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When FDA and Training Statements Become Exhibit A in Patent Litigation

A Delaware judge recently upheld a $34 million jury verdict in a patent litigation lawsuit between Sight Sciences and Alcon.  Sight Sciences’s press release about the decision can be found here.

Sight Sciences alleged that Alcon’s Hydrus Microstent infringed three of Sight Sciences’ patents.  One disputed issue was whether Hydrus allows fluid to move through a canal without “substantial interference.”  Alcon argued Sight Sciences failed to prove that Hydrus adequately allows fluid flow because Sight Sciences’ expert did not perform any real-world flow testing.  Instead of testing, Sight Sciences’ expert performed computational modeling and relied largely on Alcon’s own materials–including physician training materials and Alcon’s communications with the FDA–stating that Hydrus readily allows and enhances fluid flow.

The jury sided with Sight Sciences.

This case underscores the importance of having IP counsel review and approve statements in marketing and training materials, as well as FDA submissions, about how a company’s products operate.  Those statements can be and often are used as evidence of infringement in patent litigation.

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