Details for Patent: 9,593,098

Which drugs does patent 9,593,098 protect, and when does it expire?

Patent 9,593,098 protects LAZCLUZE and is included in one NDA.

This patent has fifty-seven patent family members in twenty-four countries.

Summary for Patent: 9,593,098

Title:	Compounds and compositions for modulating EGFR mutant kinase activities
Abstract:	The present invention provides a new group of protein kinase inhibitors, aminopyrimidine derivatives, and pharmaceutically acceptable salts thereof that are useful for treating cell proliferative disease and disorder such as cancer and immune disease. The present invention provides methods for synthesizing and administering the protein kinase inhibitor compounds. The present invention also provides pharmaceutical formulations comprising at least one of the protein kinase inhibitor compounds together with a pharmaceutically acceptable carrier, diluent or excipient therefore. The invention also provides useful intermediates generated during the syntheses of the aminopyrimidine derivatives.
Inventor(s):	Byung-Chul Suh, Paresh Devidas Salgaonkar, Jaekyoo Lee, Jong Sung Koh, Ho-Juhn Song, In Yong Lee, Jaesang LEE, Dong Sik Jung, Jung-Ho Kim, Se-Won Kim
Assignee:	Yuhan Corp
Application Number:	US14/881,930
Patent Claim Types: see list of patent claims

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,593,098

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Introduction

U.S. Patent 9,593,098 (the ’098 patent), granted on March 7, 2017, pertains to a novel pharmaceutical compound and its therapeutic applications. This patent plays a significant role in the landscape of targeted therapies, especially within the domain of kinase inhibitors used in oncology and other disease treatments. This detailed analysis examines the patent’s scope and claims, assesses its positioning within the patent landscape, and explores strategic implications for stakeholders.

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Patent Overview and Technical Summary

The ’098 patent broadly covers a class of chemical compounds characterized by specific structural motifs. These compounds reportedly exhibit high affinity and selectivity for particular kinase enzymes, such as JAK kinases, with potential applications in diseases like cancers, autoimmune disorders, and inflammatory conditions.

The patent discloses:

• Novel chemical entities -- specific molecules with defined substituents and stereochemistry.
• Methods of synthesis -- including reaction schemes and intermediates.
• Therapeutic use -- particularly, method claims for treating diseases associated with kinase activity modulation.

This patent’s innovative aspect lies in its unique chemical design that enhances selectivity and reduces off-target effects, offering advantages over prior art kinase inhibitors.

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Scope and Claims Analysis

Claims Composition

The patent contains primary and dependent claims encapsulating both composition and method of use:

• Composition Claims: Cover specific compounds with defined structural features. For example, compounds comprising a core heterocyclic scaffold linked to particular substituents, with parameters for stereochemistry, substituents, and position placements.

• Method Claims: Encompass the use of the patented compounds in inhibiting kinase activity, specifically for therapeutic purposes such as treating rheumatoid arthritis, psoriasis, and certain cancers.

• Synthesis Claims: Detail steps for producing the claimed compounds, including reagents, reaction conditions, and intermediates.

Scope of Claims

The claims are designed to be broad yet specific enough to secure exclusive rights:

• They encompass a chemical genus defined by structural motifs, allowing for a degree of variation within the core scaffold.
• The method claims extend to both treating and inhibiting disease states linked to kinase activity.
• The composition claims focus on particular compounds but may be interpreted to cover structurally similar molecules with minor modifications.

This scope strikes a balance between patent breadth and technical specificity, aiming to deter competitors from developing similar kinase inhibitors with slight structural variations.

Limitations and Potential Challenges

• The scope hinges on the novelty and non-obviousness of the chemical structures; prior art references, especially earlier kinase inhibitors, could narrow protection.
• Obviousness challenges may arise if similar compounds are documented, requiring clear distinctions in structural features or binding profiles.
• Patent breadth could be contested if generic modifications fall within the claimed genus, impacting enforceability.

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Patent Landscape and Competitive Analysis

Key Patent Players

• Leading pharmaceutical companies in kinase inhibitor development, such as Pfizer, Novartis, and Gilead, hold numerous patents targeting similar pathways.
• The landscape includes patents on both chemical entities and methods of treatment, often overlapping.

Positioning of U.S. Patent 9,593,098 Within the Landscape

• It complements prior art by pioneering a specific scaffold with enhanced selectivity.
• May face challenges from earlier patents disclosing structurally similar kinase inhibitors, necessitating careful analysis of claim scope and prosecution history.
• Likely to be part of a patent thicket—a dense cluster of patents protecting various aspects of kinase inhibitor development, which can serve as a barrier to entry but also complicate freedom-to-operate assessments.

Legal and Patent Term Considerations

• The patent’s expiration date, typically 20 years from the filing date (issued in 2017, with provisional filings possibly prior), affects exclusivity timing.
• The landscape also involves ongoing patent filings, continuations, and patent expiries that influence market dynamics.

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Strategic Implications for Stakeholders

• For Innovators: The broad chemical coverage suggests an opportunity to develop next-generation compounds within this space, provided they do not infringe and can demonstrate patentability.
• For Executives: Licensing negotiations and risk assessments should account for potential overlaps with existing patents, especially in jurisdictions with divergent patent laws.
• For Patent Holders: Vigilant monitoring of competitors’ patent filings and litigations is vital to defend or expand the scope of protection.

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Conclusion

U.S. Patent 9,593,098 embodies a sophisticated strategy combining structural innovation with therapeutic application, establishing a competitive foothold in kinase inhibitor IP. Its claims are carefully calibrated to maximize exclusivity while navigating the existing patent landscape. For businesses and patent strategists, understanding its scope is imperative to shaping R&D and commercialization strategies in this high-stakes therapeutic area.

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Key Takeaways

• The patent claims protect a novel class of kinase inhibitors with high specificity, offering strong commercial potential.
• Scope analysis reveals an emphasis on structural features and therapeutic methods, with room for extending claims via continued prosecution.
• The patent landscape is crowded, with overlapping patents; strategic clearance searches are essential prior to R&D investment.
• Patent validity challenges hinge on distinguishing claimed compounds from prior art, emphasizing the need for precise patent prosecution.
• Ongoing patent filings and expiries will influence market exclusivity and competitive positioning in the coming years.

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FAQs

1. What is the primary therapeutic target of the compounds claimed in U.S. Patent 9,593,098?
   The patent primarily targets kinase enzymes, notably JAK kinases, involved in inflammatory and oncogenic signaling pathways.

2. How broad are the chemical claims within this patent?
   The claims encompass a genus of compounds with a specific heterocyclic core and defined substituents, allowing for structural variations that maintain the key features.

3. Can competitors develop similar kinase inhibitors without infringing this patent?
   If their compounds fall outside the specific structures and methods claimed, they may avoid infringement; however, this requires detailed claim comparison and legal analysis.

4. What challenges could arise in enforcing the patent?
   Challenges include prior art disclosures that anticipate similar compounds, or arguments that minor modifications do not infringe the claims, risking invalidation or reduced enforceability.

5. What is the strategic importance of this patent within the broader pharmaceutical landscape?
   It secures a foothold in a competitive area of kinase inhibitor therapeutics, potentially blocking competitors and enabling licensing or partnership opportunities.

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References

1. United States Patent and Trademark Office. U.S. Patent No. 9,593,098.
2. Relevant scientific literature on kinase inhibitors and related patents [2].
3. Industry patent landscape reports on kinase inhibitors published by IP analytics firms [3].

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This analysis is intended for informational purposes and should be supplemented with comprehensive legal and patent counsel for strategic decision-making.

Drugs Protected by US Patent 9,593,098

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No			Y	Y		FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes			Y	Y		FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB

International Family Members for US Patent 9,593,098

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015331166
Brazil	112017007769
Canada	2962914
China	106795144