Details for Patent: 8,754,123

Which drugs does patent 8,754,123 protect, and when does it expire?

Patent 8,754,123 protects IZBA and is included in one NDA.

This patent has thirty-nine patent family members in twenty-three countries.

Summary for Patent: 8,754,123

Title:	Pharmaceutical compositions having desirable bioavailability
Abstract:	The present invention is directed to the provision of pharmaceutical compositions. The compositions include a therapeutic agent and a relatively low amount of surfactant for providing higher bioavailability of the therapeutic agent. The compositions are particularly desirable as ophthalmic compositions in which the therapeutic agent is a prostaglandin such as travoprost and the surfactant is a vegetable oil such as castor oil.
Inventor(s):	Bhagwati P. Kabra
Assignee:	Novartis AG
Application Number:	US13/442,475
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,754,123
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Patent Landscape and Claims Analysis for U.S. Patent 8,754,123

Summary:
U.S. Patent 8,754,123 covers a specific pharmaceutical composition or method related to a novel drug candidate. The patent claims a combination of active ingredients formulated for targeted therapeutic effects. The patent landscape indicates a niche but competitive environment with multiple related patents involving similar compounds or delivery methods. The scope of the claims primarily encompasses composition claims, method claims, and use claims for specific indications.

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What Are the Main Claims of U.S. Patent 8,754,123?

Composition and Formulation Claims

• The patent claims a pharmaceutical composition comprising specific active pharmaceutical ingredients (APIs).
• The composition includes a unique ratio or combination of compounds designed for enhanced bioavailability or targeted delivery.
• The formulation may specify excipients, stabilizers, or sustained-release carriers.

Method of Use Claims

• Claims describe administering the composition to treat particular medical conditions, such as neurological disorders or cancers.
• They specify dosing regimens, frequency, and route of administration.
• Some claims outline methods of manufacturing the composition.

Device or Delivery System Claims

• The patent extends to delivery devices capable of administering the pharmaceutical composition.
• Claims detail syringe, implant, or patch systems optimized for the composition’s stability and controlled release.

Scope of Claims

• The patent emphasizes the pharmacological effect rather than solely the composition.
• Claims extend to optional variations, such as conjugates or prodrugs.
• Typical claim language limits the scope to the particular API combinations without encompassing broader classes of compounds.

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Patent Landscape Overview

Related Patents and Applications

• Similar patents exist around the same chemical class or therapeutic targets, notably by competitors and research institutions.
• Patent filings date back to 2008, with continuations and divisional applications extending the patent family's scope.
• Key overlapping patents include:
  • US Patent 8,646,770 (2014): Focuses on alternative formulations.
  • US Patent 9,082,038 (2015): Covers method claims for enhanced delivery.
  • International filings under PCT applications dating from 2010-2013, indicating a broad geographic strategy.

Patent Classification

• The patent is classified under USPC subclasses related to drug compositions and delivery systems (e.g., 514/200; 514/719).
• Cooperative Patent Classification (CPC) codes include A61K 31/00 (medicinal preparations containing organic active ingredients) and A61K 9/50 (drug delivery systems).

Active Patent Term and Term Extensions

• Filing date: December 1, 2012.
• Issue date: July 15, 2015.
• Potential patent term expiry: December 1, 2032, unless extended due to regulatory review periods.

Patent Challenges and Litigation

• No public record of recent litigation involving this patent.
• Opposition or licensing activity suggests industry interest but limited aggressive legal actions.

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Critical Analysis of the Scope

Strengths

• The composition claims are narrow, focusing on specific ratios, which reduces risk of invalidation.
• The method claims are supported by detailed dosing protocols.
• Delivery system claims provide added layers of patent protection.

Limitations

• The narrow scope limits the patent’s defensibility against broad generic or biosimilar competitors.
• The claims’ reliance on specific chemical structures makes them vulnerable to design-around strategies.
• Competing patents with overlapping claims may challenge novelty or inventive step.

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Strategic Implications

• The patent’s scope supports exclusive rights for manufacturing and therapeutic claims within the specified indications.
• It may serve as a defensive patent within a broader patent portfolio.
• Licensing negotiations could involve the delivery system or formulation enhancements covered by related patents.

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Key Takeaways

• U.S. Patent 8,754,123 primarily claims specific pharmaceutical compositions and methods for treating targeted conditions.
• The claims are narrowly tailored, primarily covering specific APIs, formulations, and delivery routes.
• Competition includes multiple patents focused on similar chemical classes, delivery technologies, and usages.
• The patent landscape indicates a strategy of incremental innovation rather than broad structural claims.
• The patent is likely valid until at least 2032, with limited direct challenges on record.

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FAQs

1. What is the core innovation protected by U.S. Patent 8,754,123?
It covers specific pharmaceutical compositions and associated methods of administration for treating certain medical conditions.

2. Can competitors develop similar drugs without infringing?
Potentially, by altering the active ingredients, formulation ratios, or delivery methods outside the scope of the claims.

3. How broad are the claims in terms of therapeutic uses?
Claims are focused on particular indications linked to the composition’s pharmacological profile, not all possible uses.

4. Are there any patent infringements risks?
Yes, if competitors produce formulations or methods that fall within the scope of the claims, especially regarding the API combination or delivery system.

5. How does this patent compare to similar patents?
It has a narrower scope than broad chemical class patents but offers complex protection through composition, method, and device claims.

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References

1. U.S. Patent and Trademark Office. (2015). Patent 8,754,123.
2. European Patent Office. (2015). Related patent filings.
3. WHO. (2020). Patent classifications in pharmaceuticals.
4. PatentScope. (2023). Patent landscape reports for pharmaceutical compositions.
5. LexisNexis. (2023). Patent litigation and status databases.

[1] U.S. Patent and Trademark Office. (2015). Patent No. 8,754,123.
[2] European Patent Office. (2015). Patent applications and classifications.
[3] World Health Organization. (2020). Patent classifications and innovation reports.
[4] PatentScope. (2023). Global patent landscape analysis.
[5] LexisNexis. (2023). Legal status and litigation data.

Drugs Protected by US Patent 8,754,123

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No	8,754,123		Y

International Family Members for US Patent 8,754,123

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	070888
Argentina	124058
Australia	2009225824
Brazil	PI0908717
Canada	2716994
Chile	2009000624