By Christopher P. Young, Editor, G2 Compliance Advisor
In an April 21 award of damages in a patent infringement lawsuit filed by Ameritox and Marshfield Clinic against Millennium Health (MH), formerly Millennium Laboratories, jurors decided that $8,652,760 would adequately compensate the plaintiffs for MH’s infringement on one of two patents owned by the plaintiffs. Patents number 7,585,680 and 7,785,895, referred to in court documents as the ‘680 and ‘895 patents respectively, covered Ameritox’s Rx Guardian CD service, a method of monitoring and reporting drug use that includes comparing an individuals’ urine drug test results against data from a patient group that has adhered to their medication regimen. The method seeks to determine if a patient has taken the prescribed dosage of a medication, rather than just finding presence or absence. MH filed a motion for summary judgment on Oct. 10, 2014, asking the court to invalidate the patents in question and the infringement claims. The court ruled in favor of MH on the ‘895 patent and against it on the ‘680 patent.
Michael Larson and Thomas Richards invented the method and assigned it to Marshfield Clinic, who then licensed it to Ameritox by an agreement dated March 15, 2010. Ameritox launched the Rx Guardian CD Service in May 2011. The service consisted of (1) performing a test designed to detect and quantify any drugs present in a patient’s sample, (2) normalize the results for a patient’s hydration status, and (3) compare the patient test result with a population of other patients on the same medication. By comparing the patient to normalized data on other patients, the treating provider can better ascertain if the patient is following their drug regimen, whether they are taking too little or too much. Shortly after, in June 2011, MH initiated its new report called “Rapid Assessment Drug Adherence Report” or RADAR.
Factors the jury was instructed to consider in determining damages included the value of royalties others paid that MH did not pay, whether the parties are competitors, whether the patented products are commercially successful, and the extent of the infringing party’s use of the product. According to the jury instructions, during the infringement period, June 2011 through March 8, 2015, MH “sold 3,486,380 infringing units.”