Claims for Patent: 5,075,222

Summary for Patent: 5,075,222

Title:	Interleukin-1 inhibitors
Abstract:	DNA sequences that encode Interleukin-1 inhibitors and recombinant-DNA methods for the production of interleukin-1 inhibitors are provided. The DNA sequences encode proteins having interleukin-1 inhibitors activity.
Inventor(s):	Hannum; Charles H. (Boulder, CO), Eisenburg; Stephen P. (Boulder, CO), Thompson; Robert C. (Boulder, CO), Arend; William P. (Denver, CO), Joslin; Fenneke G. (Denver, CO)
Assignee:	Synergen, Inc. (Boulder, CO)
Application Number:	07/506,522
Patent Claims:	1. An isolated DNA sequence encoding a physiologically functional interleukin-1 inhibitor (IL-li) comprising a DNA sequence that is selected from the group consisting of (1) a DNA sequence that encodes IL-li X, IL-li alpha, or IL-li beta and (2) a DNA sequence (i) that cross-hybridizes to a DNA sequence that encodes IL-li X, IL-li alpha, or IL-li beta or (ii) that cross-hybridizes to a DNA sequence that is complementary to a DNA sequence that encodes IL-li X, IL-li alpha, or IL-li beta, wherein said DNA sequence of (i) or (ii) encodes a protein having IL-1 inhibitor activity. 2. The recombinant DNA molecular GT10-lLli-2A. 3. The isolated DNA sequence of claim 1 wherein said DNA sequence comprises a DNA sequence that encodes IL-li X, IL-li alpha or IL-li beta. 4. The isolated DNA sequence of claim 1, wherein said DNA base sequence includes the nucleic acids from position 99 to 554 from the sequence which follows: ##STR5## 5. The isolated DNA sequence of claim 1, wherein said DNA base sequence includes the nucleic acids from position 99 to 554 from the sequence which follows: ##STR6## 6. The recombinant DNA vector comprising the DNA sequence of claim 1. 7. The vector of claim 6, wherein said vector is an expression vector and further comprises at least one regulatory element needed for the expression of the DNA sequence in a host. 8. The vector of claim 7, wherein said DNA sequence is capable of being expressed in bacteria. 9. The vector of claim 7, wherein said DNA sequence is capable of being expressed in mammalian cells. 10. The vector of claim 6 wherein said DNA sequence comprises a DNA sequence that encodes IL-li X, IL-li alpha or IL-li beta. 11. A cell host including the vector of claim 6 inserted therein. 12. The host cell of claim 11, wherein said host cell is capable of expressing said DNA sequence. 13. The host cell of claim 12, wherein said host cell is a microorganism. 14. The host cell of claim 13, wherein said host cell is a bacterial cell. 15. The host cell of claim 14, wherein said host cell is Escherichia coli. 16. The host cell of claim 13, wherein said host cell is a mammalian cell. 17. A recombinant-DNA method for the production of an interleukin-1 inhibitor (IL-li) comprising: (a) preparing a DNA sequence encoding a protein having IL-1 inhibitor activity, wherein said DNA sequence is selected from the group consisting of (1) a DNA sequence that encodes IL-li X, IL-li alpha, or IL-li beta and (2) a DNA sequence (i) that cross-hybridizes to a DNA sequence that encodes IL-li X, IL-li alpha, or IL-li beta or (ii) that cross-hybridizes to a DNA sequence that is complementary to a DNA sequence that encodes IL-li X, IL-li alpha, or IL-li beta, wherein said DNA sequence of (i) or (ii) encodes a protein having IL-1 inhibitor activity; (b) subcloning the DNA sequence into a vector capable of being inserted into and replicated in a host cell, such vector containing at least one regulatory element needed to express the DNA sequence; (c) inserting the vector containing the DNA sequence and at least one regulatory element into a host cell capable of expressing the DNA encoding the IL-1 inhibitor; (d) culturing the host cell sunder conditions appropriate for replication of the vector and expression of the IL-1 inhibitor; and (e) harvesting the IL-1 inhibitor. 18. The method of claim 17 wherein said DNA sequence comprises a DNA sequence that encodes IL-li X, IL-li alpha or IL-li beta. 19. The method of claim 17 wherein said DNA sequence is a cDNA. 20. The method of claim 17 wherein said DNA sequence is a genomic sequence. 21. The method of claim 17 wherein said DNA sequence is derived from mammalian cells. 22. The method of claim 21 wherein said DNA sequence is derived from human monocytes. 23. The method of claim 17 wherein said host cell is a microorganism. 24. The method of claim 23 wherein said microorganism is E. coli. 25. The method of claim 17 wherein said host cells are mammalian cells. 26. The method of claim 25 wherein said mammalian cells are CHO cells. 27. The method of claim 17 wherein said DNA sequence is a synthetic polynucleotide. 28. A recombinant-DNA method for the production of an interleukin-1 inhibitor (IL-li) comprising: (a) culturing a host cell that includes inserted therein a vector comprising the DNA sequence of claim 1 operatively linked to at least one regulatory element needed for the expression of the DNA sequence in the host cell; (b) harvesting the protein having IL-1 inhibitor activity. 29. A recombinant-DNA method for the construction of an interleukin-1 inhibitor (IL-li) expression vector comprising: (a) preparing the DNA sequence of claim 1; and (b) subcloning the DNA sequence into a vector capable of being inserted into and replicated in a host cell, such vector containing at least one regulatory element needed for the expression of the DNA sequence. 30. The method of claim 27 wherein said DNA sequence comprises a DNA sequence that encodes IL-li X, IL-li alpha or IL-li beta. 31. The method of claim 28 wherein said DNA sequence comprises a DNA sequence that encodes IL-li X, IL-li alpha or IL-li beta.

Details for Patent 5,075,222

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	November 14, 2001	5,075,222	2008-12-24

International Patent Family for US Patent 5,075,222

Country	Patent Number	Estimated Expiration
South Africa	911981
South Africa	905593
South Africa	894052
World Intellectual Property Organization (WIPO)	9534326
World Intellectual Property Organization (WIPO)	9216221
World Intellectual Property Organization (WIPO)	8911540
United States of America	6858409