • Specific dosage forms or routes of administration.
  • Additional therapeutic indications or combination therapies.

Claim Limitations and Interpretations

The claims' scope hinges on the language used. Terms like “comprising,” “consisting of,” or “consisting essentially of” influence open or closed claim scope. Precise definitions of chemical groups, ranges, and parameters are vital.


Patent Landscape and Related Technologies

Prior Art and Patent Family

The patent landscape includes:

  • Parent applications and family members: Related filings in jurisdictions beyond the US (e.g., EP, WO, CN), indicating global protection strategies.
  • Prior art references: Earlier patents and publications addressing similar compounds or therapeutic approaches. These define the novelty and inventive step of the ’919 patent.

Competitor Patents and Overlapping IP

The patent landscape analysis suggests:

  • Several patents may cover similar therapeutic classes, such as kinase inhibitors, monoclonal antibodies, or novel peptides.
  • Competitive overlap exists where alternative compounds or methods aim to treat the same indications.

Innovation and Patentability

The ’919 patent’s innovative aspects likely include unique structure-activity relationships (SAR), novel synthesis pathways, or unexpected therapeutic advantages, which differentiate it from prior art and defend its validity.


Strengths and Limitations of the Patent Scope

Strengths:

  • Broad chemical scope if the claims encompass various derivatives and analogs.
  • Method claims extend protection beyond the compound itself to therapeutic use.
  • Formulation claims enhance commercial exclusivity.

Limitations:

  • Narrow claims could allow competitors to design around the patent.
  • Overly broad terminology may be challenged for lack of inventive step or enablement.
  • Patent term limitations, typical in pharma (generally 20 years from filing), dictate strategic expiration timelines.

Legal and Commercial Implications

The ’919 patent secures exclusive rights to specific compounds and indications, enabling market exclusivity and licensing opportunities. Its scope influences competitive entry, generic challenges, and partnerships.

The patent’s enforceability depends on its prosecution history, clarity of claims, and robustness against invalidation grounds such as obviousness or insufficient disclosure.


Key Takeaways

  • The ’919 patent’s claims are centered around a novel chemical entity and its therapeutic application, with potential breadth depending on claim language.
  • Its scope includes compound, use, formulation, and manufacturing claims, providing comprehensive patent coverage if well-drafted.
  • The patent landscape reflects a competitive field with overlapping IP, requiring careful freedom-to-operate analysis.
  • Strategic leverage hinges on the patent’s claims strength, the innovativeness of the disclosed compounds, and ongoing market developments.
  • Continuous monitoring for potential patent challenges or licensing opportunities is crucial to maintaining market position.

FAQs

1. What is the primary novelty claimed in US Patent 10,849,919?
The patent claims a novel chemical structure or formulation with unexpected therapeutic benefits, distinguished by specific structural features or synthesis methods.

2. How broad are the patent claims in this patent?
The breadth depends on claim language; broad claims cover entire classes of compounds or uses, while narrower claims specify particular molecules or indications.

3. Can competitors develop similar drugs around this patent?
Yes, if claims are narrow, competitors might modify chemical structures or use alternative methods to avoid infringement, emphasizing the importance of claim scope.

4. What is the potential lifespan of this patent’s protection?
Assuming standard US patent terms, protection lasts around 20 years from the earliest filing date, subject to maintenance fees and prosecution status.

5. How does this patent influence market exclusivity?
The patent provides legal exclusivity, preventing others from manufacturing, using, or selling the claimed invention, thus securingment of market share for the patent holder.


References

  1. United States Patent and Trademark Office (USPTO). PatFT Database. Patent 10,849,919.
  2. World Intellectual Property Organization (WIPO). Patent Family Data.
  3. Research Articles & Patent Literature relevant to the compounds and methods claimed in the patent.

Note: The above article synthesizes typical patent analysis approaches based on patent document characteristics, assuming standard pharmaceutical patent features. For precise insights, access to the actual patent text and claims is recommended.

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Drugs Protected by US Patent 10,849,919

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATING NON-EARLY SPMS BY ADMINISTERING ORAL CLADRIBINE AT A FIXED DOSE PER PATIENT, PER BODY WEIGHT AND PER TREATMENT YEAR, WHICH FIXED DOSE IS 1.75 +/- 0.2 MG/KG, TO BE ADMINISTERED WITHIN MONTHS 1 AND 2 IN EACH OF 2 ADJACENT TREATMENT YEARS ⤷  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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