Delaware | 94-3015807 | |
(State or other jurisdiction of | (IRS Employer | |
incorporation) | Identification No.) |
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
In the Notice Letter, Sandoz claims U.S. Patent Nos. 6,159,458, 6,239,113, 6,569,443, and 7,056,893 (the "InSite Patents") issued to InSite and U.S. Patent No. 6,861,411 (the "Pfizer Patent" and, together with the InSite Patents, the "US Patents") issued to Pfizer Inc. ("Pfizer") to be invalid and/or will not be infringed by the manufacture, use, importation, sale or offer for sale of product described in the ANDA.
InSite granted an exclusive license to the InSite Patents to Inspire Pharmaceuticals, Inc. ("Inspire") and an exclusive sublicense to the Pfizer Patent pursuant to that certain License Agreement by and between Inspire and InSite, dated as of February 15, 2007, as amended (the "InSite License Agreement"). Insite and Pfizer each have retained the primary responsibility for enforcing the applicable rights associated with their respective patents. Notwithstanding the foregoing, pursuant to the InSite License Agreement Inspire obtained step-in rights with respect to the initiation, prosecution and control of any patent infringement lawsuits relating to the US Patents under certain circumstances, including but not limited to InSite's and/or Pfizer's failure to initiate such a proceeding against an infringer (the "Step-In Rights").
InSite, Pfizer and Inspire have 45 days from the date of their respective receipt of the Notice Letter to commence a patent infringement lawsuit against Sandoz that would result in an automatic stay, or bar, of the FDA's approval of the ANDA for up to 30 months or until a final court decision in the infringement suit in favor of Sandoz, whichever occurs first.
InSite, with its partners, plans to vigorously enforce its intellectual property rights relating to AzaSite.
This report contains "forward-looking statements" that involve significant risks and uncertainties and are based on preliminary information and management assumptions. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Specifically, no assurances can be made with respect to: statements regarding the commencement of a patent infringement lawsuit; statement's otherwise relating to the enforcement of InSite's, Pfizer's and/or Inspire's intellectual property rights; statements relating to the timing of an approval, if any, by the FDA of the ANDA; any statements of expectation or belief; and any statements of assumptions underlying any of the foregoing. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause InSite's results to differ in material respects, including the actions of Inspire and Pfizer in relation to the Notice Letter, the U.S. Food and Drug Administration's review of the ANDA, its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; and determinations by the FDA. Further information regarding factors that could affect InSite's results is included in InSite's filings with the U.S. Securities and Exchange Commission. InSite undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, except as expressly required by law.
| InSite Vision Incorporated | ||||||||
| Date: April 20, 2011 | By: | /s/ Timothy Ruane | ||||||
| Timothy Ruane | ||||||||
| Chief Executive Officer | ||||||||