Last Updated: May 10, 2026

Details for Patent: 5,342,623


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Summary for Patent: 5,342,623
Title:Subsaturated transdermal therapeutic system having improved release characteristics
Abstract:Rate controlled transdermal delivery devices are disclosed which utilize an in-line adhesive to maintain the device on the skin and deliver an agent which is a solvent or a plasticizer for the in-line adhesive. The initial equilibrated concentration of the agent in the agent reservoir and the adhesive is below saturation, and the reservoir comprises the agent dissolved in a solvent with respect to which the rate controlling element of the device is substantially impermeable. In preferred embodiments the initial loading of the agent in reservoir is sufficient to prevent the activity of the agent in the reservoir from decreasing by more than about 50% and preferably no more than about 25% during the predetermined period of administration; and the thicknesses of the adhesive, rate controlling membrane and reservoir layers are selected so that at least 50% and preferably at least 75% initial equilibrated agent loading is in the reservoir layer. The devices are usable to deliver agents which are liquid at body temperatures such as benztropine, secoverine, nicotine, arecoline, polyethylene glycol monolaurate, glycerol monolaurate, glycerol monooleate and ethanol, for example.
Inventor(s):David J. Enscore, Patricia S. Campbell, James L. Osborne, Melinda K. Smart, Su I. Yum
Assignee: Alza Corp
Application Number:US08/080,645
Patent Claim Types:
see list of patent claims
Use; Device;
Patent landscape, scope, and claims:

Overview of US Patent 5,342,623: Scope, Claims, and Patent Landscape

US Patent 5,342,623 covers a pharmaceutical composition and method for treating a specific disease or condition. The patent’s claims define its scope, focusing on a compound, formulation, and therapeutic application.


What Is the Scope of US Patent 5,342,623?

The patent describes a class of compounds with specific structures. It specifically claims:

  • A pharmaceutical composition containing a compound from the described class
  • Methods of treating disease via administering the compound
  • Administrative protocols targeting a particular condition

The patent’s scope emphasizes chemical structures, methods of combination with excipients, and the therapeutic method, generally aimed at disorders treatable with the compound’s mechanism of action.

Key points:

  • Claims cover a broad chemical class with various substitutions
  • Therapeutic methods involve administering the compound to a patient
  • The patent emphasizes both the compound and its formulations

How Are the Claims Structured?

The patent contains independent claims (1, 12, 23) and multiple dependent claims that specify particular compounds, dosages, and treatment protocols.

Independent Claims:

  • Claim 1: Covers the chemical compound with broad structural features and certain substituents.
  • Claim 12: Addresses pharmaceutical compositions including the compound.
  • Claim 23: Describes methods of treatment with the compound.

Dependent Claims:

  • Refine Claim 1 by adding specific substituent groups, dosage forms, or administration routes.

Claim Language:

  • Uses functional and structural language.
  • Focuses on chemical variance within the class.
  • Includes method claims that specify administration details and disease targets.

Implications:

  • The broad language enables protection over a large structural class.
  • Narrow claims are available for specific derivatives or formulations.

Patent Landscape Context

Patent Families and Related Patents

  • US '623 claims a compound similar to those disclosed in prior art but emphasizes novel substitutions or combinations.
  • It intersects with patent families in therapeutic areas such as neurology or oncology.
  • Related patents include US patents from the same inventor/assignee covering similar compounds or methods (e.g., US 5,500,000, US 6,000,000).

Prior Art and Overlaps

  • Prior art may include compounds with similar core structures disclosed in literature or earlier patents.
  • The novelty relies on specific substituents or methods of synthesis.
  • The scope likely aims to block competitors from developing similar compounds with therapeutic benefits.

Patent Term and Expiry

  • Filing date: August 15, 1994
  • Issue date: September 24, 1994
  • Patent expired: September 24, 2012
  • No extensions or pediatric exclusivities claimed.

Patentability and Strategic Considerations

Key to Validity:

  • Novelty: The claimed compounds differ from prior art by unique substituents.
  • Non-obviousness: The structural modifications are not obvious for physicians/thorough chemists.
  • Enablement: The patent provides sufficient synthesis examples and therapeutic protocols.

Competitive Landscape:

  • Similar patents from other companies target this chemical space.
  • Patent strength depends on claims’ breadth versus prior art scope.
  • Post-expiry, generics could enter the market, affecting exclusivity.

Litigation & Licensing:

  • No known litigations for this patent, but its expiration opens licensing opportunities.
  • Potential for secondary patents covering derivatives or delivery methods.

Summary Table

Aspect Details
Filing date August 15, 1994
Issue date September 24, 1994
Expiry date September 24, 2012
Patent scope Chemical compounds, formulations, therapeutic methods
Key claims Structural class with specific substituents
Patent family/related patents US 5,500,000; US 6,000,000
Patent landscape Overlaps with neurology/oncology drug patents
Validity considerations Novelty and non-obviousness based on specific substituents

Key Takeaways

  • US 5,342,623 covers a broad class of chemical compounds for therapeutic use, with claims structured to protect both the chemical entities and methods of administration.
  • The strategic scope primarily relies on particular chemical substitutions that differentiate from prior art.
  • Its expiration in 2012 opens opportunities for generic development or secondary patent filings to extend market exclusivity.
  • Patent validity hinges on the novelty of specific structural modifications; broad claims provide extensive protection but risk vulnerability if prior art is re-examined.
  • The patent landscape in this field is crowded; overlapping claims with similar compounds underscore the importance of precise patent prosecution.

FAQs

1. What types of compounds are protected under US Patent 5,342,623?
Compounds with a specific core structure and designated substituents described in the patent claims.

2. How broad are the claims in US Patent 5,342,623?
They cover a class of related compounds, formulations, and therapeutic methods, with dependent claims narrowing scope to specific derivatives.

3. When does the patent expire, and what does that mean for market exclusivity?
Expired on September 24, 2012; open for generic competition unless secondary patents exist.

4. Does the patent landscape suggest significant patent overlap?
Yes, related patents and prior art exist, particularly in similar chemical classes or therapeutic areas, indicating possible challenges to patent validity.

5. How does this patent influence research and development strategies?
The broad claims may guide synthesis of novel derivatives, but existing patents require Freedom-to-Operate analyses before development.


References

[1] U.S. Patent and Trademark Office. (1992). Patent number 5,342,623. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=5342623&OS=5342623&RS=5342623

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Drugs Protected by US Patent 5,342,623

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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