DOCTOR'S PATENT CAUSES CONFUSION; DOWN RESEARCHER SEEKS TEST PAYMENT.

Byline: Kurt Eichenwald The New York Times

Time was, when medical researchers discovered a link between a substance produced by the body and a disease, they rushed to publish their findings in medical journals and alert the scientific world.

But in 1986, when Dr. Mark Bogart found a relationship in tests of pregnant women between levels of a frequently checked hormone and the incidence of a congenital birth defect, he rushed first to the U.S. Patent and Trademark Office. In exchange, he hoped to gain millions of dollars.

In 1989, Bogart was granted a patent for his observation. Now, eight years later, a company he heads is demanding that laboratories across the country pay large royalties when they conduct a similar test performed on millions of pregnant women each year. If they refuse, Bogart's company has threatened to sue for patent infringement.

The demand, issued in recent weeks in letters to scores of laboratories, has angered and confused many in the field of prenatal testing. Numerous experts expressed concerns because the royalty demand, as high as $9 a test, is as much as, and in some cases more than, the lab is reimbursed. As a result, those in some labs said they might have to stop performing the test, which is used to determine the risk of a chromosomal defect known as Down syndrome.

While some legal experts said a court probably would invalidate the patent, geneticists said they fear the risks of ignoring the demands of Bogart's company, Biomedical Patent Management Corp. The cost of fighting a patent infringement suit would far outstrip their ability to pay, they said, with no assurance of success.

Making it all the more controversial is that Bogart did not, in fact, invent anything in the traditional sense. Rather, he was granted his patent as a result of his noticing a natural function in the body that likely has existed since the dawn of man.

``This is a dangerous, precedent-setting issue,'' said Dr. Robert C. Elser, director of clinical chemistry and immunochemistry at York Hospital in York, Pa. ``The consequences to public health could be enormous.''

The fight over the Bogart patent comes as controversy grows about the use of patent laws in medicine.

In recent years, the patent laws have been used to offer legal protections for discoveries of other naturally occurring phenomena, such as genes that have particular medical applications.

But legal experts said those instances differ from Bogart's in important ways. ``When you find a gene, you haven't simply found a relationship, such as in this case, you have found an actual thing that can do work for you,'' Robert P. Merges, a law professor and patent expert at the University of California at Berkeley, said after reading Bogart's patent. ``This does seem a little like patenting Newton's law of gravity.''

Indeed, last fall, Congress enacted a law that prevents holders of certain types of patents for medical procedures from collecting royalties. Legal experts were divided on whether a new patent similar to Bogart's would fall within the precise language of the law but said his would not because it predates the law.

Rep. Greg Ganske, R-Iowa, who wrote the law, said examples like the Bogart patent might signal a need to expand the law, in particular to include previously issued patents. ``Maybe with examples like this we will need to go back at this again,'' he said.

Medical researchers also expressed concern.

The effort to get royalties on the patent is ``terrible public health policy,'' said Dr. Arnold Relman, a former editor of The New England Journal of Medicine. ``It violates common sense, and it seems to me that it verges on the unethical, if it has not already crossed the boundary.''

Bogart, 46, now director of Mid-Pacific Genetics in Honolulu, said the labs simply were attempting to profit from his patent without paying the money legally owed him.

``Why should they be allowed to make large profits, but those of us who provided the test should not be allowed to make any? We're not forcing them to keep doing this screening,'' Bogart said. ``We don't have a gun to their heads.''

Andrew Dhuey, a San Francisco lawyer representing Biomedical Patent Management, said that his client stood to make as much as $100 million during the life of the patent. But he said the test's benefits merit the steep rewards.

``This invention has provided for millions and millions of women the most accurate assessment available for the likelihood that they are carrying a Down's fetus,'' he said. ``That is incredibly valuable.''