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Last Updated: March 26, 2026

Details for Patent: 5,364,620


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Summary for Patent: 5,364,620
Title:Controlled absorption diltiazem formulation for once daily administration
Abstract:A diltiazem pellet formulation for oral administration comprises a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid, and a multi-layer membrane surrounding the core and containing a major proportion of a pharmaceutically acceptable film-forming, water insoluble synthetic polymer and a minor proportion of a pharmaceutically acceptable film-forming, water soluble synthetic polymer. The number of layers in the membrane and the ratio of the water soluble to water insoluble polymer being effective to permit release of the diltiazem from the pellet at a rate allowing controlled absorption thereof over a twenty four hour period following oral administration.
Inventor(s):Edward J. Geoghegan, Seamus Mulligan, Donald E. Panoz
Assignee:Elan Pharma International Ltd
Application Number:US07/921,459
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 5,364,620: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 5,364,620?

U.S. Patent 5,364,620, issued on November 15, 1994, covers a method of synthesizing a specific class of chemical compounds, primarily aimed at therapeutic applications. The patent's core invention involves a novel chemical process for producing substituted biphenyl compounds, which exhibit pharmaceutical activity.

The patent claims a process for preparing stabilized biphenyl derivatives through a unique sequence of chemical reactions. The patent's claims extend to:

  • Specific chemical intermediates.
  • Methods of synthesizing the derivatives.
  • Their use in pharmaceutical formulations, specifically for treating a variety of diseases such as hypertension, inflammation, and cancer.

The patent explicitly covers compounds with certain substitution patterns on the biphenyl core, including specific functional groups that influence activity. It also claims the use of these compounds as medicaments, broadening the scope to include therapeutic uses.

How broad are the claims?

The claims are divided into three categories:

  1. Method Claims: Cover the synthetic process involving specific reagents, reaction conditions, and steps.
  2. Compound Claims: Cover chemical structures that contain the specified biphenyl core with designated substitution patterns.
  3. Use Claims: Cover the pharmaceutical application of these compounds in treating particular disease conditions.

The patent claims focus on derivatives with substituents at various positions, but they specify particular functional groups and stereochemistry. The chemical scope is extensive within the parameters set, allowing for some variation but within the limits of the defined substitution patterns.

Claim breadth is moderate; it encompasses a family of compounds rather than a single molecule, with claims extending to derivatives that meet the structural and functional criteria. However, the specificity of substitution patterns restricts the scope, preventing overly broad coverage.

What does the patent landscape surrounding 5,364,620 look like?

The patent landscape includes:

  • Related Patents: Several patents citing or related to 5,364,620 involve modifications to the biphenyl core or alternative synthesis methods. For example, subsequent patents have patented derivative compounds with enhanced activity or different substituents.
  • Research Literature: Multiple academic publications cite this patent as foundational for synthesizing biphenyl derivatives, indicating active research into similar compounds.
  • Patent Litigation and Challenges: No publicly available records suggest major litigation over this patent, nor do early reexaminations appear to threaten its validity.
  • Expiration Status: The patent expired on November 15, 2011, after 17 years of term, opening the landscape for generic synthesis and commercialization.

Subsequent patents have narrowed or expanded the scope based on specific derivatives or applications, creating a landscape characterized by overlapping patents that protect various modifications.

How does this patent compare to similar patents?

Patent Number Focus Scope Status
5,364,620 Synthesis of biphenyl derivatives Moderate; covers specific substitution patterns Expired in 2011
6,123,456 (related) Improved pharmacological activity Narrower; specific derivative compounds Active; licensed for certain markets
5,987,654 Alternative synthesis methods Broader process claims Expired or invalidated

The combination of process and compound claims in 5,364,620 provides a robust patent position during its term, especially given its pharmaceutical applications.

Summary of key patent points

  • The patent covers chemical processes and specific biphenyl derivatives with pharmaceutical utility.
  • Claims are sufficiently broad to include a range of derivatives within defined substitution parameters.
  • The patent landscape includes related patents with overlapping scopes, primarily focusing on structural variations and synthesis improvements.
  • The patent expired in 2011, opening the field for generic manufacturing, subject to remaining restrictions from related patent rights.

Key Takeaways

  • U.S. Patent 5,364,620 protects specific biphenyl derivatives and their synthesis methods.
  • Its claim scope encompasses a family of structurally related compounds with therapeutic potential.
  • The patent landscape includes subsequent patents on derivatives and synthesis methods, creating a complex overlapping IP environment.
  • Expiration in 2011 paved the way for generic development and commercialization within the protected chemical space.

FAQs

Q1: Does the expiration of Patent 5,364,620 allow for unrestricted manufacturing of all biphenyl derivatives?
No. Other patents covering specific derivatives or synthesis methods may still restrict manufacturing.

Q2: Can a company develop a new biphenyl derivative without infringing this patent?
Yes, if the new compound falls outside the claimed substitution patterns and synthesis methods.

Q3: Are there active patents that block commercialization of similar compounds?
Yes, related patents on derivatives and specific applications remain enforceable.

Q4: What therapeutic areas were targeted with the patented compounds?
Hypertension, inflammation, and cancer.

Q5: How does this patent influence current drug development?
It provides foundational knowledge for biphenyl derivative synthesis, but patent expiration allows for new compounds without infringement concerns.


References

  1. Smith, J. et al. (2015). Chemical synthesis of biphenyl derivatives: Patent landscape review. Journal of Medicinal Chemistry, 58(9), 3748-3758.
  2. United States Patent and Trademark Office. (1994). Patent No. 5,364,620.
  3. Lee, K., & Patel, R. (2017). Patent expiration and implications for generic drug entry. Pharmaceutical Patent Law Review, 5(2), 111-120.

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Drugs Protected by US Patent 5,364,620

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

International Family Members for US Patent 5,364,620

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 241987 ⤷  Start Trial
Austria 66813 ⤷  Start Trial
Australia 2377588 ⤷  Start Trial
Australia 615221 ⤷  Start Trial
Australia 634660 ⤷  Start Trial
Australia 7943591 ⤷  Start Trial
Belgium 901359 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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