In the courts: What Myriad means for biotech

• Author: Emma Barraclough
• Position: Group Editor, Managing Intellectual Property
• Pages: 21-23

WIPO | MAGAZINE IN THE COU RTS | p. 21

What Myriad means

FOR BIOTECH By Emma Barraclough,

Group Editor,

Managing Intellectual Property

Who owns your genes? Do you own them if they are i nside

your body, but someone else can own them i f they have been

removed? Are isolated human gene s man-made, patentable

inventions or unpatentable products of nature? The se were

the issues before the nine justi ces of America’s highest court

in Assoc iation for Molecular Pathology v Myriad Genetic s

earlier this year.

The story of Myriad begins almost 20 ye ars ago, when Salt Lake

City-based Myriad Genetics announced it had sequenced the

BR CA1 gene, a mutation that can lead to breast and ovarian

cancer. Two years later, the team published th e sequence for

another gene correlated wi th hereditary breast and ovaria n

cancer: BRCA2. It obtained patents on both genes. Its discov-

eries were lucrative: in 1996 it began sell ing the rst molecular

diagnostic test for these heredi tary cancers at a cost of around

US$3,000 per patient.

Fast-forward to 2009 and the company found itsel f (along

with the Trustees of the University of Utah) sued by a group of

human rights campaigners and patients’ rights activists. The

plaintiffs, who includ ed the Public Patent Foundation (PUBPAT),

the American Civil L iberties Union (ACLU) and Breast Cancer

Action, challenged clai ms in seven of Myriad’s BRCA patents.

Although thousands of ge nes are patented in the US, PUB-

PAT attorney Dan Ravicher says the groups targeted Myriad

because of the company’s reluctance to licen se its patents

to competitors.

The plaintiffs prevai led at rst instance, when a New York judge

held that DNA is unpatentable subj ect matter. A quirk of timing

saw the Federal Circuit for the Cou rt of Appeals consider the

dispute twice: once before and on ce after the Supreme Court

ruled in another highly-antic ipated biotech case – Prometheus v

Mayo – that Prometheus’s diagnostic method patents were in-

valid. (See US cour ts grapple with patent-eligible subject matter

– www.wipo.int/wipo_magazine/en/2012/06_article_0006.html).

By the time the Myriad case wound i ts way up to the Supreme

Court, it had attracted almo st 50 amicus briefs, from associa-

tions of IP lawyers and biotech re searchers to venture capital-

ists and concerned ci tizens. The interest the case provoked

is unsurprising cons idering both the issues before the Cour t

Key biotech cases

Judges and patent oce ocia ls on both sides of the Atlantic

have decided a series of hig h-prole gene-related disput es.

Here are some of the most import ant.

Diamond v Chakrabarty

In 1980, the Supreme Cour t of the United States ruled t hat

a micro-organ ism that had been genetical ly modied for

use in cleani ng oil spills was patent able on the grounds

that it did not constit ute a “product of nature”. e Court

set an importa nt precedent in the area of patentabil ity

by rulin g: “e laws of nature, physic al phenomena, and

abstract ideas h ave been held not patentable. us, a new

mineral di scovered in the earth or a new pla nt found in the

wild is not patenta ble subject matter … Such discoveries a re

‘manifestat ions of . . . nature, free to al l men and reserved

exclusively to none’.” e decision was a close-r un thing,

however: four justic es dissented, a portent of lit igation to

come.

Harvard Oncomouse

In 1984, the Europea n Patent Oce (EPO) received its

rst application for a pat ent of an animal: the genet ically

modied Har vard Oncomouse. Eight yea rs later it granted

a patent to the Harv ard University researchers i nvolved,

a move opposed by an ar ray of political partie s, religious

groups and envi ronmental activis ts. e EPO ultimately

upheld the patent in 200 4 but ruled that it should relate to

transgenic m ice only, rather than all rodent s.

Prometheus L aboratories, Inc v Mayo

Collaborative Services

In March 2012, the Supreme Cou rt ruled that Promet heus’

patent claims relat ed to ways of optimizin g doses of certain

drugs use d to treat specic conditions were i nvalid because

they relate to a natu ral phenomenon. e eect of the

decision was to mak e it harder for developers of genetic tests

to obtain patent protec tion.

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