International Trade Commission Rules ACON’s 3-1 Lipid Panels Infringe PTS Diagnostics’ Patents

International Trade Commission Rules ACON’s 3-1 Lipid Panels Infringe PTS Diagnostics’ Patents

Final determination finds PTS Diagnostics’ patent numbers 7,087,397 and 7,625,721 were infringed upon

WHITESTOWN, Ind. (April 17, 2020) – PTS Diagnostics, a U.S.-based manufacturer of point-of-care medical testing devices announced today that the U.S. International Trade Commission (ITC) issued a final determination finding that ACON Laboratories, Inc. and ACON Biotech (Hangzhou) Co.’s importation of (ACON) 3-1 Lipid Panels has violated Section 337 of the Tariff Act because their devices infringe PTS Diagnostic’s U.S. patent numbers 7,087,397 and 7,625,721.

The ITC, a federal agency responsible for investigating unfair trade practices, issued a limited exclusion order prohibiting ACON from importing their 3-1 Lipid Panels into the U.S. (International Trade Commission Investigation No. 337-TA-1116).

The ruling explained that ACON’s 3-1 Lipid Panels infringe claim 19 of the ‘397 patent and claims 1, 4, 6, 8, and 15 of the ‘721 patent. Further, the ITC found that the two patents are valid, rejecting all ACON’s arguments to the contrary. The ITC concluded that ACON’s importation into the U.S., sale for importation, or sale in the U.S of the ACON 3-1 Lipid Panel’s violated section 337 of the Tariff Act.

“We applaud the International Trade Commission’s determination; the ruling demonstrates that we are committed to protecting ourselves against anyone who infringes our broad patent portfolio,” said Jonathan Chapman, President and CEO of PTS Diagnostics. “Moreover, we are proud that the healthcare industry has widely embraced our CardioChek® lipid measurement system, which has screened millions of patients worldwide. I would personally like to thank the PTS Diagnostics’ employees who create our innovative products which positively impact so many patients and their diligence around protecting these inventions, as well as our legal counsel for their strong representation.”

Recognizing the link between cardiovascular disease and diabetes, CardioChek analyzers accurately test lipid profile and glucose simultaneously in as little as 90 seconds via fingerstick in order to help identify at-risk individuals. PTS Panels® lipid test strips measure total cholesterol, HDL cholesterol, and triglycerides, calculate LDL cholesterol and TC/HDL ratio, and do not require refrigeration. CardioChek® systems are CLIA- waived and meet NCEP guidelines for accuracy and precision.

The patents declared in the investigation cover the CardioChek family of products, including lipid analyzers and PTS Panels® test strips, which are manufactured in the U.S. PTS Diagnostics was represented in the proceeding by Haynes and Boone, LLP and intends to fully defend the final determination against any efforts for review or appeals.

About PTS Diagnostics

Through its People, Technology and Service, PTS Diagnostics creates health innovation that drives action and results. Since 1992, we have helped medical professionals and patients achieve better health outcomes through our accurate, precise, fast, affordable, and certified point-of-care medical devices. Healthcare professionals have used our CardioChek products to assess cardiovascular disease risks for millions of patients worldwide through lipid panel screening. And, our A1CNow® systems, which provide fast and reliable HbA1c testing, have helped physicians deliver more effective treatments to patients with diabetes. For more information, visit

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