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Each year, nearly every pregnant woman in the United States takes a blood test to screen for the possibility that the child she carries will have a birth defect. By measuring the concentration of several substances in the pregnant woman’s blood, the so-called multiple-marker blood screen can warn a woman that her baby likely has a birth defect such as Down’s syndrome, a genetic defect that causes retardation.

One of the substances measured in this way is human chorionic gonadotrophin, or HCG, a hormone that women produce in the days after conception.

Since the mid-1960s, medical researchers have actively studied HCG and its role in building up the placenta. In 1989, a researcher named Mark Bogart was awarded a patent for a method based on an observation he’d made about HCG: that elevated levels of the hormone can signal the presence of Down’s syndrome in a fetus.

Bogart, whose work was done in 1986 at the University of San Diego, didn’t create a new device to obtain his patent. Instead, he observed a connection between the levels of HCG and the likelihood of Down’s syndrome-and recognized the potential use of this correlation in a diagnostic test. Nor did his observation by itself result in the multiple-marker blood screen, since his was only one of three separate observations that make possible today’s most commonly administered test. Nonetheless, combined with measurements of other factors in the blood, Bogart’s research did open the door for the development of a diagnostic test that inexpensively alerts doctors when more accurate and invasive tests on a fetus might be warranted.

Bogart received U.S. Patent No. 4,874,693, affording him monopoly protection over a “method for assessing placental dysfunction.” Now he has made clear his intention to turn his patent into dollars. Bogart claims the patent entitles him to a $3 to $9 royalty every time a lab administers the multiple-marker test. He has made good on his threat to sue labs, doctors’ offices, and health maintenance organizations that refuse to pay.

Many are paying. According to Andrew Dhuey, Bogart’s lawyer, laboratories owned by SmithKline Beecham are now paying Bogart royalties in excess of $1 million per year. Recently, Dhuey says, the Arizona Institute for Genetics and Fetal Medicine agreed to Bogart’s royalty demand covering all future screening tests, as well as paying $90,000 in royalties for tests conducted over the past six years. Given the test’s widespread use, Bogart could earn as much as $100 million in royalties from hospitals, laboratories, and medical research institutions over the patent’s life.

Bogart’s intellectual and financial claims have inspired outrage in some quarters of the medical community. As Arnold Relman, former editor of the New England Journal of Medicine told Technology Review, for Bogart “to claim private ownership rights over natural phenomena, the nature of disease, or human biology is a restriction of intellectual freedom that will stifle medical research.”

Bogart refused to be interviewed for this story, but Dhuey, his lawyer, argues that Bogart is fully justified in law and logic. Dhuey notes that hospitals and labs “pay royalties every day on devices and on drugs that are being used, and it’s unfortunate that they don’t see that there’s no fundamental difference.”

Bogart’s claims are far from unique. He is one of thousands of medical doctors and biomedical researchers who have patented medical observations, surgical techniques, and other procedures, some as common as determining the sex of a fetus from an ultrasound image. These patent holders contend the procedures they develop are no less worthy of patent protection than an improved version of a catheter or x-ray machine.

Supporters of these claims believe that patents of this kind are essential for medical progress. Patricia Granados, a patent lawyer at the Washington, D.C.-based firm of Foley and Lardner who has litigated many related patent infringement cases, warns that without patent protection emerging industries like gene therapy and medical diagnostics will suffer. “It is questionable whether such industries will be able to obtain the investment money needed for research and development,” Granados explains. Corporations aren’t going to invest their money in anything, she adds, “unless they can get a proprietary position.”

Welcome to the field of medical research on the cusp of the millennium. A stark and accelerating clash has emerged between the drive to privately own medical knowledge and techniques, and the tradition of freely sharing them to improve public health-a tradition enshrined in the Hippocratic oath, which mandates that every physician must teach the craft of medicine “without fee or covenant.”

The clash has implications that go far beyond the philosophical underpinnings of the Hippocratic oath. For example, Bogart’s royalty demand is greater in some cases than what an insurance company will reimburse labs for conducting the test. Already some labs have threatened to drop the blood screen, and public health officials worry that fewer health plans will offer it.

“If the patent is enforced, it will have serious consequences to the health care of women in this country,” Mark Evans, professor of obstetrics and gynecology at Hutzel Hospital in Detroit told ABC News. “I believe in capitalism and rewarding discoveries, but there has to be a point where social responsibility takes precedence over greed.”


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