By Kevin E. Noonan --
In the aftermath of the Supreme Court's decision in AMP v. Myriad Genetics in 2013, Myriad (paradoxically to those either not paying attention or who over interpreted the scope of the Court's holding in its opinion) filed suit against six genetic diagnostic test providers (Ambry Genetics, Gene-by-Gene, Quest, GeneDx, Invitae, and LabCorp) and was itself sued in declaratory judgment actions by three others (Quest, Invitae, and Counsyl) (see "Myriad Genetics Sues LabCorp over BRCA Gene Testing"). On Myriad's motion, the Judicial Panel on Multidistrict Litigation consolidated five of these actions (involving Ambry Genetics, GeneDx, Quest Diagnostics (infringement), and Quest and Counsyl (declaratory judgment) in the District of Utah (Myriad's "home court") under 28 U.S.C. § 1407 under the caption In Re: BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (see "Panel on Multidistrict Litigation Consolidates Myriad Cases in Utah District Court"). The Panel decision also noted that other cases, such as the ones involving Invitae Corp. and LabCorp, could be consolidated as "potential tag-along actions."
As it turned out, Utah District Court Judge Shelby denied Myriad's preliminary injunction motion, on the grounds that Myriad was unlikely to prevail on the merits regarding the asserted claims (*) in view of the Supreme Court's Myriad opinion (see "Utah Judge Denies Myriad's Preliminary Injunction Motion"). This decision was affirmed by the Federal Circuit last month in an opinion that left little more for the District Court to do than consider motions for judgment by the infringement defendants and declaratory judgment plaintiffs (see "In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation (Fed. Cir. 2014)").
And it also turns out that that won't be necessary, at least for Ambry Genetics, LabCorp, Invitae, and Pathway Genomics (this company was sued by Myriad in June 2014 and was not part of the consolidated case), all of whom issued a press release announcing that the action as to them had settled. (Another defendant, Gene-by-Gene, settled early in 2014 on essentially the same terms announced by these defendants.) The press releases, using similar language, stated that Myriad's infringement allegations had been dismissed "with prejudice" and that each of the parties had received a "covenant not to sue" by Myriad. The only financial considerations announced were that each party would bear its own costs of the litigation, which Myriad may count as a "win" in view of its potential liability under even more recent Supreme Court precedent (Octane Fitness v. ICON Health & Fitness and Highmark v. Allcare Health Management); this is particularly true of the Pathmark settlement, insofar as Myriad sued Pathmark after both the District Court's opinion denying its preliminary injunction and the Supreme Court lowered the threshold for attorneys' fees in patent litigation.
It can be reasonably expected that Myriad will settle with the remaining defendants/DJ plaintiffs, ending a series of cases that changed the landscape for biotechnology patenting. It is hard for even an evenhanded observer not to be tempted to ask, "Are you happy now, Myriad?"
Myriad's patents on its BRCA gene technology begin to expire early next year.
* The specific claims Myriad alleges are infringed include the following: claim 6 of U.S. Patent No. 5,709,999; claims 6, 16 and 17 of U.S. Patent No. 5,709,999; claims 7, 8, 12, 23, and 26 of U.S. Patent No. 5,753,441; claims 29 and 30 of U.S. Patent No. 5,837,492; claim 4 of U.S. Patent No. 6,033,857; claims 2, 3 and 4 of U.S. Patent No. 5,654,155; claims 2, 3, 4, 5, 6, and 7 of U.S. Patent No. 5,750,400; claim 5 of U.S. Patent No. 6,951,721; and claims 3, 4, 5, 6, 7, 8, 11, 14, 17, 18, 19 of U.S. Patent No. 7,250,497. Missing from the complaint against Gene by Gene were allegations of infringement of claims 32 and 33 of U.S. Patent No. 6,051,379 asserted in the complaint Myriad filed against Ambry Genetics. Similar combinations of these claims were asserted against the other defendants.