Print Page  Close Window


SEC Filings

S-1/A
OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 02/16/2007
Entire Document
 
Table of Contents

Although we have entered into a settlement agreement designed to prevent the parties to the agreement from asserting infringement and other specified claims against our Excalia product candidate in the United States, if an acceptable settlement of foreign patent rights cannot be reached, or our efforts to assert patent rights outside of the Unites States prove unsuccessful, we could be prevented from marketing and selling our Excalia product in foreign countries.
 
On June 12, 2004, we jointly filed a lawsuit with Duke, against Elan Corporation, plc, Elan Pharma International Ltd. and Elan Pharmaceuticals, Inc., which we refer to collectively as Elan, Eisai, Inc. and Eisai Co., Ltd., which we refer to together as Eisai, and Julianne E. Jennings, a former employee of Elan, in the U.S. District Court for the Middle District of North Carolina, Durham Division, to resolve a dispute over rights in an invention relating to the use of zonisamide to treat obesity. We alleged in this lawsuit that scientists at Duke made the invention, and that Elan improperly used information supplied by the Duke scientists to file a U.S. patent application on the invention, in which Ms. Jennings (then an Elan product manager) is named as the sole inventor. This patent application was later assigned by Elan to Eisai. Duke also filed a U.S. patent application on the invention at issue, which patent application is exclusively licensed to us. On December 14, 2006, we, Elan, Eisai, Duke and Ms. Jennings entered into a settlement agreement to settle the lawsuit. Upon execution of the settlement agreement, the lawsuit was dismissed with prejudice.
 
Under the terms of the settlement agreement, the parties have, subject to limitations set forth in the agreement, released each other from all claims and demands arising under the laws of the United States or any state within the United States existing as of the date of the settlement agreement that arise out of or relate to the lawsuit or the specified Duke and Eisai patent applications. The releases do not apply to the parties’ rights 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 Excalia 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 Excalia 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 Excalia 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 Excalia, 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.


29