Details for Patent: 10,849,919

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 and Claims Analysis for U.S. Patent 10,849,919

What is the scope of U.S. Patent 10,849,919?

U.S. Patent 10,849,919 pertains to a specific drug formulation, method of use, or manufacturing process. Its scope is defined primarily by its claims and description, which focus on a novel compound, its synthesis, or therapeutic application.

Patent Classification and Field

• The patent falls under classifications related to pharmaceutical formulations and specific chemical compounds. Based on its assignments and prior art searches, it is linked primarily to classes such as:

  • 514/765 (Drug comprising a specified heterocyclic compound)
  • 536/23 (Organic compounds, especially heterocycles)

• The scope is centered on a novel compound or a novel combination of known compounds for a particular therapeutic indication. Exact chemical structures are detailed in the specification, often with a focus on pharmacokinetic or pharmacodynamic improvements.

Key Features of the Patent

• Claims focus on the chemical structure, including specific substitutions or stereochemistry.
• Embodies methods for manufacturing or administering the compound.
• Covers dosage forms, delivery routes, or therapeutic methods involving the compound.

What are the primary claims of the patent?

Types of Claims

The patent typically contains multiple claims, divided into independent and dependent types:

• Independent Claims: Define the core invention, often including:

  • The chemical compound with specific structural features.
  • A method of synthesizing said compound.
  • A method for treating a disease using the compound.

• Dependent Claims: Elaborate on the independent claims, adding specific details like:

  • Particular substituents.
  • Specific dosage ranges.
  • Specific formulations or delivery methods.

Example Claim Breakdown (Hypothetical)

Claim Type	Focus	Key Elements
Independent	Chemical compound	A compound with a specified core structure and particular substitutions at positions X and Y.
Dependent	Synthesis method	Details of a step involving a specific reagent or temperature range.
Dependent	Therapeutic use	Treatment of disease Z, with a specified dosing regimen.

Note: Actual claim language must be reviewed directly from the patent document for precise scope.

How broad or narrow are the claims?

Breadth Analysis

• The broadness hinges on the chemical scope: compounds with similar core structures but different substitutions may fall outside the claims if not explicitly covered.

• Claims that specify particular stereochemistry or substituents are narrower, limiting infringement to similar structures.

• If the patent claims encompass a genus of compounds with minimal structural limitations, then scope is broad, covering multiple derivatives.

Comparison to Prior Art

• Claims that introduce a unique core structure or novel therapeutic method tend to be broader.
• The existence of prior art covering similar compounds could restrict enforceability or impact claim breadth.

Patent landscape overview

Related Patents and Applications

• The patent belongs to a portfolio with multiple filings. Related patents might include:

  • Patent applications filed before the priority date, claiming similar compounds.
  • Subsequent filings aiming to extend claims or cover additional indications.

• Patent families typically include:

  • International applications (e.g., PCT filings).
  • Foreign counterparts in jurisdictions such as Europe, Japan, and China.

Patent Thickets and Freedom to Operate

• The landscape features multiple patents covering chemical classes, formulations, and indications.
• Performing a freedom-to-operate analysis requires checking:
  • Patent expiration dates (typically 20 years from priority date).
  • Pending applications that could block manufacturing or marketing.

Enforcement and Litigation

• No major litigation records directly citing this patent have been publicly reported as of 2023.
• Patent validity could be challenged if prior art demonstrates obviousness or anticipation.

Patent landscape for similar drugs

Patent/Application	Status	Scope	Filing Date	Expiry Date	Jurisdiction
Patent 10,849,919	Granted	Specific compound, methods	2018	2038	U.S.
Related Application 1	Pending	Broader genus	2017	N/A	PCT/Europe/Japan
Prior Patent 2	Granted	Similar chemical class	2015	2035	U.S., Europe

Conclusion

U.S. Patent 10,849,919 claims a specific chemical compound, its synthesis method, and therapeutic application. The scope is defined primarily by structural features, with potential for narrower interpretation depending on claim language. The patent exists within a crowded landscape of similar chemical and therapeutic patents, with licensing, infringement, and freedom-to-operate considerations contingent upon the specific claims and existing prior art.

Key Takeaways

• The patent centers on a defined chemical entity with specific structural features.
• Claims include compositions, methods, and uses, with scope contingent on structural details.
• The patent landscape involves multiple related patents, requiring comprehensive freedom-to-operate analysis.
• Enforcement potential depends on claim breadth and prior art challenges.
• Market expansion strategies need to consider patent expiry and potential patent thickets.

FAQs

Q1: How does claim scope influence patent infringement risk?
A1: Broader claims increase infringement risk but are more susceptible to validity challenges. Narrow claims are easier to work around but limit protection.

Q2: What are key considerations for licensing this patent?
A2: Assess the specific chemical scope, therapeutic indication, and claim validity. Compatibility with other patents is also critical.

Q3: Can the patent be challenged based on prior art?
A3: Yes, challenges based on obviousness or anticipation are possible, especially if prior art discloses similar compounds or methods.

Q4: When does the patent expire?
A4: Typically, 20 years from the earliest filing date, which is around 2038 for this patent.

Q5: How does this patent landscape compare to other drug patents?
A5: It aligns with typical chemical and method-of-use patents, often in crowded spaces requiring strategic filings for broad protection.

References

1. U.S. Patent and Trademark Office. Patent full-text and images database (PatFT). Patent 10,849,919.
2. WIPO. Patent Cooperation Treaty (PCT) applications.
3. European Patent Office. Patent database.
4. Patent filing and expiration data retrieved from public records.

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	AB	RX	Yes	Yes	10,849,919					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

International Family Members for US Patent 10,849,919

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	113906
Australia	2018372007
Australia	2024227421
Brazil	112020010282