Gene-by-Gene Cries Uncle, Settles with Myriad Genetics

By Kevin E. Noonan --

Gene-by-Gene, Inc. was one of the first direct-to-consumer (DTC) genetic diagnostics companies to announce that it would offer BRCA1/BRCA2 testing after the Supreme Court's decision last June that certain of Myriad Genetics' claims (those that encompassed isolated genomic DNA) were invalid for reciting patent-ineligible subject matter.  And Gene-by-Gene was one of the first DTC genetic diagnostic companies sued by Myriad for offering such testing. (see "Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes"), followed by lawsuits against several other companies offering or threatening to offer Myriad's BRCA tests.

Now, Gene-by-Gene has become the first DTC genetic diagnostic company to settle with Myriad, in what can only be characterized as complete victory for the patentee.  Under the terms of the agreement, Gene-by-Gene will immediately cease "selling or marketing" BRCA gene tests, either as standalone tests or as part of a wider panel in the U.S.  The company will be able to offer "whole genome" testing and exome testing, as well as "custom" array products for Mendelian-inherited disease and disorders (which may include the BRCA genes).  This agreement will last until either February 12, 2016 or the expiration date of the last-to-expire valid patent claims of any of the patents in the Myriad v. Gene-by-Gene lawsuit (which 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; 6,951,721; and 7,250,497).  Myriad's suit against Gene-by-Gene was dismissed without prejudice, leaving open the possibility for Myriad to reinstitute the lawsuit should Gene-by-Gene violate any of the terms of the agreement.

There was a great deal of crowing by the ACLU and its friends and supporters when the Supreme Court rendered its decision, while cooler (and more experienced) commentators noted that Myriad had many more patent claims not challenged by the plaintiffs in the AMP v. Myriad Genetics case.  This settlement indicates that, at least for one company, the prospect of successfully challenging Myriad's remaining patent estate was sufficiently daunting that litigation was not a happy prospect.  This settlement also suggests that the ACLU failed in its purported goal of making BRCA testing more widely available than it has become due to Myriad's efforts over the past 17 years.

For information regarding this and other related topics, please see:

• " Invitae Files Motion to Dismiss for Lack of Personal Jurisdiction in Myriad Genetics v. Invitae Corp.," December 11, 2013
• " Myriad Genetics Sues LabCorp over BRCA Gene Testing," December 4, 2013
• " Myriad Genetics Sues Invitae over BRCA Gene Testing and Invitae Sues Right Back," November 27, 2013
• "Where Do We Stand?" October 31, 2013
• "Defendants' Oppose Myriad's Motions to Dismiss Antitrust Counterclaims," October 28, 2013
• "Myriad Genetics Files Amended Complaint Relating to Colon Cancer Genetic Diagnostic Testing," October 23, 2013
• "Myriad Genetics Sues Quest for Patent Infringement," October 22, 2013
• "Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents," October 21, 2013
• "Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics," October 13, 2013
• "Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics," October 10, 2013
• "Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies," October 9, 2013
• "Defendants' Response to Myriad's Preliminary Injunction Motions," September 19, 2013
• "Myriad Moves to Dismiss Ambry's Antitrust Counterclaims on Noerr-Pennington Doctrine," August 28, 2013
• "Amici Submit Brief in Support of Ambry Genetics and Gene by Gene," August 27, 2013
• "Ambry Responds to Myriad Lawsuit," August 7, 2013
• "Why Does Myriad Think It Can Win BRCA Gene Lawsuits?" July 30, 2013
• "Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes," July 10, 2013
• "Myriad Genetics Files Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes," July 9, 2013

Comments

[EG]

"There was a great deal of crowing by the ACLU and its friends and supporters."

Hey Kevin,

There sure was. Are they still "crowing" now?

[Gary Johnston]

Giddy much?

As the great Inigo Montoya said "I do not think it means what you think it means."

[JNRoss]

"while cooler (and more experienced) commentators"

Kevin Noonan is bragging about his ability to modulate himself?

That's funny.

[Skeptical]

JNRoss,

Tell me something really funny. Are you the posted commonly known as Malcolm Mooney, MM, or any of a multitude of various other names?

Thanks.

[Kevin E. Noonan]

Well, Gary, if you know something, share. Otherwise, just admit that this round has gone to Myriad - doesn't mean they will ultimately prevail, but it is a good start.

[Gary Johnston]

Here's what I know:

1. patent litigation is expensive
2. 2016 is pretty soon
3. patent litigation is expensive

[CC]

Absolutely agree with Gary. The patents only have 2 more years left. Even if Gene-by-Gene does invalidate Myriad's patents, the profit it can generate in the U.S., in what seems to be a crowded market now (Quest, Ambry, Labcorp, Invitae...), does not necessarily justify the litigation costs. The most recent PI case I was involved in, the tab ran over 2 million. AND, that was after both side agreed to drop the patents that only had about 1 year of term left. Gene-by-Gene is a pretty small player. Settlement makes a lot of sense, and the settlement says nothing about the strength of Myriad's patents.

I personally disagree with the Myriad and Prometheus by the Supreme Court, in particular Prometheus. However, given the precedent, I think attacking Myriad's remaining claims look quite promising.