Patent Applications for SARS Virus and Genes

Background

The media have recently reported that teams of scientists in Canada, Hong Kong, and the U.S have filed patent applications on all or part of the SARS virus genome and on the virus itself. The detailed claims in these applications have not yet been made public but are reported to be sufficiently broad to allow their holders to claim rights in most diagnostic tests, drugs, or vaccines that have been or would be developed to cope with the outbreak. In addition to the claims filed by these laboratories, several other institutes and companies involved in decoding the SARS genome have announced that they will not file patent applications; still others have not disclosed whether or not they have filed or will do so but are believed to have done so.

Some of the university and public health laboratories that have filed patents assert that they have acted "defensively." That is, by filing patent applications, they intend to preempt commercial applicants from obtaining intellectual property rights that might hinder further research and development on SARS. It has been reported, however, that some of the university or governmental patent applicants have themselves begun negotiations with commercial partners to develop diagnostic tests and other products.

Some people have objected to the SARS patent applications on the ground that the virus and its genes should not be patentable because they are mere discoveries, not inventions. This distinction no longer prevents the granting of patents; the novel claim rests not with the virus itself but with its isolation, and likewise with the identification of the genetic sequence not its mere occurrence. Many patents have been issued on viruses and genetic sequences, though the appropriate policies to follow in such cases--particularly as genomic sequencing becomes more routine and less "inventive"--remain matters of dispute.

WHO and SARS-Patents

For continued progress against SARS, it is essential that we nurture the spirit of the unprecedented, global collaboration that rapidly discovered the novel virus and sequenced its genome.

At the moment, it is too soon to know all the effects that the patenting of SARS-related discoveries will have, but the filing of the patent applications does not in itself erect any barriers to continued scientific collaboration on SARS.

The "defensive" use of patents can be a legitimate part of researchers' efforts to make their discoveries (and further discoveries derived therefrom) widely available to other researchers, in the best collaborative traditions of biomedical science.

WHO intends to monitor the effects of patents (and patent applications) on the speed with which SARS diagnostic tests, treatments, and vaccines are developed and made available for use and on the manner in which prices are set for these technologies.

In the longer term, the manner in which SARS patent rights are pursued could have a profound effect on the willingness of researchers and public health officials to collaborate regarding future outbreaks of new infectious diseases. WHO will therefore examine whether the terms of reference for such collaborations need to be modified to ensure that the credit for any intellectual property developed is appropriately attributed, that revenues derived from licensing such property are devoted to suitable uses, and that legitimate rewards for innovative efforts do not impose undue burdens on efforts to make tests, therapies, and preventive measure available to all.