From: Alik Widge alik@
I am writing as a technology researcher, a medical professional, and a consumer in response to the Commission's request for public comment on intellectual property, competition, and innovation. The Constitution justifies intellectual property law by stating that limited monopolies are an acceptable price to pay for increased innovation. It is my belief that current IP regimes have passed beyond reasonable limits and begun to stifle innovation. I will address two key themes: patents in the life sciences and copyrights in a knowledge-based economy.
In approximately the past five years, there has been a proliferation of patents and patent applications on proteins, genetic material, and other basic building blocks of living things. My best estimate, derived from a search of patent databases, is that roughly 5,000 patents have been granted to date; I am aware of over 20,000 further provisional patents that have been filed. Each of these patents represents a claim of private ownership over one of the essential components of an organism, often a human being. Setting aside the troubling ethical issues of such a claim, such patents provide a strong disincentive for further research and innovation on the genes to which they lay claim. There is little incentive for a scientist to study a particular gene if the profits from his/her findings will go to whomever was first to stake a tenuous claim to that gene. (It is worth noting here that the majority of genetic patents are issued without definitive knowledge of the function of the patented gene.) Moreover, recent data have shown that the requirement to pay royalties on gene-based diagnostic testing has caused a significant fraction of laboratories to not offer those tests. (See Nature, vol. 415, pp. 577-9.) It has further been shown that academic researchers are becoming increasingly reticent to share data with other scientists. (Journal of the American Medical Association, vol. 287 no. 4, pp. 473-80 and vol. 277 pp. 1224-8.)
It is therefore clear that the patenting of genetic materials and similar basic elements of life (in their raw form, divorced from clinical and other applications) is already limiting our ability to advance the state of scientific knowledge and detect chronic diseases before they cause irreparable damage. I therefore urge the Commission to seek an alteration in current patenting standards to limit patents within the life sciences to specific applications of biological knowledge.
The second area in which intellectual property protections are imbalanced is copyright. The Digital Millenium Copyright Act of 1998 (DMCA) makes it illegal to circumvent a technological protection that controls access to a copyrighted work, or to distribute circumvention tools. However, the DMCA includes no strong protections for academic research or the "fair use" rights that have been assigned to consumers for decades. Academic researchers doing legitimate cryptographic research have been prevented from publishing their findings due to legal threats from publishers; the most recent and famous case is Professor Edward Felten of Princeton University.
A complete list of the harms and potential harms arising from the DMCA's provisions would require more space than brevity permits. I respectfully refer the Commission to the summary article of Professor Pamela Samuelson (Science, vol. 293, no. 5537, pp. 2028-31) and the extensive writings of the Electronic Frontier Foundation (available on the World Wide Web at http://www.eff.org/IP/DMCA/ , most notably their previous comments to various Federal agencies and courts.
In addition to scientific threats, it is my feeling that the current intellectual property regime will eventually be harmful in clinical medicine. Owing to the overly strong protection given to copyright holders, it is becoming increasingly difficult to effectively transfer information between different digital systems and formats. As it becomes harder for clinicians to share informational resources, it becomes more likely that knowledge relevant to a given patient's care will simply not be available because some necessary fee has not been paid or a file format has been made deliberately incompatible with all other systems. While this does not necessarily constitute a harm to innovation, it clearly would have an overall detrimental effect on society.
As with patents, the action I would suggest to the Commission is a rebalancing of copyright laws towards protection of consumers' rights, particularly the "fair use" and "first sale" doctrines. Depending on the scope of such an overhaul, it might also be valuable to consider the current length of copyright terms. It seems inappropriate and counterproductive that a work should continue to be copyrighted a century after the death of the original creator.
I thank the Commission for addressing these issues and your consideration of my comments.