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SEC Filings

OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 02/16/2007
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If an acceptable settlement of the foreign patent rights cannot be reached, then it may be necessary for us to formally challenge Eisai’s entitlement to the patent rights at issue through legal proceedings in Europe, Japan, and perhaps other countries. If it is necessary to commence foreign legal proceedings, it likely will take several years to reach a decision in those proceedings. If the decision in those proceedings is unfavorable to us, and if a foreign patent issues to Eisai containing a claim that encompasses the use of zonisamide as the sole active ingredient to treat obesity or other weight-related disorders or conditions, then we could be prevented from marketing and selling our Excalia product in those countries where such patents exist.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees on the Gadde patent covering Excalia are due to be paid to the PTO in several stages over the lifetime of the patent. Future maintenance fees will also need to be paid on the Dante patents. We have systems in place to remind us to pay these fees, and we employ an outside firm, Computer Patent Annuities, to remind us to pay annuity fees due to foreign patent agencies on our pending foreign patent applications. The U.S. PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to enter the market and this circumstance would have a material adverse effect on our business.
We have not yet registered our trademarks in all of our potential markets, and failure to secure those registrations could adversely affect our business.
We have received a Notice of Allowance from the PTO for the intent-to-use trademark application for our corporate logo for use in connection with pharmaceutical preparations and substances, including for the treatment of obesity, inducement of weight loss and prevention of weight gain. We have foreign trademark applications pending in Europe, Canada and Japan for the same mark. We have obtained foreign trademark registrations for the corporate name Orexigen Therapeutics, Inc. and the mark OREXIGEN in Japan and have pending trademark applications for the same mark in the United States, Canada and Europe. We have received a Notice of Allowance from the PTO for the intent-to-use trademark application for the mark CONTRAVE for use in connection with pharmaceutical preparations, including for the treatment of obesity and inducing weight loss. We have also applied for U.S. trademark registrations for the mark EXCALIA and have filed applications to register these marks in Europe, Canada and Japan. However, no assurance can be given that our allowed trademark applications will actually become registered, or that our registered trademarks can be maintained or enforced. During trademark registration proceedings in the various countries, we have received and expect to receive rejections. Although we are given an opportunity to respond to those rejections, there can be no assurance that the rejections can be successfully overcome. In addition, in the PTO and in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to cancel registered trademarks. No assurance can be given that opposition or cancellation proceedings will not be filed against our trademarks, nor can there be any assurance that our trademarks would survive such proceedings. On February 6, 2007, Novartis AG, or Novartis, filed an opposition to our U.S. trademark application for EXCALIA, claiming that it is confusingly similar to its registered trademark EXTAVIA. We have also been informed that Novartis has opposed the registration of the EXCALIA mark in Europe, though we have not received a formal notice of opposition. Novartis has expressed interest in resolving this dispute, but no assurance can be given that such a resolution will be achieved, or that we would be successful in defending the pending oppositions, or that Novartis or another party will not oppose our application or seek to cancel any registrations in foreign jurisdictions.