Jumping off point might be the S1 -
"...UNCERTAINTIES RELATED TO PATENTS AND PROPRIETARY RIGHTS The Company's success will significantly depend upon its ability to obtain patent protection for its products and technologies under development, to defend its issued patents, including patents and patent applications related to phage display, biotechnology and separations, and to avoid the infringement of patents issued to others. The Company is aware of certain patents for which it will likely need to obtain licenses to commercialize its products and technologies. While the Company believes that it will be able to obtain such licenses, there can be no assurance that such licenses, or licenses to other patent rights, will be available on reasonable terms, if at all. Further, if such licenses are not available, the Company may need to halt or modify the activities which are covered by the other patent rights, which could have a material adverse effect on the Company's business, financial condition and results of operations. Patent positions are complex in the fields of biotechnology, therapeutic and diagnostic products and separations processes and products and the validity or infringement of any given patent may be uncertain. In order for the Company to commercialize a process or product, many patent rights of other parties may need to be analyzed and often several licenses may be required. There can be no assurance that any patents issued to the Company or its collaborative partners, or for which the Company has licensed rights, will not be challenged, narrowed, invalidated or circumvented, or that the rights granted thereunder will provide competitive advantages to the Company. In addition, there can be no assurance that (i) the Company will be able to obtain patent protection for any therapeutic, diagnostic or separations products it may develop; (ii) others will not obtain patents covering the manufacture, use or sale of such products; (iii) the Company's patents or any future patents will prevent other companies from designing their products or conducting their activities so as to avoid the coverage of the claims of the Company's patents; or (iv) others will not be able to develop other competing technologies to supplement or replace the Company's processes or products. There exists substantial patent litigation in the pharmaceutical, biomedical and biotechnology industries. Patent litigation is generally time-consuming, costly and involves complex legal and factual questions, and the outcome is frequently difficult to predict. Litigation may be necessary to enforce the Company's patent and license rights, to enforce or defend an infringement claim, or to determine the scope and validity of others' proprietary rights. Many of the Company's competitors have substantially greater resources than the Company, and such competitors may be able to sustain the costs of complex patent litigation to a greater 8 10 degree and for a longer period of time than the Company. In addition, such proceedings or litigation, or any other proceedings or litigation to protect the Company's intellectual property rights or defend against infringement claims by others, could result in substantial costs and a diversion of management's time and attention, subject the Company to significant liabilities to third parties, and require the Company to cease using the technology or to license disputed rights from third parties (which licenses may not be available at a reasonable cost, if at all), any of which events could have a material adverse effect on the business, financial condition and results of operations of the Company. The Company is particularly dependent on its U.S. and foreign patents and patent applications relating to its Phage Display technology (the "Phage Display Patent Rights"). Although the Company is not aware of any challenges to the Phage Display Patent Rights to date in the United States, there can be no assurance that a challenge will not be brought in the future. The Company plans to protect its patent rights, including the Phage Display Patent Rights, to the maximum practical extent. There can be no assurance that the Company will have sufficient resources necessary to defend its patent rights against all such challenges. However, if the Company commences legal action against an alleged infringer of any of the Company's patent rights, the alleged infringer can be expected to claim that the Company's patent rights are invalid for one or more alleged reasons, thus subjecting the Company's patent rights in question to a judicial determination of validity with the attendant risk that an adverse determination could result in a loss of patent rights. In addition, in certain situations, an alleged infringer could seek a declaratory judgment of invalidity of the Company's patents. Uncertainties resulting from the initiation and continuation of any patent or related litigation, including those involving the Phage Display Patent Rights, could have a material adverse effect on the Company's ability to maintain and expand its licensing program and collaborative arrangements and to compete in the marketplace pending resolution of the disputed matter. Two European patent oppositions were filed in late 1997 against the Company's Phage Display patent issued by the European Patent Office ("EPO"), and the Company expects that these oppositions will not be resolved for several years. The oppositions are currently being reviewed by the Company's patent counsel, and Dyax intends to vigorously defend its European patent. However, there can be no assurance that the Company will prevail in the opposition proceedings or any litigation contesting the validity or scope of this EPO patent or other foreign patents, if any. The Phage Display Patent Rights are central to the Company's non-exclusive patent licensing program. In connection with the licensing program, the Company regularly monitors publications and other sources for information regarding the practice by others of technology covered by the Phage Display Patent Rights, and there are unlicensed parties whose activities the Company believes may be covered by its issued patents. In such circumstances, the Company generally seeks to negotiate a Phage Display license agreement. There can be no assurance, however, that the Company will be able to identify all parties practicing the Phage Display Patent Rights, all products derived by such parties, including its licensees, or that the Company will be successful in entering into license agreements with parties that the Company believes require such a license. In jurisdictions where the Company has not applied for or obtained patent rights, the Company will be unable to prevent others from developing or selling products or technologies derived using Phage Display. In addition, even in jurisdictions where the Company has Phage Display Patent Rights, there can be no assurance that the Company will be able to prevent others from selling or importing products or technologies derived elsewhere using Phage Display. The inability of the Company to protect and enforce its patent rights, whether by licensing or otherwise, could have a material adverse effect on the Company's business, financial condition and results of operations. The Company is aware that other parties have patents and pending applications to various phage display inventions. The Company has filed, and in the future may file, oppositions to European and other patents issued to others. To date, the Company has filed oppositions against two European patents in the general field of phage display. The Company does not believe these European patents cover any of its present activities, but the Company cannot predict whether the claims in these patents may, in their current or future form, cover the Company's activities or the activities of its collaborative partners and licensees. In addition, through its patent licensing program, the Company has secured a limited freedom to practice some of these patent rights pursuant to its standard license agreement, which contains a covenant by the licensee that it will not sue the 9 11 Company under certain of the licensee's phage display improvement patents. The Company may from time to time seek affirmative rights of license or ownership under existing patent rights relating to phage display technology of others. There can be no assurance, however, that the Company will be successful in maintaining any covenants of nonsuit from its licensees, or in acquiring similar covenants in the future, or that the Company will be able to obtain satisfactory licenses. The inability of the Company to obtain and maintain such licenses and covenants could have a material adverse effect on the Company's business, financial condition and results of operations. To protect its existing and future chromatography separations products, the Company relies primarily upon trade secrets and know-how, as well as the experience and skill of its technical personnel. The Company also has several patents and patent applications on its proprietary chromatography technology which are not based on Phage Display, but it cannot predict the extent to which any such patents or future patents will provide protection for its existing or any new separations products. In all of its activities, the Company relies substantially upon proprietary materials and information, trade secrets and know-how to conduct its research and development activities and to attract and retain collaborative partners, licensees and customers. Although the Company takes steps to protect these materials and information, including through the use of confidentiality and other agreements with its employees, consultants and academic and commercial relationships, there can be no assurance that these steps will be adequate, that these agreements will not be violated, that there will be an available or sufficient remedy for any such violation or that others will not also develop similar proprietary information...." |
