Why Is Myriad Genetics Still Filing Patent Suits for Breast-Cancer Tests?

The Supreme Court declared human genes unpatentable, but it didn’t free the market for genetic testing.

National Journal
Brian Resnick
Aug. 8, 2013, 8:28 a.m.

You can’t pat­ent a piece of the hu­man gen­ome, the Su­preme Court de­clared in a un­an­im­ous de­cision in June. So why, in the weeks after, did Myri­ad Ge­net­ics — the com­pany whose pat­ents were voided — sue a com­pet­it­or for pat­ent in­fringe­ment for test­ing for the very gene de­clared un­pat­entable by the Court?

Some back­ground: In the case, the As­so­ci­ation for Mo­lecu­lar Patho­logy brought suit against Myri­ad be­cause it thought it one com­pany shouldn’t have the sole rights to a seg­ment of the hu­man gen­ome — es­pe­cially when that seg­ment in­dic­ates a per­son’s breast-can­cer risk. The or­gan­iz­a­tion ar­gued that Myri­ad’s mono­poly of test­ing for the ma­lig­nant vari­ants of the BRCA1 and BRCA2 genes plugged up in­nov­a­tion in the sci­ence and drove up costs for pa­tients. Those with a cer­tain vari­ant of these genes have a 60 per­cent like­li­hood of de­vel­op­ing breast can­cer. If you re­call, the act­ress An­gelina Jolie dis­covered she was a car­ri­er for the gene, which promp­ted her to un­der­go a double mastec­tomy to void the risk.

The Su­preme Court largely agreed with the As­so­ci­ation for Mo­lecu­lar Patho­logy, de­clar­ing slices of the nat­ur­ally oc­cur­ring hu­man gen­ome un­fit for pat­ents. And right after the de­cision, two com­pan­ies — Ambry Ge­net­ics and Gene By Gene — saw an open­ing to start of­fer­ing the  breast-can­cer screen­ing tests that Myri­ad had been per­form­ing. And then Myri­ad sued … for pat­ent in­fringe­ment.

The short an­swer to how Myri­ad could jus­ti­fy its move is this: Sci­ence is so very com­plic­ated, and the Court ruled nar­rowly.

In its de­cision, the Su­preme Court main­tained that man-made cop­ies of hu­man DNA were still pat­entable. These pieces are called cDNA, which are slightly altered cop­ies of the nat­ur­ally oc­cur­ring genes. They are use­ful tools for ge­net­ic test­ing, since they can be used to re­lay a per­son’s ge­net­ic in­form­a­tion in a stable form. This bit of the rul­ing, in ef­fect, al­lows Myri­ad to still lay claim to much of the breast-can­cer test­ing.

Writ­ing in Sci­entif­ic Amer­ic­an, Megan Krench, a ge­net­i­cist, provides a more de­tailed an­swer (Read­er’s Di­gest ver­sion: While the Court took away Myri­ad’s castle, they left them the moat):

Why do Myri­ad’s pat­ent rights to cDNA mat­ter? There are sev­er­al reas­ons. First, cDNA is an im­port­ant re­search tool. For ex­ample, the ed­ited cDNA se­quence, not the longer DNA se­quence, is of­ten used to cre­ate an­im­al mod­els of dis­eases. Those mod­els are es­sen­tial for re­search­ing new treat­ments and cures. Without the li­cens­ing to BRCA1/2 cDNA, cer­tain can­cer re­search may be re­stric­ted to Myri­ad. Next, cDNA is crit­ic­al for de­vel­op­ing new dia­gnost­ic tests for ge­net­ic dis­orders. Since the BRCA1/2 genes them­selves are not pat­en­ted, it may be pos­sible for oth­er com­pan­ies to de­vel­op new ge­net­ic tests — but the pat­en­ted cDNA will make this pro­cess much more dif­fi­cult.

In all, after the Court’s de­cision, Myri­ad ar­gues in the doc­u­ments filed against Ambry, it has re­tained 515 of 520 pat­ent claims re­gard­ing the test.

This is­sue is go­ing to get an­oth­er go-around in the courts, as Ambry has coun­ter­sued, cit­ing an­ti­trust vi­ol­a­tions. A lot of money is at stake here for Myri­ad and its com­pet­it­ors. Ac­cord­ing to Ars Tech­nica, Myri­ad hauled in $57 mil­lion from the tests that can cost $3,000 or more. And the in­tro­duc­tion of com­pet­it­ors, however brief, pushed the mar­ket price way down: Ambry star­ted to sell the tests for $2,280; Gene by Gene offered a re­l­at­ive steal at $995. The ge­net­ic-test­ing in­dustry is on the verge of boom­ing, as I re­por­ted in June. By 2021, the na­tion­al costs for ge­net­ic test­ing could rise to $25 bil­lion. Right now, they are around $5 bil­lion.

What We're Following See More »
STAFF PICKS
When It Comes to Mining Asteroids, Technology Is Only the First Problem
14 hours ago
WHY WE CARE

Foreign Policy takes a look at the future of mining the estimated "100,000 near-Earth objects—including asteroids and comets—in the neighborhood of our planet. Some of these NEOs, as they’re called, are small. Others are substantial and potentially packed full of water and various important minerals, such as nickel, cobalt, and iron. One day, advocates believe, those objects will be tapped by variations on the equipment used in the coal mines of Kentucky or in the diamond mines of Africa. And for immense gain: According to industry experts, the contents of a single asteroid could be worth trillions of dollars." But the technology to get us there is only the first step. Experts say "a multinational body might emerge" to manage rights to NEOs, as well as a body of law, including an international court.

Source:
STAFF PICKS
Obama Reflects on His Economic Record
15 hours ago
WHY WE CARE

Not to be outdone by Jeffrey Goldberg's recent piece in The Atlantic about President Obama's foreign policy, the New York Times Magazine checks in with a longread on the president's economic legacy. In it, Obama is cognizant that the economic reality--73 straight months of growth--isn't matched by public perceptions. Some of that, he says, is due to a constant drumbeat from the right that "that denies any progress." But he also accepts some blame himself. “I mean, the truth of the matter is that if we had been able to more effectively communicate all the steps we had taken to the swing voter,” he said, “then we might have maintained a majority in the House or the Senate.”

Source:
STAFF PICKS
Reagan Families, Allies Lash Out at Will Ferrell
16 hours ago
WHY WE CARE

Ronald Reagan's children and political allies took to the media and Twitter this week to chide funnyman Will Ferrell for his plans to play a dementia-addled Reagan in his second term in a new comedy entitled Reagan. In an open letter, Reagan's daughter Patti Davis tells Ferrell, who's also a producer on the movie, “Perhaps for your comedy you would like to visit some dementia facilities. I have—I didn’t find anything comedic there, and my hope would be that if you’re a decent human being, you wouldn’t either.” Michael Reagan, the president's son, tweeted, "What an Outrag....Alzheimers is not joke...It kills..You should be ashamed all of you." And former Rep. Joe Walsh called it an example of "Hollywood taking a shot at conservatives again."

Source:
PEAK CONFIDENCE
Clinton No Longer Running Primary Ads
19 hours ago
WHY WE CARE

In a sign that she’s ready to put a longer-than-ex­pec­ted primary battle be­hind her, former Sec­ret­ary of State Hil­lary Clin­ton (D) is no longer go­ing on the air in up­com­ing primary states. “Team Clin­ton hasn’t spent a single cent in … Cali­for­nia, In­di­ana, Ken­tucky, Ore­gon and West Vir­gin­ia, while” Sen. Bernie Sanders’ (I-VT) “cam­paign has spent a little more than $1 mil­lion in those same states.” Meanwhile, Sen. Jeff Merkley (D-OR), Sanders’ "lone back­er in the Sen­ate, said the can­did­ate should end his pres­id­en­tial cam­paign if he’s los­ing to Hil­lary Clin­ton after the primary sea­son con­cludes in June, break­ing sharply with the can­did­ate who is vow­ing to take his in­sur­gent bid to the party con­ven­tion in Phil­adelphia.”

Source:
CITIZENS UNITED PT. 2?
Movie Based on ‘Clinton Cash’ to Debut at Cannes
20 hours ago
WHY WE CARE

The team behind the bestselling "Clinton Cash"—author Peter Schweizer and Breitbart's Stephen Bannon—is turning the book into a movie that will have its U.S. premiere just before the Democratic National Convention this summer. The film will get its global debut "next month in Cannes, France, during the Cannes Film Festival. (The movie is not a part of the festival, but will be shown at a screening arranged for distributors)." Bloomberg has a trailer up, pointing out that it's "less Ken Burns than Jerry Bruckheimer, featuring blood-drenched money, radical madrassas, and ominous footage of the Clintons."

Source:
×