Myriad Throws in the Towel

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.

Comments

[Dan Feigelson]

In view of Breyer's dissent in LabCorp, it's hard to know if some other shmendrick beside Myriad would have served as the straight man for this court's joke of patent jurisprudence, had Myriad not pressed its case (several GVRs in the wake of Myriad suggest that those cases might have been the vehicle for Breyer et al. to get their fix). But Myriad was the one that did so, using questionable tactics, ultimately leading to the current patent landscape that is much poorer for at least the biotech industry. "Are you happy now, Myriad?" is most definitely the question to be asked.

[Simon J Elliott]

I agree that Myriad might have been better served by asserting narrower claims.

But hindsight is cheap. SCOTUS rewrote the law in a way that was unexpected by most commentators, radically reinterpreted cases, and waded directly into an area of policy that should be reserved for the political branches of government. How is that Myriad's fault?

[Marlan]

I get that many are mad at Myriad for the changes to the patent law. But....

Based on my read of what is in the public record, Myriad never broke even on the diagnostic tests it endeavored to create. Other diagnostic companies wantonly ripped them off (where is the righteous indignation for "infringers" from the patent bar?!?).

As patent attorneys, the fact that a company cannot have exclusivity to at least break even should ring a note of discord. What does our future look like when companies look at a technology then steer away because the "juice isn't worth the squeeze?" Certainly we aren't writing more patents.

[Kaptain Korwood]

" SCOTUS rewrote the law in a way that was unexpected by most commentators,"

Meanwhile, other commenters recognized that Myriad's claims had severe flaws from the beginning (and not just subject matter eligibility problems). These flaws were identified in real time. Not everybody wanted to discuss the flaws but that doesnt mean those flaws disappear.

Live and learn.

[Simon J Elliott]

Kap'n: Perhaps, but the petitioners bore the burden of invalidating Myriad, and won on the 101 issue.

My other surprise was that the SCOTUS accepted review. Scalia, in particular, had been a big force in reforming/changing standing doctrine, making it much harder to get review without actual injury. [But maybe that is only for environmental cases]

[Skeptical]

(One of) the problems exemplified by the good Kaptain's desire for judicially activist solutions - especially in regards to a statutory law regime such as patent law - is that as long as the results obtained are in accord with the person's desired philosophical ends, that the means to those ends are not given a second thought.

Woe then, when different results are obtained through identical "whatever" means...

[Doug]

Changes to the patent law, while bad for attorney business, were completely necessary. Myriad cloned a gene--by a process that was already known. Sure it was "hard work", but it wasn't an invention. They didn't even discover the correlation with hereditary cancer! How does that translate to a patent estate on the diagnostic and diagnostic interpretation. Is that too high an altitude for this pedantic discussion??

[Kevin E. Noonan]

Well, Doug, that's where you are wrong. Changes in patent law are great for the attorney business - the more unpredictable things get the more clients need good lawyers to help them. As I've said to others who have accused me of taking the positions I have on these issues for personal gain, please don't worry about me - my retirement is secure and getting moreso everyday.

As I have posited before, there are countless situations where the argument could be made that "they didn't invent it" - antibiotics, lubricants from petroleum, all sorts of natural products made into drugs. Myriad "invented" a composition of matter comprising the BRCA genes isolated from the rest of tbe chromosomal DNA, just as Amgen did for EPO and Genentech did for tPA, etc.

And remember - we live in the world Myriad made. In 1997 precious few insurance companies believed that cancer could be predicted by a blood test, and few state Medicare/Medicaid programs believed, either. Myriad did the work of getting these folks on board, establishing that the test was reliable and would save money in the long run. And, oh yes, saving countless women the worry of whether they would get breast cancer and giving those at risk the information to make an informed decision. If Mary Clare King or any other academic had won the BRCA gene race and "dedicated it to the public,' do you think women in economically disadvantaged areas of the country (i.e., outside the scope of major academic medical centers) would have gotten the test? Myriad didn't do this out of altruism, but the profit motive in this case led to the happy outcome that more women got the test that otherwise would have, and faster too.

The irony is that, in a world where patent incentives don't exist, these types of tests will only be available when the big corporations develop them. Who would have predicted that a group like the ACLU would be working for the corporate man?

Thanks for the comment.