Menus Subscribe Search

Follow us


Breast Cancer Court Case Pits Patients’ Genes vs. Gene Patents

• April 07, 2011 • 11:23 AM

A court case surrounding gene patents for high-risk forms of breast cancer puts two viewpoints of “products of nature” on the stand.

The United States Court of Appeals for the Federal Circuit heard a case earlier this week involving a fine point of patent law with major implications for public health and science: Can individual human genes be patented by private companies?

The United States Patent and Trademark Office has, in fact, been saying yes for years. According to one 2005 study published by the journal Science, gene patents for 20 percent of the human genome — or more than 4,000 genes — have been created, despite court precedent that says no one can own the “products of nature.”

This particular case, brought by the American Civil Liberties Union and the Public Patent Foundation on behalf of several cancer patients and scientific organizations, revolves around a pair of genes associated with an elevated risk of breast and cervical cancer. The genes BRCA1 and BRCA2 have been patented by the private firm Myriad Genetics, making it the only company that can test and diagnose women for the mutation (at a cost of a few thousand dollars).

“Everybody that we’ve talked to — and we’ve all talked to doctors and told them about this case — everybody’s shocked to know that this DNA is patented,” said Sabrina Hassan, senior counsel for Public Patent.

Last March, a federal court in New York agreed that genes shouldn’t be patented. And then in the fall, the federal government surprisingly filed a friend-of-the-court brief agreeing with the cancer patients and the district judge in Myriad’s appeal. Neal Katyal, the U.S. acting solicitor general, argued in court alongside the ACLU’s lawyers on Monday, effectively opposing the government’s own longstanding policy on the question.

[class name="dont_print_this"]

Idea Lobby

THE IDEA LOBBY
Miller-McCune's Washington correspondent Emily Badger follows the ideas informing, explaining and influencing government, from the local think tank circuit to academic research that shapes D.C. policy from afar.

[/class] That move looks like a “change of heart” on the government’s part, said Aaron Kesselheim, an assistant professor of medicine at Harvard Medical School. He and colleague Michelle Mello wrote about the case in the New England Journal of Medicine last May, tracking a historical context in U.S. gene patent policy that now appears to be shifting.

“It is significant,” Kesselheim said, “that the government has come out on the plaintiffs’ side on this case and said this probably is not what the Patent Act was meant to cover.”

While the human genome is obviously a product of nature, the patent office has long approved applications by companies for the work of isolating individual genes. Myriad holds patents both on the isolated BRCA1 and BRCA2 and on the process it uses to compare those genes when diagnosing women for the risk.

The lawsuit rests largely on the question of whether merely isolating something in nature should make it patentable — and the court’s ultimate answer would affect not just these two genes but the notion that any DNA is patentable.

“If a surgeon cuts me open and slices out my kidney and takes it out and holds it in his hand, it’s an ‘isolated’ kidney, but it’s still a kidney,” argued ACLU lawyer Chris Hansen in court on Monday. “It’s not an invention.”

The ACLU has also argued that patenting the process of comparing DNA, as Myriad does in its diagnostic tests, is akin to patenting thought.

Myriad counters that gene patents are essential to luring the investment money needed to conduct the research that isolates such DNA in the first place, allowing for the development of advances in personal medicine that benefit society as a whole.

Both parties are, in a sense, arguing that their positions benefit patients. And this touches on the other big question raised by the case: Does society stand to gain more when patents encourage financial investment in scientific innovation or when public ownership of genes spurs wider research and cheaper diagnostic tools?

Kesselheim pointed to one recent study that has tried to answer this question. Economist Heidi Williams compared gene sequencing by the public Human Genome Project with the private firm Celera to determine whether intellectual property rights really spurred innovation. She found that assigning intellectual property to genes sequenced by Celera led to less future research and product development than did the public effort.

If the appeals court upholds the earlier decision in the BRCA case — a substantial break in policy for gene patenting, Kesselheim said, but a narrow one that would not extend to other naturally occurring substances like proteins — Kesselheim predicts society won’t lose out on important basic research. After all, much of the work in this area (including research that led to the genes Myriad ultimately patented) is supported by the government.

But this is a separate policy issue.

“The government is funding this initial research, and on the other hand, patients are paying extremely high costs for the output of the research,” Kesselheim said. “That means patients are paying twice — once in their taxes and once out of their pocket — for the same output.”

Sign up for the free Miller-McCune.com e-newsletter.

“Like” Miller-McCune on Facebook.

Follow Miller-McCune on Twitter.

Add Miller-McCune.com news to your site.

Subscribe to Miller-McCune

Emily Badger
Emily Badger is a freelance writer living in the Washington, D.C. area who has contributed to The New York Times, International Herald Tribune and The Christian Science Monitor. She previously covered college sports for the Orlando Sentinel and lived and reported in France.

More From Emily Badger

A weekly roundup of the best of Pacific Standard and PSmag.com, delivered straight to your inbox.

Recent Posts

October 24 • 12:00 PM

What Makes You So Smart, Middle School Math Teacher?

Noah Davis talks to Vern Williams about what makes middle school—yes, middle school—so great.


October 24 • 10:00 AM

Why DNA Is One of Humanity’s Greatest Inventions

How we’ve co-opted our genetic material to change our world.


October 24 • 8:00 AM

What Do Clowns Think of Clowns?

Three major players weigh in on the current state of the clown.


October 24 • 7:13 AM

There Is No Surge in Illegal Immigration

The overall rate of illegal immigration has actually decreased significantly in the last 10 years. The time is ripe for immigration reform.


October 24 • 6:15 AM

Politicians Really Aren’t Better Decision Makers

Politicians took part in a classic choice experiment but failed to do better than the rest of us.


October 24 • 5:00 AM

Why We Gossip: It’s Really All About Ourselves

New research from the Netherlands finds stories we hear about others help us determine how we’re doing.


October 24 • 2:00 AM

Congratulations, Your City Is Dying!

Don’t take population numbers at face value.


October 23 • 4:00 PM

Of Course Marijuana Addiction Exists

The polarized legalization debate leads to exaggerated claims and denials about pot’s potential harms. The truth lies somewhere in between.


October 23 • 2:00 PM

American Companies Are Getting Way Too Cozy With the National Security Agency

Newly released documents describe “contractual relationships” between the NSA and U.S. companies, as well as undercover operatives.


October 23 • 12:00 PM

The Man Who’s Quantifying New York City

Noah Davis talks to the proprietor of I Quant NY. His methodology: a little something called “addition.”


October 23 • 11:02 AM

Earliest High-Altitude Settlements Found in Peru

Discovery suggests humans adapted to high altitude faster than previously thought.


October 23 • 10:00 AM

The Psychology of Bribery and Corruption

An FBI agent offered up confidential information about a political operative’s enemy in exchange for cash—and they both got caught. What were they thinking?


October 23 • 8:00 AM

Ebola News Gives Me a Guilty Thrill. Am I Crazy?

What it means to feel a little excited about the prospect of a horrific event.


October 23 • 7:04 AM

Why Don’t Men Read Romance Novels?

A lot of men just don’t read fiction, and if they do, structural misogyny drives them away from the genre.


October 23 • 6:00 AM

Why Do Americans Pray?

It depends on how you ask.


October 23 • 4:00 AM

Musicians Are Better Multitaskers

New research from Canada finds trained musicians more efficiently switch from one mental task to another.


October 22 • 4:00 PM

The Last Thing the Women’s Movement Needs Is a Heroic Male Takeover

Is the United Nations’ #HeForShe campaign helping feminism?


October 22 • 2:00 PM

Turning Public Education Into Private Profits

Baker Mitchell is a politically connected North Carolina businessman who celebrates the power of the free market. Every year, millions of public education dollars flow through Mitchell’s chain of four non-profit charter schools to for-profit companies he controls.


October 22 • 12:00 PM

Will the End of a Tax Loophole Kill Off Irish Business and Force Google and Apple to Pay Up?

U.S. technology giants have constructed international offices in Dublin in order to take advantage of favorable tax policies that are now changing. But Ireland might have enough other draws to keep them there even when costs climb.


October 22 • 10:00 AM

Veterans in the Ivory Tower

Why there aren’t enough veterans at America’s top schools—and what some people are trying to do to change that.


October 22 • 8:00 AM

Our Language Prejudices Don’t Make No Sense

We should embrace the fact that there’s no single recipe for English. Making fun of people for replacing “ask” with “aks,” or for frequently using double negatives just makes you look like the unsophisticated one.


October 22 • 7:04 AM

My Politicians Are Better Looking Than Yours

A new study finds we judge the cover by the book—or at least the party.


October 22 • 6:00 AM

How We Form Our Routines

Whether it’s a morning cup of coffee or a glass of warm milk before bed, we all have our habitual processions. The way they become engrained, though, varies from person to person.


October 22 • 4:00 AM

For Preschoolers, Spite and Smarts Go Together

New research from Germany finds greater cognitive skills are associated with more spiteful behavior in children.


October 21 • 4:00 PM

Why the Number of Reported Sexual Offenses Is Skyrocketing at Occidental College

When you make it easier to report assault, people will come forward.


Follow us


Politicians Really Aren’t Better Decision Makers

Politicians took part in a classic choice experiment but failed to do better than the rest of us.

Earliest High-Altitude Settlements Found in Peru

Discovery suggests humans adapted to high altitude faster than previously thought.

My Politicians Are Better Looking Than Yours

A new study finds we judge the cover by the book—or at least the party.

That Cigarette Would Make a Great Water Filter

Clean out the ashtray, add some aluminum oxide, and you've (almost) got yourself a low-cost way to remove arsenic from drinking water.

Love and Hate in Israel and Palestine

Psychologists find that parties to a conflict think they're motivated by love while their enemies are motivated by hate.

The Big One

One company, Amazon, controls 67 percent of the e-book market in the United States—down from 90 percent five years ago. September/October 2014 new-big-one-5

Copyright © 2014 by Pacific Standard and The Miller-McCune Center for Research, Media, and Public Policy. All Rights Reserved.