Patent protection is the sine qua non of that bonanza. Discovering and developing a new gene-based pharmaceutical product in the United States requires years of commitment and immense capital resources-as much as $500 million. Without the possibility of recouping investment that is bestowed by patents, no biotechnology company would be able to raise the financing necessary to develop these products.
Recently there has been a surge of public confusion and anxiety over gene patenting. It began in March of this year, with misreading of a joint statement by President Clinton and Prime Minister Tony Blair of Great Britain. And it has been exacerbated by widespread public misunderstanding of the nature of patents, compounded, sad to say, by those of us in genomics research, who too often assume that our own highly specialized understanding of the term “gene” is shared universally.
The most common public misunderstanding seems to be that patents convey ownership, rather than temporary commercial benefits to inventors. Many laymen also seem to regard genes as an almost spiritual collective essence of humanity and therefore not appropriately subject to commerce. But the patents that my company, Human Genome Sciences, and other leading biotechnology companies have been filing are neither unusual nor threatening to our core cultural or spiritual values. The “genes” being patented are not the genes in people’s bodies, much less the aggregation of all genes. Rather, “genes,” as we in genomics understand them, are isolated DNA sequences and the proteins expressed by those DNA sequences-individual genes removed from the natural context of the human body and rendered useful by crafting them in specific ways for medical use. These genes are artifacts made by the hand of man, and as such, they are subject to patents. Indeed, recombinant proteins and the DNA that encodes them have been patented in numerous instances during the last 20 years.
Finally, while Messrs. Clinton and Blair early this year called for free sharing of information on the human genome, their statement also specifically underscored the necessity to protect the intellectual rights to genomics-derived products and treatments. The U.S. Patent and Trademark Office has further clarified the gene patenting process by developing new guidelines that will help specify which gene-based inventions are patentable.
Under these guidelines, there remains little doubt that a full-length human gene coupled with medical utility is a patentable invention. Conversely, there is little controversy that raw genomic data with no further explanation of its
utility or use is not patentable. What the new guidelines do is determine more precisely just where to draw the line between these two extremes.
Because each patent application is different, no fixed bright line can be drawn. Rather, the effort to define patentability is an administrative process that has been ongoing over the last several years and will continue in the future-both in the Patent Office and in the federal court system. And, as the numerous issued patents on gene-based inventions demonstrate, it is a process that works.