Advice of Counsel Q&A On Tech Transfer
by Michael Lytton
Answer: A great deal of confusion has arisen over the statements by Bill Clinton and Tony Blair concerning the patentability of genes and other nucleic acid sequences and the rights of the government to own the results of research which it funds. It is first worth noting that their statements reflected simply a shorthand, perhaps overly vague, summary of current law and policy and implied no new initiatives harmful to the biotechnology industry.
An inventor funded by the US government is entitled to own and file patent applications on the inventions which result from his research. Patent protection is available in the US for nucleic acid sequences, including genes, ESTs and partial sequences, and the proteins which these sequences encode. However, this ownership right is subject to a few well-understood requirements and limitations. Genetic inventions arising from some government-funded research programs must be made publicly available twenty-four hours after they are discovered. All government-funded research comes with the stipulation that the government has a royalty-free license back to inventions arising from the research for internal not-for-profit governmental research purposes (i.e., for further study and expansion of the field of knowledge by the NIH). While these requirements serve the public interest and have been in existence for some time, neither of them stand in the way of obtaining patent protection for genes or other nucleic acid sequences.
Under the US patent law, an inventor has one year from the date of public disclosure of an invention to file a patent application. However, his priority over other parties dates back to the date of the invention. So mandatory inclusion of nucleic acid sequence data in a public database does not sacrifice US patent rights.
However, foreign patent laws generally do not provide a grace period for filing an application after public disclosure: disclosure before filing a patent application will preclude patentability in most countries outside of the US. To preserve foreign patent rights, an application must be filed in the US or abroad before publication. In order to preserve the right to obtain a patent in foreign countries, a US patent application should be filed as early as possible, preferably prior to public disclosure of the invention. If only the novel nucleic acid sequence information is known and public disclosure of it is legally required, the inventor can still secure US and foreign patent rights by filing a provisional application in the US prior to public disclosure. The provisional application need only contain the sequence; the inventor then has one year to supplement the application with a description of the "utility" of the sequence (i.e., its function in the body).
In order to obtain a patent on a gene or other nucleic acid sequence, the patent law does require that it be isolated or that at least its exact structure be identified. This was at the crux of the Amgen Inc. v. Chugai Pharmaceutical Co. Ltd. case. While Amgen's patent claimed a purified and isolated DNA sequence encoding human erythropoietin (EPO), Chugai claimed that another inventor (Dr. Fritsch) had conceived earlier a method for obtaining EPO. However, Fritsch had not isolated the gene or identified its structure. As we know, the court ruled in favor of Amgen on the basis that the "conception" required by the patent law does not include the mere description of a process that might be used for obtaining the human EPO gene.
But US gene patents need to show more than the gene; they must demonstrate utility, describing the function of the gene or other sequence and the protein which it encodes. It is not enough to simply speculate about function; an application must contain the results of experiments or refer to other sources of support for its assertion of functionality. One helpful circumstance occurs if the inventive sequence is homologous with a known gene whose function or activity is known; one can then infer that the new sequence will have the same or similar function and by doing so satisfy the utility requirement.
In addition to utility, the "written description" requirement presents the second hurdle, requiring that the patent application contain an actual description of the pertinent gene sequence information (e.g., the nucleotide sequence of the gene). A written description in a patent application of a protein or amino acid sequence encoded by the gene will not be enough by itself to obtain patent protection on the DNA encoding the protein or amino acid sequence.
Interesting questions arise over whether a prior applicant for a patent on a gene sequence with an unknown function can prevent a party from obtaining a patent on the gene and/or the protein which the gene encodes where the function is known. Patents on genes which encode proteins that serve as biological "targets" have considerable value as screening assays or diagnostics. The answer is that under the current guidelines, the US Patent Office most likely will favor the party who has determined the DNA sequence and utility of the gene and protein first, even if that party found the DNA sequence after the first party filed a provisional application on the sequence alone. Simply describing a nucleotide sequence in a patent application does not earn the inventor the right to a patent or the protein which the sequence encodes; conversely, describing a protein in a patent application does not give rights to the nucleotide sequence which encodes the protein. This was the holding of the court in a famous case between the University of California and Eli Lilly & Co. over the University's patent covering recombinantly produced insulin.
So, being the first to plant many stakes in the ground through filing of patent applications on nucleic acid sequences will not guarantee ultimate patentability of the sequence or of the proteins encoded by these sequences. A claim to an EST alone for example, will ultimately be rejected for lack of utility if the application fails to state a function or protein activity associated with the EST. The same is true for SNP filings; a patent application describing only the sequence of the SNP will be rejected for lack of utility unless the application describes a mutational effect associated with the SNP, or alternatively, if the activity or function of the wild type gene is known.
Since very few regions of DNA and very few SNPs will ultimately be shown to have biological significance, the field is really wide open to competition among the many players in the genomics world. With the advent of functional genomics, proteomics, and pharmacogenomics, the understanding of the role of gene function is being enhanced at multiple stages of the discovery process, from nucleotide sequence to protein to biological pathway. An inventor's entry point into this chain of biological activity is far less important than his ability to be the first to understand the chain in its entirety. The expected publication of the complete human genome later this year and the anticipated public availability of SNP data will further level the playing field. The patent law will hopefully keep pace with the rate of technological innovation, so that inventors are appropriately rewarded for their contribution to this exciting area of science.
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