Letters

Paying for Tissue: The Case of WI-38

Science  14 Sep 2012:
Vol. 337, Issue 6100, pp. 1292
DOI: 10.1126/science.337.6100.1292-a

In their Policy Forum “Paying patients for their tissue: the legacy of Henrietta Lacks” (6 July, p. 37), R. D. Truog et al. overlook the L929 cell line, which, contrary to their statement about HeLa, was the first immortal cell line (1). Also overlooked are the commercial uses and questions of legal ownership first raised for normal human cell strains (2). WI-38, derived from the lung tissue of a surgically aborted fetus, has not only been used in research worldwide whenever a normal human cell is required, but has also been used as the substrate for the production of many of the world's human virus vaccines since the mid-1960s. About 2 billion people have directly benefitted from the use of WI-38 and similar strains (3). Although the commercial sales of vaccines produced in WI-38 cannot be accurately determined, it is certainly in the multiple billions of dollars. In the 1960s, I distributed WI-38 gratis to vaccine manufacturers and researchers worldwide because biological material could not be patented.

CREDIT: PEARL JACKSON/ISTOCKPHOTO.COM

Truog et al. seem unaware that in 1975, the National Institutes of Health (NIH), Food and Drug Administration (FDA), and Department of Health, Education, & Welfare (DHEW) argued that the WI-38 I used in my research was the sole property of the U.S. government. I and my colleagues had never received government support for the research or development of WI-38. In response to the government's claims of propriety, we sued. We believed that there are several stakeholders in the title to any human cell culture: the researchers who actually developed the culture, their institution, the individual from whom the tissue was derived, and the organization that supported the research.

During the 7 years of litigation, several decisive events torpedoed the government's position that it had sole title to WI-38. First, the Supreme Court decided that biological material could be patented (4). This decision established the principle that, even with federal research support, biological researchers have patentable intellectual property rights for their discoveries.

Second, the Bayh-Dole Act reversed the presumption of government title. Bayh-Dole permits a university, small business, or nonprofit institution to claim as its intellectual property the control of an invention in preference to the government and despite federal funding (5). The act further provides that royalties be shared with the inventor.

Third, in 1983, President Reagan instructed federal agency heads that all businesses should be able to retain patent rights on inventions made in the course of government-funded R&D work. His executive order explained that giving the private sector clear title to patents on inventions developed under federal contracts and grants would lead to more rapid commercialization of new products (6).

Fourth, the nascent biotechnology industry was then being formed by entrepreneurial biologists whose companies were founded by using biological materials discovered in federally funded university research laboratories. Thus, the NIH found itself in the untenable position of first claiming sole title to WI-38 by alleging that it was discovered using federal funds and later praising the use of federal funds to discover biological materials that were then used in the founding of new biotechnology companies.

The Justice Department, which defended the NIH, FDA, and DHEW, recognized their contradictory positions and accepted an out-of-court settlement. This is the first, and perhaps the only, instance where an individual scientist obtained federal legal title to a normal human cell strain, an event contradicted by subsequent state court decisions. The question of title to a self-duplicating human cell line or strain is still, after 50 years, a controversial issue.

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