Throughout the United States and abroad, these patents directly impact patient health care by placing limits on gene research and testing. By granting these gene patents, the U.S. Patent Office has put corporate profits before the health and well-being of patients, and the time has come to stop this practice. Gene patents have a detrimental impact on health care and research. Gene patents can prevent more accurate, affordable, and complex diagnostic tests from being developed. Gene patent holders often use their exclusive control to charge excessive fees for diagnostic testing and prevent other researchers from utilizing the specific gene for further research. Recent research suggests that dozens or even hundreds of genes may be involved in diseases like Alzheimer's. When researchers cannot get permission from the patent holder to perform research on a gene that contributes to the disease they are working on, progress is delayed.
Ever since the US Patent and Trademark Office (PTO) began issuing patents on DNA sequences, critics have raised moral and religious objections to the patenting of biological materials, such as genes, gene fragments, proteins, and cell lines. The initial criticisms claimed that DNA patents are immoral in principle, regardless of their consequences for society. The controversy started simmering in the mid-1990s as a result of the National Institutes of Health's (NIH's) patent applications on viral DNA extracted from indigenous human populations as well as patent applications on thousands of gene fragments known as expressed sequences tags (ESTs) (Hanson, 1997) This initial round of criticism reached a boiling point on May 18, 1995, when biotech critic Jeremy Rifkin led 180 religious leaders in a “Joint Appeal Against Human and Animal Patenting” in Washington, DC. According to these critics, patents on human genes or gene fragments are wrong because they treat human beings and animals as commercial products, co-opt our common heritage, exploit indigenous peoples, or are an attempt to patent God's creation(Merz, 1998).
These criticisms had little effect on the PTO's policies, however. By 1999, the PTO had issued 2330 DNA patents, and patent applications had risen from 500 in 1994 to nearly 3000 in 1999. In the late 1990s, critics focused on consequentialist objections to DNA patents, arguing that patents would have adverse effects on science and society . Critics argued that DNA patents can block access to fundamental knowledge, are too broad in scope, and allow inventors to patent items that have no practical utility or have only a speculative utility . Several companies had filed patents on thousands of ESTs, hoping that they would find some practical use for these sequences. As a result of these concerns, the PTO issued some new guidelines on DNA patents in December 1999, which “raised the bar” on DNA patents. The new guidelines require substantial proof of a practical use for patented DNA sequences, prevent “speculative” patenting of genes or gene fragments, and restrict the scope of patents on ESTs.