Healthcare Industry News: Capsule Endoscopy
News Release - October 23, 2006
Given Imaging Files Patent Infringement Claims Against Olympus CorporationYOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Oct 23, 2006 -- Given Imaging (NASDAQ:GIVN ), the company that pioneered Capsule Endoscopy, today announced that it has filed claims of patent infringement against Olympus Corporation and its subsidiaries Olympus Medical Systems Corporation and Olympus America, Inc. ("Olympus"). Given Imaging's claims were filed as a counterclaim to a complaint filed by Olympus in May 2006 in the Eastern District of Pennsylvania.
Given Imaging's claims assert that the Capsule Endoscopy system which Olympus stated it intends to market in the United States, will infringe four of Given Imaging's patents. These patents include Given Imaging's first patent, U.S. Patent 5,604,531 (the "'531 Patent"), issued in 1997, and other patents covering innovative features of capsule endoscopes and Capsule Endoscopy systems. To that end, Given Imaging requests an injunction to prevent Olympus from selling in the United States any product that infringes on Given Imaging's patents.
"Given Imaging is committed to leading innovation in the field of Capsule Endoscopy and offering our customers the broadest and most advanced platform for Capsule Endoscopy. We also have built a broad patent estate including hundreds of patent applications and dozens of issued patents worldwide," said Homi Shamir, president and CEO of Given Imaging. "As such, we intend to protect our interests and our market vigorously."
At the same time, Given Imaging filed its answer to Olympus' request for a declaratory judgment that it will not infringe Given Imaging's '531 Patent and to Olympus' allegation that Given Imaging infringes U.S. Patent 5,010,412 (the "'412 Patent") bought by Olympus from The Boeing Company in July 2005. In its answer, Given Imaging denies infringement of the '412 Patent and asserts that the '412 Patent is invalid.
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam(TM) Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPIDŽ software. Given Imaging has three commercially available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 50 other countries; the PillCam ESO video capsule to visualize the esophagus; and the Agile(TM) patency capsule to determine the free passage of the PillCam capsule in the GI tract. The PillCam COLON video capsule to visualize the colon has been cleared for marketing in the European Union and clinical trials are underway in the United States to support submission for marketing clearance from the FDA. A capsule to visualize the stomach is under development. More than 400,000 patients worldwide have benefited from the PillCam Capsule Endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. For more information, visit http://www.givenimaging.com.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) satisfactory results of clinical trials with PillCam Colon, (2) changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) the reimbursement policies for our product from healthcare payors, (9) quarterly variations in operating results, (10) the impact of the newly adopted SFAS 123R for expensing option-based payments, (11) the possibility of armed conflict or civil or military unrest in Israel, and (12) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.
Source: Given Imaging
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