Myriad targets Gene By Gene in second BRCA patent suit

After a June Supreme Court ruling spurred a free-for-all among makers of cancer diagnostic tests, Myriad Genetics ($MYGN) is staking its claim to intellectual property it says newfound competitors are violating, filing its second patent-infringement lawsuit in as many days.

In a complaint filed in Utah on Wednesday, Myriad and four other patent owners allege that Houston's Gene By Gene violated 9 patent claims when it started offering BRCA1 and BRCA2 analysis tests on June 13, the same day the Supreme Court nullified 5 of Myriad's patents on isolated genes.

The Gene by Gene filing comes on the heels of Myriad and company's Tuesday lawsuit against Ambry Genetics, and both allege that the defendants violated intellectual property related to the testing process, not isolated gene expressions. In both, Myriad is seeking a jury trial, asking the court to halt its competitors from offering the tests in question and force them to pay out damages and royalties.

A spokeswoman for Gene By Gene said the company had no comment at this time. Ambry, in a statement issued Wednesday, said it stands by its tests and plans to vigorously defend itself.

It's unclear whether Myriad plans to sue every competitor that has sprung up since June, and a company spokesman declined to comment on future litigation.

However, Myriad released a "pledge to our patients and the research community" this week, in which the company promises not to impede noncommercial research using its patents, not to interfere with labs conducting confirmatory assays for Myriad's tests and to offer financial assistance programs to patients in need of BRCA analysis. In light of Myriad's recent litigation, the document reads a bit like an establishment of ground rules before undertaking a legal battle.

Myriad owns four of the patents allegedly infringed by Gene By Gene, licensing the other 5 from the University of Utah, University of Pennsylvania, Endorecherche and Ontario's Hospital for Sick Children. Myriad hands over 8% of its related profits to the other patent owners, a spokesman said, which has amounted to $57 million over the life of the patents.

Like Ambry, Gene by Gene put out a statement hours after the June ruling saying it was getting into the BRCA testing game, joined by Quest Diagnostics ($DGX), GeneDx and others who said they planned to roll out competing tests over the next year. In a statement following the court's decision, Gene By Gene announced it would offer BRCA analysis for $995, saying "exorbitant licensing fees" previously kept it from selling the tests in the U.S.

- read the lawsuit (PDF)
- check out Myriad's pledge (PDF)

Industry Voices: SCOTUS decision on gene patenting: A win-win for (almost) everyone

Editor's note: An earlier version of this story misstated where the lawsuit was filed. We regret the error.

Sponsored By Metabolon

Five Translational Insights Key to a Successful First-in-Human (FIH) Study – Metabolite-Based Biomarker Discovery and Validation

Translational success rates from pre-clinical animal studies to human clinical trials remain frustratingly low. Learn how metabolomics helps you bridge between the theoretical & practical, between the function & actual activity of your drug molecule to get you closer to the phenotype, sooner.