publication date: Mar. 14, 2014

Robert Cook-Deegan’s Viewers’ Guide To the Super Bowl of Gene Patent Cases


Patent litigation is a blood sport if you see corporations as people and count spilled ink or loss of money as hemorrhage.

One of the most closely watched cases in recent years centers on genetic testing for BRCA1 and BRCA2 genes.

On March 10, Judge Robert Shelby from the Federal District Court for Utah denied Myriad Genetics’ motion for a preliminary injunction against its competitors that had entered the market starting June 13, 2013, when the Supreme Court handed down its ruling in Association of Molecular Pathology v. Myriad Genetics.

The key conclusion in Judge Shelby’s ruling is that Myriad and its co-plaintiffs are “unable to establish that they are likely to succeed on the merits of their claims.”

The case may now go to trial or get settled out of court. If it goes to trial there will be several more steps, including hearings to interpret the claims, a vigorous process of discovery to uncover facts and documents, and then a possible trial.

Just Shelby’s ruling is 106 closely argued pages. It is dense and intricate, but clear. Basically, he concedes that Myriad will suffer irreparable harm, but does not have a persuasive case it will prevail on the merits. The main reason is that the claims to DNA molecules—mainly to DNA primers used to amplify the DNA in its tests—are in trouble; and the claims to methods are in very deep trouble.

BRCA1 and BRCA2 are the most commonly mutated genes associated with inherited risk of breast and … Continue reading 40-11 Cook-Deegan’s Viewers’ Guide 1

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