Genetics Institute Inc.'s licensee, Sandoz Ltd., on Wednesdayreceived a European patent covering the process for makinggranulocyte macrophage colony stimulating factor.

The patent, No. 188,479, is the first European GM-CSF patentto issue, said GI spokeswoman Melinda Lindquist. The patentcovers the DNA, vectors, host cells and the process for makingrecombinant human GM-CSF.

In response, competitor Immunex Corp. on Wednesday said itexpected its European licensee to challenge the scope of theSandoz patent in an opposition proceeding. Immunex estimatesthe European market for CSFs at between $300 million and$500 million annually.

GM-CSF is a protein that stimulates certain white blood cells.Sandoz and its sublicensee, Schering-Plough Corp., filed inmid-1990 for European marketing approval of GM-CSF to treatneutropenia, a decrease in the number of white blood cellscaused by chemotherapy, and other disorders. Sandoz andSchering filed for U.S. marketing approval in January 1990.Both applications are pending.

GM-CSF is also being developed by Immunex of Seattle.Immunex's European licensee, Behringwerke AG, has applied forfour European patents. Immunex has received a notice ofintention to grant two of those patents, said Scott Hallquist,Immunex's general counsel.

Hallquist said that unless the scope of Sandoz's patent claimsis narrowed by the opposition proceedings, Sandoz's patentwill dominate Immunex's. "But who knows what will happen inthe opposition proceeding?" he asked. "We very much disagreewith the scope of the patent they were granted."

"We fully expect Behringwerke will oppose the (Sandoz) patentand that it will be quite some time before there is anyresolution of the patent issue in Europe," said Immunexspokesman Jason Rubin. He said Immunex expects to file formarketing approval in the United Kingdom by the end of theyear.

GI of Cambridge, Mass., and Immunex are in interferenceproceedings in the U.S. Patent and Trademark Office. Otherparties to that dispute are Schering, Biogen Inc. and ResearchCorp.

Immunex in March received U.S. marketing approval for GM-CSFto speed bone marrow recovery in certain cancer patientsundergoing autologous bone marrow transplantation.

Amgen Inc. of Thousand Oaks, Calif., has marketing approval inthe United States and some European countries for a rivalproduct, granulocyte colony stimulating factor (G-CSF).

GI's stock (NASDAQ:GENI) closed at $34.74, up $1.75, onWednesday. Immunex's stock (NASDAQ:IMNX) rose $1 to $43.50.

-- Karen Bernstein BioWorld Staff

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