Glaukos announced that it has entered into a settlement agreement with Transcend Medical to resolve all existing patent litigation between the two companies, according to a company news release.
Under the settlement agreement, Glaukos grants Transcend a covenant not to sue Transcend for patent infringement in connection with Transcend’s CyPass Micro-Stent devices, appliers and delivery systems. In exchange, Transcend grants Glaukos a covenant not to challenge the validity or enforceability of any Glaukos patent and will make quarterly payments to Glaukos equal to 1% of future net sales of the CyPass Micro-Stent devices until April 8, 2022 or up to a maximum aggregate payment amount of $6 million. These CyPass Micro-Stent devices are not currently approved by the FDA. Glaukos and Transcend also have agreed to file a joint stipulation of dismissal with prejudice of all of their claims against each other in this matter, with each party responsible for its own legal expenses. The settlement agreement eliminates the need for the trial that was scheduled to begin November 2, 2015 in the U.S. District Court for the District of Delaware.
The covenant not to sue is limited to Transcend’s Micro-Stent ab interno devices that facilitate drainage of aqueous humor through the uveoscleral, or unconventional, outflow pathway and are used to treat glaucoma. The settlement agreement does not affect Glaukos’ ability to commercialize its iStent Supra Suprachoroidal Micro-Bypass Stent, which accesses the unconventional outflow pathway and is currently being evaluated in a US IDE pivotal trial. The covenant not to sue expressly excludes devices that drain aqueous humor to other locations such as into Schlemm’s canal, aqueous humor collector ducts or channels, or implants that elute any drug or another therapeutic agent.
“We believe this settlement provides an efficient and reasonable solution to this patent dispute,” Thomas Burns, Glaukos president and CEO, said in the news release. “It allows us to move forward and focus our full attention and resources on executing our growth strategy to transform glaucoma therapy with a family of micro-scale injectable therapies that can be used individually or in combination to address the full range of glaucoma disease states and progression.”