To: xcr600 who wrote (1026 ) 10/6/1999 6:43:00 PM From: Saulamanca Read Replies (1) | Respond to of 2515
This patent issue was already described in the original S-3 filed on Sept. 21. This is nothing new. The wording is different from the S-3/A filed today. From the S-3, Sept 21: "...We know that others have filed patent applications in various countries that relate to several areas in which we are developing products. Some of these patent applications have already been issued as patents and some are still pending. The pending patent applications may issue as patents. Issued patents are entitled to a rebuttable presumption of validity under the laws of the U.S. and certain other countries. These issued patents may therefore limit our ability to develop commercial products. If we need licenses to such patents to permit us to develop or market our products, we cannot be certain that we would be able to get such licenses on acceptable terms. Proprietary trade secrets and unpatented know-how are important to our research and development activities. We cannot be certain that others will not develop the same or similar technologies on their own. Although we have taken steps, including entering into confidentiality agreements with our employees and third parties, to protect our trade secrets and unpatented know-how and keep them secret, third parties may still obtain such information. The following are some of the specific areas in which we may be negatively affected by the patents and patent applications of others: We have an exclusive license to an issued U.S. patent for the murine form of C225, our EGF receptor antibody product. We believe that this patent covers C225 under the patent law doctrine of equivalents. Under this doctrine, the subject matter of a claim is deemed to cover variations that are known and routine, which we believe, in this instance, extends protection to C225. Our licensor of this patent did not obtain patent protection outside the U.S. for this antibody. While this patent covers only our antibody and would not block third parties from obtaining patents covering other antibodies to the EGF receptor, we are pursuing additional patent protection for the use of any antibody that inhibits the EGF receptor in combination with chemotherapy or radiation therapy, or when used to treat refractory patients. We have done this by filing specific patent applications in the U.S. and elsewhere and by exclusively licensing from a major pharmaceutical company patent applications that relate to the use of EGF receptor antibodies together with chemotherapy. We are currently prosecuting these applications. We cannot be certain that we will be successful in these efforts or that patents will ever be issued or that we will have sufficient protection for C225. The C225 monoclonal antibody is chimerized, meaning that it is made of antibody fragments derived from more than one type of animal (specifically, in the case of C225, mouse and human). Patents have been issued to other biotechnology companies that cover the chimerization of antibodies. Therefore, we will be required to obtain licenses under these patents, some of which have already been obtained, before we can commercialize our own chimerized monoclonal antibodies, including C225. We cannot be certain that we will be able to obtain such licenses in the territories where we want to commercialize, or how much such licenses would cost. We know that others have been issued patents in the U.S. and Europe covering anti-idiotypic antibodies or their use for the treatment of tumors. These patents, if valid, could be interpreted to cover our BEC2 monoclonal antibody and certain uses of BEC2. Merck KGaA, our worldwide licensee of BEC2, has informed us that it has obtained non-exclusive, worldwide licenses to these patents in order to market BEC2 in its territory. We are entitled to co-promote BEC2 in North America. However, we cannot be certain that we can obtain the necessary licenses on commercially acceptable terms, if at all. We have patents and have filed patent applications to protect our proprietary rights to anti-angiogenic therapeutics, as well as therapeutic methods of treating angiogenic disease. We are aware that others have filed patent applications that could affect our ability to commercialize some of our anti-angiogenic therapeutics or therapeutic treatments. 11 <PAGE> 16 We are aware that third parties have filed patent applications in areas that could affect our ability or Abbott Laboratories's ability to commercialize our diagnostic products. These areas could include target amplification technology and signal amplification technology. Third party patents have already been issued in the field of target amplification such as polymerase chain reaction technology. There has been significant litigation in the biopharmaceutical industry over patents and other proprietary rights. Such litigation has been costly for the parties involved. We are not currently involved in any such litigation; however, if we became involved in similar litigation over our intellectual property rights, the cost of such litigation could be substantial and could have a material negative effect on us...."freedgar.com