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SEC Filings

S-1/A
OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 04/09/2007
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with respect to claims and demands outside the United States. In addition, each of Elan and Ms. Jennings have represented that they are not currently seeking and do not currently possess any patent rights in the United States relating to the use of zonisamide for the treatment of obesity or other weight-related disorders or conditions. In addition, Elan, Eisai and Ms. Jennings have agreed not to assert any such U.S. patent against our Empatic product, which contains zonisamide and bupropion to treat obesity, even if Eisai later obtains a U.S. patent containing a claim that encompasses the use of zonisamide as the sole active ingredient to treat obesity or other weight-related disorders or conditions that issues from or is based upon the Eisai patent application. Likewise, if Duke obtains a U.S. patent containing a claim that encompasses the use of zonisamide as the sole active ingredient to treat obesity or other weight-related disorders or conditions that issues from or is based upon the Duke patent application, we and Duke have agreed that we will not assert any such patent against Elan, Eisai or Ms. Jennings for any conduct relating to Zonegran, which is a zonisamide product currently marketed by Eisai.
 
Although we have resolved the U.S. lawsuit and entered into a settlement agreement containing terms that would prevent Eisai, Elan and Ms. Jennings from asserting specified U.S. patents against our Empatic product, there is no assurance that Eisai, Elan and/or Ms. Jennings will abide by the settlement agreement. There also is no assurance that Eisai, Elan and/or Ms. Jennings do not have, or will not in the future obtain, other patent rights not covered by the settlement agreement that could be asserted against our Empatic product candidate or our other product candidates.
 
We believe that Eisai also owns and is prosecuting foreign patent applications in at least Europe and Japan that are based upon and claim priority to the Eisai patent application that was filed in the United States. We have entered into negotiations with Eisai with respect to any and all foreign patent rights based on the Eisai and Duke patent applications. These settlement negotiations are ongoing and settlement terms similar to the U.S. settlement are being sought in the foreign settlement process. If an acceptable settlement of the foreign patent rights is reached, we anticipate that it will contain a covenant by at least Eisai that, if Eisai obtains a foreign patent containing a claim that encompasses the use of zonisamide as the sole active ingredient to treat obesity or other weight-related disorders or conditions that claims priority to or is based upon the disclosure of Eisai patent application, Eisai will not assert any such foreign patent against any of our products, such as Empatic, containing zonisamide in combination with any other active pharmaceutical agent intended for use in the treatment of humans. However, we may not be able to enter into a settlement agreement relating to any countries outside the United States on acceptable terms, or at all.
 
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 Empatic 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 Empatic 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


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