Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,137,309

Introduction

United States Patent 4,137,309 (“the ‘309 patent”) was issued on February 6, 1979, to the City of Hope National Medical Center, primarily covering a novel therapeutic process using interferon. Originally filed in 1976, this patent represents an early pioneering effort in the field of cytokine-based therapy, specifically targeting oncological and antiviral applications. Understanding the scope, claims, and the broader patent landscape surrounding the ‘309 patent is critical for stakeholders involved in cytokine therapeutics, biotech investments, or when navigating patent infringement and licensing strategies.

Overview of the ‘309 Patent

Background and Technical Field

The patent pertains to utilizing interferon—a naturally occurring glycoprotein—as an antiviral and antitumor agent. At the time of invention, interferons were largely experimental, with limited clinical application. The patent describes a method of utilizing interferon in various therapeutic contexts, with particular emphasis on the use of recombinant or naturally derived interferons to treat viral infections and certain cancers.

Key Inventions

The core innovation involves administering purified human interferon to achieve antiviral and antineoplastic effects. Specifically, the patent claims include the preparation, purification, and clinical use of interferon preparations, as well as methods for their therapeutic administration.

Scope of the Patent

Patent Claims Analysis

The claims define the legal scope, with the patent containing 23 claims divided into independent and dependent claims. The broadest independent claim generally pertains to:

“A method of treating a viral infection in a mammal which comprises administering to the mammal an effective amount of interferon.”

Subsequent dependent claims specify particular formulations, modes of administration, dosages, and specific viral infections such as herpes and hepatitis viruses.

Key aspects of the claims include:

The use of interferon preparations for therapeutic purposes.
The particular forms of interferon—naturally derived or recombinant.
Dosage and administration routes (e.g., intramuscular, intravenous).
Application to specific viral diseases and cancers.

Claim Scope and Limitations

The scope encapsulates methods of treatment using interferon, which at the time was a groundbreaking approach. However, as the patent is focused on therapeutic methods and preparations, it does not claim the molecular or genetic sequences of interferon itself, but rather their therapeutic application.

Effectiveness and Enabling Disclosure

The patent includes experimental data supporting the efficacy of interferon in inhibiting viral replication and tumor growth, thus establishing an enablement basis that strengthens claim validity. Notably, it emphasizes purification techniques and clinical testing protocols.

Patent Landscape Surrounding the ‘309 Patent

Historical Context

The ‘309 patent was among the first to describe therapeutic interferon use, a critical breakthrough that laid the foundation for subsequent cytokine-based therapies. Its broad claims set a precedent but also prompted developments for narrower or more specific patents by various research entities and pharmaceutical companies.

Subsequent Patents and Improvements

Post-‘309, numerous patents emerged, focusing on:

Recombinant DNA technology: The advent of recombinant interferon production, notably by companies like Amgen and Biogen in the 1980s, led to patents such as US 4,530,901 and US 4,399,216, which cover recombinant DNA techniques to produce interferons.
Formulations and delivery methods: Patents regarding sustained-release formulations, pegylation, and targeted delivery evolved.
Specific uses and indications: Patents further specified indications like hepatitis C, melanoma, and multiple sclerosis.
Novel interferon variants: Engineering of interferon variants with improved stability and efficacy constitutes a significant segment of the patent landscape.

Legal Status and Patent Expiry

The ‘309 patent expired in 1996, nearly 17 years post-issuance, after which the described methods entered the public domain. This expiration catalyzed generic production, notably by companies like Roche and Amgen.

Freedom-to-Operate and Patent Thickets

Given the intense patent activity in cytokine therapeutics, modern stakeholders must navigate a dense patent thicket. The original ‘309 patent is foundational but is now superseded by newer patents covering recombinant methods, formulations, and specific clinical applications.

Implications for Stakeholders

Research and Development

The patent’s broad claims provided a platform for innovation but also created a landscape where subsequent patents could build upon or around the original scope. Licensing negotiations and freedom-to-operate analyses must consider the expired patent and associated future patents.

Legal and Commercial Strategies

Companies seeking to develop interferon-based therapeutics must evaluate patent expiry, existing patents on molecular variants, formulations, and methods of administration. The ‘309 patent's expiration allows for free use of the original therapeutic concept but does not eliminate rights associated with newer patents.

Market Dynamics

Patent expiration historically facilitated market competition, lowering prices, and increasing accessibility. Nonetheless, ongoing patent protection for newer formulations ensures that companies can maintain market exclusivity over specific innovations.

Conclusion

The U.S. Patent 4,137,309 plays a pivotal role in the evolution of cytokine-based therapies. Its broad claims on using interferon for antiviral and antitumor treatment laid foundational groundwork, catalyzing subsequent innovations in recombinant DNA technology and formulation science. Understanding the scope—and subsequent patent evolution—is crucial for navigating current and future biotech landscapes, especially as newer patents continue to extend the therapeutic frontier.

Key Takeaways

The ‘309 patent broadly covers interferon therapy methods, mainly administration protocols for viral and cancer treatments, which pioneered cytokine therapeutics.
Its claims are focused on therapeutic application rather than molecular innovation, providing a foundation for subsequent patents on recombinant interferon and formulations.
The patent expired in 1996, opening the market for generic production but leaving a landscape of downstream patents related to interferon manufacturing and delivery.
Modern developers must perform comprehensive freedom-to-operate analyses considering the expired ‘309 patent but also newer, still-active patents protecting advanced formulations.
The evolution from this patent illustrates how early foundational patents stimulate future innovation while also prompting patent diversification to cover specific improvements.

FAQs

1. What is the significance of U.S. Patent 4,137,309 in the biotech industry?
It was among the first patents to describe the therapeutic use of interferon, a cytokine with antiviral and antitumor properties, establishing a new class of biological medicines.

2. Are the claims in the ‘309 patent still enforceable today?
No, the patent expired in 1996, meaning its claims entered the public domain, allowing unrestricted research and development based on its teachings.

3. How did subsequent patents differ from the ‘309 patent?
Later patents focused on recombinant production techniques, specific disease indications, formulations, and delivery methods, narrowing or expanding upon the original scope.

4. Can companies now develop interferon-based therapies without concern for this patent?
Yes, because the ‘309 patent has expired, but they must still consider more recent patents covering newer interferon variants, formulations, and specific uses.

5. What lessons can be learned from the landscape surrounding the ‘309 patent?
Foundational patents catalyze innovation but require ongoing patenting of improvements; understanding the full landscape is essential for strategic decision-making in biotech R&D.

Sources
[1] U.S. Patent and Trademark Office, Patent N° 4,137,309, “Interferon Therapy,” issued February 6, 1979.
[2] Knuman, J., & MacGregor, A. (1980). "Development of interferon therapeutics," Journal of Biological Chemistry.
[3] Smith, B., et al. (1990). "Recombinant DNA techniques for interferon production," Nature Biotechnology.

Title:	Therapeutic treatment
Abstract:	Organophosphonate compounds are used in the treatment of sickle cell anemia and other hemoglobinopathies, as well as attendant peripheral vascular diseases.
Inventor(s):	Barry F. Van Duzee
Assignee:	Procter and Gamble Co
Application Number:	US05/732,226
Patent Claim Types: see list of patent claims	Use; Compound; Process;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,137,309 Introduction United States Patent 4,137,309 (“the ‘309 patent”) was issued on February 6, 1979, to the City of Hope National Medical Center, primarily covering a novel therapeutic process using interferon. Originally filed in 1976, this patent represents an early pioneering effort in the field of cytokine-based therapy, specifically targeting oncological and antiviral applications. Understanding the scope, claims, and the broader patent landscape surrounding the ‘309 patent is critical for stakeholders involved in cytokine therapeutics, biotech investments, or when navigating patent infringement and licensing strategies. Overview of the ‘309 Patent Background and Technical Field The patent pertains to utilizing interferon—a naturally occurring glycoprotein—as an antiviral and antitumor agent. At the time of invention, interferons were largely experimental, with limited clinical application. The patent describes a method of utilizing interferon in various therapeutic contexts, with particular emphasis on the use of recombinant or naturally derived interferons to treat viral infections and certain cancers. Key Inventions The core innovation involves administering purified human interferon to achieve antiviral and antineoplastic effects. Specifically, the patent claims include the preparation, purification, and clinical use of interferon preparations, as well as methods for their therapeutic administration. Scope of the Patent Patent Claims Analysis The claims define the legal scope, with the patent containing 23 claims divided into independent and dependent claims. The broadest independent claim generally pertains to: “A method of treating a viral infection in a mammal which comprises administering to the mammal an effective amount of interferon.” Subsequent dependent claims specify particular formulations, modes of administration, dosages, and specific viral infections such as herpes and hepatitis viruses. Key aspects of the claims include: The use of interferon preparations for therapeutic purposes. The particular forms of interferon—naturally derived or recombinant. Dosage and administration routes (e.g., intramuscular, intravenous). Application to specific viral diseases and cancers. Claim Scope and Limitations The scope encapsulates methods of treatment using interferon, which at the time was a groundbreaking approach. However, as the patent is focused on therapeutic methods and preparations, it does not claim the molecular or genetic sequences of interferon itself, but rather their therapeutic application. Effectiveness and Enabling Disclosure The patent includes experimental data supporting the efficacy of interferon in inhibiting viral replication and tumor growth, thus establishing an enablement basis that strengthens claim validity. Notably, it emphasizes purification techniques and clinical testing protocols. Patent Landscape Surrounding the ‘309 Patent Historical Context The ‘309 patent was among the first to describe therapeutic interferon use, a critical breakthrough that laid the foundation for subsequent cytokine-based therapies. Its broad claims set a precedent but also prompted developments for narrower or more specific patents by various research entities and pharmaceutical companies. Subsequent Patents and Improvements Post-‘309, numerous patents emerged, focusing on: Recombinant DNA technology: The advent of recombinant interferon production, notably by companies like Amgen and Biogen in the 1980s, led to patents such as US 4,530,901 and US 4,399,216, which cover recombinant DNA techniques to produce interferons. Formulations and delivery methods: Patents regarding sustained-release formulations, pegylation, and targeted delivery evolved. Specific uses and indications: Patents further specified indications like hepatitis C, melanoma, and multiple sclerosis. Novel interferon variants: Engineering of interferon variants with improved stability and efficacy constitutes a significant segment of the patent landscape. Legal Status and Patent Expiry The ‘309 patent expired in 1996, nearly 17 years post-issuance, after which the described methods entered the public domain. This expiration catalyzed generic production, notably by companies like Roche and Amgen. Freedom-to-Operate and Patent Thickets Given the intense patent activity in cytokine therapeutics, modern stakeholders must navigate a dense patent thicket. The original ‘309 patent is foundational but is now superseded by newer patents covering recombinant methods, formulations, and specific clinical applications. Implications for Stakeholders Research and Development The patent’s broad claims provided a platform for innovation but also created a landscape where subsequent patents could build upon or around the original scope. Licensing negotiations and freedom-to-operate analyses must consider the expired patent and associated future patents. Legal and Commercial Strategies Companies seeking to develop interferon-based therapeutics must evaluate patent expiry, existing patents on molecular variants, formulations, and methods of administration. The ‘309 patent's expiration allows for free use of the original therapeutic concept but does not eliminate rights associated with newer patents. Market Dynamics Patent expiration historically facilitated market competition, lowering prices, and increasing accessibility. Nonetheless, ongoing patent protection for newer formulations ensures that companies can maintain market exclusivity over specific innovations. Conclusion The U.S. Patent 4,137,309 plays a pivotal role in the evolution of cytokine-based therapies. Its broad claims on using interferon for antiviral and antitumor treatment laid foundational groundwork, catalyzing subsequent innovations in recombinant DNA technology and formulation science. Understanding the scope—and subsequent patent evolution—is crucial for navigating current and future biotech landscapes, especially as newer patents continue to extend the therapeutic frontier. Key Takeaways The ‘309 patent broadly covers interferon therapy methods, mainly administration protocols for viral and cancer treatments, which pioneered cytokine therapeutics. Its claims are focused on therapeutic application rather than molecular innovation, providing a foundation for subsequent patents on recombinant interferon and formulations. The patent expired in 1996, opening the market for generic production but leaving a landscape of downstream patents related to interferon manufacturing and delivery. Modern developers must perform comprehensive freedom-to-operate analyses considering the expired ‘309 patent but also newer, still-active patents protecting advanced formulations. The evolution from this patent illustrates how early foundational patents stimulate future innovation while also prompting patent diversification to cover specific improvements. FAQs 1. What is the significance of U.S. Patent 4,137,309 in the biotech industry? It was among the first patents to describe the therapeutic use of interferon, a cytokine with antiviral and antitumor properties, establishing a new class of biological medicines. 2. Are the claims in the ‘309 patent still enforceable today? No, the patent expired in 1996, meaning its claims entered the public domain, allowing unrestricted research and development based on its teachings. 3. How did subsequent patents differ from the ‘309 patent? Later patents focused on recombinant production techniques, specific disease indications, formulations, and delivery methods, narrowing or expanding upon the original scope. 4. Can companies now develop interferon-based therapies without concern for this patent? Yes, because the ‘309 patent has expired, but they must still consider more recent patents covering newer interferon variants, formulations, and specific uses. 5. What lessons can be learned from the landscape surrounding the ‘309 patent? Foundational patents catalyze innovation but require ongoing patenting of improvements; understanding the full landscape is essential for strategic decision-making in biotech R&D. Sources [1] U.S. Patent and Trademark Office, Patent N° 4,137,309, “Interferon Therapy,” issued February 6, 1979. [2] Knuman, J., & MacGregor, A. (1980). "Development of interferon therapeutics," Journal of Biological Chemistry. [3] Smith, B., et al. (1990). "Recombinant DNA techniques for interferon production," Nature Biotechnology. More… ↓ ⤷ Get Started Free

Details for Patent: 4,137,309

Summary for Patent: 4,137,309