Lipid Panel Infringe on PTS Diagnostics' Patents

Initial Determination Finds ACON’s 3-1 Lipid Panels Infringe PTS Diagnostics’ Patents

United States International Trade Commission issues initial determination finding ACON’s 3-1 Lipid Panels infringe PTS Diagnostics’ Patent Nos. 7,087,397 and 7,625,721

INDIANAPOLIS (June 6, 2019) – PTS Diagnostics announced today that an administrative law judge of the U.S. International Trade Commission (ITC) issued a notice of initial determination on June 4, 2019, in Investigation No. 337-TA-1116 finding ACON Laboratories, Inc. and ACON Biotech (Hangzhou) Co.’s (ACON) 3-1 Lipid Panels have violated Section 337 of the Tariff Act by importing devices that infringe PTS Diagnostics’ U.S. Patent Nos. 7,087,397 and 7,625,721. The ruling is an important step toward PTS Diagnostics obtaining an order excluding ACON’s 3-1 Lipid Panels from importation into the United States.

The ITC is a U.S. federal agency charged by Congress to investigate unfair trade practices that impact U.S. domestic industries. In the initial determination, the ALJ found that ACON’s 3-1 Lipid Panels infringe claims of both the ‘397 patent and the ‘721 patent. Further, the ALJ found that all of PTS Diagnostics’ patents asserted in the investigation are valid, rejecting all of ACON’s arguments to the contrary. The ALJ concluded that ACON’s importation into the U.S., sale for importation, or sale in the U.S. following the importation of the ACON 3-1 Lipid Panels violated section 337 of the Tariff Act.

The PTS Diagnostics patents asserted in the investigation cover PTS Diagnostics’ CardioChek® family of lipid analyzers and PTS Panel test strips, which are made in the U.S. PTS Diagnostics is pleased that the initial determination found that ACON 3-1 Lipid Panels infringe these patents, and the company will pursue an order from the ITC excluding all ACON infringing products from the U.S. PTS Diagnostics was represented in the ITC proceeding by Haynes and Boone, LLP.

“PTS Diagnostics appreciates the administrative law judge’s thorough consideration after extensive briefing and a hearing and the determination that ACON has infringed our patents,” said Robert Huffstodt, President and CEO of PTS Diagnostics. “PTS Diagnostics is proud that the healthcare industry has widely embraced our CardioChek lipid measurement system, which has been used to screen more than 140 million patients worldwide. Further, this investigation demonstrates that we are committed to protecting ourselves against anyone who infringes our broad worldwide patent portfolio.”

Recognizing the strong connection between heart attack, stroke, and diabetes, CardioChek analyzers provide rapid point-of-care blood-chemistry values and measurements to help identify at-risk individuals. As one of the fastest, most cost-efficient and user-friendly analyzers on the market today, CardioChek systems accurately test lipid profile and glucose simultaneously with one fingerstick. In as little as 90 seconds, they provide on-site results with similar accuracy to clinical laboratories.

PTS Diagnostics’ PTS Panels® lipid test strips measure total cholesterol, HDL cholesterol, and triglycerides, calculate LDL cholesterol and TC/HDL ratio, and do not require refrigeration. The accompanying meter is handheld, battery-operated, and compact and lightweight, making it easy to transport and store. CardioChek systems are CLIA-waived and meet NCEP guidelines for accuracy and precision. The CardioChek Plus analyzer offers simultaneous testing of lipid profile and glucose, has wireless communication capabilities, and is CRMLN-certified for total cholesterol and HDL cholesterol testing.

PTS Diagnostics will fully defend the ITC’s initial 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 more than 140 million 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. From our headquarters in the United States of America, we design, manufacture, and market our products to more than 130 countries around the globe. For more information, visit ptsdiagnostics.com.

PTS Diagnostics and Jant Pharmacal Corporation Jointly Resolve Pending Litigation

PTS Diagnostics and Jant Pharmacal Corporation Jointly Resolve Pending Litigation

Indianapolis and Encino, Jan. 19, 2016 — PTS Diagnostics, Infopia Co., LTD, Infopia America LLC, and Jant Pharmacal Corporation today announced the settlement of PTS Diagnostics’ claims that Infopia’s HDL-cholesterol testing products sold by Jant in the United States infringe PTS Diagnostics’ U.S. patent no. 7,087,397. The settlement was entered into by the parties to amicably resolve pending litigation without admission of liability or lack of liability by any party.

In recognition of limited sales and the expenses associated with protracted patent litigation, the sale of LipidPlus test strips that contain the HDL-cholesterol test will be discontinued over a period of time in the United States. The sales of products that do not contain a current LipidPlus HDL-cholesterol test remain unaffected.

The settlement resolves PTS Diagnostics’ claims in both United States District Court and the International Trade Commission. In light of the terms of the settlement, Jant and Infopia have dropped all challenges to the validity and enforceability of PTS Diagnostics’ patent in perpetuity and PTS Diagnostics has released Infopia and Jant (and their customers) from all claims that could have been made relating to use of the LipidPlus products

Source: PTS Diagnostics and Jant Pharmacal Corporation.

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PTS Diagnostics will Present at the American Diabetes Association's (ADA) 76th Scientific Sessions

PTS Diagnostics will Present at the American Diabetes Association’s (ADA) 76th Scientific Sessions

Manufacturer of A1CNow+® will exhibit and present a poster at the world’s largest meeting on diabetes June 10-14 in New Orleans

Indianapolis – June 9, 2016 PTS Diagnostics, the U.S.-based manufacturer of point-of-care blood testing devices, including the CardioChek® and A1CNow® systems, will exhibit and participate in the poster sessions at the American Diabetes Association’s (ADA) 76th Scientific Sessions held in New Orleans.

PTS Diagnostics and eTrueNorth’s poster titled “Failure of Fasting Blood Glucose Screening to Detect All Persons with Diabetes or Prediabetes” will be on display in the “Clinical Therapeutics/New Technology–Glucose Monitoring and Sensing” area in the Poster Hall on June 11 to June 13. James Anderson, MD, lead author of the presentation and PTS Diagnostics’ medical director, will be available to discuss his research on Sunday, June 12, from noon to 2:00 p.m. at the poster’s location, 864-P.

Further, Dr. Anderson will participate in a moderated poster discussion in the session titled “The Role of Glucose Testing and Variability” on Monday, June 13 from 1 to 2:00 p.m.

Attendees to the ADA Scientific Sessions can visit PTS Diagnostics in Booth #117 during the show.

“PTS Diagnostics is pleased to be contributing to the body of knowledge that strives to screen, diagnose, treat and manage diabetes,” said Dr. Anderson. “At PTS Diagnostics, our focus is to provide healthcare professionals an easy, fast and accurate way to measure A1C. Our presentation focuses on the importance of A1C screening and testing for at-risk individuals.”

At the conclusion of the ADA event (June 14), this poster presentation will be available at www.a1cnow.com.

PTS Diagnostics manufactures A1CNow+® system, a fast and easy way of obtaining accurate A1C results with just a fingerstick in just 5 minutes at the point of care. The portable, small medical device can easily be used in multiple exam rooms, is CLIAwaived, FDA-cleared and is NGSP certified. This innovative technology enables healthcare professional to communicate face-to-face with patients about their diabetes control in minutes, not days.

About PTS Diagnostics
PTS Diagnostics is an innovative global point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service. Headquartered in Indianapolis, Indiana, PTS Diagnostics designs, manufactures, distributes and markets products for distribution in more than 135 countries around the world. For more information, visit www.ptsdiagnostics.com or contact Tom Wiser at 317- 870-5610 or twiser@ptsdiagnostics.com.

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