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.

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