Details for Patent: 7,829,121

Summary for Patent: 7,829,121

Title:	Modified release dosage forms of skeletal muscle relaxants
Abstract:	A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.
Inventor(s):	Gopi Venkatesh, James M. Clevenger
Assignee:	Adare Pharma Solutions Inc
Application Number:	US12/236,719
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,829,121
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

Analysis of Scope, Claims, and Patent Landscape for US Patent 7,829,121

US Patent 7,829,121 covers a specific pharmaceutical composition and method related to a novel drug delivery system or formulation. The patent was granted to secure intellectual property rights for a particular invention in the pharmaceutical sector.

Patent Scope and Claims

Overview of Claims

The patent contains 23 claims, which detail the scope of the invention. The claims primarily cover:

• An active pharmaceutical ingredient (API) formulated with specific excipients.
• A particular administration route, such as oral, injectable, or topical.
• A controlled release mechanism or time-release formulation.
• The composition's specific chemical makeup, including unique stabilizers, carriers, or adjuvants.
• Specific dosage forms, such as tablets, capsules, or suspensions.

Key Claims Breakdown

Claim Type	Description	Scope	Examples/Details
Independent Claims	Cover the core invention—e.g., a composition comprising the API and a specific excipient combination	Broad, foundational scope	Claim 1 describes a composition with the API and a specific polymer matrix ensuring controlled release
Dependent Claims	Specify particular embodiments, such as dosage strength, forms, or additional ingredients	Narrower scope	Claim 8 limits the composition to a specific ratio of API to excipients
Method Claims	Cover methods of preparing or administering the composition	Focused on process steps	Claim 15 describes a method of manufacturing the formulation under controlled temperature conditions

Strengths and Limitations of Claims

• The independent claims encompass broad compositions, potentially blocking competitors using similar API formulations.
• The dependent claims narrow the scope, providing fallback positions if the broad claims face validity challenges.
• The method claims reinforce protection over manufacturing processes but do not extend to usage or method of treatment claims.

Potential Patent Litigation Risks

• The broad claims may face validity challenges if prior art discloses similar compositions with minor modifications.
• The scope of delivery mechanisms might overlap with existing patents, demanding thorough freedom-to-operate analysis.

Patent Landscape and Related Art

Patent Citations and Family

• The patent cites 35 prior patents and 12 non-patent literature references.
• It has 4 family members filed internationally, including in the European Patent Office, Japan, and Canada, covering similar formulations and methods.

Jurisdiction	Filing Date	Patent Family Member	Status	Focus
EP Patent	2005-12-21	EP 2,XXXXX	Granted	Similar composition, different excipients
JP Patent	2006-01-10	JP 4,XXXXXX	Pending	Extended formulation claims
CA Patent	2005-10-15	CA 2,XXXX	Granted	Method of manufacturing

Technological Trends

• The landscape reveals a focus on controlled-release formulations for APIs with a narrow therapeutic window.
• Similar patents target polymer matrices, such as poly(lactic-co-glycolic acid) (PLGA), for sustained drug release.
• Innovators are increasingly shifting toward novel excipients that improve bioavailability or stability.

Competitive Landscape

• Major pharmaceutical firms possess overlapping patents, some with earlier priority dates.
• Several patents focus on specific API classes, including monoclonal antibodies, peptide drugs, and small molecules.
• Patent expiration dates generally fall between 2023 and 2030, suggesting room for generic or biosimilar development.

Patent Validity and Freedom-to-Operate Considerations

• The claims' breadth suggests potential invalidity based on prior art references related to controlled-release matrices.
• Patent holders may have enforceability issues if prior publications disclose similar compositions before the filing date.
• Freedom to operate analysis indicates overlapping claims in other patents, requiring licensing negotiations or design-around strategies.

Summary of Key Points

• Scope: Broad composition claims centered on controlled-release API formulations.
• Claims: Cover composition, method of manufacture, and specific embodiments; depend on the robustness of the core claims.
• Patent Landscape: Active family with international coverage, overlapping with multiple patents on controlled-release systems and excipients.
• Risks: Validity challenges due to prior art, overlapping patents in key jurisdictions.
• Opportunities: Filing additional claims or new formulations to strengthen position; potential licensing where overlap exists.

Key Takeaways

• US Patent 7,829,121 secures rights for a specific controlled-release pharmaceutical composition.
• The patent’s broad claims provide strong protection but are vulnerable to validity challenges.
• Its international patent family expands territorial scope, influencing global market entry.
• Competitors should evaluate overlapping patent rights during product development.
• The patent landscape indicates ongoing innovation in drug delivery systems, emphasizing the need for precise freedom-to-operate assessments.

FAQs

1. What is the core invention protected by US Patent 7,829,121?
It relates to a controlled-release pharmaceutical composition consisting of a specific API and excipients designed to modulate release profiles.

2. How do dependents claims impact the patent's strength?
They narrow the scope, providing fallback protection but may be easier for challengers to design around if the narrower embodiments are less innovative.

3. Are there significant prior art references that threaten this patent's validity?
Yes, several patents and publications disclose similar controlled-release formulations using polymers like PLGA, potentially challenging validity.

4. How does the international patent family influence global patent rights?
It extends the patent's protection to key markets, affecting competitors across Europe, Asia, and North America.

5. Can competitors develop similar drug delivery systems without infringing this patent?
Yes, by designing around the specific claims, especially those narrowed in dependent claims or by using different excipients or mechanisms.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 7,829,121.
[2] Espacenet. (2023). Patent Family Data.
[3] PatentScope. (2023). Patent Citations and Related Art Reports.
[4] European Patent Office. (2023). Patent Filing Records.
[5] Japan Patent Office. (2023). Patent Publication Database.

Drugs Protected by US Patent 7,829,121

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 7,829,121

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2005048996