Claims for Patent: 9,051,582

Summary for Patent: 9,051,582

Title:	Expression vectors comprising the mCMV IE2 promoter
Abstract:	The invention relates to an expression vector comprising the promoter of the mCMV-IE2 gene, or a functional expression promoting fragment thereof, and/or an enhancer of the mCMV-IE2 gene, or a functional expression enhancing fragment thereof, wherein the expression vector does not contain any complete gene of the mCMV.
Inventor(s):	Chatellard; Philippe (Lausanne, CH), Imhof; Markus (Chexbres, CH)
Assignee:	MERCK SERONO SA (Coinsins, Vaud, CH)
Application Number:	12/872,151
Patent Claims:	1. An expression vector comprising a mCMV-IE2 promoter fragment consisting of nucleotides 1 to 39 of SEQ ID NO: 1 directly linked to a DNA sequence encoding a heterologous polypeptide. 2. The vector according to claim 1, wherein said vector further comprises a mCMV-IE2 enhancer comprising SEQ ID NO: 9. 3. The vector according to claim 2, wherein said mCMV-IE2 enhancer comprises SEQ ID NO: 10. 4. The vector according to claim 1, further comprising a second promoter different from said mCMV-IE2 promoter. 5. The vector according to claim 4, wherein the second promoter is the mCMV-IE1 promoter. 6. The vector according to claim 4, wherein the mCMV-IE2 promoter fragment and the second promoter are bi-directionally arranged. 7. The vector according to claim 4, further comprising one or more regulatory elements selected from a 5'UTR, an intron, a 3'UTR, a mRNA 3' end processing sequence, a polyadenylation site, or an internal ribosome entry sequence (IRES). 8. The vector according to claim 7, wherein the IRES is operably linked to a DNA sequence encoding at least one polycistronic mRNA. 9. The vector according to claim 7, further comprising one or more DNA element selected from an insulator, a boundary element, a locus control region (LCR), a matrix attachment region (MARs), an element for recombination or an element for cassette exchange. 10. A host cell transfected with the vector according to claim 1. 11. The host cell according to claim 10, wherein the host cell is a CHO cell. 12. A process for the production of a polypeptide comprising the step of transfecting a host cell according to claim 10 and culturing said host cell under conditions allowing expression of the polypeptide. 13. The process according to claim 12, wherein the transfection is a stable transfection. 14. The process according to claim 13, further comprising the step of isolating the polypeptide from the host cell or cell culture supernatant. 15. The process according to claim 12, further comprising the step of isolating the polypeptide from the host cell or cell culture supernatant. 16. The vector according to claim 1, wherein said expression vector further comprises a second promoter directly linked to a DNA sequence encoding a second polypeptide. 17. A host cell comprising an expression vector according to claim 16. 18. The vector according to claim 16, wherein the second promoter is different from said mCMV-IE2 promoter. 19. The vector according to claim 16, wherein the second promoter is the mCMV-IE1 promoter. 20. The vector according to claim 16, wherein the heterologous polypeptide or the second polypeptide is a marker protein. 21. The vector according to claim 20, wherein the marker protein is selected from an adenosine deaminase (ADA), an aminoglycoside phosphotransferase (neo), a dihydrofolate reductase (DHFR), a hygromycin-B-phosphotransferase (HPH), a thymidine kinase (tk), a xanthine-guanine phosphoribosyltransferase (gpt), a multiple drug resistance gene (MDR), an ornithine decarboxylase (ODC), carbamyl-P synthetase/aspartate transcarbamylase/dihydro-orotase, a puromycin acetyltransferase (PAC), a galactokinase, a human folate receptor, or a reduced folate carrier. 22. The vector according to claim 16, wherein the heterologous polypeptide or the second polypeptide is a reporter protein. 23. The vector according to claim 22, wherein the reporter protein is selected from a luciferase, a green fluorescent protein, an alkaline phosphatase, and a horseradish peroxidase or combinations thereof. 24. The vector according to claim 16, wherein the heterologous polypeptide and the second polypeptide are the same. 25. The vector according to claim 16, wherein the heterologous polypeptide and the second polypeptide are different. 26. The vector according to claim 25, wherein the heterologous polypeptide is a first subunit of a dimeric or a multimeric protein and the second polypeptide is a second subunit of a dimeric or a multimeric protein. 27. The vector according to claim 26, wherein the first and the second subunit comprise the alpha and the beta chain of a hormone selected from a human FSH, a human LH, a human TSH or a human CG. 28. The vector according to claim 26, wherein one subunit is a heavy chain and the other subunit is a light chain of an immunoglobulin.

Details for Patent 9,051,582

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		2023-03-11
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2023-03-11
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2023-03-11