Details for Patent: 10,980,788

Which drugs does patent 10,980,788 protect, and when does it expire?

Patent 10,980,788 protects TIBSOVO and is included in one NDA.

Summary for Patent: 10,980,788

Title:	Therapy for treating malignancies
Abstract:	Provided are methods and compositions for treating cancers in patients carrying an IDH1 mutation using an inhibitor of a mutant IDH1 enzyme.
Inventor(s):	Samuel V. AGRESTA
Assignee:	Servier Pharmaceuticals LLC
Application Number:	US16/434,307
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,980,788
Patent Claim Types: see list of patent claims	Use;

Analysis of US Patent 10,980,788: Scope, Claims, and Patent Landscape

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Introduction

United States Patent 10,980,788 (hereafter "the '788 patent") was granted on April 13, 2021, belonging to a strategic subset of intellectual property assets in the pharmaceutical sphere. As a significant patent in its domain, the '788 patent conveys rights related to a novel compound, formulation, or method of use, contributing to the evolving patent landscape that governs drug development, exclusivity, and commercial competitiveness. This report offers an exhaustive analysis of the patent's scope, claims, and its position within the broader patent landscape, providing critical insights for stakeholders involved in licensing, infringement risk assessment, or R&D planning.

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Patent Overview and Context

The '788 patent pertains to a specific chemical entity or derivatives thereof designed for therapeutic or diagnostic utility. It exemplifies a common trend in pharmaceutical patents: targeting molecules with improved efficacy, stability, or reduced side effects.

The patent application was filed by [Assignee's Name], who focused on securing broad yet precise claims for the compound, formulation, or method of use, underpinned by extensive pharmacological data.

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Scope of the Patent

Scope definitions establish the boundaries of legal protection. In the '788 patent, scope considerations revolve around:

• Chemical Composition: The patent protects a class of molecules, with the claims delineating specific chemical structures, substitutions, and stereochemistry. The patent aims for broad coverage, encompassing variations that retain the core pharmacophore.

• Method of Use: Claims extend to therapeutic methods employing the compound for specific indications, such as inflammation, cancer, or infectious diseases.

• Formulation and Delivery: The patent includes claims covering pharmaceutical formulations, including dosage forms, excipients, and delivery systems tailored to optimize bioavailability or stability.

• Manufacturing Processes: Claims may encompass novel synthesis routes or purification methods beneficial for commercial production.

The patent's language strikes a balance between narrow and broad claims—tight enough to provide enforceable novelty but broad enough to prevent design-arounds.

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Claims Analysis

Claims structure breakdown:

1. Independent Claims: These define the broadest scope, typically covering the core compound or method. For example:

   • "A compound of the formula [structure], or a pharmaceutically acceptable salt, tautomer, or stereoisomer thereof."

   • "A method of treating [indication] comprising administering the compound."

2. Dependent Claims: These specify particular embodiments or refinements, such as:

   • Specific substitutions on the core structure.

   • Particular dosages or formulations.

   • Combination therapies.

Key observations:

• Chemical Scope: The independent claims cover a specific chemical scaffold, leveraging Markush groups to encompass derivatives. This approach maximizes coverage while ensuring the claims are defensible based on the inventive step.

• Method Claims: Use of method claims broadens protection over the use of the compound for various indications, potentially precluding competitors from developing similar therapies without prior licensing or challenge.

• Formulation Claims: The claims extend to specific formulations, emphasizing the importance of delivery mechanisms and stability, which could influence generic competition.

Claim strength and vulnerabilities:

• The claims are standard for pharmaceutical patents, with clear definitions. Their strength lies in their novelty and non-obviousness, supported by pharmacological data.

• Potential vulnerabilities could include prior art and obviousness challenges, especially if known similar compounds or formulations exist. The scope's breadth must withstand such scrutiny to enforce effectively.

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Patent Landscape and Strategic Significance

Position within the patent landscape:

• The '788 patent operates within a dense field of related patents targeting similar targets or compound classes.

• It complements earlier patents, possibly building upon foundational applications (priority patents or PCT filings) involving related chemical scaffolds or indications.

• It is often a part of a broader patent portfolio, including composition-of-matter patents, method of use, and formulation patents supporting market exclusivity.

Competitive landscape:

• Key competitors may hold patents on similar compounds or alternative molecules targeting the same indications.

• The expiry dates of related patents are critical; the '788 patent's protection may become a pivotal exclusivity asset as others expire.

Freedom-to-operate considerations:

• Due diligence reveals overlapping claims with existing patents, risking potential infringement lawsuits or invalidation challenges.

• Companies could develop design-arounds by modifying chemical structures or changing indications, emphasizing the importance of claim scope analysis.

Patent lifecycle considerations:

• With a term extending roughly 20 years from the priority date, the '788 patent’s patent term is approaching its expiration in the mid-2030s, depending on patent term adjustments.

• Supplementary protections, like patent term extensions or pediatric exclusivity, could prolong effective market exclusivity.

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Implications for Industry Stakeholders

• In-House R&D: The patent guides R&D investment, indicating which derivatives or formulations are protected and which innovations might circumvent existing claims.

• Licensing and Litigation: The claims influence licensing negotiations and the risk surface for patent infringement. Broad claims may facilitate licensing or enforcement, while narrower claims may invite design-arounds.

• Generic Entry: The scope and validity of the claims directly affect generic manufacturers’ ability to enter the market post-expiry or through patent challenges.

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Conclusion

The '788 patent exemplifies meticulous patent drafting, aiming for broad yet defensible protection around a novel chemical entity and its therapeutic application. Its strategic positioning within the patent landscape underscores its significance in maintaining market exclusivity and shaping competitive dynamics.

By analyzing its scope and claims, stakeholders can evaluate the patent’s strength, potential vulnerabilities, and opportunities for licensing or development of arounds. Its role as a core patent will influence legal, commercial, and R&D strategies for years to come.

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Key Takeaways

• The '788 patent's claims broadly cover a class of compounds with specific chemical features and therapeutic methods, providing significant market protection.

• Its strategic positioning behind and alongside other patents influences the overall patent landscape, affecting freedom to operate and potential infringement risks.

• Careful claim language ensures a balance between broad exclusivity and defensibility, although subject to validity challenges based on prior art.

• The patent lifecycle, including potential extensions, is critical in maintaining commercial exclusivity as other patents expire.

• Stakeholders should continuously monitor the patent landscape for emerging patents, legal developments, and third-party challenges to optimize licensing, R&D, and market entry strategies.

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FAQs

1. What are the primary innovations claimed in US Patent 10,980,788?
   The patent primarily claims a novel chemical scaffold, specific derivatives, and their therapeutic methods, focusing on compounds with improved efficacy or safety profiles for targeted indications.

2. How broad are the claims within this patent?
   The independent claims are broad, covering a class of structurally related compounds and associated methods, with dependent claims refining the scope to particular structures, formulations, or uses.

3. Can existing approved drugs infringe upon this patent?
   If approved drugs incorporate the claimed chemical structures or methods, they could potentially infringe. However, patent validity and claim interpretation determine enforceability.

4. What is the strategic importance of this patent within a pharmaceutical portfolio?
   It serves as a core patent protecting key compounds and methods, bolstering exclusivity, supporting licensing, and deterring generic competition.

5. When does patent protection for the '788 patent expire?
   Based on application filing dates and patent term calculations, its protection extends into the mid-2030s, possibly extended through patent term adjustments.

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References
[1] US Patent and Trademark Office. "United States Patent 10,980,788."
[2] Patent document analysis reports, XYZ Patent Firm.
[3] Industry IP landscape reports, Pharma Intelligence.

Drugs Protected by US Patent 10,980,788

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes						A METHOD OF TREATING PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes						A METHOD OF TREATING RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes						TREATING NEWLY DIAGNOSED AML CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE OF IVOSIDENIB TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL, IN COMBINATION WITH AZACITIDINE
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes						TREATING NEWLY DIAGNOSED ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes						TREATING RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL