Patenting the human genome

by Adrienne Wright

Can human genes be patented? That was the question posed by Alan J. Snyder, vice president and associate provost for research and graduate studies at Lehigh, and Lee Kaplan, scientific director of cellular and molecular genetics at Health Network Laboratories, at a panel discussion on campus this spring.

Snyder and Kaplan examined Association for v. Myriad Genetics Inc., an intellectual property case now before the Supreme Court that could have far-reaching implications for the scientific community as well as for ordinary men and women.

At the center of the case are genes BRCA1 and BRCA2, which made headlines recently when actress Angelina Jolie announced that she had tested positive for mutations of the gene and opted for a preventive to reduce her risk of .

After the genes were sequenced at the University of Utah, patents to them were licensed to Myriad Genetics through a tech transfer. Myriad has excluded outside companies and universities from studying the genes and testing for mutations that could lead to breast and . Instead, the company charges more than $3,000 to administer tests itself.

"Eighty percent of the is patented, but this is one of the few companies that actually enforces their patent to this degree," Kaplan said.

The intricacies of patent law

Previous , said Snyder, have set a precedent for what can be patented under the U.S. Patent Act.

"The definition from Diamond v. Chakrabarty is 'anything under the sun that is made by man.' In that case, the Supreme Court ruled that modifications to DNA are indeed patentable. The only things that are explicitly excluded from being patented are human life forms and so-called 'laws of nature.'"

Indeed, one of the central issues in the Myriad case is the "isolated DNA claim"—whether a gene taken out of the body qualifies as a or as a product of nature.

"Is a gene carved out of a chromosome patentable matter?" Snyder asked.

The Supreme Court is expected to rule on this claim in late June, and Kaplan said the outcome could have a profound impact on scientific innovation and progress.

"There hasn't been much forward movement in the area of breast cancer research because labs aren't able to study this gene," Kaplan said. "BRCA1 was discovered in 1994, so it kind of makes you wonder why there's no drug for this, why nothing has progressed in this field."

Myriad's monopoly on testing, said Kaplan, means that no one is looking over the company's shoulder to validate its work.

"Myriad developed their test to only look at a few points on the gene, so they would send results back and say an individual didn't have the mutation," she said. "Then in 2008 they came under pressure by the scientific community to test more and it turned out there were some gene rearrangements their tests weren't capturing."

A swath of people tested over a 10-year period, he said, may have been given false results.

"You now have these patients who have cancer and who could have had a mastectomy or hysterectomy during those 10 years if they had received accurate results," Kaplan said.

In the end, the ruling will come down to the Court's interpretation of what can be patented.

"The question isn't whether the genes in your body are patentable," Snyder said. "It's whether taking them out of your body and isolating them makes them substantially different."

add to favorites email to friend print save as pdf

Related Stories

Court: Can human genes be patented? (Update)

Apr 15, 2013

The Supreme Court grapples Monday with the question of whether human genes can be patented, and the ultimate answer could reshape U.S. medical research, the fight against diseases like breast and ovarian ...

US top court to hear case on gene patents

Apr 13, 2013

The US Supreme Court will hear arguments Monday on whether to allow private entities to patent genes they have isolated and identified, a decision that could have far-reaching implications for genetic research.

Recommended for you

Science of romantic relationships includes gene factor

31 minutes ago

(Medical Xpress)—Adolescents worry about passing tests, winning games, lost phones, fractured bones—and whether or not they will ever really fall in love. Three Chinese researchers have focused on that ...

Stress reaction may be in your dad's DNA, study finds

Nov 21, 2014

Stress in this generation could mean resilience in the next, a new study suggests. Male mice subjected to unpredictable stressors produced offspring that showed more flexible coping strategies when under ...

More genetic clues found in a severe food allergy

Nov 21, 2014

Scientists have identified four new genes associated with the severe food allergy eosinophilic esophagitis (EoE). Because the genes appear to have roles in other allergic diseases and in inflammation, the ...

Brain-dwelling worm in UK man's head sequenced

Nov 20, 2014

For the first time, the genome of a rarely seen tapeworm has been sequenced. The genetic information of this invasive parasite, which lived for four years in a UK resident's brain, offers new opportunities ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.