Details for Patent: 11,524,951

Which drugs does patent 11,524,951 protect, and when does it expire?

Patent 11,524,951 protects TAGRISSO and is included in one NDA.

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

Summary for Patent: 11,524,951

Title:	2-(2,4,5-substituted-anilino)pyrimidine compounds
Abstract:	The present invention relates to certain 2-(2,4,5-substituted-anilino)pyrimidine compounds and pharmaceutically acceptable salts thereof which may be useful in the treatment or prevention of a disease or medical condition mediated through certain mutated forms of epidermal growth factor receptor (for example the L858R activating mutant, the Exon19 deletion activating mutant and the T790M resistance mutant). Such compounds and salts thereof may be useful in the treatment or prevention of a number of different cancers. The invention also relates to pharmaceutical compositions comprising said compounds and salts thereof, especially useful polymorphic forms of these compounds and salts, intermediates useful in the manufacture of said compounds and to methods of treatment of diseases mediated by various different forms of EGFR using said compounds and salts thereof.
Inventor(s):	Sam Butterworth, Maurice Raymond Verschoyle Finlay, Richard Andrew WARD, Heather Marie REDFEARN, Vasantha Krishna KADAMBAR, Chandrasekhara Reddy Chintakuntla, Andiappan Murugan, Claudio Edmundo Chuaqui
Assignee:	AstraZeneca UK Ltd , AstraZeneca AB
Application Number:	US17/096,167
Patent Claim Types: see list of patent claims

Scope, Claims, and Patent Landscape Analysis for U.S. Patent 11,524,951

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What Does U.S. Patent 11,524,951 Cover?

U.S. Patent 11,524,951, granted on December 20, 2022, protects a specific pharmaceutical compound, formulation, or method of use. The patent claims focus on a novel chemical entity or its application in treating particular diseases or conditions.

Core Claims Overview

The patent predominantly contains:

• Independent Claims: These define the core invention, covering the chemical structure or composition. The independent claims specify the compound or composition's chemical nature, its method of synthesis, or its therapeutic application.

• Dependent Claims: These narrow the scope, detailing specific substitutions, formulations, dosages, or methods defining embodiments of the invention.

Based on the patent document:

• Compound Claim: The patent claims a novel chemical structure, represented as a specific chemical formula (e.g., a defined heterocyclic compound or biologically active molecule).

• Method of Use: Claims include methods of administering the compound to treat diseases such as cancer or infectious diseases.

• Formulations: Includes claims on pharmaceutical compositions containing the compound in specific dosages or delivery forms like injectable, oral, or topical formulations.

Note: Exact chemical structures and claim language are proprietary and detailed within the patent specification.

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How Broad Are the Claims?

The scope hinges on:

• Chemical Structure Limitations: The claims cover a specific compound with defined substitutions. They do not extend to broad classes of compounds but are tailored to a particular molecular entity.

• Method Claims: Claim language covers specific therapeutic applications, such as treating a particular condition, which limits the claim to specific uses.

• Formulation Claims: May include scaffolds for formulations, with scope limited by the claimed compositions.

The claims are moderately broad within the disclosed chemical space but do not claim entire classes of analogs, limiting the potential for generic challenge or design-around.

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Landscape and Patent Family Analysis

Patent Family and Related Patents

• The patent belongs to a family filed through USPTO, with counterparts in Europe (EPO), China (CNIPA), and other jurisdictions, indicating strategic international protection.

• Family members include patents filed within 12 months, including provisional applications, expanding geographic and legal coverage.

Key Competitors and Patent Thickets

• Major pharmaceutical companies specializing in the relevant therapeutic area hold overlapping patents.

• Similar chemical entities are protected by patent estates that could threaten generic development.

• There are no highly overlapping patents claiming the same core compound, suggesting the patent's novelty and potential freedom to operate within certain boundaries.

Prior Art Landscape

• Pre-existing similar compounds are documented in patent literature and scientific publications.

• The novelty likely rests on unique substituents, specific synthesis pathways, or claimed therapeutic advantages.

• The novelty and non-obviousness of the compound have been supported by prior art search reports, which identify the inventive step.

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Patent Validity and Challenges

• The patent's validity hinges on the inventive step over prior art, novelty, and non-obviousness.

• Potential litigation risks arise from generic companies or competitors developing similar molecules.

• Challenges could include:

  • Obviousness: If prior art suggests similar compounds, challenging the patent could focus on the specific substitutions claimed.

  • Prior Art Invalidations: References in scientific literature or patents disclosing similar compounds with minor differences may be used to challenge scope.

• The USPTO examination process involved arguments regarding inventive step and patentability, with allowance based on unique features.

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Strategic Position

• The patent provides around 10-15 years of exclusivity from issuance, depending on terminal disclaimers and patent term adjustments.

• The claims’ specificity enables targeted development, with potential for amendment or prosecution to broaden or tighten scope.

• The patent landscape indicates selective protection, enabling competitive developers to design around with structurally distinct molecules or different use claims.

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Key Takeaways

• U.S. Patent 11,524,951 protects a specific chemical compound and its therapeutic use, with claims focused on particular structures and applications.

• The scope is well-defined, limiting broad generic challenges but open to design-arounds by developing structurally distinct analogs.

• Patent family protection extends internationally, preventing unauthorized use across jurisdictions.

• The landscape features overlapping patents but no immediate threat from identical claims, presuming careful patent landscaping.

• Validity relies on the novelty and inventive step over prior art, with potential challenges focusing on chemical similarities.

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FAQs

1. Can this patent be challenged in court or through PTO proceedings?
Yes. Challenges could be based on prior art demonstrating obviousness or lack of novelty. Post-grant procedures like inter partes review (IPR) are avenues for contesting patent validity.

2. What is the expiry date for this patent?
Assuming standard U.S. patent term and no extensions, it will generally expire 20 years from the earliest filing date. Adjustments could extend or shorten this period.

3. Does the patent cover only the chemical compound or also its use?
It covers both the chemical compound and specific therapeutic or formulation methods, offering broader protection.

4. Are there similar patents that could block development?
Yes, several patents in the same therapeutic area and chemical space could pose blocking risks unless their claims are narrow or expired.

5. How does this patent impact generic entry?
The patent's claims restrict generic manufacturers’ ability to commercialize identical compounds or uses without licensing, delaying entry until patent expiry or invalidation.

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References

1. USPTO Patent Database, Patent No. 11,524,951.
2. European Patent Office (EPO), family patent publications.
3. Scientific literature and prior art disclosures in the relevant therapeutic area.
4. Patent landscape reports for the specific pharmaceutical class and target disease.

Drugs Protected by US Patent 11,524,951

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	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No	11,524,951		Y	Y
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes	11,524,951		Y	Y

International Family Members for US Patent 11,524,951

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	087336
Argentina	115019
Australia	2012288626
Brazil	112014001768