[Ip-health] "Corporate takeover" (Boston Globe magazine piece on Myriad Genetics & testing for breast cancer)

[Alexander Tsai]

http://www.boston.com/globe/magazine/2002/0224_patent_part2.htm

Corporate takeover

Exploiting the US patent system, a single company has gained control over
genetic research and testing for breast cancer. And scientists, doctors, and
patients have to play by its rules.

By Kimberly Blanton, Globe Magazine Staff, 2/24/2002

Ferocious snow flies outside Myriad Genetics Inc.'s office, flush against
the Wasatch Range standing guard over Salt Lake City. A moose has wandered
down from the mountains and is loping through the parking lot. Inside the
nondescript brick building, a marvel of industrial medicine is taking place:
genetic tests that tell thousands of women each year whether they are among
an unlucky minority with a high risk of developing breast cancer.

Myriad became the dominant player in breast cancer testing after its
founder, Mark Skolnick, discovered a gene responsible for breast cancer in
September 1994. He and his team of scientists followed clues from big Mormon
families whose genealogical records dating to the pioneers are stored in
vaults carved into the granite of the Wasatch mountains. One family, tagged
"Kindred 2082," had 18 women with breast cancer, eight with ovarian cancer
(the same gene is linked to both diseases), and two with both cancers. After
decoding the gene, Myriad invested thousands of hours and millions of
dollars to design a test for mutations, nature's mistakes that can cause a
gene to malfunction and generate cancer cells.

Today, ordering a genetic test from Myriad is as easy as buying a book from
Amazon.com, and the tests are conducted with assembly-line precision. But
why would any woman want to know her genetic fate? Because for those women
born into families plagued by cancer, it can be better to know than to be
ignorant. If a woman tests positive for a mutation, she may take preventive
measures, such as a mastectomy. A negative result can ease a woman's fears.
"We know we're making a difference in people's lives," says Dr. Gregory
Critchfield, president of Myriad's laboratory division, during an interview
at the company's headquarters. "To me, it's one of the most exciting
businesses that anyone could ever hope to be in."

If the discovery of the breast cancer gene put Myriad on the map, United
States Patent 5,693,473 ensures its place there. Awarded on December 2,
1997, the patent grants Myriad broad rights to determine how the breast
cancer gene, named BRCA1, is used by other scientists or biotechnology
companies; to charge royalties for its use in research or development; and
even to bar its use entirely in any product. Another patent covers Myriad's
later discovery of a second breast cancer gene, BRCA2.

But while patents protect Myriad's investment in the genes and help the
company raise money for research, they also have enabled the company to
enforce a near-perfect monopoly on full sequencing, or chemical analysis, of
BRCA1 and BRCA2, genetic testing once scattered around the country in
university and medical school laboratories. By flexing monopoly rights not
tolerated in the manufacture of consumer products - anything from toasters
to lemon squeezers - Myriad is able to dictate terms under which academic
researchers may or may not perform their own tests on the company's patented
genes and sometimes even determine which projects they can pursue.
Physicians and geneticists say their academic freedom is being crimped by
the limits imposed on them by patents, with the toll ultimately falling on
the same women whom Myriad seeks to help.

The controversy swirling around Myriad's patents goes to a fundamental
question about all gene patents: Is there something wrong with a patent
system that allows one company - or any institution, for that matter - to
"own" the genetic material found in every human being?

While there is little interest in Congress for delving into patent
protections at the heart of the nation's free-enterprise system, geneticists
say that the urgency of this issue will only grow. Myriad and other
trailblazers have some 1,300 human-gene patents in force - there are often
multiple patents on a single gene - while other companies and universities
have been rushing to patent thousands of genes since the decoding two years
ago of the entire human genome, comprising some 30,000 to 40,000 genes. Some
corporations are seeking patents on genes numbering in the hundreds.

The gene-patent issue is also sending shudders through Europe's and Canada's
research communities, where Myriad is engaged in a heated legal fight to
ensure the same kind of patents on the breast cancer gene that it has
secured in this country. Geneticists in other countries view this as an
unwelcome invasion of US-style patent practices that shut out scientific
inquiry and lock them into endless legalities. "It doesn't seem that's
really what science is all about," says Douglas Easton, who runs the genetic
epidemiology unit for the University of Cambridge in England. "It would be
much better if what's basically a process of [gene] discovery - it's not
really a process of invention - could not be patented."

Dr. Allen Bale of the Yale University School of Medicine is in the prime of
his career. Five years ago, he discovered the "human patched" gene
responsible for hereditary basal cell carcinoma. Now 47 years old, he sees
patients with the rarest genetic disorders. He can pursue any question that
tickles his curiosity - or so he thought.

Bale's work on breast cancer genes, once a third of the research in his lab,
has been snuffed out by restrictions imposed by a licensing agreement
between Myriad and Yale. Myriad, empowered by patents that specify the
sequence, or ordering, of the four nucleotides present in BRCA1 and BRCA2,
licenses dozens of the nation's most prestigious teaching hospitals, medical
schools, and cancer clinics, including Yale's, to do their own, limited
genetic tests for known mutations. For example, the medical institutions are
permitted to screen for mutations common in Ashkenazi Jewish women. But the
licenses do not allow university faculty to perform full-blown genetic
sequencing tests for patients - the kind of tests that Bale was doing in the
lab for his own research.

To keep from violating Myriad's patent, Bale was forced to withdraw from one
ambitious project to study women with early-stage breast cancer. Bale and
Dr. Elizabeth Claus, also at Yale, had submitted a grant proposal in May
1997 to the National Institutes of Health to study whether this sub-group
carried BRCA1/2 mutations. Months later, Yale signed a licensing agreement
with Myriad for testing patients at the Yale Cancer Center that effectively
barred Bale from participating in his own study.

Claus has begun the five-year study without him. Rather than have Bale do
the sequencing, she sends her research subjects' samples to Myriad's lab in
Utah. Myriad, says Bale, referring to a folder with meticulous notes of each
conversation with executives, "made it really clear nobody but Myriad can do
sequencing."

Sitting in his office, piled high with medical-journal articles, Bale is
comfortable in well-worn blue khakis and beat-up tennis shoes. But patents
and licensing agreements make him tense. He seems incredulous of the need to
bother with patents at all; it's as though an alien landed in his lab, and
he must figure out how to communicate with it. To be fair, Bale says, when
he talks with Myriad executives about how the patents are encroaching on his
research, the executives don't seem to understand where he's coming from
either.

Indeed, Myriad's Critchfield roundly denies that the company interferes with
research. On the contrary. He insists that the company promotes research by
making its genetic test available to all and by slashing the test fee for
academics doing NIH-funded research. NIH researchers paid $1,200 last year
for a test that costs patients $2,680. "We've actually collaborated and
stimulated research to a great degree," Critchfield says.

That may be true, but research that crosses the line into commercial use
violates Myriad's patents. And Myriad defines what is commercial: According
to a copy of an agreement provided to the Globe by one university - not
Yale - researchers are permitted to sequence BRCA1/2 "provided that no fee
is charged for such tests" and "no direct clinical use shall be made of any
research test results." Critchfield explains, "If you give test results back
to patients, it crosses over the line, and it's no longer a simple research
test." That, he says, "is really a very bright line."

For geneticists like Bale, that is also a straitjacket. It is difficult to
enlist patients for blind studies in which test results are not disclosed.
Even if patients can be recruited that way, a study might be biased if the
most desirable subjects are discouraged from taking part: women in families
with a high incidence of breast cancer. Bale charged patients for the test.

Bale could certainly send his research samples to Myriad. But that misses
the point. He prefers his own sequencing techniques. And there's much still
to learn about breast cancer genes, which are unusually large and complex.
For example, Bale is interested in tackling whether he can find a way to
sequence sections of the gene not yet sequenced, "the intermolecular glue
that connects the bits of coding."

But Myriad's patents stand in the way. Beyond that, to researchers like
Bale, they seem to mock science. A cure, a discovery, a breakthrough - all
come through painstaking research in the lab and accretion of results,
sometimes apparently insignificant, and even failures. Losing his share of
NIH funding for the project with Claus "had a major financial impact on our
lab," he says. What's worse, gene patents have "a chilling effect on the
work we do," says Bale, who was inspired to become a scientist by a
10th-grade biology teacher in Springfield, Massachusetts. "There are things
I won't even think about doing anymore, because I don't want to get involved
in patent issues." Pushed to explain how he feels, the unsentimental Bale
says, "It's making me feel disappointed about what the life of a scientist
is like now."

With genes now deemed "property," Bale and his collaborators on the skin
cancer discovery have no choice but to seek a patent of their own. But their
motivation, he says, is far different from Myriad's profit motive: The
patent is "purely a defensive move," to preempt a company from patenting the
gene and profiting from his discovery.

Throughout the genetics world, attention to patents is increasingly
competing with attention to science. Michael Watson, executive director of
the American College of Medical Genetics in Maryland, which has come out
against gene patents, says university labs must relinquish samples to a
company with a patent that can profit from the information contained in
them. "If you can't do the test," he says, "someone else does it and gets to
use clinical information you've accumulated over decades."

There are practical concerns, too, when patent holders bar teaching
hospitals from genetic testing. Medical residents don't learn the procedure
and don't understand the genetics that underlie it, says Dr. Debra Leonard,
who directs the molecular pathology lab at the University of Pennsylvania in
Philadelphia. She says her work is repeatedly frustrated by a deluge of
corporate letters concerning patents on genes involved in Alzheimer's
disease; cystic fibrosis; a neurodegenerative disease called spinocerebellar
ataxia type 1; hemochromatosis, an iron-overload disorder; Canavan, a rare
brain disease that afflicts children; and others.

"You have no idea how long I studied to be able to do this," says Leonard,
who is in her mid-40s. "Imagine a lawyer who is told: You can't have any
clients who have had car accidents. That part of your practice is carved
out. I am being told I can't practice part of my medical profession - that
it's owned by somebody else."

Sharon calls herself "a member of the shot-and-missed club." She survived
cancer in her left breast 30 years ago, only to have it reappear in her
right breast a decade later. But ovarian cancer in 1990 was the worst,
ravaging her hope as the chemotherapy weakened her hands and feet and caused
double vision. After a hysterectomy, an oophorectomy to remove her ovaries,
and chemotherapy, she returned to the hospital for a second surgery to
determine whether the ovarian cancer had been excised. She waited three days
for the results. "Those were the longest three days of my life," Sharon, now
60, recalls. "I really didn't want to go through a lot more."

During all those years that Sharon endured illness, long before there were
genetic tests, she believed her cancers were hereditary. Both her
grandmother and older sister died of ovarian cancer, and her younger sister
survived breast cancer. A well-to-do resident of Southern California with
glittering sapphires on each hand, Sharon would do anything in her power to
help her only child, Julie, avoid the family's cruel fate. At a restaurant
in downtown Los Angeles, Sharon and her daughter agree to tell their story
if their last names are withheld.

Julie was a young adult living in Washington, D.C., in the early 1990s when
the race to find the breast cancer gene was in full swing. She recalls being
mesmerized by a magazine cover, its headline glaring up at her from a coffee
table: "Is Breast Cancer Genetic?" It was an urgent personal question.

To help her daughter, several years later Sharon went to the Cedars-Sinai
Medical Center in Los Angeles. Dr. Maren Scheuner counseled her and ordered
Myriad's BRCA1/2 test for her. The doctor explained that since Sharon had
already had cancer, it made more sense for her to be tested first. If a
mutation of BRCA1/2 were detected in Sharon, a second test on her daughter
would then determine whether Sharon had passed the mutation on. Sharon's
test, Myriad reported back, was negative.

Sharon wanted to be happy about the results, but "I didn't believe it." Nor
did Scheuner. A physician with extensive training in genetics - she was a
genetics major in college and earned a master's degree in genetic counseling
prior to medical school - she knew that Sharon's result didn't square with
the family's prevalent cancers.

Meanwhile, Julie's cancer clock ticked, making her feel like "a walking time
bomb." It is hard to fathom the dark avenues of Julie's reasoning as she
explains that her mother's negative test result was worse than a positive,
which would have given her the information she needed to make difficult
decisions to have her breasts and ovaries removed. "I was left with no
direction," she says.

Scheuner, who created Cedars-Sinai's genetic risk assessment program, was
determined to figure things out. "That is where the art of practicing
medicine and being a clinical geneticist is," she says. "Knowing when you
need to go that one step further and say, this family history is too
striking, and, statistically, I'm very concerned there's something there. I
haven't found it yet."

Hope came at a genetics conference on the West Coast, where Scheuner heard
researchers from the Institut Curie in Paris present a paper about a
technique for finding rare mutations, known as "big deletions," in French
women. Scheuner approached Curie's researcher at the conference. Intrigued
by Sharon's case, the French researcher agreed to test Sharon's DNA.

Less than 10 percent of breast cancer is hereditary, with the vast majority
of mutations in BRCA1/2 genes being small, or point, mutations, errors in
gene coding. A slim percentage of mutations are "big deletions." These are
actual missing pieces of DNA that can also cause the gene to malfunction and
cause cancer. Myriad's test was not designed to detect big deletions.

Scheuner, encouraged by Myriad, mailed Sharon's blood to Paris. The test
came back positive. At the time, the finding was so unusual that Sharon's
case was published in the Journal of Medical Genetics. Next, Institut Curie
tested Julie. It was genetic roulette, a 50-50 chance she carried her
mother's mutation. Again, it was positive. "With a positive test result,"
Julie recalls, "I felt like, all right, I know what I'm going to go do."

With so few US academic labs performing breast cancer tests for patients,
it's not surprising that Sharon and Julie had to go all the way to Paris for
answers, says Leonard at the University of Pennsylvania. To be fair,
geneticists only recently have begun to understand the role of big deletions
in breast cancer and to tackle the technology for finding them. But, Leonard
says, "It took a long time for the deletion issue to come up. Maybe it
would've come up sooner if more academic labs had been doing this research."

Last summer, as Julie turned 31, she had a double mastectomy to prevent what
was, to her, inevitable cancer. Julie was unconsolable when she awoke from
surgery, with her husband and parents hovering close. But it would have been
even more difficult to have had that mastectomy without the proof of cancer
in her genes, she says. If not for the French test, "I don't know what I
would've done."

The cancer time bomb Julie spoke of continues to tick for her and her
offspring. She wants children but must become pregnant soon, before she has
her ovaries removed. There's a chance she will pass the genetic defect to
her children. "One of my major questions is `What do I do when I have
children? How do I get them tested?' "

Myriad Genetics, having locked down US patent rights on BRCA1/2, is seeking
to do the same at the European Union's patent office. It is not going as
smoothly as it did in the United States. European and Canadian medical
institutions and government health ministries are battling to block Myriad.
Institut Curie's attorneys, arguing that Myriad could have testing halted at
the same lab that performed Sharon's and Julie's tests, filed a formal
opposition to Myriad's patent application in Europe. "Monopoly is not good
for genetic testing," says Dr. Dominique Stoppa-Lyonnet, a member of
Institut Curie's faculty, "because the commercial interests are stronger
than the quality interests."

Myriad's dominance over breast cancer gene testing for patients has stifled
debate of the merits or shortcomings of patents in some corners of the
medical community. Medical staff at numerous university hospitals and
nonprofit research centers declined interview requests, including Memorial
Sloan-Kettering Cancer Center in New York and the Dana-Farber Cancer
Institute in Boston. Even the National Institutes of Health had to be
reminded numerous times that it is part of the US Department of Health and
Human Services before officials agreed to explain NIH's agreement with
Myriad for cut-rate testing for NIH-funded research.

There are reasons for the reticence. These institutions' licensing
agreements with Myriad are, like most business documents, confidential. And
some breast cancer experts, who pride themselves on their independence, may
not be eager to discuss their relationship to a company whose patents hinder
work in their field. But the main reason for the silence is that Myriad, as
sole purveyor of BRCA1/2 sequencing for patients, holds power over the
doctors relying on it for their livelihood. As Michael Watson of the
American College of Medical Genetics puts it, "Without them, you can't
legally test."

Myriad also uses its unique position to court physicians with gold-plated
reputations. Barbara Weber, a physician at the University of Pennsylvania
Health System and head of breast cancer genomics at the university, has an
ongoing relationship with Myriad. In the past, she has worked as a paid,
outside consultant to the company and even owned Myriad stock. Today, she's
involved in a research collaboration with Myriad.

Weber was the exception to those who declined interviews, and her openness
about ties to Myriad - past and present - was refreshing. During an
interview in her airy office high above the UPenn campus, she explains that
she severed her consulting arrangement "so that I can say what I want
without tainting myself internally about these things." She sold the stock
for the same reason. Weber also feels free to criticize Myriad at one point
during the interview, remarking on a "nasty" letter that UPenn once received
from a company attorney.

At other times, she sounds like a Myriad cheerleader. Weber feels strongly
that the company's US patent "has not in any way affected people's ability
to get tested." While it is true that Myriad has the only clinical test, it
is also "the only lab that's had the resources to really do this right.
We've been very impressed with their accuracy, turnaround time, and response
to our questions."

The goal of her research collaboration with Myriad is to develop a new
genetic technique that the company can commercialize to test for those rare
big deletions. Her reputation among breast cancer geneticists is
well-established: Weber was among those involved in the early-1990s race to
find a breast cancer gene. If she can design a test for big deletions -
others are working on the same problem for Myriad - the company would have a
follow-up test to offer high-risk patients, like Sharon and her daughter,
who test negative on its sequencing test. Weber is "very much on the case
and a very important collaborator," says Dr. Thomas Frank, vice president of
medical services for Myriad.

Weber receives no money from Myriad for this work. But Myriad has saved her
valuable lab time by cloning and sequencing reagents she needed to develop
her technique. Myriad also handed over anonymous patients' samples and
records to her.

Collaborations with industry are hardly unusual in academia. In fiscal 2000,
UPenn's Center for Technology Transfer, on behalf of faculty, entered into
82 agreements with companies for product development. Nationwide, some 4,000
such collaborations between industry and academia were signed in 1999, the
most recent figures available.

If Weber's test works, and if Myriad commercializes it, her share of
royalties, she says, "wouldn't be very much money." She's unsure whether she
would accept royalties anyway. "Would it be worth it to go through the
hassle of trying to get royalties? I don't know. Maybe not." But if she
does, she will disclose it. "Everybody will know, every time I give a talk,
that I have this relationship where I get royalties for the test from
Myriad."

If not money, then what is in it for Weber? "What's in it for me," she says,
"is figuring out if we can make the test work, and can we find genomic
deletions this way."

While Weber is on Myriad's "A team," Margaret Reece isn't even in the game.
Reece works in a cramped basement lab at Baystate Medical Center in
Springfield with peeling paint, old equipment, and a small $200,000 annual
budget. But four years ago, that didn't prevent Reece from stumbling onto
something exciting.

A jolly soul with a passion for immunohistochemistry - a technique of
studying the proteins generated by genes - she was helping a graduate
student find a quick and dirty way to screen for BRCA mutations. She knew
from the literature that "tails" on BRCA proteins are cut off in genes with
mutations. Through nifty detective work and late nights, her group figured
out a way to swab DNA from buccal cells in the mouth and then test for the
presence of a tail.

Her technique, though not as thorough as Myriad's sequencing test, was
easier and cheaper - breast cancer's equivalent to a Pap smear, which is
essentially an initial screen for cervical cancer that may lead to follow-up
tests. But was Reece's technique reliable? First, she swabbed the mouths of
people hanging around the lab. All negatives, as expected; none had a family
history of breast cancer. She also tried it out on a small group of Baystate
patients who were also undergoing Myriad's sequencing test. The Q-tip test's
results matched Myriad's, except for one "oddball."

Excitement rumbled through the lab over the remarkable results. But Reece
realized that, without further verification, it would likely wind up in "the
journal of nonreproducible results." Lab technician Lorrie Adams, who worked
alongside Reece, explains: "We don't let ourselves get excited until we're
really, really sure, so we do it over and over and over. It was exciting to
realize it actually worked, and it could be significant for women."

In breast cancer genetics, many roads lead to Myriad, as Reece discovered.
To validate her new buccal-cell screens and win federal approval to take it
into clinics, it must be compared in rigorous experiments with Myriad's
"gold-standard clinical test." When she does go to Myriad, could the company
conceivably refuse to help her, a potential competitor, perfect her product?
"There is no way Myriad would be able to refuse doing tests for patients,"
Reece insists. "No way."

A Myriad spokesman declined to discuss the legal matter.

Myriad's patent, on the other hand, could be a roadblock. Baystate has
obtained a US patent on Reece's buccal-cell technique. But the two patents,
Baystate's and Myriad's, may be on a legal collision course. Baystate's
attorneys have written Myriad, saying that her screen does not infringe on
its BRCA patents, Reece says. But, she speculates, "if anything salable came
out of my research, Myriad might try to say they owned the salable part of
it."

Reece worries more about the overall impact of patents on science than on
her own situation. Myriad's patent, for example, covers not only genetic
mutations and testing technology but also therapies based on the breast
cancer gene. "As an academic, I am concerned about it," Reece says. "It's
not just Myriad. Everybody's out patenting genes, and my concern is we're
going to have everything so locked up in intellectual property rights that
nobody's going to be able to do anything, or if they do anything, they're
not going to be able to use it."

In March 2000, theatergoers heading to the red velvet seats in the John F.
Kennedy Center for the Performing Arts in Washington were handed a Playbill
for the upcoming performance of Wit. It starred Judith Light as Vivian
Bearing, PhD, an eminent and lonely poetry scholar who has ovarian cancer.
As disease consumes her, professor Bearing's biting British wit prevents
her - and the play - from plunging into despair.

Tucked into the Playbill was an advertisment for Myriad Genetics Inc. It
pictured an earnest woman with her left hand held against her right breast
and asked: "If you could discover your risk for a second breast cancer or
for ovarian cancer, would you? There is no stronger antidote to fear than
information."

Today, as then, the company wants to sell more tests. The Playbill ad was a
rare appeal directly to women. Myriad mainly relies on a US sales force
visiting hospitals and clinics and educating and selling gynecologists,
oncologists, and primary care physicians on the test. Myriad tests some
10,000 women each year. The potential market could be nearly double that:
Last year, about 200,000 women were diagnosed with breast cancer; up to
20,000 of those cases were hereditary.

Each blood sample mailed to Myriad's lab by doctors for their breast cancer
or ovarian cancer patients brings in more than just a fee. Each sample adds
to Myriad's databank of DNA and patient profiles. Myriad posts the varieties
of mutations publicly on the Internet for researchers. These data are also
scrutinized by Myriad.

Thomas Frank, whose medical degree is from Washington University in St.
Louis, is Myriad's liaison with doctors who order tests. He is devoted to
getting to the bottom of a puzzling test result found in some women. Some
mutations are known to be harmful and cause cancer. Others are innocuous
alterations in a BRCA sequence that don't lead to breast cancer. And then
there are the puzzles; not enough is known about these mutations to
determine whether or not they do cause cancer.

As samples with similar, unknown mutations come in, Myriad can compare those
patients' family histories and build a case to determine whether they are
linked to cancer. Frank has shrunk the unknowns, from 20 percent of all
mutations detected in 1998 to 12 percent. His "personal goal" this year is
to get below 10 percent.

Diagnostic tests are only the first step for genetic medicine. Geneticists
and biotechnology executives, including Frank, speak of an exciting future
in which medicine increasingly revolves around using new drugs and
therapeutics that treat a disease, such as cancer, based on the disease's
genetics. For breast cancer, for example, scientists hope to target the
proteins generated by a gene, altering the protein in a way that interferes
with the creation of cancer cells. They also envision drugs tailored to the
unique genetic characteristics of an individual patient.

Genetic-based drugs may be years in the future for breast cancer, but the
research has already begun at Myriad, which is interested, for example, in
how BRCA interacts with other genes in the body to cause a breast cancer
tumor. It's also pursuing drug targets involving genetic mechanisms for cell
division that may be responsible for various cancers. Tumors, Frank
explains, may look the same under the microscope but might not have the same
genetic origin. "We may find that drugs will act differently, or better, or
worse in hereditary cancers," he says, "but unless we know the underlying
biology, we can't treat the cancer."

Where Frank envisions medical advances, others see a wall of gene patents.
Myriad's patents on BRCA2, according to its US Patent and Trademark Office
filing, cover "the therapy of human cancers which have a mutation in the
BRCA2 gene, including gene therapy, protein replacement therapy and protein
mimetics." For therapies relying on BRCA1, Myriad sold those rights to
Indianapolis-based Eli Lilly and Co. but retained rights for sequencing
BRCA1.

Will these companies or others use their gene patents to monopolize the
market for genetic therapies or cures? Will they deem some therapies
unprofitable and unworthy of pursuit? Will some university researcher who
spent a lifetime seeking a cure for breast cancer be thwarted by a patent
dispute with Myriad? Or will another avoid pursuing breast cancer research
at all?

"To even look at any part of the breast cancer gene, you have to pay
Myriad," says Lori B. Andrews, an expert on gene patents at the Chicago-Kent
College of Law at Illinois Institute of Technology. "Myriad can say, `Don't
look at that, because we're thinking of looking at it.' Or maybe Myriad
isn't looking at it because it won't affect many people."

It's too early to know how gene patents will play out. What is known about
the breast cancer genes, Andrews says, is that Myriad's patents put the
company squarely in the driver's seat.