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Ravgen Prevails Over Streck in Patent Challenge

NEW YORK – Baltimore-based prenatal testing firm Ravgen scored another victory Tuesday in its series of disputes over its patents on noninvasive prenatal testing methods, prevailing in a challenge by Streck before US patent authorities.

The US Patent and Trademark Office's Patent Trial and Appeal Board ruled on Tuesday that blood collection tube maker Streck had failed to prove its claims that patent authorities had erred in granting Ravgen US Patent number 7,332,277, which relates to methods of sampling fetal DNA from a maternal blood sample and identifying genetic disorders. Ravgen has also withstood patent challenges before the PTAB with rulings against Quest Diagnostics, Laboratory Corporation of America, and Illumina.

Since 2020, Ravgen has sued eight NIPT makers, and has been in negotiations with about a dozen more, to secure royalties over commonly used methods to identify genetic abnormalities using NIPTs. The firm secured its latest settlement last week, with Illumina, which followed previous settlements with Quest and PerkinElmer as well as a $273 million verdict against Laboratory Corporation of America.

That verdict aligns with the $100 per test royalty Ravgen has been seeking through courts and negotiations.

Though Streck is not a NIPT maker, it sells blood collection tubes to most of the companies sued by Ravgen, and it sought an inter partes review by the PTAB over the '277 patent on the use of an agent to inhibit cell lysis. Ravgen has said in its complaints before the courts that maternal blood samples contain sufficient amounts of fetal cell-free DNA for genetic testing, but unchecked lysis of maternal cells releases an overwhelming amount of maternal DNA.

Ravgen has also filed lawsuits alleging violations of US Patent number 7,727,720, which also relates to the methods of isolating and detecting cell-free DNA from a sample while using methods to prevent lysis.

Both patents expired in March, and the remaining disputes are over allegations of past infringement.

Brian Matty, partner at the Desmarais law firm representing Ravgen, said in a statement that the PTAB's decision Tuesday concluded the last of 10 inter partes reviews of Ravgen's genetic testing patents, which have been upheld in each decision.

"We look forward to continuing to help Ravgen protect their foundational innovations," he said.