Aus­tralian High Court rules patent on can­cer gene in­valid


An Aus­tralian can­cer sur­vivor Wed­nes­day tri­umphed in a land­mark chal­lenge against biotech com­pa­nies, with the coun­try’s top court rul­ing they could not patent a gene linked to breast can­cer.

Yvonne D’Arcy took her case to the High Court of Aus­tralia, ar­gu­ing that the so-called breast can­cer gene BRCA1 — the mu­ta­tion fa­mously car­ried by Hol­ly­wood star An­gelina Jolie — was a nat­u­rally oc­cur­ring sub­stance.

Breast can­cer is the lead­ing can­cer killer of women aged 20-59 world­wide, and sup­port­ers of the case had ar­gued that patent­ing a gene could stymie med­i­cal re­search and test­ing.

“I screamed. I was just ex­cited to know that we had it seven-nil our way,” an ec­static D’Arcy, a 69-year-old breast can­cer sur­vivor, said of the court’s unan­i­mous de­ci­sion.

“For all those peo­ple who do have the ge­netic foot­print for breast can­cer, ovar­ian can­cer, any can­cer ba­si­cally, it’s a win for them be­cause they are fore­warned,” she said, adding that she ex­pected test­ing would be­come cheaper and more avail­able.

The High Court found that while iso­lat­ing the gene re­quired hu­man ac­tiv­ity, that was not enough to clas­sify it as a man­u­fac­tured prod­uct and so make it patentable.

“While the in­ven­tion claimed might be, in a for­mal sense, a prod­uct of hu­man ac­tion, it was the ex­is­tence of the in­for­ma­tion stored in the rel­e­vant se­quences that was an es­sen­tial el­e­ment of the in­ven­tion,” the judges said.

D’Arcy’s case was pre­vi­ously dis­missed by Aus­tralia’s Fed­eral Court, which ruled in fa­vor of the two med­i­cal re­search com­pa­nies that hold the patent — U.S.-based Myr­iad Ge­net­ics and Mel­bournebased Ge­netic Tech­nolo­gies Ltd.

But the High Court agreed in Fe­bru­ary to hear an ap­peal and Darcy con­ceded that tak­ing on the U.S. cor­po­ra­tion had ap­peared an un­even con­test.

“It was a David and test,” she ad­mit­ted.

“I’m only a lit­tle per­son — but it’s not the size of the dog in the fight, it’s the size of the fight in the dog.”

The ar­gu­ments used in the Aus­tralian case were sim­i­lar to those ap­plied in the United States, where the Supreme Court ruled in 2013 that the iso­la­tion of BRCA1 it­self was not enough to ren­der genes patentable.

Ex­perts said the Aus­tralian de­ci­sion could im­pact ac­cess to ge­netic test­ing, med­i­cal re­search and treat­ments in the coun­try.


“We have been wait­ing al­most 30 years for a de­ci­sion of this na­ture, on the is­sue of whether iso­lated DNA se­quences are patentable sub­ject mat­ter,” said Dianne Ni­col, di­rec­tor of the Cen­tre for Law and Ge­net­ics at the Univer­sity of Tas­ma­nia.

Car­ri­ers of the BRCA1 mu­ta­tion, in which the BRCA stands for BReast CAn­cer sus­cep­ti­bil­ity, have a much higher risk of de­vel­op­ing breast and ovar­ian can­cer than those women with­out it.

Breast can­cer claims some 458,000 lives ev­ery year, with around 1.38 mil­lion new cases recorded an­nu­ally, ac­cord­ing to the U.N.’s World Health Or­ga­ni­za­tion.

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