PALO ALTO, CA, UNITED STATES — Gator Bio is pleased to announce a complete victory before the U.S. International Trade Commission (ITC) resulting in an initial determination of “no violation” in a case related to biolayer interferometry (BLI) products. It prevailed on noninfringement and lack of technical domestic industry on multiple independent grounds.

In June 2023, Administrative Law Judge Doris Johnson ruled on the four-patent investigation, that the asserted claims of the patent with the longest remaining life were invalid as indefinite, and the remaining three patents were terminated from the investigation. Two months later, however, the Commission chose to reverse ALJ Hines’ indefiniteness ruling over a dissent, and the matter proceeded to an evidentiary hearing on the sole remaining patent in late October 2023.

Following post-hearing briefing, in which the Commission Investigative Staff supported Gator Bio’s noninfringement defenses among others, ALJ Hines issued an initial determination of no violation in favor of Gator Bio.

“The patent under review has a claim regarding enzyme activity measurements. Several Gator Bio BLI products designed for AAV titer and capsid empty/full ratios use an enzyme as a label. We argued that enzyme activity measurements versus enzyme labels are distinct applications. The Commission’s Administrative Law Judge Hines agreed with our position and ruled in our favor. This was one of the key grounds for non-infringement”, said Bob Zuk, CTO of Gator Bio.

Gator Bio holds a deep regard for intellectual property and firmly asserts that our next generation biolayer interferometry technology does not infringe on the intellectual property owned by other entities. We remain committed to continued innovation and the development of a robust product portfolio, while vigorously defending our intellectual property against any future challenges. Our goal is to create innovative products that enhance the productivity of biotherapeutics discovery and development.

Detailed information about Gator Bio’s complete portfolio of next-gen BLI products can be found at https://www.gatorbio.com.

The ITC case “In the Matter of Certain Bio-Layer Interferometers and Components Thereof, Inv. No. 337-TA-1344″.