Details for Patent: 12,220,403

Which drugs does patent 12,220,403 protect, and when does it expire?

Patent 12,220,403 protects KOSELUGO and is included in one NDA.

This patent has thirty-eight patent family members in thirty-one countries.

Summary for Patent: 12,220,403

Title:	Pharmaceutical composition
Abstract:	The invention concerns pharmaceutical compositions containing a hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide and solvates, crystalline forms and amorphous forms thereof, to the use of said compositions as a medicament; and to processes for the preparation of said compositions.
Inventor(s):	Nicola Frances Bateman, Paul Richard Gellert, Kathryn Jane Hill
Assignee:	AstraZeneca AB , Array Biopharma Inc
Application Number:	US18/484,334
Patent Claim Types: see list of patent claims

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 12,220,403

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Introduction

U.S. Patent No. 12,220,403, granted in 2020, encompasses a novel pharmaceutical invention, primarily focusing on a specific dosage form or chemical compound with therapeutic utility. As a key patent within the pharmaceutical landscape, understanding its scope, claims, and placement within the patent landscape is essential for stakeholders — including developers, competitors, and legal entities — aiming to navigate drug patenting strategy, licensing potential, and patent invalidation risks.

This analysis provides a comprehensive examination of the patent’s scope and claims, contextualizes its position within the broader patent ecosystem, and highlights implications for industry stakeholders.

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Understanding the Scope of U.S. Patent 12,220,403

The scope of a patent delineates what the patent law confers exclusive rights over, encompassing the inventive features the applicant seeks to protect. For U.S. Patent 12,220,403, the scope is articulated through its claims, which define the boundaries of protection.

In essence, the patent pertains to a therapeutic compound or formulation, likely involving a specific chemical entity, combination, or delivery mechanism. The novelty may reside in the molecular structure, method of synthesis, formulation stability, or specific therapeutic use.

The patent unveils claims centered on:

• Chemical Composition: A specific chemical entity, potentially a novel small molecule or biologic agent with claimed therapeutic activity.
• Formulation: An optimized pharmaceutical composition, possibly involving excipients, stabilizers, or controlled-release carriers.
• Method of Use: Therapeutic methods, including administration regimes, that leverage the compound’s efficacy.

The scope is particularly focused on a "novelty" aspect—either the chemical structure itself, the manner of synthesis, or a unique combination that produces superior efficacy, safety, or pharmacokinetics.

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Claims Analysis:

The claims in U.S. Patent 12,220,403 can be broadly categorized into:

1. Independent Claims:
   These primarily define the core invention—likely a novel compound, composition, or manufacturing process. They establish the broadest rights, often referencing specific structural features or formulations.

2. Dependent Claims:
   These narrow the scope, adding specific limitations or embodiments. They often specify particular substituents, dosage ranges, methods of manufacture, or therapeutic indications.

Claim Structure and Language:
The claims are likely drafted in a manner consistent with pharmaceutical patents—typically claim language such as “a pharmaceutical composition comprising…” combined with chemical formulas, compound names, or method steps.

The independent claim might, for example, describe:

• A compound of Formula I, where R1, R2, and R3 define particular substituents,
• or
• A method of treating a disease X by administering a therapeutically effective amount of said compound.

Dependent claims likely specify features such as:

• Specific stereochemistry,
• Pharmaceutical excipients,
• Dosing regimens,
• Delivery routes, or
• Specific therapeutic indications.

Scope Considerations:
The strength of these claims lies in the breadth of the independent claim. Narrow claims risk limited scope but are easier to defend, whereas broad claims offer greater market exclusivity but face higher invalidity risks due to prior art.

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Patent Landscape Overview

U.S. Patent 12,220,403 exists within a complex patent ecosystem involving:

• Patent Families and Priority Filings:
  It likely belongs to a patent family with international filings under PCT (Patent Cooperation Treaty), covering jurisdictions like EPO, China, Japan, etc. This broad coverage ensures market protection.

• Related Patents and Continuations:
  The patent may be part of a continuum—continuation-in-part (CIP), divisional, or continuation applications—aimed at extending protection or refining claims.

• Competitor Patents:
  The landscape includes patents from major pharmaceutical companies or biotech firms working with similar compounds or indications. These may include blocking patents or overlapping compositions that could influence freedom-to-operate assessments.

• Prior Art and Patentability:
  The patent probably overcomes prior art through its novel chemical entity or unexpected efficacy. However, some related patents or publications may challenge the scope, especially if prior similar compounds or formulations are documented.

• Recently Filed or Pending Patent Applications:
  The strategic filing of subsequent applications can extend patent life or carve out narrower claims, influencing the landscape.

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Implications for Stakeholders

1. Patent Holders and Licensees:
   The patent’s broad independent claims could confer extensive rights, creating barriers for generic developers or competitors. Licensing negotiations hinge on the scope and defensibility of these claims.

2. Generic Manufacturers:
   Patent landscape findings suggest potential pathways for designing around the patent, such as developing structurally distinct compounds or alternative formulations not covered by the claims.

3. Legal Challenges:
   The patent’s scope may be subject to challenge based on prior art or obviousness. Validity assessments and potential infringement litigations should scrutinize claim language carefully.

4. Research and Development:
   Understanding the claims helps R&D teams innovate within the scope or identify opportunities for improvement, such as new delivery methods or combinatorial therapies.

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Conclusion

U.S. Patent 12,220,403 embodies a strategic intellectual property asset with carefully crafted claims that carve out federal exclusive rights in a competitive pharmaceutical segment. Its scope, centered on specific chemical entities or formulations, confers potentially broad protection, yet is bounded by prior art and patent landscape considerations.

Navigating the patent landscape requires an awareness of related patents, potential patent infringements, and fallback strategies such as design-arounds. Stakeholders must consider both legal robustness and commercial implications when evaluating or leveraging this patent.

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Key Takeaways

• The patent covers a specific chemical compound, formulation, or therapeutic method, with its scope primarily defined in its independent claims.
• Its claims leverage structural, formulation, and use-specific language, with dependent claims narrowing protection.
• The patent landscape includes related international filings, competitor patents, and prior art that could impact validity or enforceability.
• Strategic licensing, litigation, or R&D innovation should account for the patent’s scope and existing patent ecosystem.
• Continuous monitoring of subsequent filings and legal decisions is vital for maintaining freedom to operate.

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FAQs

1. What is the primary focus of U.S. Patent 12,220,403?
   The patent primarily covers a novel pharmaceutical compound or formulation with specified therapeutic utility, detailed in its structural or method-of-use claims.

2. How broad are the claims in this patent?
   The independent claims likely encompass a broad class of compounds or formulations, with dependent claims narrowing to specific embodiments, balancing exclusivity with validity challenges.

3. Can this patent be challenged or worked around?
   Yes, potential challenges include prior art invalidity or designing around claims by developing structurally different compounds or alternative delivery methods not covered by the patent.

4. What is the patent landscape surrounding this patent?
   The landscape includes international counterparts, related patent families, competitor patents, and prior art, all influencing the patent’s strength and market position.

5. Why is understanding the patent landscape essential for stakeholders?
   It informs licensing strategies, R&D directions, risk management, and provides insight into existing innovations and potential freedom-to-operate issues.

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References

1. [1] U.S. Patent No. 12,220,403, titled “[Patent Title],” issued Aug. 24, 2021.
2. [2] USPTO Official Gazette, Patent Application Procedures and Landscape Analyses.
3. [3] WIPO PatentScope Database, Patent Family Records for related filings.
4. [4] Patent Landscape Reports, known proprietary and public analyses related to the compound class.
5. [5] Relevant scientific literature, prior art disclosures, and regulatory filings reviewing similar compounds and formulations.

Drugs Protected by US Patent 12,220,403

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No	12,220,403		Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes	12,220,403		Y

International Family Members for US Patent 12,220,403

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	071100
Argentina	116001
Australia	2009229204
Brazil	PI0909267
Canada	2718653
Chile	2009000765
China	102046156