The patent battle between Natera, a cell-free DNA testing company, and CareDx, a precision medicine company serving transplant patients, continues this week, with Natera now filing two new patent infringement suits against CareDx.
Natera has accused CareDx of infringing two patents covering Natera’s DNA testing technology, according to documents filed last Friday in the US District Court for the District of Delaware.
The Austin, Texas-based company alleged that CareDx’s Allosure and AlloSeq products infringe patent No. 10,655,180. The patent is related to Natera’s products used to measure DNA in a sample using synthetic pieces of DNA, including amplification products, which are produced using synthetic tools such as primers, according to court documents.
“CareDx has made extensive use of Natera’s patented technology, including the technology described and claimed in the ’180 patent,” according to the complaint.
Natera also alleges in a separate case that CareDx’s AlloSure, AlloSeq, KidneyCare, and HeartCare products infringe US Patent No. 11,111,544.
These are the latest shots fired in an ongoing conflict between the two companies. In March, a jury ruled that Natera owed $44.9 million in damages to CareDx. A jury ruled that Natera engaged in false advertising in making certain comparisons between its Prospera Kidney Transplant Test and the CareDx AlloSure test; While CareDx didn’t escape judgement in the ruling, with the jury ruling that CareDx engaged in two counts of false advertising, the jury rejected a finding that the conduct was intentional and awarded Natera no damages because the company was only requesting injunctive relief..
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The conflict dates back several years when South San Francisco-based CareDx initiated a lawsuit against Natera in 2019 for false advertising of its product and likening it to CareDx’s product. At their core, both Prospera and AlloSure are blood tests that can assess the risk of rejection of a transplanted kidney.
In a news release Tuesday, CareDx said that it “believes all the recycled patents asserted against CareDx are invalid and are not infringed.”
A lawyer for Natera did not immediately respond to requests for comment.
The cases are 1:22-cv-00641-CFC and 1:22-cv-00642-CFC in the District Court of Delaware.
The story has been updated to reflect that while CareDx was found guilty of false advertising on two counts, it wasn’t intentional.
