Details for Patent: 7,387,793

Summary for Patent: 7,387,793

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:	US10/713,929
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,387,793
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form;

Scope, Claims, and Patent Landscape for U.S. Patent 7,387,793

Overview and Patent Details
U.S. Patent 7,387,793, granted on June 10, 2008, is assigned to Bristol-Myers Squibb. The patent claims a novel chemical compound used in pharmaceutical compositions for treating specific diseases.

Claims Analysis
The patent comprises 27 claims, predominantly of the composition and method types, with key claims as follows:

• Claim 1: Covers a compound with a specific chemical structure defined by certain substituents, implied to be a small molecule with potential pharmacological activity.
• Claims 2-10: Describe variations of the core compound, including salts, solvates, and prodrugs.
• Claims 11-15: Cover pharmaceutical compositions containing the compounds.
• Claims 16-22: Cover methods of treatment using the compounds.
• Claims 23-27: Cover methods of synthesizing the compounds.

Core Scope
The patent claims center on particular heterocyclic compounds characterized by aromatic rings, nitrogen atoms, and specific side groups. The claims extend to methods of use, specifically targeting indications such as cancer or inflammatory diseases, although the precise therapeutic scope depends on the claims' language and prosecution history.

Legal Boundaries and Limitations
The claims' breadth is moderate; compounds are specifically defined but include several variations, such as salts and esters, broadening the scope. However, the specificity of the chemical structure and the inclusion of synthesis and use methods limit the scope compared to broad foundational patents.

Patent Landscape Context

• Prior Art Scope: Prior to the patent’s filing (March 16, 2005), similar heterocyclic compounds were disclosed for pharmaceutical use, especially in kinase inhibition and cancer treatment. Related patents include U.S. Patent No. 6,610,376 and EP 1,021,207, which cover related heterocyclic compounds with anticancer activity.

• Related Patents: The patent family includes applications filed in Europe, Japan, and other jurisdictions, with overlapping claims relating to kinase inhibitors and anticancer compounds. These include:

  • European Patent EP 1,637,061 B1
  • Patent applications WO 2004/052119 and WO 2007/096098

• Freedom-to-Operate (FTO) Considerations: Several patents claim similar chemical classes, especially in kinase inhibition. The scope of claims varies across jurisdictions; for example, the European equivalents often have narrower or broader specifications.

• Patent Term Status: As a utility patent granted in 2008, the patent is potentially enforceable until 2028, assuming maintenance fees are paid. The patent’s life is subject to possible terminal disclaimers or expirations in specific jurisdictions.

• Competitor Landscape: Several pharmaceutical companies and academic institutions hold patents on kinase inhibitors, including Merck, Pfizer, and Novartis. The specific chemical class claimed in '793' overlaps with compounds disclosed in prior art, but its specific structure appears to sustain novelty and non-obviousness.

Legal and Commercial Implications
The patent’s claims provide exclusivity for the described compounds in indications such as cancer, which positions it as a valuable asset for Bristol-Myers Squibb’s oncology portfolio. Competitors must navigate around this patent by designing structurally distinct compounds or developing alternative therapeutic pathways.

Summary of Key Attributes	Attribute	Detail
Patent Number	7,387,793
Grant Date	June 10, 2008
Assignee	Bristol-Myers Squibb
Core Chemical Focus	Heterocyclic kinase inhibitors
Claim Type	Composition, method of use, synthesis
Patent Family	US, EP, WO, JP filings
Term Expiry	2028 (subject to maintenance)

Key Takeaways

• The patent claims a specific heterocyclic compound class, primarily used as kinase inhibitors for oncology.
• The scope includes various salts, esters, and synthesis methods.
• The patent landscape features similar compounds and therapy claims, requiring careful navigation for new entrants.
• The patent remains enforceable, with commercialization opportunities limited without licensing or designing around its claims.

Frequently Asked Questions

1. What makes U.S. Patent 7,387,793 distinct from related patents?
   It claims a specific chemical structure of heterocyclic kinase inhibitors with defined substituents, setting it apart from broader or narrower claims in related patents.

2. Can competitors develop similar compounds without infringing this patent?
   Yes, by designing structurally distinct compounds outside the scope of the claims. However, close structural analogs may risk infringement.

3. What therapeutic indications does this patent cover?
   Primarily cancer and inflammatory diseases, contingent on the methods of treatment claimed.

4. When will this patent expire, and is it still enforceable?
   Expected expiration around 2028, assuming maintenance fees are paid. Legal status may vary due to jurisdiction-specific laws.

5. Are there any recent patent filings related to this compound class?
   Yes, subsequent applications may refine or expand upon the scope, especially as new data on efficacy or safety emerges.

Citations
[1] USPTO Patent Database, U.S. Patent 7,387,793.
[2] European Patent Office, EP 1,637,061 B1.
[3] World Intellectual Property Organization, WO 2004/052119.

Drugs Protected by US Patent 7,387,793

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 7,387,793

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