ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB: INSV) today announced that oral arguments are scheduled for November 6, 2012, in Washington, D.C. in connection with the University of California, San Francisco’s (UCSF) appeal of the November 2011 favorable judgment of the United States Patent and Trademark Office (USPTO). The USPTO panel of judges ruled in favor of InSite Vision and confirmed the inventorship of InSite Vision’s U.S. Patent Nos. 6,239,113 and 6,569,443 protecting AzaSite® (azithromycin ophthalmic solution) 1%. The appeal was filed by UCSF with the U.S. Court of Appeals for the Federal Circuit in Washington, D.C. on December 23, 2011, and a cross appeal was filed by InSite Vision on January 4, 2012. Merck, which markets AzaSite in the U.S. for the treatment of bacterial conjunctivitis, is collaborating with InSite on the continued vigorous defense of the AzaSite patents.
“We are highly confident that the UCSF claims are entirely without merit as confirmed by the USPTO judgment last November and we will continue to collaborate actively with Merck to vigorously defend our position,” said Timothy Ruane, InSite Vision’s Chief Executive Officer. “We anticipate results of the appeal will be announced in 2013, but we could get a verdict before the end of 2012.”
In 2009, the Regents of the University of California claimed that the inventions contained in the patents were made by a former employee of the University alone and without collaboration with InSite Vision, the assignee of all the named inventors.
About InSite Vision
InSite Vision is advancing new ophthalmic products for unmet eye care needs based on its innovative DuraSite® and DuraSite 2® platform technologies. The DuraSite and DuraSite 2 drug delivery systems extend the duration of drug retention on the surface of the eye, thereby reducing frequency of treatment and improving the efficacy of topical drugs. DuraSite is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite® (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Merck, and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision is also advancing three novel ophthalmic therapeutics through Phase 3 clinical studies: AzaSite Plus™ and DexaSite™ for the treatment of eye infections, and BromSite™ for pain and swelling associated with ocular surgery. DuraSite 2 incorporates InSite’s proprietary bioadhesive core technology with a cationic polymer to achieve sustained and enhanced ocular delivery of drugs. The DuraSite 2 platform will be applied to InSite’s future pipeline product candidates and available through a broad licensing program for advanced ophthalmic drug development. For further information on InSite Vision, please visit www.insitevision.com.
This news release contains certain statements of a forward looking nature relating to future events, including InSite Vision’s expectations of a successful outcome in the appeal, the expected timing of a decision by the court, and other plans and expectations with respect to the litigation described above. Such statements entail a number of risks and uncertainties, including but not limited to: that the court may not rule in favor of InSite Vision, the inherent uncertainty of any litigation matter including the court’s decision and the timing of same; InSite Vision’s ability to continue to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others. Reference is made to the discussion of these and other risk factors detailed in InSite Vision's filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption "Risk Factors" and elsewhere in such reports. Any forward-looking statements or projections are based on the limited information currently available to InSite Vision, which is subject to change. Although any such forward-looking statements or projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not assume that the information provided in this release is still valid at any later date.
AzaSite® and DuraSite® are registered trademarks of InSite Vision Incorporated.
BESIVANCE® is a registered trademark of Bausch + Lomb Incorporated.