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27 January 2015Americas

Myriad and Pathway settle BRCA patent litigation

Genetic diagnostic companies Myriad Genetics and Pathway Genomics have settled their patent dispute involving BRCA gene testing.

Myriad’s BRCA tests determine an individual’s chance of developing breast or ovarian cancer by analysing the genetic sequences of the BRCA1 and BRCA2 genes and mutations.

The company holds a number of patents that protect these tests. The University of Utah Research Foundation, HRC Research and Development Limited Partnership, Endorecherche, and the Trustees of the University of Pennsylvania also hold patents directed to the BRCA tests.

Myriad and the patent owners sued Pathway at the US District Court for the District of Utah in June last year after Pathway started offering its own BRCA tests. It has also asserted its BRCA patents against fellow diagnostic companies Ambry Genetics and Gene by Gene.

Under the agreement, announced on Friday (January 23), Myriad and Pathway dismiss their respective claims, and the patent owners have agreed not to sue Pathway in relation to any of the patents asserted in the litigation.

Jim Plante, Pathway’s founder and chief executive, said: “We are very pleased to close this chapter and continue our focus on providing innovative cancer risk testing to patients around the world.”

A spokesperson for Myriad told LSIPR that the company had now settled five of its seven BRCA patent disputes, and that it is in settlement discussions with the remaining two.

The ruling comes soon after the US Court of Appeals for the Federal Circuit’s December ruling, which found that some of the patent claims at issue in the case were not eligible under Section101 of the US Code.

In June 2013, the US Supreme Court ruled that isolated human DNA is not patent eligible, and invalidated a number of Myriad’s patent claims directed to mutations on the BRCA1 and BRCA2 genes.

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