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The following discussion thread excerpt is from an ongoing law.com online seminar, “The Life Science Revolution and the Law: Emerging Controversies in Biotechnology,” produced in conjunction with the University of San Francisco Law Review. For information on this program and other law.com seminar offerings, please visit www.law.com/seminars. PANELIST DR. ARTI K. RAI, PROFESSOR, UNIVERSITY OF SAN DIEGO LAW SCHOOL, SAN DIEGO Hi. I am Arti Rai, a professor at the University of San Diego, and I have been asked to launch the topic for today. The role of the DNA molecule as information — that is, as a code for creating proteins — is, of course, a fact of which we have been aware for quite a while. Only recently, however, with the advent of bioinformatics, have we begun to see DNA (and proteins for that matter) being treated as solelyinformation, and not as a molecule. Thus, for example, Human Genome Sciences has filed a patent application on the DNA sequence of H. influenzae that claims the sequence not as a molecule but as information stored in a computer-readable medium. With the advent of computer-based protein modeling, it should not be long before we see patent applications on computer-based protein models. The recently issued PTO utility guidelines indicate that the PTO may not grant such patents. According to the PTO, molecular information stored in computer-readable form is descriptive, not functional, and therefore fails the utility requirement. However, the PTO’s argument may be in tension with Federal Circuit opinion such as In re Lowry, which have upheld the patentability of data structures. Moreover, to the extent that it was used to search DNA databases, or to perform other functions, a DNA sequence in computer-readable form could be “functional descriptive material.” Under the PTO’s own guidelines, functional descriptive material is patentable. Even if patents on DNA and proteins as pure information are not allowed, the process of drug development has become increasingly reliant on the informational role of these molecules. Increasingly, research that was formerly conducted in vitro or in vivo can be conducted “in silica.” One salutary effect of this convergence of information science and biotechnology may be a reduction in the cost of preclinical and clinical research. If such reductions in time and cost are realized, we might begin to think about the system of biopharmaceutical patenting that we currently have in place and whether the biopharmaceutical industry should be treated any differently from other information-based industries in terms of the structure of patent protection available to it. Currently, because of the Hatch-Waxman Act, a sui generis type of protection is available to the pharmaceutical industry. ATTENDEE JEREMY MANNING, INTELLECTUAL PROPERTY ATTORNEY, KENYON & KENYON, NEW YORK What do you think the grounds would be to support such different treatment for in silica bio/bioinformatics applications, algorithms and information? PROFESSOR ARTI K. RAI My initial post may have been unclear. I think that bioinformatics applications should be treated in the same way as other applications on information. I do think, however, that if the process of pharmaceutical development becomes faster and cheaper as a consequence of genomics, we may want to think about whether special protections for pharmaceuticals(e.g. some of the provisions of the Hatch-Waxman Act that allow pharmaceutical companies added protection based on marginal patent applications) are warranted. PANELIST DR. MARGARET R. MCLEAN, DIRECTOR OF BIOTECHNOLOGY AND HEALTHCARE ETHICS, MARKKULA CENTER FOR APPLIED ETHICS AT SANTA CLARA UNIVERSITY, SANTA CLARA, CALIF. This is Margaret McLean — not an expert in law, patent or otherwise. However, I do want to raise a concern that I hear regularly from people interested in “the new genetics” and “genetic information.” In the minds of many, “patenting a gene (or base sequence)” is equated with “owning the essence” of what it means to be human. There is an unspoken concern for slavish ownership when one considers DNA as “information” unique to individuals. Public reaction to gene patents in my experience is frequently not of a positive nature based — at least in part — on the equating of “patent” with “ownership.” Clarification of the relevant complexities of patent law for the public would enhance our ability to think through the ethical and policy considerations of genetic biotech. PANELIST DR. THANE KREINER, VICE-PRESIDENT, CORPORATE OPERATIONS AND COMMUNICATIONS, AFFYMETRIX, INC., SANTA CLARA, CALIF. This is Thane, like Margaret not an expert in law. I concur that some public education on the complexities of patent law is warranted, since the public (or at least the media) appears to equate gene patents with “patenting life.” Further, technology patents are sometimes inappropriately grouped with gene patents in media discussions and depictions of biotech patents. These trends can lead to the erroneous conclusion that all biotech patents are patents on life. A first priority, then, is to distinguish patents on technology from patents on genes or portions of genes. When considering patents on genes or pieces of genes, it seems we are struggling with how to optimize the public good. Enabling broad scientific access to primary genetic information fosters basic research, which helps us all. However, without some incentive such as that provided by a patent, few firms will invest in developing a new therapeutic compound based on a particular gene or set of genes because the development is still an expensive and lengthy process. ATTENDEE PHILLIP JONES, SENIOR PATENT ATTORNEY, ZYMOGENETICS INC., SEATTLE It seems that an article on the “evils” of gene patenting appears at least two or three times a week. Several months ago, “60 Minutes” had a segment on this topic. I remember [the interviewer] asking why the scientists cannot realize that it is unethical to patent genes. The reality of gene patenting is pretty mundane. That is, to obtain a claim on a nucleotide or amino acid sequence, the claimed invention must meet certain criteria set by the patent offices; obtaining a patent has nothing to do with slavery or ownership of bits of humans; having the rights to a “gene patent” gives the owner no right to practice the invention (in the U.S., this may be dictated by state or federal law), etc. But until journalists become convinced that the mundane true story can sell as much air time or advertising space as the sensational stories, I am not too hopeful about the advancement of public education on this issue. Editor’s Note: Please be advised that the panelists and attendees are expressing their own opinions and not necessarily those of their companies, firms or clients.

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