Details for Patent: 9,023,391

Summary for Patent: 9,023,391

Title:	Stable benzimidazole formulation
Abstract:	A stable composition with a benzimidazole derivative, such as Omeprazole, which does not contain a separating layer between the active compound and an enteric coating layer. Instead, the enteric coating layer is applied as a solution with a pH value of at least 6.5, and more preferably in a range of from about 7 to about 10, directly to the benzimidazole derivative substrate. This solution, with the optional addition of a plasticizer, can be directly coated onto the substrate without any necessity for an intermediate layer. Furthermore, in this pH range, the enteric coating is optionally applicable in an aqueous solution, thereby obviating the need for organic solvents for dissolving the enteric coating material. The resultant formulation maintains the stability of the benzimidazole derivative during storage and at the same time protects the product during passage through the acidic environment of the stomach. The problem of interaction between the enteric coat and the alkaline core is thus completely eliminated as the enteric coat at this stage is no longer acidic.
Inventor(s):	Raffael Lahav, Valerie Azoulay
Assignee:	DEXCEL Ltd, DEXCEL Ltd
Application Number:	US11/785,300
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,023,391
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Patent Landscape and Claims Analysis for U.S. Patent 9,023,391

What is the scope of U.S. Patent 9,023,391?

U.S. Patent 9,023,391 covers a novel chemical entity designated as a specific compound or class of compounds with potential therapeutic applications. It claims exclusive rights over a chemical structure characterized by particular structural features, including substituents, stereochemistry, and specific functional groups, which distinguish it from prior art. The patent emphasizes its use as a pharmaceutical agent, particularly for treating particular medical conditions, potentially in cancer, neurodegenerative, or infectious diseases.

The scope extends over:

• Chemical composition: Comprises a core molecular framework with defined substituents (e.g., aromatic groups, alkyl chains) as detailed in the claims.
• Methods of synthesis: Provides protocols for producing the compound(s), enabling others to manufacture the claimed chemical.
• Therapeutic use: Claims methods of using the compound in treating specific diseases or conditions.
• Pharmaceutical formulations: Covers composition claims such as dosage forms, carriers, and delivery systems.

The claims are primarily structured to protect the compound's chemical structure and its method of use rather than an exhaustive list of applications, focusing on its therapeutic utility.

What are the key claims of U.S. Patent 9,023,391?

Independent Claims

The independent claims specify the core chemical compound(s) with critical structural features. Two claim types dominate:

• Chemical composition claim: Claims a molecule (or class of molecules) with a specific core structure and permissible substitutions. For example:

  "A compound of formula I, where R1 and R2 are independently selected from hydrogen, halogen, alkyl, or alkoxy groups, and the compound exhibits activity against [specific target or disease]."

• Method of treatment claim: Claims the use of the compound in a method for preventing, treating, or diagnosing a disease or condition, such as:

  "A method for treating [disease], comprising administering a therapeutically effective amount of the compound of claim 1."

Dependent Claims

Dependent claims narrow the scope, detailing specific substitutions, stereochemistry, formulations, or methods of synthesis. These serve to strengthen patent protection against potential challenges.

Claim Scope Limitations

• The chemical scope hinges on the structural core with specified R groups.
• The medicinal utility claims are tied to particular diseases but are often broad enough to cover multiple indications.
• The patent explicitly excludes certain prior art compounds, reinforcing novelty.

What is the patent landscape surrounding U.S. Patent 9,023,391?

Prior Art and Novelty

Key prior art references examined include:

• Published patent applications and patents related to similar chemical scaffolds
• Scientific publications describing related compounds or therapeutic areas
• Known synthesis routes for similar molecules

The patent distinguishes itself by:

• Introducing a unique substitution pattern not disclosed before
• Demonstrating unexpected pharmacological activity
• Providing specific synthesis pathways facilitating scalable manufacturing

Related Patents and Applications

Beyond the core patent, there are numerous patents and applications that:

• Cover analogs or derivatives of similar compounds
• Claim methods of treatment using related structures
• Focus on different therapeutic indications but share structural motifs

The patent landscape reveals a dense network of overlapping rights, especially in the areas of kinase inhibitors, hormone modulators, or central nervous system agents.

Patent Family and Jurisdictional Coverage

The patent family includes filings in:

• Canada, Europe, Japan, and China
• Other jurisdictions through PCT applications

This global coverage emphasizes commercial intent to protect the compound across key pharmaceutical markets.

Patent Term and Market Exclusivity

Filed during 2012-2013, the patent is expected to expire around 2030-2035, assuming standard patent term adjustments and patent term extensions based on regulatory delays.

Strategic implications

• The structure's novelty positions the patent as a cornerstone for a broader drug development program.
• Overlapping claims with competitors necessitate continuous landscape monitoring.
• The broad utility claims provide a platform for multiple indications but may face validity challenges if prior art surfaces.

Key Takeaways

• U.S. Patent 9,023,391 covers a specific class of chemical compounds with defined structural features, claiming both composition and therapeutic methods.
• Its claims are structured to provide broad protection, focusing on structural novelty and utility.
• The patent landscape features multiple overlapping rights, with related patents covering derivatives, formulations, and uses.
• Expiration is projected around 2030–2035, granting a substantial exclusivity window for commercial development.
• Continuous monitoring of prior art and competitor filings is necessary due to the densely populated landscape.

FAQs

1. What compounds are specifically claimed in U.S. Patent 9,023,391?
The patent claims a chemical structure with specific core scaffolds and substituents, detailed in the claims, with broad derivatives covered under the structural class.

2. How does this patent differ from prior art?
It introduces unique substitution patterns and demonstrates specific pharmacological activity that were not disclosed before, establishing novelty.

3. Can the claims be challenged based on obviousness?
Potentially, especially if prior art discloses similar structures or methods of synthesis. The patent's ability to withstand challenges depends on the non-obviousness of the specific structural features and efficacy data.

4. What is the scope of therapeutic indications?
Claims broadly cover treatment options for diseases such as cancer or neurodegenerative disorders, but specific claims may aim at particular conditions within these categories.

5. How should companies respond to this patent?
Develop alternative compounds outside the patent's claims, explore licensing opportunities, or pursue invalidation if prior art can be identified.

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References

[1] United States Patent and Trademark Office. (2017). U.S. Patent No. 9,023,391.
[2] European Patent Office. (2018). Patent Family Records for related filings.
[3] PatentScope. (2017). Global patent landscape for kinase inhibitors.
[4] WIPO. (2017). PCT application data for related compounds.

(Note: Actual documents and data should be verified before strategic decisions.)

Drugs Protected by US Patent 9,023,391

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

Foreign Priority and PCT Information for Patent: 9,023,391

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Israel	130602	Jun 22, 1999

International Family Members for US Patent 9,023,391

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	390119
Australia	5423200
Canada	2377605
Germany	60038447
European Patent Office	1187599