LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE:GKOS) announced today that the United States District Court for the District of Delaware issued rulings on three pending summary judgment motions in the company’s patent lawsuit with Transcend Medical related to Transcend’s CyPass Micro-Stent.
At issue in the lawsuit are three Glaukos patents related to its iStent Supra® Suprachoroidal Micro-Bypass Stent, which is currently being evaluated in a U.S. IDE pivotal trial. The patents generally cover micro-stent implant systems that facilitate drainage of aqueous humor into the eye’s uveoscleral, or unconventional, outflow pathway and are used to treat glaucoma. The patents at issue are not related to Glaukos’ glaucoma products that access the eye’s conventional aqueous humor outflow pathway through the trabecular meshwork and into Schlemm’s canal, including the FDA-approved iStent® Trabecular Micro-Bypass Stent and the iStent inject® Trabecular Micro-Bypass Stent, which is currently being evaluated in U.S. IDE clinical trials.
In its ruling, the court granted Transcend’s motion for summary judgment that Transcend’s CyPass Micro-Stent does not infringe the Glaukos patents at issue in the lawsuit. The court also granted in part Transcend’s summary judgment motion of invalidity, which affects a small subset of claims in each of Glaukos’ patents but not the primary claims of the patents. The court also denied Glaukos’ motion for summary judgment of no inequitable conduct with respect to its patents, and a trial on this matter is scheduled to begin November 2, 2015.
Glaukos is evaluating its options with respect to the rulings related to non-infringement and invalidity, including a possible appeal. Glaukos also plans to continue to defend itself vigorously against Transcend’s claims of inequitable conduct. Glaukos does not believe the rulings or an adverse outcome in the litigation will affect its ability to commercialize the iStent Supra, if it is approved by the FDA, but could potentially affect its market share and sales due to the addition of one or more competing products in the market.
About Glaukos
Glaukos (www.glaukos.com) is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures to transform the treatment of glaucoma, one of the world’s leading causes of blindness. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in July 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company believes the iStent, measuring 1.0 mm long and 0.33 mm wide, is the smallest medical device ever approved by the FDA.
Forward-Looking Statements
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. These include statements concerning our expectations about our litigation with Transcend Medical and its impact on the commercialization of our products. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations and are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse rulings or other uncertainties that impact our ability to successfully appeal the court’s rulings or successfully defend ourselves in the litigation, which may result in continued findings that some or all of our asserted patents are not infringed, findings that our patents are invalid or unenforceable (including some of our patents on other iStent products, which Transcend is not challenging in this lawsuit, but which Transcend has identified in its pleadings in this suit to support its allegations of inequitable conduct, which could later be subject to similar claims from other third parties, which could potentially weaken the general scope of protection these patents afford our products) or the award of attorneys’ fees to Transcend or others, and could potentially affect our market share and sales due to the addition of one or more competing products in the market. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law. Additional risks, uncertainties and other factors relating to our operations and business environment are described in detail under the caption “Risk Factors” and elsewhere in our filings with the Securities and Exchange Commission (SEC), including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, which are available in the Investor section of our website at www.glaukos.com or at www.sec.gov.