In a departure from tradition, Cedars-Sinai Medical Center in Los Angeles has become one of a handful of private hospitals not affiliated with universities to seek to patent new discoveries by staff researchers.
While many universities have had such a policy for years--mostly for nonmedical discoveries--few medical researchers have sought to file patents on their work. Traditionally, instead, they have chosen simply to publish their findings in scientific journals for the benefit of anyone who wants to use them.
But the Cedars-Sinai policy is to require researchers to apply for patents before publication.
Cedars-Sinai officials made the announcement in an article in one of the most prestigious of the medical publications, the New England Journal of Medicine. Although Cedars-Sinai spokesmen indicated that the medical center has been quietly following such a patent policy for five years, the announcement seems certain to refocus attention on the ethics of such policies, which are becoming more prevalent in the medical community.
Paul M. Yaeger, vice president for planning at Cedars-Sinai, said that diminishing federal and private funding for research is forcing the medical center to adopt a more stringent policy in the hopes that patent royalties will augment the research budget.
Cedars-Sinai is a 1,200-bed nonprofit facility with a $5-million annual research budget. About 100 researchers are engaged in about 150 projects in a wide variety of medical disciplines ranging from cardiology to genetics. Although Cedars-Sinai is not the first non-university hospital to establish a patent policy--on the West Coast, Scripps Clinic in La Jolla is a pioneer--other hospitals with research programs are expected to follow.
In the Journal article, Yaeger and Stuart J. Marylander, Cedars-Sinai's president, said the medical center holds 17 patents and has filed 60 patent applications in 20 countries for medical devices and procedures ranging from cardiac laser surgery to hepatitis virus inactivation in blood products. In an interview, Yaeger said the royalties amount to about $1 million a year.
All new hospital employees--even part-time workers--are asked to sign a statement in which they agree to inform hospital officials of any discovery they make on hospital time and to share any royalties that may result from the marketing of the item. Inventors receive up to 50% of the royalties. A hospital committee has been set up to evaluate each discovery and determine whether it has a marketing potential.
According to the hospital officials, the first investigator to receive a patent has received more than $1 million in royalty income, which he may use as he wishes. The researcher, Dr. Alan Rubenstein, was credited with the 1980 discovery of a method of deactivating viruses in a blood product used by hemophiliacs. The method is used to eliminate the hepatitis and AIDS viruses from blood products.
In recent years there has been growing uneasiness in some segments of the medical profession over business arrangements that tie doctors too closely with the marketing of medical products. One concern is with the conflict of interest that can arise if a doctor allows his medical judgment to be influenced by his business interests.
Dr. Arnold Relman, editor of the New England Journal of Medicine, has become a leading spokesman against what he calls the "medical-industrial complex." He has called on the medical profession to declare as an article of its ethical code that doctors should derive income only from their professional services and not from any kind of entrepreneurial interest in the health-care industry. Relman could not be reached for comment on the Cedars-Sinai decision.
Referring to such criticism and to suggestions that technological advances can unnecessarily add to the cost of health care, Yaeger said Cedars-Sinai has adopted criteria to avoid that.
"The criteria we use is that it have the potential to improve patient care and the potential to be marketable," he said. "We are not marketing the medical center or our own doctors. We are helping to bring to market new products that have the potential to enhance the quality of health care in the world."
Yaeger said there are occasions when the medical center patents an item but charges no royalty. He said that royalty-free licenses have been granted to the American Red Cross and affiliated organizations in Canada and Holland for the hepatitis and AIDS virus deactivation process for which the medical center holds patents.
Yaeger also argued that patenting a procedure or device can hasten its availability to patients by giving manufacturers confidence in investing millions of dollars for development without fear that someone else will produce it first.