September 2003 - #16. Intellectual Property Law and the Biotech Challenge: Searching for an Elusive Balance *.

 
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Vermont Bar Journal

2003.

September 2003 - #16.

Intellectual Property Law and the Biotech Challenge: Searching for an Elusive Balance *

Vermont Bar Journal - September 2003

U.S. Intellectual Property Law and the Biotech Challenge: Searching for an Elusive Balance *

Peter J. Gardner, Esq.

The American intellectual property law regime has for more than two centuries struggled to keep up with rapid technological change, yet it seems always to have managed to do so in the end. The biotechnology revolution, however, will create unprecedented challenges to our intellectual property rights system, perhaps especially in the allocation of rights to balance the interests of scientists, investors and those from whom valuable genetic material is obtained. Indeed, for human DNA, some people question whether there should be any property rights at all.

DNA and Genes

"DNA" is a molecule with four chemical components symbolized as A, C, G and

T. The human genome sequence is estimated to comprise roughly three billion pairs of these letters1 and would be about six feet long if stretched out2 and would fill two hundred New York City phone books.3 To "sequence" DNA is to determine the precise order of these letters along the DNA molecule. A "gene" is a length of DNA that contains all the information necessary to make a protein - the "business end"4 of the cellular process that creates cellular structure and directs certain cellular functions. The "human genome" itself is all the hereditary material in our cells - approximately 31,000

5

genes.

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Editor's note: This article was first published in the March 2003 issue of the New Hampshire Bar Journal and is reprinted with permission.

Scientists seek to identify the comparatively few genes in the vast sea of DNA and to determine the protein each gene encodes.6 The biotechnology and pharmaceutical industries seek to find the disease-causing genes that could lead to new drug treatments.7

The Legal and Statutory Framework

American intellectual property law, which includes patent law, is designed to advance knowledge and to stimulate innovation for the benefit of society.8 To encourage this goal, a patent grants to an inventor a 20-year limited monopoly with which to profit from his or her invention.9

Not everything under the sun is patentable, however. Justice Douglas wrote in 1948 that "patents cannot issue for the discovery of the phenomena of Nature" which, he asserted, "are part of the storehouse of knowledge of all men."10 Eighteen years later, the Supreme Court expressed concern that a monopoly of knowledge granted through a patent "may confer power to block off whole areas of scientific development, without compensating benefit to the public."11

But in 1980 the Court held that a genetically engineered strain of bacteria "with markedly different characteristics from any found in nature" was patentable,12 and in 1991 the Federal Circuit upheld the patentability of human DNA sequences that are "purified and isolated" from the original object in nature.13 So although one cannot patent a fundamental scientific breakthrough, one can patent a specific technological application enabled by that breakthrough.14

A 1998 Federal Circuit decision that an abstract idea (a mathematical algorithm in that case) is patentable if it has practical utility15 presages a bioinformatics industry16 built on the creation of the genomic information that is now a key strategic and competitive business asset independent of applied products.17

Within this case law setting, an innovation or invention must also meet Patent and Trademark Office requirements to be patented.18 A key requirement in the gene patent context is that an invention must be "useful,"19 although until recently human DNA sequences and gene fragments were permitted to be patented without any knowledge of their biological function.20 In 2001, however, the Patent Office revised its guidelines to emphasize specific, substantial, and credible utility,21 that is, a "real world context for using the invention"22 as distinct from a context that requires further research to establish or verify usefulness.23

An additional key requirement is that an invention not have been previously known or described in a written publication.24 With this in mind, the 1996 "Strategy Meetings on Human Genome Sequencing" hosted in Bermuda by the Wellcome Trust resulted in an agreement among participants that all raw sequence data from human genome sequencing efforts should be "freely available and in the public domain."25 As a result, sequence data are now released daily into public databases, which destroys patentability in a raw sequence itself.26

Even without property rights, though, genomic companies seek to profit from information in the public domain by providing easier or more efficient access,27 as Lexis and Westlaw do for legal research. Celera Genomics Group, for example, derives its revenues primarily from database subscription fees rather than from patent rights.28

The Intersection of Law, Policy, and Morality

To treat his leukemia, John Moore was asked over a seven-year period to provide his physician at the UCLA Medical Center with certain bodily materials including DNA which, it turned out, had the unusual characteristic of overproducing proteins that regulate the immune system.29 With these materials the physician, without telling Moore, developed and patented the "Mo cell line" and granted a license to, and received stock options and a consulting arrangement from, a biotech company.30 The Mo cell line produced three billion dollars worth of drugs.31 Once he learned of the cell line and the drugs, Moore sued the physician, the University of California, the patent assignee, and various biotech firms.

Moore argued in part that the defendants had misappropriated his property - DNA, cells and tissue - to develop the cell line and drugs.32 The...

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