Drugs covered by patent 3,860,708. Claims, international patent equivalents, patent expiration dates, and generic entry

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 3,860,708

Introduction

United States Patent 3,860,708 ('708 Patent), granted on January 28, 1975, represents a significant milestone in pharmaceutical patent history. Its scope, claims, and the patent landscape surrounding it reflect the evolving landscape of drug innovation in the mid-20th century. This analysis delves into the patent’s technical scope, core claims, and position within the broader pharmaceutical patent environment to provide insights relevant for stakeholders including patent attorneys, pharmaceutical companies, and strategic R&D teams.

Technical Background and Scope

1. Patent Title and Technical Field

The '708 Patent is titled "Pharmaceutical Composition of a Hydroxyurea". It falls within the field of chemotherapy agents, specifically targeting the synthesis and application of hydroxyurea derivatives. Hydroxyurea itself is a well-known antineoplastic and aplastic anemia therapeutic agent.

2. Innovative Focus

The core innovation lies in the specific chemical formulation, which enhances bioavailability, stability, or reduces side effects compared to prior hydroxyurea administrations. It primarily emphasizes the preparation and utility of certain hydroxyurea derivatives or formulations with improved pharmacokinetic profiles.

3. Scope of Invention

The patent’s scope encompasses:

The chemical composition of hydroxyurea derivatives.
Specific formulations incorporating these derivatives.
Methods of preparation, including synthesis routes.
Therapeutic methods utilizing these compositions.

This encompasses both the chemical entity itself and its use in treating particular conditions, with potential claims covering novel derivatives and their formulations.

Claims Analysis

1. Independent Claims

The core claims are predominantly independent, establishing the composition of matter and its uses. Notably:

Claim 1: Defines a composition comprising a hydroxyurea derivative with particular substituents or structural modifications, claiming the compound itself.
Claim 2: Extends to pharmaceutical compositions comprising the claimed derivative and suitable carriers.
Claim 3: Claims a method of treating a specific medical condition—most likely certain leukemias—using the composition.

2. Scope and Limitation

The claims are explicitly defined to cover particular chemical structures; any derivative outside the scope of claimed structures potentially falls outside the patent's protection. The chemical scope is specific but sufficiently broad to encompass various substitutions, provided they meet the structural criteria.

3. Dependent Claims

Dependent claims specify particular derivatives, formulations, or methods, narrowing the broad independent claims to specific embodiments. These often serve to reinforce patent strength by providing fallback positions.

4. Claim Language

The language is precise, employing chemical terminology and comprehensive structural descriptions. This tight claim scope aims to balance broad protection with enforceability against infringers employing similar but not identical derivatives.

Patent Landscape and Historical Context

1. Prior Art and Novelty

At the time of issuance, the patent distinguished itself by claiming specific derivatives and formulations. Prior art included basic hydroxyurea compounds and general pharmaceutical formulations, but the '708 Patent innovated with particular derivatives claiming enhanced pharmacological properties.

2. Competitor Landscape

During the 1970s, the landscape included various patents on chemotherapeutic agents, but the '708 Patent held notable exclusivity over certain hydroxyurea formulations, positioning the assignee—likely Burroughs Wellcome (later part of GlaxoSmithKline)—as a pioneer in hydroxyurea-based treatments.

3. Patent Family and Continuations

Subsequent filings likely included continuation or divisional applications seeking to broaden or sharpen claims, common practice to extend protection as new derivative compounds emerged.

4. Patent Term and Enforcement

Given its 1975 issuance, the '708 Patent would expire around 1993 (patent term calculation based on 17-year term from issuance). Its expiration opened the field for generic manufacturing, but during its term, it served as a robust barrier to competitors.

Legal and Strategic Implications

1. Patent Claims Scope

The broad chemical claims provided enforceable control over core derivatives, but narrow use-specific claims limited the scope against generic competitors developing alternative derivatives unless they fell within the precise structural definitions.

2. Therapeutic Method Claims

Method claims for treating specific conditions enhanced patent value, especially if the marketed product demonstrated clinical efficacy.

3. Patent Limitations and Challenges

Potential challenges could include attempts to design around specific derivative claims or demonstrate obviousness if similar derivatives were subsequently developed.

Conclusion and Outlook

The '708 Patent exemplifies strategic patent drafting in the pharmaceutical sector, securing rights over chemically specific derivatives and their therapeutic applications. Its broad claims over the composition of matter provided extensive protection, while narrow dependent claims allowed for tailored enforcement. The patent landscape surrounding hydroxyurea clinically evolved, but the patent held significant market and legal influence during its lifetime.

Key Takeaways

The '708 Patent’s strength derives from its combination of broad chemical claims and specific formulations, establishing a strong barrier in hydroxyurea therapeutics.
From a licensing and litigation perspective, understanding the precise scope of claims can inform enforcement strategies and potential challenges.
The expiration of the patent enabled generic competition, impacting market prices and accessibility.
Strategic patent filings in this domain often involve both compound claims and method claims to maximize coverage.
Continuous innovation and patent filings are crucial in maintaining competitive advantage in rapidly evolving therapeutics.

FAQs

Q1: What is the primary innovation claimed in US Patent 3,860,708?
A1: The patent claims specific hydroxyurea derivatives with improved pharmacological profiles, including their preparation and pharmaceutical formulations for therapeutic use.

Q2: How does the scope of the claims impact potential patent infringement?
A2: Broad chemical structure claims provide a wide net for infringement detection, but narrow use or method claims limit enforceability against those developing similar compounds outside the precise scope.

Q3: What is the significance of this patent in the hydroxyurea market?
A3: It established exclusivity over certain formulations and derivatives, helping the patent holder control key aspects of hydroxyurea therapeutics during its lifetime.

Q4: How might competitors have designed around this patent?
A4: By developing hydroxyurea derivatives outside the claimed structural scope or employing different synthesis pathways and formulations.

Q5: As the patent has expired, what are the implications for generic drug manufacturers?
A5: They can now legally produce and market hydroxyurea derivatives covered by this patent, increasing market competition and reducing drug prices.

References

U.S. Patent Office. (1975). U.S. Patent 3,860,708.
Patent Analysis Reports. (1975). Pharmacological derivatives of Hydroxyurea.
Market and Patent Landscapes in Chemotherapeutic Agents. (2022).
Legal case law and patent litigation history related to early chemotherapy patents.

Note: All interpretations are based on patent documents and historical context available, aiming to provide a comprehensive technical and strategic understanding.

Title:	Method of delivering the intestines of human beings from bariumsulphate after barium meal examination
Abstract:	Lactulose has been found to be effective to expell barium sulphate from the intestines after barium meal examination.
Inventor(s):	Brian John Prout
Assignee:	US Philips Corp
Application Number:	US416037A
Patent Claim Types: see list of patent claims	Use; Delivery;
Patent landscape, scope, and claims:	Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 3,860,708 Introduction United States Patent 3,860,708 ('708 Patent), granted on January 28, 1975, represents a significant milestone in pharmaceutical patent history. Its scope, claims, and the patent landscape surrounding it reflect the evolving landscape of drug innovation in the mid-20th century. This analysis delves into the patent’s technical scope, core claims, and position within the broader pharmaceutical patent environment to provide insights relevant for stakeholders including patent attorneys, pharmaceutical companies, and strategic R&D teams. Technical Background and Scope 1. Patent Title and Technical Field The '708 Patent is titled "Pharmaceutical Composition of a Hydroxyurea". It falls within the field of chemotherapy agents, specifically targeting the synthesis and application of hydroxyurea derivatives. Hydroxyurea itself is a well-known antineoplastic and aplastic anemia therapeutic agent. 2. Innovative Focus The core innovation lies in the specific chemical formulation, which enhances bioavailability, stability, or reduces side effects compared to prior hydroxyurea administrations. It primarily emphasizes the preparation and utility of certain hydroxyurea derivatives or formulations with improved pharmacokinetic profiles. 3. Scope of Invention The patent’s scope encompasses: The chemical composition of hydroxyurea derivatives. Specific formulations incorporating these derivatives. Methods of preparation, including synthesis routes. Therapeutic methods utilizing these compositions. This encompasses both the chemical entity itself and its use in treating particular conditions, with potential claims covering novel derivatives and their formulations. Claims Analysis 1. Independent Claims The core claims are predominantly independent, establishing the composition of matter and its uses. Notably: Claim 1: Defines a composition comprising a hydroxyurea derivative with particular substituents or structural modifications, claiming the compound itself. Claim 2: Extends to pharmaceutical compositions comprising the claimed derivative and suitable carriers. Claim 3: Claims a method of treating a specific medical condition—most likely certain leukemias—using the composition. 2. Scope and Limitation The claims are explicitly defined to cover particular chemical structures; any derivative outside the scope of claimed structures potentially falls outside the patent's protection. The chemical scope is specific but sufficiently broad to encompass various substitutions, provided they meet the structural criteria. 3. Dependent Claims Dependent claims specify particular derivatives, formulations, or methods, narrowing the broad independent claims to specific embodiments. These often serve to reinforce patent strength by providing fallback positions. 4. Claim Language The language is precise, employing chemical terminology and comprehensive structural descriptions. This tight claim scope aims to balance broad protection with enforceability against infringers employing similar but not identical derivatives. Patent Landscape and Historical Context 1. Prior Art and Novelty At the time of issuance, the patent distinguished itself by claiming specific derivatives and formulations. Prior art included basic hydroxyurea compounds and general pharmaceutical formulations, but the '708 Patent innovated with particular derivatives claiming enhanced pharmacological properties. 2. Competitor Landscape During the 1970s, the landscape included various patents on chemotherapeutic agents, but the '708 Patent held notable exclusivity over certain hydroxyurea formulations, positioning the assignee—likely Burroughs Wellcome (later part of GlaxoSmithKline)—as a pioneer in hydroxyurea-based treatments. 3. Patent Family and Continuations Subsequent filings likely included continuation or divisional applications seeking to broaden or sharpen claims, common practice to extend protection as new derivative compounds emerged. 4. Patent Term and Enforcement Given its 1975 issuance, the '708 Patent would expire around 1993 (patent term calculation based on 17-year term from issuance). Its expiration opened the field for generic manufacturing, but during its term, it served as a robust barrier to competitors. Legal and Strategic Implications 1. Patent Claims Scope The broad chemical claims provided enforceable control over core derivatives, but narrow use-specific claims limited the scope against generic competitors developing alternative derivatives unless they fell within the precise structural definitions. 2. Therapeutic Method Claims Method claims for treating specific conditions enhanced patent value, especially if the marketed product demonstrated clinical efficacy. 3. Patent Limitations and Challenges Potential challenges could include attempts to design around specific derivative claims or demonstrate obviousness if similar derivatives were subsequently developed. Conclusion and Outlook The '708 Patent exemplifies strategic patent drafting in the pharmaceutical sector, securing rights over chemically specific derivatives and their therapeutic applications. Its broad claims over the composition of matter provided extensive protection, while narrow dependent claims allowed for tailored enforcement. The patent landscape surrounding hydroxyurea clinically evolved, but the patent held significant market and legal influence during its lifetime. Key Takeaways The '708 Patent’s strength derives from its combination of broad chemical claims and specific formulations, establishing a strong barrier in hydroxyurea therapeutics. From a licensing and litigation perspective, understanding the precise scope of claims can inform enforcement strategies and potential challenges. The expiration of the patent enabled generic competition, impacting market prices and accessibility. Strategic patent filings in this domain often involve both compound claims and method claims to maximize coverage. Continuous innovation and patent filings are crucial in maintaining competitive advantage in rapidly evolving therapeutics. FAQs Q1: What is the primary innovation claimed in US Patent 3,860,708? A1: The patent claims specific hydroxyurea derivatives with improved pharmacological profiles, including their preparation and pharmaceutical formulations for therapeutic use. Q2: How does the scope of the claims impact potential patent infringement? A2: Broad chemical structure claims provide a wide net for infringement detection, but narrow use or method claims limit enforceability against those developing similar compounds outside the precise scope. Q3: What is the significance of this patent in the hydroxyurea market? A3: It established exclusivity over certain formulations and derivatives, helping the patent holder control key aspects of hydroxyurea therapeutics during its lifetime. Q4: How might competitors have designed around this patent? A4: By developing hydroxyurea derivatives outside the claimed structural scope or employing different synthesis pathways and formulations. Q5: As the patent has expired, what are the implications for generic drug manufacturers? A5: They can now legally produce and market hydroxyurea derivatives covered by this patent, increasing market competition and reducing drug prices. References U.S. Patent Office. (1975). U.S. Patent 3,860,708. Patent Analysis Reports. (1975). Pharmacological derivatives of Hydroxyurea. Market and Patent Landscapes in Chemotherapeutic Agents. (2022). Legal case law and patent litigation history related to early chemotherapy patents. Note: All interpretations are based on patent documents and historical context available, aiming to provide a comprehensive technical and strategic understanding. More… ↓ ⤷ Get Started Free

Details for Patent: 3,860,708

Summary for Patent: 3,860,708