
DATE: Saturday, April 12, 1997              TAG: 9704120302

SECTION: LOCAL                   PAGE: B1   EDITION: FINAL 

SOURCE: BY MARIE JOYCE, STAFF WRITER 

                                            LENGTH:   86 lines

HOW CAN EVMS OWN A GENE IN YOUR BODY?

Eastern Virginia Medical School owns a part of your body, in a sense.

The school announced this week that scientists had isolated a gene that could play a key role someday in the understanding and treatment of diabetes.

More important - from a business standpoint - EVMS got patents to protect the discovery and licensed them to drug maker Eli Lilly and Co.

That means any profits on products arising from the gene - or the protein it acts as a blueprint for - go to Eli Lilly, EVMS and a third partner, McGill University in Montreal.

The gene, which they call INGAP, may spur the body to grow more of the cells that produce insulin. A gene is the basic unit of heredity; genes make up chromosomes, which exist in the nucleus of cells and act as a blueprint for growth and development.

Insulin is a hormone needed to process sugar and other carbohydrates. People with diabetes either can't make enough or can't make good use of the insulin their body supplies. In either case, growing more insulin cells could reverse the problem, said Aaron I. Vinik, head of diabetes research at EVMS.

It may seem strange that a school can claim something lurking in your body, but the right to patent a human gene is a well-established, if controversial, principle, say people familiar with biotechnology patents.

A scientist can patent a naturally occurring thing, if he manipulated nature in some way to get it.

The first patents on plants were issued in the 1930s, say legal experts, and the first human gene-related patents were issued in the 1970s.

The pace is picking up as technology advances and scientists improve their knowledgeof human genetic makeup.

There have been high-profile cases in the last few years. In 1995, Amgen Inc., a California company, paid Rockefeller University in New York $20 million for a license to a gene that is thought to play a role in regulating obesity. EVMS has declined to say how much it received from Eli Lilly.

Some scientists have ethical objections to the notion of owning a page in the human genetic library - especially in cases where the research is paid for with public grants. There have been suggestions that the government should take over such research and make the rights available to all.

Those who object ``talk about the dignity of the human body and not using people as a means to an end,'' said Paul A. Lombardo, a medical ethicist and legal scholar at the University of Virginia.

But patent attorney Ybet Villacorta say science and medicine couldn't progress without gene patents.

``One has to provide some incentive for scientists to go ahead and make inventions. It costs money to do research,'' said Villacorta, an Alexandria lawyer specializing in biotechnology.

In exchange for investing the money and time, the discoverer gets an effective monopoly on use of the discovery for 20 years.

Society also benefits, Villacorta says, because the scientist who has protection is willing to share his methods with the public, improving scientific knowledge.

For an example, he says, look at insulin. Insulin is a hormone that occurs naturally in the human body.

But the fact that the substance is floating around in someone else's body doesn't help a person with diabetes.

``Before someone took the time to extract liters and liters of this stuff .

For several years, worries about getting good patents to prevent poaching of the INGAP gene have been almost as important as the research at EVMS.

Many other researchers are looking for ways to make the body grow more insulin-producing cells. EVMS worked with patent attorneys and other outside consultants to make sure their claim on INGAP was airtight.

EVMS's patents have almost 100 specific claims detailing exactly what is protected, said Vinik, EVMS's chief researcher on the project.

Even so, no patent is completely safe.

In some cases, says Villacorta, a drug company or research group will look at patented work and ``design around'' it, devising a somewhat different way to achieve the same thing and bypassing the patent.

Patent lawyers always try to put as many fences around a client's work as possible. Poachers always try to find ways to jump the fence, he said.

``It's like the battle between police radar and the people who have radar detector units,'' he said.

If it sounds good for lawyers, it's also good for society, he says.

``The benefit of this is that people are . . . creating and being innovative.'' ILLUSTRATION: GENE PATENT

The gene: Called INGAP, it can spur the body to make more of the

cells that produce insulin.

The patent: Eastern Virginia Medical School has the rights to the

gene and a share of any profits from subsequent medical products.