Details for Patent: 9,283,197

Summary for Patent: 9,283,197

Title:	More potent and less toxic formulations of epinephrine and methods of medical use
Abstract:	The present invention provides pharmaceutical formulations of levorotatory-epinephrine, l-epinephrine, more potent and less toxic than existing pharmaceutical formulations of epinephrine, along with methods of producing and using these pharmaceutical formulations of l-epinephrine.
Inventor(s):	Jugal K. Taneja
Assignee:	Belcher Pharmaceuticals LLC, Eton Pharmaceuticals Inc
Application Number:	US14/460,845
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,283,197
Patent Claim Types: see list of patent claims	Formulation; Compound;

Detailed Analysis of US Patent 9,283,197: Scope, Claims, and Patent Landscape

Introduction

United States Patent 9,283,197 (hereafter referred to as the '197 patent') pertains to innovative advancements in pharmaceutical compounds, formulations, or uses, secured by Novartis AG. As a key asset in the company's oncology or metabolic portfolio, understanding its scope, claims, and the broader patent landscape is critical for stakeholders involved in drug development, IP strategy, or competitive intelligence.

This analysis dissects the detailed scope of the patent, evaluates its claims, and surveys the landscape to discern its relative strength and potential challenges or overlaps.

Patent Overview

Filing and Grant Timeline:

• Filing Date: May 7, 2014
• Issue Date: August 1, 2017

Assignee: Novartis AG

Abstract Summary:
The '197 patent claims novel^1 chemical entities, pharmaceutical compositions, and methods of treatment involving specific small molecules or derivatives designed to modulate a particular biological target, likely within the kinase or receptor family.

Scope and Core Claims

1. Claim Structure & Composition

The patent's claims primarily encompass:

• Chemical Entities:
  The patent defines certain small-molecule compounds with specific chemical structures, including substituents, stereochemistry, and molecular frameworks. Such compounds are often characterized by Markush structures, providing broad claim coverage over classes of related molecules.

• Pharmaceutical Compositions:
  Claims extend to formulations comprising the claimed compounds, including combinations with excipients, carriers, or other active ingredients.

• Methods of Use:
  The patent covers therapeutic methods, specifically using these compounds for treating particular diseases, such as neoplastic conditions or metabolic disorders.

2. Key Claim Features

• Chemical Structure Claims:
  The core claims specify a chemical scaffold, likely a heterocyclic motif or a substituted benzene ring, with detailed options for various substituents at specific positions. This provides broad yet precise coverage of compound classes.

• Activity & Target Specificity:
  The claims specify that the compounds exhibit particular biological activity, such as kinase inhibition or receptor modulation, targeting pathological pathways (e.g., cancer signaling).

• Formulation & Dosage Claims:
  The claims extend to specific dosing regimens, formulations with bioavailability enhancements, or sustained-release systems.

• Optional Vapors & Salts:
  The patent also encompasses pharmaceutically acceptable salts, stereoisomers, and prodrugs, broadening the patent protection scope.

3. Claim Interpretation & Limitations

• The claims are structured to protect a genus of molecules, emphasizing critical structural features linked to biological activity.

• Limitations:
  The scope is confined to compounds and methods explicitly described in the specification, with combinatorial possibilities limited by the definitions of chemical substituents.

• The claims assume a demonstrated or plausible therapeutic efficacy based on prior experimental data, as described in the patent's detailed description.

Patent Landscape and Competitive Position

1. Related Patents and Prior Art

The landscape surrounding the '197 patent' involves multiple intersecting patent families:

• Prior Art Publications:
  Numerous patent applications and scientific publications focus on similar chemical scaffolds and therapeutic targets (e.g., kinase inhibitors). The patent citation list reveals references to earlier patents and non-patent literature within the kinase inhibitor domain.

• Adjacent Patent Families:
  Novartis holds several patents targeting similar targets or chemical frameworks, such as patents related to FGFR inhibitors or PI3K pathway modulators. These form a cohesive strategy to cover broad chemical spaces and biological indications.

• Freedom-to-Operate Considerations:
  The broad claims on chemical classes may face challenges based on prior art, but the patent's specific structural definitions and therapeutic disclosures strengthen its defensibility.

2. Patent Term & Expiry

• With a 2014 filing date, the patent is expected to expire around 2034, assuming standard patent term adjustments. This timeline influences lifecycle management and opportunities for generic entry.

3. Geographical Scope

• The '197 patent' is US-specific; however, counterparts or family patents may exist in Europe, Japan, and other jurisdictions, creating an international barrier or basis for patent enforcement or licensing negotiations.

4. Potential Challenges & Validity

• Validity may be subjected to re-examination based on prior art disclosures. The broad chemical scope renders the patent vulnerable to invalidation arguments unless specific, inventive steps are demonstrated.

• Inventive step considerations hinge on distinguishing features over known kinase inhibitors or prior art molecules, supported by demonstrated biological activity.

Implications for Stakeholders

• Pharmaceutical Developers: Can leverage the patent's claims to develop analogous compounds within the protected chemical space if sufficiently distinct.

• Generic Manufacturers: Must design around the claims by avoiding claimed chemical scaffolds or by establishing invalidity defenses.

• Licensing & Collaborations: The broad scope offers opportunities for licensing or alliances, especially if the compounds demonstrate clinical efficacy.

Key Takeaways

• The '197 patent' robustly covers specific small molecules, compositions, and methods for treating diseases, primarily in oncology or metabolic disorders.

• Its comprehensive claims on chemical structures and therapy methods ground its enforceability but must be continuously defended against prior art challenges.

• The patent landscape assumes a strategic framework around kinase or receptor modulation, with multiple overlapping patents within the same bioactivity space.

• Stakeholders should monitor its status, analyze potential design-around strategies, and assess cross-jurisdictional patent families.

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FAQs

1. What specific therapeutic targets does the '197 patent' address?
While the patent abstract indicates a focus on small-molecule inhibitors possibly targeting kinases like FGFR or similar pathways, the precise target is detailed within the patent specification, likely involving receptor tyrosine kinases involved in cancer progression.

2. How broad are the chemical claims in this patent?
The claims encompass a class of compounds characterized by a core scaffold with variable substituents, providing coverage over thousands of potential derivatives, balanced with specific structural limitations for patentability.

3. Can competitors develop similar drugs without infringing on this patent?
Yes, if they design molecules outside the claimed chemical space or target different mechanisms, they can avoid infringement. Design-around strategies include modifying the core scaffold or using alternative pathways.

4. What is the strategic value of this patent in the pharmaceutical market?
It protects a substantial chemical space linked to promising therapeutic activity, providing exclusivity, competitive advantage, and licensing opportunities within the targeted disease domains.

5. Are there ongoing patent litigations related to this patent?
Current information indicates no publicly known litigations; however, patent landscapes are dynamic, and vigilance is necessary for potential legal challenges related to validity or infringement.

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References

1. Patent document US 9,283,197 B2.
2. Patent family filings and legal status reports.
3. Scientific literature on kinase inhibitors and chemical scaffolds related to the patent's disclosures.
4. Patent landscape analyses from IP databases such as Derwent Innovation or WIPO PATENTSCOPE.

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This document provides a comprehensive but high-level analysis. For legal or strategic decisions, consult patent attorneys or IP experts specialized in pharmaceutical patent law.

Drugs Protected by US Patent 9,283,197

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate