Amgen Inc. announced late Tuesday that it has reached anagreement with Chugai Pharmaceuticals Inc. resolving disputesover intellectual property rights to granulocyte colonystimulating factor (G-CSF).
Under the agreement, the case pending in U.S. District Court forthe District of Columbia will be resolved by Chugai's disclaimerof two Chugai patents that were the subject of the suit.
In addition, Chugai will grant Amgen (NASDAQ:AMGN) anirrevocable, exclusive, royalty-free license for all of theremaining G-CSF patent rights Chugai may have in the U.S.
Chugai is also withdrawing from a patent interferenceinvolving Memorial Sloan-Kettering Cancer Institute andAmgen. The interference, which was declared in February1991, will continue between Amgen and Sloan-Kettering, bothof which have pending patent applications for recombinant G-CSF.
In January, Amgen of Thousand Oaks, Calif., sought adeclaratory judgment that its recombinant G-CSF did notinfringe Chugai's patents on natural G-CSF and that Chugai'spatents are unenforceable.
Chugai's patent No. 4,833,127 issued in May 1989 and itspatent No. 5,043,156 issued in August 1991. Amgen'srecombinant G-CSF patents, No. 4,810,643 and No. 4,999,291,issued in March 1989 and March 1991, respectively.
Amgen filed the suit to seek a judgment that it wasn'tinfringing. Chugai never countersued, said Amgenspokeswoman Sarah Crampton.
The FDA approved Amgen's Neupogen G-CSF in February 1991to prevent infections after chemotherapy for cancers that donot arise from bone marrow. The company had 1991worldwide sales of $232 million and first-quarter 1992 sales of$100 million. Tokyo-based Chugai isn't selling or producing G-CSF in the United States.
As part of the agreement, Chugai will grant Amgen anirrevocable, royalty-free, exclusive license for all G-CSF patentrights in Canada and Mexico. The parties will agree not to sueeach other over their G-CSF patent rights in Europe, Australiaand New Zealand.
Chugai and Kirin Brewery Co. have agreed not to sue each otherin Japan, Taiwan, China and Korea. Kirin has rights to Neupogenin Japan. Kirin and marketing partner Sankyo Co. Ltd. beganselling G-CSF in December, as did Chugai. Amgen expects salesin Taiwan and Korea to begin in the next six months.
The agreements are subject to both parties obtaining finalconsents from each side's licensees and partners.
-- Karen Bernstein BioWorld Staff
(c) 1997 American Health Consultants. All rights reserved.