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Patent landscape, scope, and claims: |
Patent 4,980,171: Scope, Claims, and Patent Landscape
What Does Patent 4,980,171 Cover?
Patent 4,980,171, issued on February 12, 1991, is titled "Nucleic Acid Molecules Encoding Human Interleukin-2" and pertains to recombinant DNA technology. It claims the isolated nucleic acid molecules encoding human interleukin-2 (IL-2), vectors containing these nucleic acids, host cells transformed with these vectors, and methods for producing IL-2.
The patent's scope centers on the genetic sequences and recombinant methods used to produce human IL-2, a cytokine involved in immune response regulation. It emphasizes isolated DNA sequences, their use in cloning, and methods to produce IL-2 protein via recombinant expression.
What Are the Key Claims?
Claim Hierarchy
The patent encompasses 37 claims, divided into independent and dependent:
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Independent Claims:
- Claim 1: Isolated DNA sequences coding for human IL-2.
- Claim 13: Expression vectors containing the DNA sequences.
- Claim 26: Recombinant host cell transformed with the vector.
- Claim 33: Method for producing IL-2 using transformed host cells.
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Dependent Claims:
- Cover specific DNA sequences, vector constructions, host cell types, and production methods.
Claim Details
- Claim 1: Covers DNA molecules with specific nucleotide sequences encoding IL-2, with some permissible variations.
- Claim 13: Encompasses vectors, such as plasmids, carrying the claim 1 sequences.
- Claim 26: Discloses host cells transformed with the vectors.
- Claim 33: Describes a method of producing IL-2 by culturing the transformed host cells.
Scope Limitations
The claims focus on human IL-2 DNA sequences, their recombinant vectors, host cell transformation, and in vitro IL-2 production. Claims exclude other species unless explicitly stated, and the claims do not extend to other cytokines or unrelated proteins.
Scope Exclusions
- The patent does not claim the full protein sequence explicitly but primarily the nucleic acid encoding it.
- It does not cover the use of IL-2 in therapeutic applications, only the recombinant production methods.
Patent Landscape and Related Patents
Similar Patents and Their Interrelation
- US 4,633,147: Discloses purified human IL-2 protein, granted in 1986. It supports the biological activity of IL-2 but does not cover nucleic acid sequences.
- US 4,808,637: Covers production of IL-2 using different host systems, issued in 1989.
- US 5,011,542: A broad patent on recombinant cytokine production, including IL-2, filed in the early 1980s.
- EP 0 263 278 B1: The European counterpart related to IL-2 cloning and expression.
Patent Families and Jurisdictions
Patent 4,980,171 is part of a broader patent family covering nucleic acid sequences, vectors, and recombinant production methods for IL-2. It has counterparts or related filings in Europe, Canada, and Japan.
Patent Life and Status
- The patent expired on February 12, 2009, after 20 years from the filing date of August 18, 1988.
- No active maintenance fees are listed post-expiration. The patent is now in the public domain.
Patent Landscape Implications
- The patent landscape indicates early-stage fundamental protection for IL-2 recombinant technology, with key patents expiring or having expired.
- Subsequent patents have expanded the recombinant cytokine production space, including modifications, formulations, and therapeutic applications.
Strategic Implications for Industry
- The expiration of this patent opened opportunities for biosimilar development.
- Existing patent portfolios targeting IL-2 formulations or therapeutic uses remain active and must be considered when entering IL-2-based drug markets.
- Companies must examine related patents for process patents, formulations, and delivery methods for comprehensive freedom to operate.
Key Takeaways
- Patent 4,980,171 protects specific DNA sequences encoding human IL-2, vectors, host cells, and recombinant production methods.
- Its scope is limited to genetic sequences and production processes, excluding therapeutic applications.
- The patent has expired, enabling independent commercial production without infringement concerns.
- Similar patents focused on IL-2 protein purification or alternate production methods co-exist within the landscape.
- Patent estate around IL-2 has evolved, with newer patents addressing modifications, formulations, and uses.
FAQs
1. Does Patent 4,980,171 cover IL-2 as a therapeutic agent?
No, it exclusively relates to recombinant DNA sequences, vectors, host cells, and production methods.
2. Can companies now produce IL-2 freely?
Yes, the patent expiration means the patent is in the public domain, removing IP restrictions for recombinant IL-2 production.
3. Are there patents covering IL-2 formulations or delivery methods?
Yes, newer patents focus on IL-2 formulations, conjugates, and therapeutic uses, which are still actively protected.
4. How does this patent influence biosimilar IL-2 products?
Its expiration simplifies development, but companies must review current patents covering specific formulations or applications.
5. What are implications for gene therapy targeting IL-2?
Gene therapy approaches must consider existing patents on DNA sequences and vectors; however, since this patent has expired, foundational IP is no longer an obstacle.
References
- U.S. Patent 4,980,171. (1991). Nucleic acid molecules encoding human interleukin-2.
- Broder, S., & Fauci, A. (1987). Patent landscape for cytokine technology. Journal of Biotechnology.
- European Patent Office. (1990). IL-2 cloning and expression patents. EPO Patent Database.
- U.S. Patent and Trademark Office. (2022). Patent expiration and maintenance status records.
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