Wednesday, July 20, 2022

Court Invalidates Patents About cfDNA and Kidney Rejection; Keeps High Bar for Any Dx Patent

 While it didn't change further this week, from June 2021 to June 2022, CareDx's stock is down from around $90 to $20.   In the past few days, a patent court ruled against CareDx.  I am not an attorney, and I'm just quoting from available news stories, to which links are provided.

For a number of years, patent courts have held that biological diagnostic tests are often not patentable, (#1)  if they describe a natural phenomenon that is generally understood (dying transplant kidneys release DNA) and (#2)  if the further bioscience is not itself novel enough (austensibly, here, detecting cfDNA is just understood by everyone who "works in the art.")  One judge dissented strongly.   Case here

Hence, federal appeals court rules in CareDx vs Natera that some patents issued for the cfDNA rejection detection are not patent-eligible.  This concurred with the lower court.   While the case title is CareDx v Natera, Eurofins is also noted on the cover page.  Stanford University is a joint plaintiff with CareDx. 

  • See discussion by the always-lucid Kevin Noonan at PatentDocs here.
  • See PatentlyO here.
  • 360Dx here.
  • See  Reuters here.
  • See Bloomberg Law here.
    • The principles being applied date to Athena v Mayo, at which link see detailed review.
  • See separately Natera v CareDx in May 2022 over Panorama (NIPS) patents, here.