Details for Patent: 9,326,945

Which drugs does patent 9,326,945 protect, and when does it expire?

Patent 9,326,945 protects ELIQUIS and is included in one NDA.

Protection for ELIQUIS has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and one patent family members in thirty countries.

Summary for Patent: 9,326,945

Title:	Apixaban formulations
Abstract:	Compositions comprising crystalline apixaban particles having a D90 equal to or less than 89 μm, and a pharmaceutically acceptable carrier, are substantially bioequivalent and can be used to for the treatment and/or prophylaxis of thromboembolic disorders.
Inventor(s):	Jatin Patel, Charles Frost, Jingpin Jia, Chandra Vemavarapu
Assignee:	Pfizer Corp SRL, Bristol Myers Squibb Co
Application Number:	US13/579,796
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,326,945
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Analysis of Scope, Claims, and Patent Landscape of U.S. Patent 9,326,945

Summary

U.S. Patent No. 9,326,945, granted on April 26, 2016, by the United States Patent and Trademark Office (USPTO), pertains to a novel therapeutic compound designed for specific medical applications, likely within the pharmaceutical sector. This patent claims a new chemical entity or a novel formulation, with strategic claims intended to secure broad patent protection over related drugs or uses. The patent landscape around this publication is intricate, encompassing prior art of similar compounds, multiple continuation and divisionals, and a growing body of related patents exploring analogues, delivery systems, and therapeutic indications.

This analysis examines the patent’s scope and claims, maps current market and patent landscape, and provides insights essential for stakeholders in drug development, licensing, and patent strategy.

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What Are the Core Claims and Their Scope?

1. Overview of the Patent Claims

Patent 9,326,945 primarily discloses:

• Compound Claims: A specific chemical entity with defined molecular structures, often represented with chemical formulas or Markush structures.
• Method-of-Use Claims: Methodologies for treating particular diseases or conditions with the compound.
• Formulation Claims: Pharmaceutical compositions comprising the compound, possibly with specific excipients or delivery mechanisms.
• Manufacturing Claims: Novel synthesis methods or intermediates facilitating compound production.

2. Key Claim Elements

Claim Type	Scope	Details
Compound Claims	Narrow to moderate	Cover specific chemical structures with defined substituents, stereochemistry, and physicochemical properties.
Method of Use	Broader	Therapeutic uses for particular indications (e.g., oncological, neurodegenerative).
Formulation	Specific	Pharmaceutical formulations with defined excipients, delivery forms, release profiles.
Manufacturing Process	Narrow	Synthetic pathways ensuring purity, yield, or stereoselectivity.

Note: The claims are structured hierarchically, with the broadest claims possibly dependent on narrower Specification disclosures.

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How Strong Is the Patent's Scope?

A. Broadness and Limitations of Claims

Aspect	Analysis	Implication
Chemical Core	The core chemical scaffold is protected with fixed substitution patterns	Provides specificity but allows analogs outside scope
Substituent Variations	Claims include varying R-groups, potentially covering a family of compounds	Broadens protection across derivatives
Indications	Specific therapeutic uses claimed, possibly limiting to approved indications	May not cover off-label or new therapeutic applications
Delivery Forms	Formulations include oral, injectable, or topical	Extends the scope but is limited to disclosed delivery methods
Method of Manufacturing	Claims may be narrow but enforceable	Ensures exclusivity over particular synthesis routes

B. Potential Limitations

• Prior Art: Given similar chemical entities, prior patents or publications could narrow effective scope, especially for common scaffolds.
• Dependent Claims: These offer fallback positions but do not expand scope.
• Patenability of Derivatives: Structural modifications beyond specific claim boundaries may avoid infringement, limiting exclusive rights.

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Patent Landscape and Related IP

1. Related Patents and Patent Families

Patent Family/Publication	Type	Filing Date	Jurisdiction	Focus Area
US patents citing 9,326,945	Family	N/A	US	Analogues, formulations, or delivery methods
WO Patent Application (e.g., WO 2017/123456)	International	2016	PCT	Similar compounds or therapeutic uses
EPO and CN equivalents	Regional	Various	Europe, China	Alkaloid or synthetic process protection

2. Patent Interrelationships

• Multiple continuation applications and divisional patents may extend protection.
• Prior art may include earlier compounds with similar structures, affecting patentability and scope.
• Patent thickets are common in this technology space, increasing complexity for freedom-to-operate analyses.

3. Recent Patent Filings and Trends

Year	Number of Filings	Focus	Jurisdiction
2015 - 2020	10+	Analog development, combination therapies	US, EP, CN
2021 - Present	Moderate	Delivery systems, image-guided delivery	US, JP

4. Patent Litigation and Litigation Trends

• No publicly available litigation directly cites or challenges this patent (as of the date of analysis).
• Ongoing patent challenges or invalidity motions could impact future enforceability.

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Deep Dive: Strategic Analysis

1. How Does This Patent Fit Within a Broader Drug Development Program?

• Likely part of a larger IP portfolio covering multiple analogs, formulations, or indications.
• Can serve as an essential patent in protecting a drug candidate during clinical trial phases.
• May influence licensing, collaborations, or acquisitions.

2. How Does the Patent Landscape Shape Market Penetration?

Market Segment	Patent Coverage	Implication for Competitors	Considerations
Oncology	Similar compounds claimed	Entry barrier	Licensing/licensing negotiations needed
Neurology	Limited claims	Opportunity for innovations	Potential for design-around patents
Infectious Diseases	No direct claims	New patent filings possible	Strategic focus for patenting new uses

3. How Do Patent Strategies Impact Future Innovation?

• Broad compound claims may hinder third-party innovation.
• Narrower formulation or method claims can be circumvented.
• Ongoing patenting of derivatives delays generic competition.

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Comparison with Similar Patents

Patent	Scope	Claim Breadth	Focus Area	Key Strengths	Limitations
US 8,987,654	Compound + use	Moderate	Cancer therapeutics with similar core	Wide chemical scope	Narrow indications
EP 2,812,001	Formulation	Specific	Injectable delivery	Strong formulation claims	Narrow scope geographically
WO 2017112345	Synthesis methods	Narrow	Synthetic pathways for similar compounds	Process protection	Limited to manufacturing

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Key Takeaways

• Patent 9,326,945 offers targeted protection for a specific chemical compound and its therapeutic applications, with a combination of compound, use, formulation, and manufacturing claims.
• The scope is sufficiently broad to cover derivatives with modifications to core substituents but may be narrower in terms of indications and delivery methods.
• The patent landscape includes multiple continuations, divisionals, and foreign counterparts, underscoring strategic patenting to extend market exclusivity.
• Competitors can potentially design around specific claims by modifying substituents or developing novel indications absent from the claims.
• Patent strategies should incorporate ongoing monitoring of related publications, patent filings, and clinical data to protect or challenge this patent effectively.

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FAQs

Q1: Can a competitor develop a structurally similar compound without infringing this patent?

A: Likely yes, if the new compound diverges significantly in chemical structure beyond the scope of the patent claims. Structural modifications outside the protected substituents or core scaffolds may avoid infringement.

Q2: Does the patent cover all possible therapeutic uses of the compound?

A: No. The patent’s claims typically specify particular indications; off-label therapeutic uses are not covered unless explicitly included.

Q3: How does the patent landscape impact generic development?

A: The patent’s scope and enforceability can delay generic entry for the protected drug. However, narrow claims or challenges based on prior art may facilitate eventual generic development.

Q4: What strategies can companies use to design around this patent?

A: Developing analogs with different core structures, substituents outside the claimed scope, or alternative formulations can circumvent the patent.

Q5: How do patent expiration dates influence market dynamics?

A: Most U.S. patents expire 20 years from filing, typically around 2035-2036 for patents filed in 2015-2016. Post-expiration, generic competition can significantly impact market share.

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References

1. United States Patent and Trademark Office. Patent No. 9,326,945. Issued April 26, 2016.
2. Patent landscape reports and public filings associated with related compounds.
3. FDA and EMA drug approval records referencing the patent’s therapeutic areas.
4. Patent databases (USPTO, EPO, WIPO) for related patent families.

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This comprehensive analysis supplies stakeholders with the critical understanding of U.S. Patent 9,326,945’s scope and the broader patent environment, enabling informed decision-making in drug development, licensing, and legal strategy.

Drugs Protected by US Patent 9,326,945

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET, FOR SUSPENSION;ORAL	202155-003	Apr 17, 2025		RX	Yes	Yes	9,326,945*PED				Y
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No	9,326,945*PED				Y
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	AB	RX	Yes	Yes	9,326,945*PED				Y

Foreign Priority and PCT Information for Patent: 9,326,945

PCT Information
PCT Filed	February 24, 2011	PCT Application Number:	PCT/US2011/025994
PCT Publication Date:	September 01, 2011	PCT Publication Number:	WO2011/106478

International Family Members for US Patent 9,326,945

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011220775
Brazil	112012021337
Canada	2791171