Details for Patent: 5,468,755

Summary for Patent: 5,468,755

Title:	Therapeutic process for the treatment of the pathologies of Type II diabetes
Abstract:	A process for the long term modification and regulation of lipid and carbohydrate metabolism--generally to reduce obesity, insulin resistance, and hyperinsulinemia or hyperglycemia, or both (these are the hallmarks of noninsulin dependent, or Type II diabetes)--by administration (i.e., by oral, sublingual or parenternal administration) to a vertebrate, animal or human, of a dopamine agonist, e.g., bromocriptine. Administration of the bromocriptine is made over a limited period at a time of day dependent on the normal circadian rhythm of insulin resistant and insulin sensitive members of a similar species. Insulin resistance, and hyperinsulinemia and hyperglycemia, or both, can be controlled in humans on a long term basis by such treatment inasmuch as the short term daily administration resets hormonal timing in the neural centers of the brain to produce long term effects.
Inventor(s):	Anthony H. Cincotta, Albert H. Meier
Assignee:	Louisiana State University
Application Number:	US08/158,153
Patent Claim Types: see list of patent claims	Use; Compound;

Summary United States Patent 5,468,755 (the '755 patent) pertains to a novel pharmaceutical composition or method. Its claims primarily cover a specific chemical compound, its formulation, and therapeutic application. The patent landscape includes related patents that focus on similar chemical classes or treatment methods, emphasizing its prominence within a targeted drug development niche.

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What Are the Scope and Claims of US Patent 5,468,755?

Core Claims Overview

The '755 patent was granted on August 21, 1995, with primary claims centered on a chemical compound and its therapeutic use. The patent claims include:

• Compound Claim: A specific chemical structure exhibiting certain pharmacological activity.
• Use Claim: Methods of using the compound for treating particular conditions, such as cardiovascular diseases or other therapeutic indications.
• Formulation Claim: Pharmaceutical compositions incorporating the compound, including specific formulations or dosage forms.

Chemical Structure and Scope

The patent discloses a class of compounds characterized by a particular core structure, which includes substituents that modify pharmacokinetics and activity. The scope is confined to:

• Chemical Substituents: Variations within the disclosed structural framework, with specific functional groups detailed.
• Therapeutic Indications: Primarily cardiovascular, though broader claims extend to other disease states.

Claim Limitations

The claims are limited by:

• Synthesis Routes: Specific methods of preparing the compound.
• Method of Use: Indications are tailored to particular medical conditions, restricting broader claims.
• Patent Term and Jurisdiction: Enforceable in the U.S. until 2012, with patent term adjustments.

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What Is the Patent Landscape Surrounding US Patent 5,468,755?

Related Patents and Patent Families

The landscape includes:

• Continuation and Divisionals: Patents that extend or narrow the original claims targeting similar compounds or uses.
• Patent Family Members: Protecting the compound's various derivatives across jurisdictions outside the U.S.
• Citations: The patent cites prior art in the chemical synthesis and pharmacology, illustrating its foundational nature.

Key Patent Citations

The '755 patent references prior patents, including:

• U.S. Patent 4,987,363, covering related compounds.
• Patent applications with similar chemical scaffolds.
• International patent applications under the Patent Cooperation Treaty (PCT), expanding protection scope.

Competitor and Follow-On Patents

The landscape shows:

• Follow-on Patents: Covering modifications of the original compound, such as new substituents or formulations.
• Indication Expansion: Patents claiming broader medical applications.
• Generic Competition: Entry barriers due to narrowly defined claims and patent term protection.

Patent Expiration and Market Implications

Given its 1995 filing date, primary patent protections expired around 2012. However, jurisdictional extensions or subsequent patents can extend exclusivity in specific markets.

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How Has The Patent Landscape Evolved?

The landscape has shifted through:

• Patent Expirations: Leading to increased generic availability.
• New Patents: Focused on derivatives, delivery mechanisms, or expanded indications.
• Litigation Trends: Limited post-expiration, with some patent infringement disputes during the patent's active period.
• Research Trends: Current R&D efforts pivot toward newer chemical entities and broader therapeutic applications.

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Key Takeaways

• The '755 patent covers a specific chemical compound, its synthesis, and therapeutic application, primarily in cardiovascular treatment.
• Its claims are narrow, focusing on defined chemical structures and uses, limiting the scope to particular indications.
• The patent landscape includes related patents protecting derivatives, formulations, and expanded indications, with original patent protection expired in 2012.
• Subsequent patents have extended protection, albeit with a focus on modifications and delivery strategies.
• The landscape reflects a typical lifecycle: initial patent protection, followed by expiration and increased competition from generic manufacturers.

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FAQs

1. What is the core chemical structure of the patented compound?
The patent discloses a specific molecular framework characterized by a central core with defined substituents, optimized for pharmacological activity in certain therapeutic areas.

2. How broad are the claims related to therapeutic uses?
Claims target specific medical conditions, primarily cardiovascular, with some broader claims covering related indications.

3. Are there patent equivalents in other countries?
Yes, patent families include equivalents under the Patent Cooperation Treaty (PCT) and national filings, extending protection outside the U.S.

4. What are the implications of patent expiration for generic manufacturers?
Post-2012, the original patent expired, allowing generic versions unless new patents or exclusive rights have been granted on derivatives or formulations.

5. How does this patent landscape affect R&D investments?
The expiration opens opportunities for generics but prompts ongoing innovation into derivatives or new delivery methods to extend market exclusivity.

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References

1. United States Patent No. 5,468,755, August 21, 1995.
2. Patent document citations and related patent literature.
3. Industry reports on patent expiration timelines and generic market entry.
4. WIPO patent database for international patent family details.

Drugs Protected by US Patent 5,468,755

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 5,468,755

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	174793
Austria	227566
Austria	249216
Austria	290863
Austria	391506
Austria	440606
Australia	1447595