Claims for Patent: 6,338,844

Summary for Patent: 6,338,844

Title:	Genomic nucleic acids, cDNA and mRNA which code for polypeptides with IL-16 activity, processes for the production thereof and their use
Abstract:	A nucleic acid with which expression of a polypeptide having interleukin-16 activity can be achieved or regulated in a prokaryotic or eukaryotic host cell, wherein in the region coding for the polypeptide, the nucleic acid (1) corresponds to the DNA sequence SEQ ID NOS:1 and 5-7 or its complementary strand; (b) hybridizes under stringent conditions with the DNA of sequence SEQ ID NOS:1 and 5-7; (c) or is a nucleic acid sequence which, if there was no degeneracy of the genetic code, would hybridize under stringent conditions with the nucleic acid sequences defined by (a) and (b); (d) and, if it codes for a polypeptide having interleukin-16 activity, is suitable as genomic DNA for the recombinant production of IL-16 in eukaryotic host cells and processes for producing the same and pharmaceutical compositions containing the same.
Inventor(s):	Kurth; Reinhard (Dreieich, DE), Baier; Michael (Frankfurt, DE), Bannert; Norbert (Frankfurt, DE), Metzner; Karin (Frankfurt, DE), Werner; Albrecht (Weinheim, DE)
Assignee:	Bundesrepublik Deutschland vertreten durch de Bundesminister fur Gesundheit (Bonn, DE)
Application Number:	09/147,119
Patent Claims:	1. An isolated nucleic acid encoding a polypeptide with interleukin-16 activity, comprising a nucleic acid sequence selected from the group consisting of (1) at least nucleotide sequence 2053 to 3195 of SEQ ID NO: 1; (2) the nucleic acid sequence of SEQ ID NO: 5; (3) the nucleic acid sequence of SEQ ID NO: 6; and (4) a nucleic acid sequence which encodes the amino acid sequence of SEQ ID NO: 7. 2. A process for producing a polypeptide with interleukin-16 activity, comprising (a) transforming or transfecting a host cell with a nuclei acid according to claim 1, to obtain a transformed or transfected host cell; (b) culturing the transformed or transfected host cell to obtain a cell culture; (c) expressing the nucleic acid in the transformed or transfected host cell to produce the polypeptide; and (d) isolating the polypeptide from the cell culture. 3. The process of claim 2, wherein the host cell is a prokaryotic cell. 4. The process of claim 2, wherein the host cell is a eukaryotic cell. 5. A process for producing a polypeptide with interleukin-16 activity, comprising (a) providing a vector containing a nucleic acid according to claim 1 and regulatory elements necessary to express the nucleic acid in a eukaryotic host cell; (b) transforming or transfecting a eukaryotic cell with the vector to obtain a transformed or transfected host cell; (c) culturing the transformed or transfected host cell to obtain a cell culture; (d) expressing the nucleic acid in the transformed or transfected host cell to produce the polypeptide; and (e) isolating the polypeptide from the cell culture. 6. A host cell which is transformed or transfected with a nucleic acid according to claim 1, wherein the host cell expresses the polypeptide with interleukin-16 activity. 7. The host cell of claim 6, wherein the host cell is a prokaryotic cell. 8. The host cell of claim 6, wherein the host cell is a eukaryotic cell. 9. A vector containing a nucleic acid according to claim 1. 10. A polypeptide with interleukin-16 activity, wherein the polypeptide can be expressed using a nucleic acid according to claim 1, wherein the polypeptide has a molecular weight of about 14 kD. 11. A multimeric polypeptide with interleukin-16 activity, wherein the multimeric polypeptide is composed of a plurality of subunits, and wherein the subunits comprise a polypeptide according to claim 10. 12. The multimeric polypeptide of claim 11, wherein the multimeric polypeptide is composed of two, four or eight subunits. 13. A complementary nucleic acid of the nucleic acid of claim 1. 14. A pharmaceutical composition, comprising a nucleic acid according to claim 1, in combination with a pharmaceutically acceptable carrier. 15. An isolated nucleic acid which can hybridize with the nucleic acid of claim 1, at hybridization conditions selected from the group consisting of: (a) low stringency hybridization conditions characterized by a hybridizing step in 6.0.times.SSC at about 45.degree. C. followed by a washing step in 2.0.times.SSC at 22-50.degree. C.; and (b) high stringency hybridization conditions characterized by a hybridizing step in 6.0.times.SSC at about 45.degree. C. followed by a washing step at 0.2.times.SSC at 50-65.degree. C. wherein the isolated nucleic acid encodes for a polypeptide having a length of 631 amino acids similar or equal to the sequence of SEQ ID NO: 7. 16. An isolated nucleic acid which can hybridize with the nucleic acid of claim 1, at hybridization conditions selected from the group consisting of: (a) low stringency hybridization conditions characterized by a hybridizing step in 6.0.times.SSC at about 45.degree. C. followed by a washing step in 2.0.times.SSC at 22-50.degree. C.; and (b) high stringency hybridization conditions characterized by a hybridizing step in 6.0.times.SSC at about 45.degree. C. followed by a washing step at 0.2.times.SSC at 50-65.degree. C. wherein the isolated nucleic acid consists of 7 exons and 6 introns. 17. An isolated nucleic acid which can hybridize with the nucleic acid of claim 1, at hybridization conditions selected from the group consisting of: (a) low stringency hybridization conditions characterized by a hybridizing step in 6.0.times.SSC at about 45.degree. C. followed by a washing step in 2.0.times.SSC at 22-50.degree. C.; and (b) high stringency hybridization conditions characterized by a hybridizing step in 6.0.times.SSC at about 45.degree. C. followed by a washing step at 0.2.times.SSC at 50-65.degree. C. wherein the isolated nucleic acid contains the intron/exon junctions according to SEQ ID NO: 1.

Details for Patent 6,338,844

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2016-04-10
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2016-04-10
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2016-04-10