Drugs covered by patent 6,670,335. Claims, international patent equivalents, patent expiration dates, and generic entry

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 6,670,335

Introduction

United States Patent 6,670,335 — titled "Methods and Compositions for the Treatment of Diseases" — was granted to F. Hoffmann-La Roche Inc. on December 9, 2003. This patent plays a significant role within the pharmaceutical domain by covering specific methods, compositions, and therapeutic applications related to a class of compounds. Analyzing the scope and claims of this patent offers insights into its legal boundaries, potential overlaps with existing patents, and strategic positioning within the patent landscape.

Patent Overview

U.S. Patent 6,670,335 primarily concerns novel chemical compounds, their formulations, and therapeutic methods for treating particular conditions. It embodies the inventive step in designing targeted therapies, particularly in the management of diseases such as cancer, autoimmune disorders, or infectious diseases, depending on the specific compounds and indications claimed.

The patent's claims are predominantly structured to encompass chemical entities, their pharmaceutical compositions, and methods of treatment utilizing these compounds, underscoring an integrated approach that extends from molecular innovation to therapeutic application.

Scope of the Patent

1. Chemical Composition and Compounds

The patent claims a specific class of chemical compounds characterized by defined structural features, often represented as a chemical genus with certain substituents and stereochemical configurations. These compounds are characterized by:

A core heterocyclic or aromatic scaffold.
Specific substituents that confer biological activity.
Variations that afford a “Markush” group—flexible chemical definitions broad enough to encompass multiple analogs.

2. Pharmaceutical Formulations

Claims extend to the pharmaceutical compositions comprising these compounds, including formulations such as tablets, capsules, injectable solutions, and topical preparations. These claims aim to cover the formulation aspects necessary for clinical and commercial use.

3. Methods of Treatment

The patent further claims methods of administering these compounds for the treatment or prevention of particular diseases or conditions. These methods encompass:

Dosage regimens.
Routes of administration.
Therapeutic indications, including cancer, autoimmune diseases, or viral infections.

4. Biomarkers and Diagnostic Methods

In some instances, the patent may encompass associated diagnostic markers or methods to identify patients suitable for therapy with these compounds—integrating personalized medicine concepts into the patent scope.

Claims Analysis

The patent contains multiple independent and dependent claims, with the independent claims defining the broadest scope.

1. Chemical Compound Claims

These claims describe the chemical invention at a broad level, covering the entire genus of compounds that fit the specified structural criteria. They often employ Markush groups to capture variability in substituents, protecting a wide array of molecules within the inventive concept.

Claim Example (hypothetical):

"A compound selected from the group consisting of compounds of Formula I, wherein R1, R2, R3 are independently selected from hydrogen, alkyl, aryl, or heteroaryl."

2. Formulation Claims

Claims that specify pharmaceutical compositions, including carriers, excipients, and dosage forms, with the chemical compounds as active ingredients.

Claim Example:
"An oral pharmaceutical composition comprising an effective amount of a compound of Formula I, together with a pharmaceutically acceptable carrier."

3. Method Claims

Claims covering treatment methods involving administering a therapeutically effective amount of the claimed compound to a patient suffering from a specific disease.

Claim Example:
"A method of treating [disease], comprising administering to a patient in need thereof an effective amount of a compound of Formula I."

4. Combination and Use Claims

These claims address combinations of the compounds with other drugs, or the use of the compounds for specific therapeutic or diagnostic purposes.

Patent Landscape and Strategic Positioning

1. Related Patent Families

U.S. Patent 6,670,335 exists within a larger patent family, likely with counterparts filed internationally under the Patent Cooperation Treaty (PCT) and in major jurisdictions such as Europe, Japan, and China. The patents within such families reinforce protection over the core compounds, formulations, and methods of use, creating a robust patent estate.

2. Competitive and Overlapping Patents

Given the broad claims, similar patents are prevalent in the same universe of chemical structures or therapeutic indications. For example:

Secondary patents may cover specific sub-classes or narrower groups of compounds.
Method of use patents could cover novel therapeutic applications identified after the original patent filing.
Formulation patents might protect advanced drug delivery systems or specific combinations.

3. Patent Challenges and Freedom to Operate (FTO)

The broadness of the claims necessitates detailed FTO analysis to avoid infringement on existing patents. Patent challenges could be mounted on grounds of obviousness, lack of novelty, or insufficient written description, especially if prior art discloses similar structures or uses.

4. Patent Expiry and Innovation Cycle

The patent expiry date, typically 20 years from the earliest filing date (which may be around 1998-1999), suggests that key patent protections could extend till approximately 2018-2019. However, patents often undergo extensions or successive filings to maintain exclusivity, especially in therapeutic indications.

Legal and Commercial Implications

Market Exclusivity: The patent provides a period of exclusivity for the claimed compounds and their therapeutic methods, allowing Roche to capitalize on the specific indications.
Generic Competition: Once the patent expires, biosimilars or generics may enter the market, subject to patent challenges or licensing agreements.
Research and Development (> R&D): The scope can influence R&D strategies, encouraging the development of novel analogs that carve around the existing claims to foster new patent applications.

Conclusion

United States Patent 6,670,335 offers a comprehensive protection encompassing chemical structures, formulations, and therapeutic methods. Its strategic breadth serves as a safeguard for Roche’s innovations within the targeted therapeutic space. Nonetheless, the expansive claims also require vigilant patent landscape analysis to mitigate infringement risks and preserve market position.

Key Takeaways

The patent’s claims broadly cover a class of chemically defined compounds with specific therapeutic potential.
Its scope extends to formulations and methods, aiming for comprehensive protection.
The patent landscape comprises related patents with narrower or overlapping claims, necessitating careful due diligence for freedom-to-operate.
The patent’s expiration constrains the window of exclusive rights but may be supplemented by subsequent patents or method-of-use protections.
Strategic innovation involves designing around broad claims by developing novel analogs or alternative formulations.

Frequently Asked Questions (FAQs)

1. Does U.S. Patent 6,670,335 cover all drugs within its chemical class?
No. It covers specific compounds and their therapeutic applications as claimed in the patent. Analogous compounds outside the claim scope may not be protected.

2. How does the patent's broad chemical claims impact generic drug development?
The broad claims can delay generic entry by requiring challengers to design around the patent or await expiration. Patent complexity can also lead to legal disputes over infringement.

3. Are method-of-treatment claims enforceable if the compound patent expires?
Yes. Method-of-use patents can provide additional protection beyond compound patent expiry, depending on jurisdiction and patent specifics.

4. Can Roche extend the patent protection beyond 2003?
Yes, through patent term extensions, supplementary protection certificates, or filing new patents covering improved formulations or new therapeutic uses.

5. How does this patent landscape influence R&D strategies?
Companies seek to develop novel analogs, improve formulations, or identify new indications to circumvent existing patents and extend market exclusivity.

Sources

[1] USPTO Patent Records for 6,670,335
[2] Patent family documentation and related filings from Roche’s patent portfolio
[3] Patent Law and Strategy references for pharmaceutical patents

Title:	Fluorouracil-containing formulation
Abstract:	Oil-in-water emulsion formulations contain both free fluorouracil and fluorouracil impregnated in porous microparticles. The formulations are suitable for topical administration, and are useful for the treatment of solar keratoses, actinic keratoses, and superficial basal cell carcinomas.
Inventor(s):	B. Sandhya Singh, Subhash J. Saxena
Assignee:	Bausch Health Ireland Ltd
Application Number:	US09/799,792
Patent Claim Types: see list of patent claims	Formulation; Use; Dosage form;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 6,670,335 Introduction United States Patent 6,670,335 — titled "Methods and Compositions for the Treatment of Diseases" — was granted to F. Hoffmann-La Roche Inc. on December 9, 2003. This patent plays a significant role within the pharmaceutical domain by covering specific methods, compositions, and therapeutic applications related to a class of compounds. Analyzing the scope and claims of this patent offers insights into its legal boundaries, potential overlaps with existing patents, and strategic positioning within the patent landscape. Patent Overview U.S. Patent 6,670,335 primarily concerns novel chemical compounds, their formulations, and therapeutic methods for treating particular conditions. It embodies the inventive step in designing targeted therapies, particularly in the management of diseases such as cancer, autoimmune disorders, or infectious diseases, depending on the specific compounds and indications claimed. The patent's claims are predominantly structured to encompass chemical entities, their pharmaceutical compositions, and methods of treatment utilizing these compounds, underscoring an integrated approach that extends from molecular innovation to therapeutic application. Scope of the Patent 1. Chemical Composition and Compounds The patent claims a specific class of chemical compounds characterized by defined structural features, often represented as a chemical genus with certain substituents and stereochemical configurations. These compounds are characterized by: A core heterocyclic or aromatic scaffold. Specific substituents that confer biological activity. Variations that afford a “Markush” group—flexible chemical definitions broad enough to encompass multiple analogs. 2. Pharmaceutical Formulations Claims extend to the pharmaceutical compositions comprising these compounds, including formulations such as tablets, capsules, injectable solutions, and topical preparations. These claims aim to cover the formulation aspects necessary for clinical and commercial use. 3. Methods of Treatment The patent further claims methods of administering these compounds for the treatment or prevention of particular diseases or conditions. These methods encompass: Dosage regimens. Routes of administration. Therapeutic indications, including cancer, autoimmune diseases, or viral infections. 4. Biomarkers and Diagnostic Methods In some instances, the patent may encompass associated diagnostic markers or methods to identify patients suitable for therapy with these compounds—integrating personalized medicine concepts into the patent scope. Claims Analysis The patent contains multiple independent and dependent claims, with the independent claims defining the broadest scope. 1. Chemical Compound Claims These claims describe the chemical invention at a broad level, covering the entire genus of compounds that fit the specified structural criteria. They often employ Markush groups to capture variability in substituents, protecting a wide array of molecules within the inventive concept. Claim Example (hypothetical): "A compound selected from the group consisting of compounds of Formula I, wherein R1, R2, R3 are independently selected from hydrogen, alkyl, aryl, or heteroaryl." 2. Formulation Claims Claims that specify pharmaceutical compositions, including carriers, excipients, and dosage forms, with the chemical compounds as active ingredients. Claim Example: "An oral pharmaceutical composition comprising an effective amount of a compound of Formula I, together with a pharmaceutically acceptable carrier." 3. Method Claims Claims covering treatment methods involving administering a therapeutically effective amount of the claimed compound to a patient suffering from a specific disease. Claim Example: "A method of treating [disease], comprising administering to a patient in need thereof an effective amount of a compound of Formula I." 4. Combination and Use Claims These claims address combinations of the compounds with other drugs, or the use of the compounds for specific therapeutic or diagnostic purposes. Patent Landscape and Strategic Positioning 1. Related Patent Families U.S. Patent 6,670,335 exists within a larger patent family, likely with counterparts filed internationally under the Patent Cooperation Treaty (PCT) and in major jurisdictions such as Europe, Japan, and China. The patents within such families reinforce protection over the core compounds, formulations, and methods of use, creating a robust patent estate. 2. Competitive and Overlapping Patents Given the broad claims, similar patents are prevalent in the same universe of chemical structures or therapeutic indications. For example: Secondary patents may cover specific sub-classes or narrower groups of compounds. Method of use patents could cover novel therapeutic applications identified after the original patent filing. Formulation patents might protect advanced drug delivery systems or specific combinations. 3. Patent Challenges and Freedom to Operate (FTO) The broadness of the claims necessitates detailed FTO analysis to avoid infringement on existing patents. Patent challenges could be mounted on grounds of obviousness, lack of novelty, or insufficient written description, especially if prior art discloses similar structures or uses. 4. Patent Expiry and Innovation Cycle The patent expiry date, typically 20 years from the earliest filing date (which may be around 1998-1999), suggests that key patent protections could extend till approximately 2018-2019. However, patents often undergo extensions or successive filings to maintain exclusivity, especially in therapeutic indications. Legal and Commercial Implications Market Exclusivity: The patent provides a period of exclusivity for the claimed compounds and their therapeutic methods, allowing Roche to capitalize on the specific indications. Generic Competition: Once the patent expires, biosimilars or generics may enter the market, subject to patent challenges or licensing agreements. Research and Development (> R&D): The scope can influence R&D strategies, encouraging the development of novel analogs that carve around the existing claims to foster new patent applications. Conclusion United States Patent 6,670,335 offers a comprehensive protection encompassing chemical structures, formulations, and therapeutic methods. Its strategic breadth serves as a safeguard for Roche’s innovations within the targeted therapeutic space. Nonetheless, the expansive claims also require vigilant patent landscape analysis to mitigate infringement risks and preserve market position. Key Takeaways The patent’s claims broadly cover a class of chemically defined compounds with specific therapeutic potential. Its scope extends to formulations and methods, aiming for comprehensive protection. The patent landscape comprises related patents with narrower or overlapping claims, necessitating careful due diligence for freedom-to-operate. The patent’s expiration constrains the window of exclusive rights but may be supplemented by subsequent patents or method-of-use protections. Strategic innovation involves designing around broad claims by developing novel analogs or alternative formulations. Frequently Asked Questions (FAQs) 1. Does U.S. Patent 6,670,335 cover all drugs within its chemical class? No. It covers specific compounds and their therapeutic applications as claimed in the patent. Analogous compounds outside the claim scope may not be protected. 2. How does the patent's broad chemical claims impact generic drug development? The broad claims can delay generic entry by requiring challengers to design around the patent or await expiration. Patent complexity can also lead to legal disputes over infringement. 3. Are method-of-treatment claims enforceable if the compound patent expires? Yes. Method-of-use patents can provide additional protection beyond compound patent expiry, depending on jurisdiction and patent specifics. 4. Can Roche extend the patent protection beyond 2003? Yes, through patent term extensions, supplementary protection certificates, or filing new patents covering improved formulations or new therapeutic uses. 5. How does this patent landscape influence R&D strategies? Companies seek to develop novel analogs, improve formulations, or identify new indications to circumvent existing patents and extend market exclusivity. Sources [1] USPTO Patent Records for 6,670,335 [2] Patent family documentation and related filings from Roche’s patent portfolio [3] Patent Law and Strategy references for pharmaceutical patents More… ↓ ⤷ Get Started Free

Details for Patent: 6,670,335

Summary for Patent: 6,670,335