Claims for Patent: 7,812,215

Summary for Patent: 7,812,215

Title:	Methods and protein production using ovomucoid promoters
Abstract:	Methods of producing protein using a recombinant ovomucoid gene expression controlling region operably linked to one or more useful amino acid coding sequences.
Inventor(s):	Harvey; Alex J. (Athens, GA), Leavitt; Markley C. (Watkinsville, GA), Wang; Youliang (Monroe, GA)
Assignee:	Synageva BioPharma Corp. (Waltham, MA)
Application Number:	12/313,064
Patent Claims:	1. A method comprising isolating a heterologous protein from an egg laid by a transgenic avian wherein the avian contains in its genome a recombinant nucleic acid comprising a nucleotide sequence that is at least 95% identical to a nucleic acid sequence corresponding to the sequence of about 34,473 to about 36,248 of SEQ ID NO: 36 operably linked to a coding sequence encoding the heterologous protein. 2. The method of claim 1 wherein the nucleotide sequence comprises a sequence at least 99% identical to the sequence of about 34,473 to about 36,248 of SEQ ID NO: 36. 3. The method of claim 1 wherein the nucleotide sequence comprises the sequence of about 34,473 to about 36,248 of SEQ ID NO: 36. 4. The method of claim 1 wherein the nucleic acid comprises an attB site. 5. The method of claim 1 wherein the nucleic acid comprises a signal sequence coding region. 6. The method of claim 1 wherein the nucleic acid comprises an IRES. 7. The method of claim 1 wherein the nucleic acid comprises a vector. 8. The method of claim 7 wherein the vector is selected from the group consisting of a plasmid, a viral vector or an artificial chromosome. 9. The method of claim 1 wherein the nucleic acid comprises an artificial chromosome. 10. The method of claim 1 wherein the transgenic avian is selected from the group consisting of chicken and quail. 11. The method of claim 1 wherein the heterologous protein is a therapeutic protein. 12. The method of claim 1 wherein the heterologous protein is an antibody. 13. The method of claim 1 wherein the heterologous protein is a fusion protein. 14. The method of claim 1 wherein the heterologous protein is selected from the group consisting of erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), CTLA4-Fc, interferon, interferon alpha, interferon beta FSH, and beta glucocerebrosidase. 15. The method of claim 1 wherein the heterologous protein is selected from the group consisting of MAb directed against t-lymphocyte antigen CD3, MAb directed against TAG-72, tumor-associated glycoprotein, MAb or MAb fragments directed against platelet surface receptor GPII(b) and/or III(a), MAb fragment or MAb directed against tumor-associated antigen CA125, MAb or MAb fragment directed against human CEA (carcinoembryonic antigen), MAb fragment or MAb directed against human cardiac myosin MAb fragment or MAb directed against tumor surface antigen PSMA, MAb fragments or MAb directed against HMW-MAA, MAb fragment or MAb directed against carcinoma-associated antigen, MAb fragments or MAb directed against NCA 90, MAb directed against CD20 antigen found on surface of B lymphocytes, MAb directed against the alpha chain of the IL2 receptor, MAb directed against TNF-alpha, MAb directed against an epitope on the surface of respiratory, syncytial virus, MAb directed against HER 2 (human epidermal growth factor receptor 2), MAb directed against cytokeratin tumor-associated antigen, anti-CTLA4, dornase-alpha DNAse, TNF-alpha, IL-2-diptheria toxin fusion protein that targets cells displaying a surface IL-2 receptor, TNFR-IgG fragment fusion protein, enbrel, laronidase, teriparatide and parathyroid hormone derivatives. 16. A method comprising isolating a heterologous protein from egg white produced by a transgenic avian wherein the genome of the avian contains a recombinant nucleic acid comprising a nucleotide sequence that is at least 95% identical to a nucleic acid sequence corresponding to the sequence of about 34,473 to about 36,248 of SEQ ID NO: 36 operably linked to a heterologous coding sequence and the amino acid sequence encoded by the heterologous coding sequence is produced in an oviduct cell and is isolated from the egg white. 17. The method of claim 16 wherein the nucleotide sequence comprises a sequence at least 99% identical to the sequence of about 34,473 to about 36,248 of SEQ ID NO: 36. 18. The method of claim 16 wherein the nucleotide sequence comprises the sequence of about 34,473 to about 36,248 of SEQ ID NO: 36. 19. The method of claim 16 wherein the oviduct cell is a tubular gland cell. 20. The method of claim 16 wherein the heterologous coding sequence encodes at least one of a light chain and a heavy chain of an antibody. 21. The method of claim 16 wherein the heterologous coding sequence encodes an antibody selected from the group consisting of IgG, IgA, TgD, IgM and IgE. 22. The method of claim 16 wherein the transgenic avian is selected from the group consisting of chicken and quail. 23. A method comprising isolating a heterologous protein from an egg of a transgenic chicken wherein the genome of the transgenic chicken contains a nucleic acid comprising a nucleotide sequence that is at least 95% identical to a nucleic acid sequence corresponding to the sequence of about 34,473 to about 36,248 of SEQ ID NO: 36 operably linked to a heterologous coding sequence, the amino acid sequence encoded by the heterologous coding sequence being produced in an oviduct cell and packaged into the egg laid by the chicken. 24. The method of claim 23 wherein the nucleotide sequence comprises a sequence at least 99% identical to the sequence of about 34,473 to about 36,248 of SEQ ID NO: 36. 25. The method of claim 23 wherein the nucleotide sequence comprises the sequence of about 34,473 to about 36,248 of SEQ ID NO: 36. 26. The method of claim 23 wherein the heterologous protein is a fusion protein. 27. The method of claim 23 wherein the heterologous protein is a therapeutic protein. 28. The method of claim 27 wherein the therapeutic protein is a fusion protein. 29. The method of claim 23 wherein the heterologous protein is selected from the group consisting of erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), CTLA4-Fc, interferon, interferon alpha, interferon beta, FSH, an antibody and beta glucocerebrosidase. 30. The method of claim 23 wherein the heterologous protein is selected from the group consisting of MAb directed against t-lymphocyte antigen CD3, MAb directed against TAG-72, tumor-associated glycoprotein, MAb or MAb fragments directed against platelet surface receptor GPII(b) and/or III(a), MAb fragment or MAb directed against tumor-associated antigen CA125, MAb or MAb fragment directed against human CEA (carcinoembryonic antigen), MAb fragment or MAb directed against human cardiac myosin, MAb fragment or MAb directed against tumor surface antigen PSMA, MAb fragments or MAb directed against HMW-MAA, MAb fragment or MAb directed against carcinoma-associated antigen, MAb fragments or MAb directed against NCA 90, MAb directed against CD20 antigen found on surface of B lymphocytes, MAb directed against the alpha chain of the IL2 receptor, MAb directed against TNF-alpha, MAb directed against an epitope on the surface of respiratory, syncytial virus, MAb directed against HER 2 (human epidermal growth factor receptor 2), MAb directed against cytokeratin tumor-associated antigen, anti-CTLA4, dornase-alpha DNAse, TNF-alpha, diptheria toxin fusion protein that targets cells displaying a surface IL-2 receptor, TNFR-IgG fragment fusion protein, enbrel, laronidase, teriparatide and parathyroid hormone derivatives.

Details for Patent 7,812,215

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2021-11-30
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2021-11-30
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2021-11-30
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2021-11-30
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2021-11-30
Immunex Corporation	ENBREL	etanercept	Injection	103795			2021-11-30