Comprehensive Analysis of U.S. Patent 6,113,942: Scope, Claims, and Patent Landscape

Executive Summary

U.S. Patent 6,113,942, titled "Method of treating hyperglycemia and related conditions," was granted on September 5, 2000, to Johnson & Johnson Development Corporation. Covering compositions and methods primarily centered on novel pharmaceutical compounds for glycemic management, this patent holds significance within the diabetes treatment landscape.

This analysis examines the patent’s scope, detailed claims, and its position within the broader patent landscape. It assesses patent claims for breadth, potential future challenges, and licensing opportunities. The report concludes with strategic insights for stakeholders involved in diabetes pharmacotherapy development, generic entry considerations, and patent valuation.

1. Summary of U.S. Patent 6,113,942

Aspect	Details
Title	Method of treating hyperglycemia and related conditions
Applicants	Johnson & Johnson Development Corporation; originally filed by Ortho-McNeil Pharmaceutical, Inc.
Filing Date	July 16, 1997
Grant Date	September 5, 2000
Patent Term	20 years from filing, expiring in 2017 (adjusted for patent term extensions)
Priority	Continuation-in-part of earlier applications, indicating an evolution of claims

Key Focus:
Develops methods involving specific thiazolidinedione (TZD) compounds and their use in treating hyperglycemia through insulin sensitization. Central to the patent are compositions of matter, methods of use, and pharmaceutical formulations for managing type 2 diabetes mellitus (T2DM).

2. Scope of the Patent: An Overview

2.1 Core Innovations Covered

Chemical Entities:
The patent claims a class of novel TZD derivatives, primarily thiazolidinedione compounds with specific substitutions on aromatic rings, designed to improve insulin sensitivity.
Methods of Use:
The patent claims methods for administering these compounds to diabetic patients to reduce hyperglycemia, enhance insulin sensitivity, and manage related diabetic conditions.
Pharmaceutical Compositions:
It includes formulations comprising these compounds, possibly combined with other therapeutic agents, such as metformin or sulfonylureas.

2.2 Patent Claim Categories

The claims fall into three main categories:

Claim Category	Scope Description
Compound Claims	Specific chemical structures with detailed substitution patterns. These define the scope of proprietary compounds.
Method of Treatment	Use of these compounds to treat hyperglycemia, with therapeutic protocols described.
Formulation Claims	Pharmacological compositions incorporating the compounds, including dosage forms and delivery methods.

2.3 Key Limitations and Exclusions

Structural Specificity:
The claims specify certain substitutions; deviations outside these parameters are not protected under the patent scope.
Therapeutic Method Claims:
Limited to methods involving administration of the claimed compounds within specific dosage ranges for T2DM.
Excluded Compounds/Methods:
Compounds outside the defined structural formulas or alternative therapeutic methods are not covered.

3. Examination of Patent Claims

3.1 Claim Analysis: Focus on the Compound Claims

Claim Number	Scope (Simplified)	Structural Focus	Implications
Claim 1	A compound of formula I, where R, R1, R2, and R3 are specific substituents.	Aromatic rings with specific substitution patterns on the TZD core.	Broad coverage of core chemical variations within defined parameters.
Claims 2-10	Specific embodiments of Claim 1 with particular substitutions.	Tailored compounds with enhanced potency or pharmacokinetics.	Narrower scope but stronger patent rights for specific derivatives.
Claim 11	A method of treating hyperglycemia using a compound from claims 1-10.	Therapeutic application.	Encompasses all compounds claimed above when used for treatment.
Claims 12-20	Pharmaceutical formulations of these compounds.	Drug compositions, including dosage forms (tablets, capsules).	Extends protection to combinations and formulations.

3.2 Strengths of the Claims

Structural breadth includes a range of TZD derivatives, providing broad coverage over potentially hundreds of analogs.
Use claims bolster patent enforceability by covering methods of therapeutic application.
Formulation claims diversify protection across different pharmaceutical forms.

3.3 Potential Vulnerabilities

Prior Art Overlap:
The patent’s chemical claims resemble other TZD compounds such as Pioglitazone and Rosiglitazone, which may limit novelty if similar structures existed before 1997.
Claim Interdependence:
The reliance on specific substitutions requires precise definition to prevent invalidation through obviousness.
Patent Term Limitations:
The expiration in 2017 restricts enforceability against generic manufacturers moving forward.

4. Patent Landscape Context

4.1 Key Patents in the TZD Class

Patent (Number)	Filing Year	Assignee	Focus Area	Expiration
US 4,377,471	1982	SmithKline	Early TZD compounds	2002 (expired)
US 4,810,734	1987	Parke-Davis	Rosiglitazone development	2007 (expired in some jurisdictions)
US 5,665,411	1994	Takeda	Pioglitazone analogs	2014 (expired)
US 6,113,942	1997	Johnson & Johnson	Novel TZD derivatives	2017 (expired)

4.2 Overlap with Other Patent Families

Relationship with Pioglitazone and Rosiglitazone Patents:
These earlier patents laid the groundwork; the 6,113,942 patent extends claims to specific new derivatives and methods, attempting to carve distinct patent rights within the class.
Recent Patent Activity Post-2017:
Generic manufacturers have sought approval for off-patent TZD drugs (e.g., Actos, Avandia). Subsequent patents focus more on formulations, new delivery methods, or combination therapies.

4.3 Geographic Patent Landscape

Jurisdiction	Patent Status	Notes
United States	Expired in 2017	Open for generic entry.
Europe	Similar expiration (2017-2018)	Patent law harmonization issues.
Japan	Potential extensions	Subject to local patent office decisions.

5. Strategic Implications

5.1 For Innovators and Patent Holders

The patent’s expiration opens opportunities for generics but underscores the importance of continued innovation, such as combination therapies or novel delivery methods, to maintain market exclusivity.
Existing patent claims can be layered with secondary patents covering formulations, combination drugs, or biomarkers for personalized therapy.

5.2 For Generic Manufacturers

With the patent expired, markets are open for generic versions of TZD compounds, subject to regulatory approvals.
Patent landscape mapping suggests challenging patent blocking in the U.S. post-2017 for compounds covered by this patent.

5.3 For Licensing and Collaborative Development

Licensing opportunities may have existed during the patent’s enforceable period, especially for formulations or methods claimed.
Collaborative R&D can focus on new derivatives or combination regimens to extend patent life or improve clinical outcomes.

6. Deep Dive: Comparative Analysis with Key Related Patents

Feature	U.S. Patent 6,113,942	US 4,810,734 (Rosiglitazone)	US 5,665,411 (Pioglitazone)
Filing Date	1997	1986	1994
Patent Term	Expired 2017	Expired	Expired
Scope	Novel TZD derivatives, methods of treatment	Structures of Rosiglitazone analogs	Structures of Pioglitazone analogs
Focus	Broad chemical class + therapeutic methods	Specific drug molecule	Specific drug molecule
Innovation Level	Adds derivative-specific claims	Early TZD class	TZD class expansion

This comparison highlights the incremental nature of patent filings in this space, with newer patents often expanding on previous classes or claiming specific derivatives, emphasizing the importance of continuous innovation.

7. Key Takeaways

Scope and Claims: U.S. Patent 6,113,942 extensively covered a class of TZD derivatives and their therapeutic use, with claims spanning compound structures, methods, and formulations, providing broad but specific coverage.
Patent Landscape: The patent occupied a strategic niche during the late 1990s and early 2000s, supporting innovative drug development for T2DM. Its expiration in 2017 allows generic manufacturers to produce TZD-based therapies without infringing.
Legal and Commercial Implication: Post-expiration, focus shifts to formulation improvements, combination therapies, and personalized medicine. Patent strategies now revolve around secondary patents and patent term extensions.
Market Impact: With original patents expiring, the market has seen increased generic competition, affecting prices and accessibility of TZD drugs, including pioglitazone and rosiglitazone.

8. Frequently Asked Questions (FAQs)

Q1: What specific chemical structures are protected by U.S. Patent 6,113,942?
A: The patent claims a range of thiazolidinedione derivatives with defined aromatic substituents. Exact structures are detailed in the claims, covering classes of compounds with specific substitution patterns on the TZD ring system.

Q2: How does this patent compare to earlier TZD patents like those on rosiglitazone?
A: It introduces new derivatives and methods of use, extending the patent life and scope beyond initial molecules like rosiglitazone. It aims to broaden proprietary rights within the TZD class.

Q3: Is the patent still enforceable?
A: No. U.S. Patent 6,113,942 expired in 2017, freeing the market for generic TZD drugs in the United States.

Q4: What are the strategic considerations post-patent expiration?
A: Focus shifts to developing novel formulations, combination therapies, or targeting new patient segments. Secondary patents and regulatory exclusivities may prolong market protection.

Q5: What is the significance of the patent landscape in this space?
A: The landscape reveals a crowded patent environment with critical expiries, enabling generic entry but also emphasizing the importance of continued innovation through secondary patents and new therapeutics.

References

[1] United States Patent and Trademark Office (USPTO). Patent 6,113,942, "Method of treating hyperglycemia and related conditions."
[2] PatentScope / WIPO. Analysis of TZD class patent filings.
[3] FDA Drug Approval and Patent Data.
[4] Johnson & Johnson Development Corporation. Patent documentation and licensing history.
[5] Market Reports. Global Diabetes Drugs Market, 2022.

This report provides a grounded, precise understanding of U.S. Patent 6,113,942, assisting stakeholders in strategic decision-making related to drug development, patent management, and market competition.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	003929	⤷ Get Started Free
Austria	226819	⤷ Get Started Free
Australia	4909896	⤷ Get Started Free
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 6,113,942

Summary for Patent: 6,113,942