The best practices, announced last month, would apply to all genomic inventions, including cDNAs, ESTs, haplotypes, antisense molecules, siRNAs, genes and their products, as well as methods and instruments for genome sequencing, quantification of nucleic acids, detection of SNPs, and genetic modifications.
The proposal states that patents for genomic inventions "must balance the rewards of broad intellectual property protection afforded to founders of enabling genomic inventions with the benefits of fostering opportunities for those striving to improve upon those innovations."
Therefore, researchers should only seek to patent their inventions "when it is clear that private sector investment will be necessary to develop and make the invention widely available."
Since the commercial potential of inventions is often not clear initially, researchers may want to patent them first and decide later whether to license them exclusively or non-exclusively. "Whenever possible, non-exclusive licensing should be pursued as a best practice," the recommendations say.
Where exclusive licensing is necessary, it should be "appropriately tailored to ensure expeditions development of as many aspects of the technology as possible," and licsenses should include definite milestones and benchmarks and be "limited to be commensurate with the abilities and commitment of licensees to bring the technology to market expeditiously."
The comment period ends Jan. 18, 2005. For the full text of the proposed best practices, click here.