Illumina, Sequenom Under Investigation for Anticompetitive Conduct
Published Wednesday, July 06, 2016
At a Case Management Conference on Friday 1 July, the English Court ordered that it would consider Premaitha’s competition law defence after the patent hearings scheduled for July 2017, when it would have more certainty on the validity of the technical claims made, and an ongoing investigation by the European Commission ( into potentially anticompetitive conduct by Illumina and Sequenom in the NIPT market. Illumina’s attempts to have the defence dismissed were refused.
The Court also ordered Illumina to provide an unredacted copy of a Pooled Patents Agreement to the Company’s legal advisers, which Illumina had previously refused. The PPA was entered into by Illumina and Sequenom in late 2014 and is the basis for the patent litigation claims made by the Claimants against the Company in the UK and against its customers in Poland and Switzerland, along with similar litigation against other competitors that do not use Illumina sequencing platforms for their NIPT solutions. In its reasoning, the Court stated that disclosure of the PPA will very probably “shed some light on the competition arguments that are being raised”.
Because this was approved by the FDA as a prescription only test, if EXAS knowingly fills a prescription for off-label use, a use not included in their FDA approved labeling , such as a replacement for routine colonoscopy, they are definitely in violation of the FDA regulations.
"Today’s approval of the Cologuard does not change current practice guidelines for colorectal cancer screening. Stool DNA testing (also called “fecal DNA testing”) is not currently recommended as a method to screen for colorectal cancer by the United States Preventive Services Task Force (USPSTF). Among other guidelines, the USPSTF recommends adults age 50 to 75, at average risk for colon cancer, be screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy."