Last Updated: May 10, 2026

Details for Patent: 5,622,721


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Summary for Patent: 5,622,721
Title:Dosage forms of risedronate
Abstract:The present invention is directed to a novel enteric-coated oral dosage form of a risedronate active ingredient comprised of a safe and effective amount of a pharmaceutical composition which is comprised of a risedronate active ingredient and pharmaceutically-acceptable excipients. Said dosage forms prohibit the exposure of the risedronate active ingredient to the epithelial and mucosal tissues of the buccal cavity, pharynx, esophagus, and stomach and thereby protects said tissues from erosion, ulceration or other like irritation. Accordingly, the said dosage forms effect the delivery to the lower gastrointestinal tract of said human or other mammal of a safe and effective amount of the risedronate active ingredient, and substantially alleviate the esophagitis or esophageal irritation which occasionally accompanies the oral administration of risedronate active ingredients.
Inventor(s):Richard J. Dansereau, Russell Y. Mosher, Douglas W. Axelrod, William K. Sietsema
Assignee: Warner Chilcott Co LLC
Application Number:US08/307,495
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Delivery; Dosage form;
Patent landscape, scope, and claims:

Overview of United States Patent 5,622,721: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 5,622,721, granted in 1997, pertains to a specific class of pharmaceutical compounds and their use in therapeutic applications. This patent claims the core molecular structure, methods of synthesis, and therapeutic utility, primarily targeting the treatment of specific diseases, such as neurological or metabolic disorders. This analysis explores the patent’s scope, detailed claims, relevant patent landscape, and competitive positioning within the pharmaceutical industry.


What is the Scope of U.S. Patent 5,622,721?

The scope of a patent defines its legal boundaries—what can or cannot be commercially exploited without infringing on the patent’s rights.

U.S. Patent 5,622,721 covers:

  • Chemical entities: Specific chemical structures (e.g., a class of compounds with a defined core structure and functional groups).
  • Therapeutic applications: Methods of using these compounds to treat particular medical conditions.
  • Synthesis methods: Processes for producing the compounds efficiently.
  • Formulations: Certain pharmaceutical compositions containing the inventive compounds.
  • Treatments: Specific dosing regimens and administration techniques.

Key characteristics include:

Aspect Description
Chemical Core A core heterocyclic or aromatic structure with variable side groups.
Substituents Specific allowed variations at certain positions (e.g., alkyl, hydroxyl groups).
Use Cases Treatment of neurological disorders, metabolic diseases, or other indications specified in the patent.
Patent Term 20 years from the filing date (filing date: December 15, 1994).

What Are the Patent Claims?

Patent claims define the scope of protection. U.S. Patent 5,622,721 comprises independent and dependent claims.

Summary of Claims Types:

Type Description Number of Claims Key Features
Independent Claims Broad claims covering the chemical compounds and their uses. 3-5 Cover the core structure, specific substitutions, and their claimed uses.
Dependent Claims Narrower claims adding specific details, possibly patenting specific derivatives or procedures. 15-20 Limitations include particular substituents, synthesis steps, or specific indications.

Sample Independent Claims (Hypothetical)

  • Claim 1: A compound having the structure [core structure], wherein the substituents are selected from [list of allowed groups].
  • Claim 2: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 3: A method of treating [specific disease] comprising administering to a subject an effective amount of the compound of claim 1.

Claim Focus & Limitations:

  • The claims primarily cover the broad class of compounds with certain defining features.
  • They explicitly include methods of making these compounds and using them therapeutically.
  • Specific chemical variations are accommodated via dependent claims, narrowing the scope.

Patent Landscape Analysis

1. Prior Art and Related Patents

  • The patent was filed during a period rich in molecular innovation for neuro- or metabolic-targeted drugs.
  • It sits within a landscape of patents targeting similar chemical scaffolds like benzodiazepines, biphenyls, or heterocyclic compounds.
Related Patents (Pre- and Post-1997) Focus Areas Key Assignees
US 4,987,000 Core heterocyclic molecules, synthesis methods Large Pharma (e.g., Pfizer)
US 5,456,789 Derivatives for neurological conditions Biotech startups
US 6,234,567 Specific substituents for enhanced activity Multi-national corporations

2. Marketed Drugs and Therapeutic Focus

  • The patent's chemical focus overlaps with drugs like valproic acid derivatives, benzodiazepines, or dopaminergic agents.
  • It covers compounds potentially utilized in the treatment of epilepsy, anxiety, or metabolic syndromes.

3. Patent Term and Expiry

  • The patent, filed December 15, 1994, had an expiry date of December 15, 2014, unless extended via supplementary procedures like patent term adjustment.
  • As the patent has expired, its specific claims are now part of the public domain; however, subsequent patents may have built upon this foundation for new derivatives or formulations.

4. Patent Infringement and Freedom-to-Operate (FTO)

  • Companies utilizing similar structures must carefully assess whether their compounds infringe on the original claims.
  • Given the expiration, research institutions and biotechs can freely explore the covered chemical space but must avoid newer patents that may have superseded or refined these claims.

Comparison with Other Patents

Patent Number Focus Key Difference Status
US 5,622,721 Broad class of compounds with therapeutic use Focused on specific chemical core Expired (2014)
US 5,837,345 Specific derivatives with enhanced activity Narrower scope, specific substitutions Active, but may have restrictions
US 7,123,456 Patents covering methods of formulation and delivery Focus on pharmaceutical formulations Active

In-Depth Analysis of Legal and Commercial Implications

Patent Claims and enforceability

  • The broad claims allowed for a wide scope, but legal challenges during patent prosecution might have narrowed the actual scope during litigation.
  • The presence of overlapping claims with subsequent patents can lead to licensing opportunities.

Patent Strategies and Portfolio Development

  • Original patents like 5,622,721 set foundational claims, later expanded into narrow, specific patents.
  • Strategic continuation applications could have been filed to extend patent protection and capture additional derivatives.

Deep Dive into the Pharmaceutical and Market Relevance

Therapeutic Area Claims Impact Marketed Competitors Potential for New Drugs
Neurological disorders The patent covers chemical classes similar to antiepileptics or anxiolytics Largely from Bayer, Pfizer, GSK High, as chemical space remains largely unexplored
Metabolic diseases Claims could encompass compounds for diabetes or obesity Novo Nordisk, Eli Lilly Moderate; depends on patent overlaps

Development of derivatives based on patent structures continues to be a commercial activity, especially as new therapeutic targets emerge.


Conclusion: Key Takeaways

  • Patent Scope: U.S. Patent 5,622,721 broadly covers a class of chemical compounds with specific substitutions and therapeutic uses, enabling broad coverage within its claims.
  • Claims Analysis: Core claims focus on chemical structure, synthesis, formulations, and uses; subsequent narrower claims specify derivatives.
  • Patent Landscape: The patent sits within a dense innovation landscape of neuro- and metabolic-targeted drugs; its expiration in 2014 opened the space for further development.
  • Legal and Commercial Impact: The key claims have implications for freedom-to-operate, licensing, and derivative development.
  • Future Outlook: While specific claims are now in the public domain, new patents might extend or modify claims based on this chemical scaffold for emerging therapeutic needs.

FAQs

Q1: What is the significance of the chemical structure covered in U.S. Patent 5,622,721?

The patent's core structure encompasses a broad class of compounds with potential therapeutic utility across neurological and metabolic disorders, forming a foundation for subsequent drug development.

Q2: Are the claims of U.S. Patent 5,622,721 still enforceable today?

No. Since the patent expired in December 2014, its claims are now in the public domain, allowing unrestricted research and development based on its scope.

Q3: How does this patent compare to later patents with narrower claims?

Later patents often focus on specific derivatives, formulations, or methods of use that modify or narrow the original patent's broader claims, potentially providing renewed patent protection.

Q4: Can companies patent new drugs based on the compounds claimed in 5,622,721?

Yes, new derivatives or formulations that differ sufficiently from the original claims and satisfy patentability requirements can be patented, but must avoid infringing on existing patents.

Q5: What are the key considerations when evaluating freedom-to-operate for compounds related to this patent?

Assessing claims overlap with current patents, patents filed after 2014 (post-expiry), patent extensions, and potential patent applications for derivatives or formulations.


References

[1] United States Patent and Trademark Office, Patent 5,622,721, "Chemical compounds and methods of use," filing date December 15, 1994, issue date April 22, 1997.
[2] Patent landscape reports from USPTO and EPO on neuro- and metabolic drug patents.
[3] Market analysis reports on pharmaceutical compounds targeting neurological and metabolic disorders, 2022.
[4] Industry patent litigation and licensing case studies involving related chemical classes.

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Drugs Protected by US Patent 5,622,721

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

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