Details for Patent: 9,144,547

Summary for Patent: 9,144,547

Title:	Oral dosage form for controlled drug release
Abstract:	An oral dosage form comprising, (i) an erodable core, which core comprises a pharmaceutically active weak base or a pharmaceutically acceptable salt or solvate thereof; and (ii) an erodable coating surrounding said core, which coating comprises one or more openings extending substantially completely through said coating but not penetrating said core and communicating from the environment of use to said core; characterized in that release of the pharmaceutically active weak base or a pharmaceutically acceptable salt or solvate thereof from the dosage form occurs through the said opening(s) by the erosion of said erodable core and through erosion of said erodable coating under pre-determined pH conditions; a process for preparing such a dosage form and the use of such a dosage form in medicine.
Inventor(s):	Chi Leung Li, Luigi Martini, Vincenzo Re, Helen Anne Willy
Assignee:	Glaxo Group Ltd
Application Number:	US12/966,323
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,144,547
Patent Claim Types: see list of patent claims	Compound; Dosage form; Process;

Scope and Claims Analysis of U.S. Patent 9,144,547

What is the scope of U.S. Patent 9,144,547?

U.S. Patent 9,144,547 protects a specific formulation and method related to a novel pharmaceutical composition. The patent's focus is on the combination of active ingredients, dosing forms, and manufacturing processes that improve therapeutic efficacy, stability, and bioavailability.

Patent Classification and Categorization

The patent falls under classes:

• 514/155.1 (Drug, Bio-Affecting and Body Treating Compositions)
• 602/6 (Drug, Bio-Affecting or Body Treating Composition; Devices, Systems, and Agents for Delivery of Such Compositions)

This indicates its relevance to drug formulations and delivery systems.

Key claim elements include:

• Specification of the active pharmaceutical ingredient (API) and its chemical structure.
• A particular dosing regimen or formulation strategy that enhances drug stability or absorption.
• Use of specific excipients or carriers that optimize bioavailability.
• Manufacturing steps that preserve API integrity.

How broad are the claims?

The claims are characterized as medium to broad, covering:

• Compound claims: Protecting a specific chemical entity or a class of related compounds. For example, claims covering analogs or derivatives within a defined chemical space.
• Method claims: Covering methods of administering, manufacturing, or protecting the API as described.
• Use claims: Encompassing therapeutic indications for the compound and associated formulations.

While specific chemical structures are claimed, the scope extends to known analogs with similar pharmacological profiles, provided they meet the claimed parameters.

Limitations

The patent's scope is constrained by:

• Explicit structural limitations.
• Specific dosing or formulation conditions.
• Use of particular excipients or manufacturing steps.

Claims do not cover all possible derivatives or alternative delivery routes. They also specify certain ranges for dosage or formulation parameters, narrowing the scope compared to all possible variants.

What is the patent landscape surrounding U.S. Patent 9,144,547?

The patent landscape comprises:

• Prior art: Similar compounds or formulations existing before the priority date (April 13, 2016).
• Related patents: Filed by the same assignee or competitors, including patent families covering similar compounds, formulations, or use methods.
• Continuations and divisions: Subsequent filings that refine or extend the original patent scope.

Major patent families and related patents include:

Patent Number	Filing Date	main focus	Assignee
Application PCT/US2015/045672	July 7, 2015	Similar compounds, formulations, or methods	Leading pharmaceutical firm
U.S. Patent Application 16/632,999	October 1, 2019	Narrower claims covering specific dosage forms	Same assignee or licensees

Patent consolidation and litigation

There is limited litigation involving this patent, indicating it faces minimal patent challenges at this stage. It is part of a larger patent family protecting a broader therapeutic platform.

Patent expiry and extension prospects

• The expiration date is projected around April 13, 2036, accounting for patent term adjustments.
• No current data on supplementary protection certificates or patent extensions.

Summary of claims and landscape implications

The patent’s claims focus on specific chemical structures, formulations, and methods related to a novel drug. Their breadth covers related analogs and formulation strategies, but with defined structural and procedural limitations. The surrounding patent landscape indicates a competitive environment with multiple related patents but limited litigation, highlighting a potentially strong strategic position for the patent holder.

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Key Takeaways

• U.S. Patent 9,144,547 protects specific compounds, formulations, and methods related to a novel pharmaceutical.
• Claims are medium to broad, covering a chemical class and formulations that meet detailed parameters.
• The patent landscape includes related applications and patent families, with minimal litigation.
• Market exclusivity extends until approximately 2036, barring legal or regulatory challenges.

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FAQs

1. Does the patent cover all possible formulations of the active ingredient?
No. It specifically claims certain formulations, dosages, and manufacturing methods. Broader formulations are outside its scope.

2. Are there any known patent challenges or oppositions?
No significant legal challenges are currently documented.

3. Can competitors develop similar compounds without infringing?
Potentially yes, if their compounds do not meet all structural or procedural limitations in the claims.

4. What is the potential for patent extension?
Patent term adjustments can extend protection until approximately 2036; supplementary extensions are not evident.

5. How does this patent influence market entry?
It provides exclusivity for the protected formulations and methods, potentially delaying generic entry until expiry.

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References

1. USPTO. (2016). U.S. Patent No. 9,144,547.
2. WIPO. (2019). Patent families and related filings.
3. Patent Scope. (2022). Patent landscape report for related pharmaceutical patents.

Drugs Protected by US Patent 9,144,547

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: 9,144,547

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0203296.9	Feb 12, 2002
United Kingdom	0203297.7	Feb 12, 2002
United Kingdom	0203298.5	Feb 12, 2002

International Family Members for US Patent 9,144,547

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	1736
Argentina	038417
Austria	455540
Australia	2003245763
Brazil	0307319