Claims for Patent: 6,482,613

Summary for Patent: 6,482,613

Title:	Microbial production of mature human leukocyte interferons
Abstract:	Disclosed herein are methods and means of microbially producing, via recombinant DNA technology, mature human leukocyte interferons, useful in the treatment of viral and neoplastic diseases.
Inventor(s):	Goeddel; David V. (Burlingame, CA), Pestka; Sidney (North Caldwell, NJ)
Assignee:	Hoffmann-La Roche Inc. (Nutley, NJ) Genentech, Inc. (South San Francisco, CA)
Application Number:	07/145,002
Patent Claims:	1. A DNA comprising a nucleotide sequence encoding a polypeptide of 165-166 amino acids having the amino acid sequence of a mature human leukocyte interferon unaccompanied by any corresponding presequence or portion thereof, wherein said nucleotide sequence further comprises an ATG immediately preceding the codon corresponding to the amino-terminal amino acid of said polypeptide. 2. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:45, wherein the amino-terminal amino acid is cysteine. 3. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:46, wherein the amino-terminal amino acid is cysteine. 4. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:47, wherein the amino-terminal amino acid is cysteine. 5. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:49, wherein the amino-terminal amino acid is cysteine. 6. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:50, wherein the amino-terminal amino acid is cysteine. 7. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:51, wherein the amino-terminal amino acid is cysteine. 8. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:52, wherein the amino-terminal amino acid is cysteine. 9. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:48, wherein the amino-terminal amino acid is cysteine. 10. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:53, wherein the amino-terminal amino acid is cysteine. 11. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:54, wherein the amino-terminal amino acid is cysteine. 12. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:55, wherein the amino-terminal amino acid is cysteine. 13. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:56, wherein the amino-terminal amino acid is cysteine. 14. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:57, wherein the amino-terminal amino acid is cysteine. 15. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:58, wherein the amino-terminal amino acid is cysteine. 16. The DNA according to claim 1, in which the mature human leukocyte interferon has the amino acid sequence of SEQ ID NO:59, wherein the amino-terminal amino acid is cysteine. 17. A process for producing a polypeptide product, comprising culturing a bacterium transformed with a replicable bacterial expression vehicle comprising a DNA according to any of claims 1-16, said vehicle capable of expressing in said bacterium a mature human leukocyte interferon having about 165-166 amino acids unaccompanied by any corresponding presequence or portion thereof. 18. A process for producing a polypeptide product, comprising culturing a bacterium transformed with a replicable bacterial expression vehicle comprising a DNA according to claim 2, said vehicle capable of expressing in said bacterium a mature human leukocyte interferon having about 165-166 amino acids unaccompanied by any corresponding presequence or portion thereof. 19. A process for producing a polypeptide product, comprising culturing a bacterium transformed with a replicable bacterial expression vehicle comprising a DNA according to claim 10, said vehicle capable of expressing in said bacterium a mature human leukocyte interferon having about 165-166 amino acids unaccompanied by any corresponding presequence or portion thereof. 20. A bacterium transformed with a DNA according to claims 1-16. 21. A bacterium according to claim 20, wherein the bacterium is E. coli. 22. A bacterium according to claim 20, wherein the bacterium is E. coli K-12 strain 294.

Details for Patent 6,482,613

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	PEGINTRON	peginterferon alfa-2b	Injection	103949	01/19/2001		2019-11-19
Merck Sharp & Dohme Corp.	SYLATRON	peginterferon alfa-2b	For Injection	103949	03/29/2011		2019-11-19

International Patent Family for US Patent 6,482,613

Country	Patent Number	Estimated Expiration
Argentina	242833
Austria	380272
Austria	394207
Austria	394208
Austria	A170285