By Dennis Crouch
Myriad Genetics v. Ambry Genetics (D. Utah 2013)
In AMP v. Myriad, the Supreme Court ruled that the process of isolating naturally occurring DNA is insufficient to transform the natural phenomenon into a patentable invention. At the same time, the court ruled that a manmade cDNA version of naturally occurring human DNA is patent eligible.
Within hours of that Supreme Court ruling, Ambry Genetics issued a press release indicating that the company would begin offering genetic testing for the BRCA1/BRCA2 mutations at a significantly reduced rate.
Now, Myriad Genetics has filed suit against Ambry alleging infringement of ten different patents including the patents challenged in the original lawsuit. These include U.S. Patent Nos. 5,709,999; 5,747,282; 5,753,441; 5,837,492; 6,033,857; 5,654,155; 5,750,400; 6,051,379; 6,951,721; and 7,250,497. In the complaint, Myriad was careful to only assert claims that were left valid by the Supreme Court decision. Myriad writes:
As of the morning of June 13, 2013, Plaintiffs collectively had 24 patents containing 520 claims concerning two genes (BRCA1 and BRCA2), and methods of use and synthetic compositions of matter related thereto. On June 13, the Supreme Court of the United States ruled that five patent claims covering isolated naturally occurring DNA were not patent-eligible, thereby reducing the overall patent estate to 24 patents and 515 patent claims. This case involves none of those five rejected claims.
The lawsuit requests injunctive relief, damages for willful infringement and lost profits. In addition, Myriad filed a motion for preliminary injunction arguing that Ambry's low prices create irreparable harm:
Ambry is able to offer testing at [a] discounted price by unfairly and improperly "free-riding" off of the hundreds of millions of dollars invested by Myriad Genetics in developing the science and market for clinical diagnostic testing for hereditary cancers. …
At a minimum, [the harm caused by ongoing infringement] consists of: (1) price erosion and the loss of the benefit of Myriad's established pricing strategy; (2) the loss of market share; (3) reputational injury; and (4) loss of the benefit of the remaining limited term of patent exclusivity and Myriad's business plans for that period, as well as the inability to fully obtain its reliance interest obtained by disclosing its discovery and investing hundreds of millions of dollars to commercialize that discovery in exchange for a limited exclusive right. The Federal Circuit has recognized each of these forms of damage as irreparable harm that warrant the imposition of injunctive relief.
It appears that Myriad has a very strong case here. One question will be whether the district court will entertain arguments that the public's need for access to multiple sources of cancer diagnostic tools weigh heavily against injunctive relief.
The case has been assigned to one of the newest district court judges – Judge Robert Shelby. Judge Shelby is an Obama nominee who received his commission on September 25, 2012. Shelby's court has become something of a dumping ground for IP cases. About half of the 83 open intellectual property cases in Utah in his docket.