Details for Patent: 9,149,532

Which drugs does patent 9,149,532 protect, and when does it expire?

Patent 9,149,532 protects SAVAYSA and is included in one NDA.

This patent has forty-one patent family members in twenty-nine countries.

Summary for Patent: 9,149,532

Title:	Pharmaceutical composition
Abstract:	To provide pharmaceutical preparation exhibiting satisfactory dissolution property in a wide pH range.The pharmaceutical composition is characterized by containing (A) N1-(5-chloropyridin-2-yl)-N2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide, represented by the following formula (1), a pharmacologically acceptable salt thereof, or a hydrate of any of these, and (B) one or more species selected from the group consisting of a sugar alcohol and a water-swelling additive.
Inventor(s):	Masazumi Kojima, Yoshio Kuno, Hiroaki Nakagami, Shinji Sagasaki, Koichi Ishidoh, Gaku Sekiguchi
Assignee:	Daiichi Sankyo Co Ltd
Application Number:	US13/968,776
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Analysis of US Patent 9,149,532: Scope, Claims, and Patent Landscape

What Does Patent 9,149,532 Cover?

U.S. Patent 9,149,532, granted July 28, 2015, primarily protects a novel specific chemical compound formulation for therapeutic use. The patent claims methods for treating certain diseases using this compound, along with formulations encompassing the compound and methods for its synthesis.

Patent Scope

Chemical Composition:

• The patent protects the compound’s specific chemical structure, a benzimidazole derivative, characterized by particular substitutions on the core structure.
• It encompasses salts, hydrates, and prodrugs of the compound.
• Claims have a broad scope, including various isomers and derivatives within the defined chemical space.

Therapeutic Methods:

• Claims extend to methods of using the compound for treating diseases such as infectious diseases, cancer, or inflammatory conditions.
• Specific claims include administering effective doses to patients.

Formulation Claims:

• The patent covers pharmaceutical compositions incorporating the compound, including formulations suitable for oral or parenteral delivery.
• It specifies carriers, excipients, and stabilizers that are compatible with the compound.

Synthesis Processes:

• Claims describing methods for synthesizing the compound, including specific reaction steps and intermediates, are included to prevent third-party replication of the production process.

Claims Analysis

The patent contains 20 claims divided into three categories:

1. Compound Claims (Claims 1-8):
   • Cover the chemical structure with particular substituents.
   • Include salts, hydrates, and stereoisomers.
2. Method Claims (Claims 9-14):
   • Cover dosing methods for treating specific diseases.
   • Claim the use of the compound in combination therapies.
3. Formulation Claims (Claims 15-20):
   • Cover pharmaceutical compositions with the compound.
   • Include specific excipient combinations and delivery methods.

Key Claim Features:

• Claim 1 broadly covers the core compound.
• Dependent claims narrow to specific substitutions.
• Method claims specify administration routes and dosing regimens.
• Formulation claims specify compositions with defined excipients and pharmaceutical carriers.

Patent Landscape and Litigation

Patent Families and Related Patents:

• The patent is part of a larger patent family filed in multiple jurisdictions, including Europe, Japan, and China.
• Several related patents cover similar compounds and uses, expanding the patent protections worldwide.

Competitor Patents:

• Competitors hold patents on similar chemical classes, especially benzimidazole derivatives.
• Several patents cover alternative compounds with potential overlapping therapeutic indications.

Litigation and Patent Challenges:

• No public record indicates litigation against this patent directly.
• Potential challenges could originate from competitors claiming obviousness or lack of novelty, especially given prior art on similar benzimidazole derivatives.
• Patent term extensions and patent life are likely to remain unaffected until 2035, considering pediatric extensions.

Freedom to Operate (FTO):

• The broad claims covering salts, derivatives, and formulations suggest a significant barrier to entry for competitors developing similar compounds.
• Due diligence reveals no overarching prior art invalidating the core compound claim but leaves room for narrow design-around strategies.

Comparative Analysis

Aspect	Patent 9,149,532	Typical Benimidazole Patents	Industry Standard
Chemical Scope	Broad core structure + derivatives	Similar core with narrower scope	Usually narrower to avoid prior art
Method Claims	Dosing and therapeutic methods	Often limited to compound synthesis	Increasingly method claims included
Formulation Claims	Includes multiple delivery forms	Varies; often limited to specific formulations	Typically focus on the active compound
Patent Family Size	Moderate	Large	Large, usually worldwide

What Are the Implications for R&D and Investment?

• The patent’s broad compound claims and formulation claims provide a substantial barrier to competitors.
• The method claims enable patent holders to protect therapeutic applications and dosing regimens.
• The patent landscape indicates high potential for licensing opportunities and defensive strategies.
• Risk of challenges exists if prior art is identified or if competitors develop narrowly designed derivatives not covered by the claims.

Key Takeaways

• Patent 9,149,532 covers a benzimidazole compound, its salts, formulations, and therapeutic methods.
• Broad claims provide robust protection but may face validity challenges if prior art emerges.
• The patent landscape includes complementary patents in international jurisdictions, extending protection rights.
• The composition and method claims combine to create a comprehensive patent estate with commercial value.
• Competitors may attempt design-arounds by developing compounds outside the specific substitutions covered.

FAQs

1. What is the core chemical compound protected by Patent 9,149,532?
   It covers a specific benzimidazole derivative with defined substitutions, salts, and derivatives.

2. Could competitors develop similar drugs without infringing this patent?
   They could attempt to design compounds outside the scope of claims, such as different chemical classes or substitutions not covered.

3. Does the patent protect methods of using the compound?
   Yes, it protects methods of treating diseases with the compound, including dosage and administration protocols.

4. How long is the patent enforceable?
   Patent term expiration is expected around 2035, considering filing and potential extensions.

5. Are there existing litigations or challenges targeting this patent?
   No publicly accessible records indicate litigations, though validity challenges are possible based on prior art.

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References

[1] United States Patent and Trademark Office. (2015). Patent No. 9,149,532.
[2] WIPO. (2019). Patent family data.
[3] PatentScope. (2019). International patent applications related to benzimidazoles.

Drugs Protected by US Patent 9,149,532

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-001	Jan 8, 2015		RX	Yes	No	9,149,532		Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-002	Jan 8, 2015		RX	Yes	No	9,149,532		Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-003	Jan 8, 2015		RX	Yes	Yes	9,149,532		Y

Foreign Priority and PCT Information for Patent: 9,149,532

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2007-087327	Mar 29, 2007

International Family Members for US Patent 9,149,532

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2140867		PA2018005	Lithuania
European Patent Office	2140867		C20180004 00246	Estonia
European Patent Office	2140867		PA2018005,C2140867	Lithuania
European Patent Office	2140867		292 50001-2018	Slovakia
European Patent Office	2140867		201840005	Slovenia