US Supreme Court rebuffs CareDx patent lawsuit over organ-rejection tests

CareDx

02/10/2023 16:06

By Blake Brittain
       WASHINGTON, Oct 2 (Reuters) - The U.S. Supreme Court on
Monday declined to hear a lawsuit by CareDx  CDNA.O  over
organ-rejection tests made by Natera  NTRA.O  and Eurofins
Viracor  EUFI.PA , turning down another request to revisit the
contentious issue of patent eligibility.
    The justices turned away CareDx's appeal of a lower court's
ruling that invalidated patents that the Brisbane,
California-based company had accused its medical diagnostics
rivals of infringing. The justices announced their action on the
first day of their new nine-month term.
    CareDx sued Austin, Texas-based Natera and Viracor, a
Kansas-based subsidiary of Luxembourg's Eurofins Scientific, in
2019, accusing them of infringing patents related to its
AlloSure blood test for monitoring kidney transplants. The
patents, which CareDx licenses from Stanford University, cover
methods of measuring levels of an organ donor's DNA in a
transplant recipient's blood to predict whether their body will
reject the organ.
    CareDx accused Natera's competing Prospera test and
Viracor's TRAC Kidney test of violating its patent rights.
    The patent-focused U.S. Court of Appeals for the Federal
Circuit ruled last year that the patents were invalid, affirming
a Delaware federal judge's decision that they relate to the
unpatentable idea of detecting natural phenomena.
    CareDx told the Supreme Court that it was "overdue" to
address the issue of patent eligibility, which the company said
has been particularly difficult for makers of medical
diagnostics.
    The Supreme Court last addressed patent eligibility in the
2014 case Alice Corp v. CLS Bank International, which helped
establish a two-part eligibility test along with a 2012 ruling
on diagnostic patents, Mayo Collaborative Services v. Prometheus
Laboratories. The test requires courts to determine if an
invention involves an unpatentable abstract idea, natural
phenomenon or law of nature - and if so, whether it includes an
inventive concept that would make it patentable.
    Critics have said the standard has caused confusion about
what inventions can be legally protected and led to the
cancellation of valid patents in many fields.
    The justices have turned down several appeals related to
patent eligibility despite the urgings of the past two
presidential administrations and the Federal Circuit, whose 12
active judges asked the Supreme Court in 2019 to take up the
issue.
    Justice Brett Kavanaugh said in Monday's order from the
Supreme Court that he would have granted CareDx's petition.

 (Reporting by Blake Brittain in Washington; Editing by Will
Dunham)
 ((blake.brittain@tr.com; +1 (202) 938-5713;))