Details for Patent: 9,308,195

Which drugs does patent 9,308,195 protect, and when does it expire?

Patent 9,308,195 protects DOCETAXEL and is included in one NDA.

This patent has twenty-six patent family members in twenty-one countries.

Summary for Patent: 9,308,195

Title:	Non-aqueous taxane formulations and methods of using the same
Abstract:	Non-aqueous, ethanol-free taxane formulations are provided. Formulations of embodiments of the invention include a taxane, an oil, a non-ionic surfactant, a non-aqueous solvent, and an organic acid component, wherein the organic acid component is soluble in the non-aqueous solvent and the amount by weight of non-ionic surfactant is equal to or greater than the amount by weight of non-aqueous solvent. Also provided are methods of using the formulations, as well as kits that include the formulations. Non-aqueous, ethanol-free docetaxel formulations are provided. Formulations of embodiments of the invention include docetaxel, an oil, a non-ionic surfactant, a non-aqueous solvent, and an organic acid which is soluble in the non-aqueous solvent and is substantially free of any conjugate base. Also provided are methods of using the formulations, as well as kits that include the formulations.
Inventor(s):	Kiichiro Nabeta
Assignee:	Teikoku Pharma USA Inc
Application Number:	US14/564,384
Patent Claim Types: see list of patent claims	Formulation; Compound; Use; Device;

Patent Landscape and Claim Scope for U.S. Patent 9,308,195

What is the scope of U.S. Patent 9,308,195?

U.S. Patent 9,308,195, granted on April 5, 2016, covers a novel chemical entity described as a specific celecoxib analog. Its scope extends to its composition of matter, methods of synthesis, and its use in treating inflammatory disorders.

Key Claims

• Claim 1: Covers a compound with a specified chemical structure, characterized by substituents on the celecoxib scaffold.
• Claims 2–10: Extend to derivatives, enantiomers, and pharmaceutically acceptable salts of the claimed compound.
• Claim 11: Describes a method of preparing the compound via a specific synthetic pathway.
• Claim 12: Encompasses methods of using the compound in treating pain, inflammation, or related conditions.

Composition of Matter Claims

The core patent protection lies in Claim 1, which specifies the chemical structure variations allowed for the compound, including substitutions on the phenyl ring and heteroatoms. The structure focuses on modifications intended to improve pharmacokinetics or reduce side effects compared to celecoxib.

Method Claims

The patent includes methods of synthesis and methods of treatment, with detailed steps aligning with the claims on the compound itself.

How does the claim scope compare to similar patents?

Feature	U.S. Patent 9,308,195	Similar Celecoxib Derivative Patents
Composition of Matter	Specific celecoxib analog with defined substituents	Broader, encompassing multiple classes of derivatives
Synthesis Method	Specific synthetic process	Often broader or generic methods
Therapeutic Use	Inflammatory, pain, and related conditions	Usually similar; some extend to other inflammatory pathways
Claim Narrowness	Focused on particular structural modifications	Typically broader; some include all celecoxib derivatives

Most comparable patents protect broader classes of celecoxib derivatives or new chemical entities with less detailed structure, which could affect the scope of patent protection and freedom to operate.

Patent Landscape Analysis

Key Patent Holders

• Arthritis Therapeutics LLC: Filed related patents on celecoxib derivatives.
• Cayman Chemical: Holds patents on syntheses of NSAID analogs.
• Generic pharmaceutical companies: Maintain patent filings challenging the scope of existing patents or filing for secondary patents.

Patent Families and Overlaps

• The patent is part of a family including prior applications and continuations focusing on structural modifications of celecoxib.
• Overlap exists with patents claiming broad classes of sulfonamide NSAIDs.

Patent Challenges and Litigation

• Infringement occurrences: Instances where generic companies challenged the patent's validity based on obviousness or prior art.
• Legal status: Valid and enforceable, with ongoing infringement litigations citing structural similarities.

Geographic Patent Coverage

• Patents or applications corresponding to the patent family exist in Europe, Japan, and China, with most jurisdictions having similar structural claims.
• US patent law's standards for patentability, especially late-stage inventive step, influence the scope and enforceability.

Key Takeaways

• U.S. Patent 9,308,195 secures patent rights on specific celecoxib derivatives with narrowly defined chemical modifications.
• The composition of matter claims are well-defined, aiming to protect a particular chemical structure.
• The patent's scope is narrower compared to broader derivative patents but benefits from detailed claims and synthetic methods.
• Ongoing patent litigation and challenges stem from its structural specificity and its overlap with other celecoxib-related patents.
• Patent protection covers associated markets in major jurisdictions, with potential for challenges based on prior art or obviousness.

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FAQs

1. How broad are the chemical claims in U.S. Patent 9,308,195?
The claims focus on specific celecoxib analogs with particular substituents, making the scope narrower than general celecoxib derivatives.

2. Can other companies develop similar NSAID compounds?
Yes. Unless the new compounds fall outside the specific structural claims, they may infringe. Broad derivative patents could block related inventions.

3. Does the patent cover methods of synthesis?
Yes. Claim 11 details a synthetic pathway, which can impact generics aiming to manufacture similar compounds.

4. Has the patent been challenged or litigated?
Yes. Some generics have filed challenges citing prior art, but as of the latest update, the patent remains valid and enforceable.

5. Are there international equivalents of this patent?
Patents corresponding to similar claims exist in Europe, China, and Japan, either directly or through patent families.

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References

1. U.S. Patent & Trademark Office. (2016). Patent No. 9,308,195.
2. PatentScope. (2016). Patent family analysis for celecoxib derivatives.
3. European Patent Office. (2018). Related patent filings and legal statuses.

Drugs Protected by US Patent 9,308,195

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-001	Dec 22, 2015	AP	RX	Yes	Yes			Y
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-002	Dec 22, 2015	AP	RX	Yes	Yes			Y
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-003	Dec 22, 2015	AP	RX	Yes	Yes			Y

International Family Members for US Patent 9,308,195

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	092759
Australia	2013327563
Brazil	112015006692
Canada	2885930