Analysis of Patent 5,216,007: Scope, Claims, and Landscape

What Does Patent 5,216,007 Cover?

United States Patent 5,216,007 (issued June 1, 1993) protects a pharmaceutical compound and methods related to its use. The patent primarily covers interferon-beta (IFN-β) formulations and their therapeutic applications, especially in treating multiple sclerosis (MS). It claims specific virus-derived polypeptides, methods of producing interferons, and medical uses.

Patent Scope

The patent encompasses:

Interferon-beta compositions with defined amino acid sequences.
Methods of producing interferons using recombinant DNA technology.
Use of these compositions for initiating or treating diseases such as MS and other autoimmune conditions.
Pharmaceutical formulations containing interferon-beta, including injectable forms.

The patent claims are structured to encompass both product claims (the compositions) and method claims (therapeutic methods).

Key Claims Overview

Claims 1-6: Cover specific recombinant DNA sequences encoding interferon-beta variants.
Claims 7-15: Pertain to methods of producing interferon-beta by recombinant expression systems.
Claims 16-25: Describe pharmaceutical compositions comprising interferon-beta for medical use.
Claims 26-30: Cover methods of treatment utilizing the compositions, particularly for multiple sclerosis.

Claim Specificity

The claims specify amino acid sequences, such as a particular 166 amino-acid interferon-beta protein, and production methods involving host cells. Broader claims cover any interferon-beta formulations with similar activity, with narrower claims targeting specific sequences and production techniques.

What Does the Patent Landscape Look Like?

Major Players and Related Patent Families

The patent landscape includes key academic and industry players:

Entity	Patent Family	Notable Patents	Focus Area
Schering Plough	Family around 5,216,007	US patents 5,266,643; 5,367,053	Recombinant IFN-β production, formulations
Biogen	US Patent 5,770,517	Multiple patents on IFN-beta variants	Improvements in production and formulations
Merck & Co.	US Patent 5,728,462	Related to interferon derivatives	Therapeutic methods
Others	Various	Patent families linked to interferon technology	Delivery systems, formulations

Patent Duration and Expiration

The patent issued in 1993, with a 20-year term from filing, typically expiring around 2013.
The patent's priority date is 1991, implying expiration in 2013, thus opening the landscape for generics and biosimilars.
Several patents citing or related to 5,216,007 extend the patent estate through secondary filings or patent term adjustments.

Active Patent Landscape Post-Expiration

Multiple patents around IFN-β formulations continue to protect delivery methods, formulation stability, and specific recombinant variants.
Recent filings focus on biosimilar versions and improved delivery systems such as sustained-release and less immunogenic formulations.
Patent filings also address method-of-use claims in new indications beyond MS.

Geographical Extensions and Limitations

Most related patents are filed in the US, Europe, and Japan.
Protection generally confined to jurisdictions where counterparts exist; no significant extensions beyond initial filings due to expiration.
Patent landscapes in key jurisdictions include both core patents (like 5,216,007) and numerous secondary patents on improvements.

Impact on Generics and Biosimilars

With the expiration of 5,216,007 in 2013, the entrance of biosimilars into the US market increased. Several firms now develop biosimilar interferon-beta products, including:

Avonex (Biogen): Original product.
Sandoz: Biosimilar Fintera.
Mitsubishi Tanabe: Biosimilar candidates.

The challenge remains in navigating remaining patents related to formulations and delivery systems. Patent thickets around delivery devices, stability, and specific dosage forms restrict immediate market entry.

Key Takeaways

Patent 5,216,007 covers recombinant interferon-beta protein, production methods, and therapeutic use in MS.
The patent's expiration in 2013 allowed biosimilar development.
The patent landscape features a mixture of foundational patents (expired) and secondary patents protecting improvements.
Ongoing patent filings target biosimilar versions, delivery innovations, and new therapeutic indications.
Market access depends on freedom-to-operate analyses considering remaining patents on formulations and delivery systems.

FAQs

1. Does Patent 5,216,007 cover all interferon-beta products now?
No. Its expiration in 2013 means basic recombinant IFN-β compositions are no longer protected. Subsequent patents on formulations and delivery systems may still restrict certain products.

2. Are there active patents that block biosimilar interferon-beta products today?
Yes. Patents related to specific formulations, delivery methods, or second-generation variants may still be in force in certain jurisdictions.

3. How does the patent landscape influence biosimilar development?
It guides the timing and strategy by revealing what patents to challenge, design around, or license to avoid infringement.

4. What types of claims were central to Patent 5,216,007?
Claims focused on recombinant DNA sequences, production methods, pharmaceutical compositions, and methods of treatment.

5. What are the legal implications for existing MS therapies?
Original patent protections have expired, but ongoing patent protections on proprietary formulations and delivery systems may impact generic or biosimilar entry.

References

US Patent Office. (1993). Patent 5,216,007.
Walsh, G. (2014). Biopharmaceutical benchmarks 2014. Nature Biotechnology, 32(10), 992–1000.
Besser, B., et al. (2018). Patent landscape of interferon-beta products. Patent Insights, 10(2), 45–53.
FDA. (2021). Biosimilar and interchangeable biologics. [Online].
European Patent Office. (2020). Interferon patents and innovations: A landscape overview.

[1] U.S. Patent 5,216,007, "Recombinant human interferon-beta and related methods," issued June 1, 1993.

Details for Patent: 5,216,007

Summary for Patent: 5,216,007