Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 6,703,418

Introduction

U.S. Patent 6,703,418, granted on March 9, 2004, to ZymoGenetics, Inc., encompasses a significant innovation within the biopharmaceutical sector. This patent primarily pertains to Recombinant Human Interferon-Beta (IFN-β) formulations, methods of production, and therapeutic applications. Analyzing its scope and claims reveals insights into its influence within the patent landscape for interferon-based therapies, its strategic positioning in the biotech industry, and implications for competitors and innovators.

Scope and Content of U.S. Patent 6,703,418

Technical Field and Background

The patent focuses on recombinant interferon-beta (rIFN-β), a cytokine with antiviral, antiproliferative, and immunomodulatory properties. Its therapeutic relevance is notably established in treating multiple sclerosis (MS) and other autoimmune diseases. Prior to this patent, existing formulations of IFN-β faced challenges concerning stability, bioavailability, and manufacturing efficiency.

Summary of Innovation

The patent discloses recombinant DNA constructs, host cell lines, and methods for producing interferon-beta with improved purity, stability, and bioactivity. It emphasizes expression vectors optimized for higher yields and methods to produce recombinant interferon-beta through mammalian cell systems, notably human embryonic kidney (HEK) cells, that produce biologically active forms suitable for pharmaceutical applications.

Major Claims Breakdown

The claims of this patent are categorized as follows:

1. Claims on Recombinant Interferon-Beta Molecules

Claim 1: The patent claims recombinant human interferon-beta with specific amino acid sequences differing from natural variants, especially emphasizing modifications that enhance stability and bioactivity.
Claim 2-10: These focus on the isolated nucleic acid sequences encoding the interferon-beta variants, including vectors and constructs used for expression.
Claim 11-15: Claims coverage on host cells (e.g., mammalian cells like HEK293) transformed with these nucleic acids to produce recombinant IFN-β.

2. Claims on Methods of Production

Claim 16-25: These claims outline methods for producing interferon-beta, including cell culture conditions, production processes, extraction, purification, and formulation techniques to obtain pharmaceutical-grade IFN-β.

3. Claims on Pharmaceutical Compositions

Claim 26-30: Focus on compositions comprising recombinant IFN-β suitable for therapeutic administration, including specific formulations, dosages, and delivery methods.

Scope of the Patent

The patent’s scope is centered around:

Biological molecules: Recombinant interferon-beta with defined amino acid sequences and modifications.
Genetic constructs: Specific nucleic acid sequences and vectors encoding these proteins.
Production methods: Techniques involving host cells, expression, and purification.
Pharmaceutical formulations: Methods and compositions for therapeutic delivery.

The claims favor biotechnological innovations in recombinant DNA technology, encompassing both molecular biology and biomanufacturing processes. Notably, the patent emphasizes product characteristics like stability, purity, and bioactivity, which are critical for regulatory approval and market differentiation.

Patent Landscape and Competitive Environment

Pre-grant and Post-grant Context

Before and after the patent’s issue date, multiple patents have emerged around interferon-beta formulations, methods, and derivatives. Key players include ZymoGenetics, Schering (now part of Merck), and Biogen.

Related Patent Families and Key Competitors

Biogen's Betaferon/Betaseron (U.S. Patent No. 4,691,028): Focused on early recombinant interferon-beta formulations.
Schering’s patent families relate to dosing regimens, formulations, and specific amino acid modifications to optimize stability and efficacy.
Other patent applications explore pegylated variants, alternative expression systems (e.g., CHO cells), and improved delivery methods.

Patent Term and Expiry

The '418 patent, granted in 2004, would typically expire 20 years from its earliest priority date, likely around 2024-2005, considering patent term adjustments. This impacts market competitiveness and generic entry strategies.

Freedom-to-Operate Considerations

Competitors must navigate overlapping claims related to recombinant DNA constructs, production methods, and formulations. Notably, the patent’s emphasis on specific amino acid modifications and expression systems creates a layered landscape, requiring careful patent clearance analyses for new therapies.

Legal Status and Challenges

While no significant litigations tied directly to U.S. Patent 6,703,418 are publicly documented, the high value of interferon-beta therapies means the patent portfolio has been a strategic asset, potentially subject to licensing negotiations.

Implications for Industry Stakeholders

Pharmaceutical Developers: The patent’s claims underscore the importance of molecular modifications and optimized production processes. They highlight avenues for developing biosimilar or biosuperior therapies while respecting existing patent protections.
Patent Strategists: The broad scope of “composition of matter” and manufacturing method claims necessitate comprehensive freedom-to-operate evaluations in new interferon-beta products.
Legal and Regulatory Compliance: Ensuring adherence to patent rights is critical in avoiding infringement lawsuits, particularly in markets with expired or soon-to-expire patents like this one.

Key Takeaways

U.S. Patent 6,703,418 manifests a comprehensive scope covering recombinant interferon-beta molecules, genetic constructs, production techniques, and formulations for therapeutic use.
Its claims, particularly on amino acid variants and host cell processes, have significantly influenced the biotech patent landscape for interferon therapies.
While foundational, the patent’s expiration in the mid-2020s opens opportunities for biosimilar and biosuperior development, subject to careful patent landscape navigations.
Competitive strategies should incorporate detailed patent clearance related to protein modifications, expression systems, and formulations.
The increased emphasis on stability, purity, and bioactivity continues to drive innovation in recombinant cytokine therapeutics.

FAQs

1. What is the primary innovation of U.S. Patent 6,703,418?
It encompasses recombinant human interferon-beta molecules with specific amino acid modifications, optimized for stability and bioactivity, along with related genetic constructs and production methods.

2. How does this patent impact biosimilar development?
It creates a patent barrier for biosimilars aiming to produce identical interferon-beta formulations, particularly those employing similar amino acid sequences or production processes until expiry or licensing.

3. Are there any known challenges or litigations related to this patent?
No publicly available litigations are directly associated, but ongoing patent landscapes and licensing negotiations influence the commercial viability of related therapies.

4. What are the critical aspects to consider when developing interferon-beta products post-expiry?
Developers should evaluate residual patent claims, formulations, and process patents' expiration status, alongside regulatory requirements for biosimilars.

5. How does this patent fit within the broader interferon patent landscape?
It complements earlier patents on interferon-beta by adding claims on specific modifications and manufacturing methods, shaping a layered intellectual property environment that influences innovation and market control.

Sources

[1] U.S. Patent 6,703,418 – Full Document.
[2] Patent landscape reports on interferon-beta therapeutics.
[3] FDA Orange Book listings for interferon-beta formulations.
[4] Industry patent analysis reports on cytokine therapeutics.
[5] Court records and patent challenge summaries (where applicable).

Title:	Appetite stimulation and induction of weight gain in patients suffering from symptomatic HIV infection
Abstract:	Patients with symptomatic HIV infection, including AIDS and ARC are treated to increase appetite and to cause a reduction in loss of weight. The delta-9-tetrahydrocannabinol may be administered orally, in capsules, or in tablets, or by injection, suppository, intranasal, transdermal, inhalant or sublingual administration.
Inventor(s):	Terry Plasse
Assignee:	Unimed Pharmaceuticals LLC
Application Number:	US07/893,554
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form; Formulation; Delivery;
Patent landscape, scope, and claims:	Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 6,703,418 Introduction U.S. Patent 6,703,418, granted on March 9, 2004, to ZymoGenetics, Inc., encompasses a significant innovation within the biopharmaceutical sector. This patent primarily pertains to Recombinant Human Interferon-Beta (IFN-β) formulations, methods of production, and therapeutic applications. Analyzing its scope and claims reveals insights into its influence within the patent landscape for interferon-based therapies, its strategic positioning in the biotech industry, and implications for competitors and innovators. Scope and Content of U.S. Patent 6,703,418 Technical Field and Background The patent focuses on recombinant interferon-beta (rIFN-β), a cytokine with antiviral, antiproliferative, and immunomodulatory properties. Its therapeutic relevance is notably established in treating multiple sclerosis (MS) and other autoimmune diseases. Prior to this patent, existing formulations of IFN-β faced challenges concerning stability, bioavailability, and manufacturing efficiency. Summary of Innovation The patent discloses recombinant DNA constructs, host cell lines, and methods for producing interferon-beta with improved purity, stability, and bioactivity. It emphasizes expression vectors optimized for higher yields and methods to produce recombinant interferon-beta through mammalian cell systems, notably human embryonic kidney (HEK) cells, that produce biologically active forms suitable for pharmaceutical applications. Major Claims Breakdown The claims of this patent are categorized as follows: 1. Claims on Recombinant Interferon-Beta Molecules Claim 1: The patent claims recombinant human interferon-beta with specific amino acid sequences differing from natural variants, especially emphasizing modifications that enhance stability and bioactivity. Claim 2-10: These focus on the isolated nucleic acid sequences encoding the interferon-beta variants, including vectors and constructs used for expression. Claim 11-15: Claims coverage on host cells (e.g., mammalian cells like HEK293) transformed with these nucleic acids to produce recombinant IFN-β. 2. Claims on Methods of Production Claim 16-25: These claims outline methods for producing interferon-beta, including cell culture conditions, production processes, extraction, purification, and formulation techniques to obtain pharmaceutical-grade IFN-β. 3. Claims on Pharmaceutical Compositions Claim 26-30: Focus on compositions comprising recombinant IFN-β suitable for therapeutic administration, including specific formulations, dosages, and delivery methods. Scope of the Patent The patent’s scope is centered around: Biological molecules: Recombinant interferon-beta with defined amino acid sequences and modifications. Genetic constructs: Specific nucleic acid sequences and vectors encoding these proteins. Production methods: Techniques involving host cells, expression, and purification. Pharmaceutical formulations: Methods and compositions for therapeutic delivery. The claims favor biotechnological innovations in recombinant DNA technology, encompassing both molecular biology and biomanufacturing processes. Notably, the patent emphasizes product characteristics like stability, purity, and bioactivity, which are critical for regulatory approval and market differentiation. Patent Landscape and Competitive Environment Pre-grant and Post-grant Context Before and after the patent’s issue date, multiple patents have emerged around interferon-beta formulations, methods, and derivatives. Key players include ZymoGenetics, Schering (now part of Merck), and Biogen. Related Patent Families and Key Competitors Biogen's Betaferon/Betaseron (U.S. Patent No. 4,691,028): Focused on early recombinant interferon-beta formulations. Schering’s patent families relate to dosing regimens, formulations, and specific amino acid modifications to optimize stability and efficacy. Other patent applications explore pegylated variants, alternative expression systems (e.g., CHO cells), and improved delivery methods. Patent Term and Expiry The '418 patent, granted in 2004, would typically expire 20 years from its earliest priority date, likely around 2024-2005, considering patent term adjustments. This impacts market competitiveness and generic entry strategies. Freedom-to-Operate Considerations Competitors must navigate overlapping claims related to recombinant DNA constructs, production methods, and formulations. Notably, the patent’s emphasis on specific amino acid modifications and expression systems creates a layered landscape, requiring careful patent clearance analyses for new therapies. Legal Status and Challenges While no significant litigations tied directly to U.S. Patent 6,703,418 are publicly documented, the high value of interferon-beta therapies means the patent portfolio has been a strategic asset, potentially subject to licensing negotiations. Implications for Industry Stakeholders Pharmaceutical Developers: The patent’s claims underscore the importance of molecular modifications and optimized production processes. They highlight avenues for developing biosimilar or biosuperior therapies while respecting existing patent protections. Patent Strategists: The broad scope of “composition of matter” and manufacturing method claims necessitate comprehensive freedom-to-operate evaluations in new interferon-beta products. Legal and Regulatory Compliance: Ensuring adherence to patent rights is critical in avoiding infringement lawsuits, particularly in markets with expired or soon-to-expire patents like this one. Key Takeaways U.S. Patent 6,703,418 manifests a comprehensive scope covering recombinant interferon-beta molecules, genetic constructs, production techniques, and formulations for therapeutic use. Its claims, particularly on amino acid variants and host cell processes, have significantly influenced the biotech patent landscape for interferon therapies. While foundational, the patent’s expiration in the mid-2020s opens opportunities for biosimilar and biosuperior development, subject to careful patent landscape navigations. Competitive strategies should incorporate detailed patent clearance related to protein modifications, expression systems, and formulations. The increased emphasis on stability, purity, and bioactivity continues to drive innovation in recombinant cytokine therapeutics. FAQs 1. What is the primary innovation of U.S. Patent 6,703,418? It encompasses recombinant human interferon-beta molecules with specific amino acid modifications, optimized for stability and bioactivity, along with related genetic constructs and production methods. 2. How does this patent impact biosimilar development? It creates a patent barrier for biosimilars aiming to produce identical interferon-beta formulations, particularly those employing similar amino acid sequences or production processes until expiry or licensing. 3. Are there any known challenges or litigations related to this patent? No publicly available litigations are directly associated, but ongoing patent landscapes and licensing negotiations influence the commercial viability of related therapies. 4. What are the critical aspects to consider when developing interferon-beta products post-expiry? Developers should evaluate residual patent claims, formulations, and process patents' expiration status, alongside regulatory requirements for biosimilars. 5. How does this patent fit within the broader interferon patent landscape? It complements earlier patents on interferon-beta by adding claims on specific modifications and manufacturing methods, shaping a layered intellectual property environment that influences innovation and market control. Sources [1] U.S. Patent 6,703,418 – Full Document. [2] Patent landscape reports on interferon-beta therapeutics. [3] FDA Orange Book listings for interferon-beta formulations. [4] Industry patent analysis reports on cytokine therapeutics. [5] Court records and patent challenge summaries (where applicable). More… ↓ ⤷ Get Started Free

Details for Patent: 6,703,418

Summary for Patent: 6,703,418