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Biotech / Medical : Imclone systems (IMCL) -- Ignore unavailable to you. Want to Upgrade?

To: WYD who wrote (1023)	10/6/1999 3:02:00 PM
From: xcr600	Read Replies (3) \| Respond to of 2515

Could it be this? Seems like a bit of over reaction at this point. Could use some mgmt comments to maybe clarify a bit. We are aware of a U.S. patent issued to a third party that includes claims covering the use, subject to certain restrictions, of antibodies to the EGF receptor and chemotherapeutic agents to inhibit tumor growth. Our outside patent counsel has indicated to us that, in its opinion, we will not be liable for infringement of this third party patent by reason of our manufacture or sale, or medical professionals' use, of C225 alone or in combination with chemotherapy or radiation therapy. Based upon this opinion, as well as our and our counsel's review of other relevant patents, we believe that we will be able to commercialize C225 alone and in combination with chemotherapy and radiation therapy upon successful completion of our clinical trials and receipt of necessary FDA approvals. If claims under our U.S. patent application covering the use of C225, an EGF receptor antagonist, and chemotherapy are determined by the patent examiner to be ready for allowance, an interference could be declared or another proceeding may be initiated to determine whether our claims or the claims in the third party patent should prevail. The opinion of our counsel, however, is not binding on any court, and there can be no assurance that we will not in the future become subject, in the U.S. or any other country, to patent infringement claims, interferences and other litigation involving patents, including the third party patent referenced above. C225 is a "chimerized" monoclonal antibody, which means it is made of antibody fragments derived from more than one type of animal. Patents have been issued to other biotechnology companies that cover the chimerization of antibodies. Therefore, we may be required to obtain licenses under these patents before we can commercialize our own chimerized monoclonal antibodies, including C225. Some of these licenses have already been obtained. We cannot be certain that we will be able to obtain the rest of such licenses in the territories where we want to commercialize C225, or how much such licenses would cost. Our exclusive license agreements with the University of California, San Diego and Rhone-Poulenc Rorer require us to pay royalties on sales of C225 that are covered by these licenses.