Brenda Simon:

I’m blogging from the 2011 IP Scholars Conference.  Professor Chris Holman presented his fascinating research examining whether the assumption that 20% of genes are patented are correct and the implications on whole genome sequencing.

The 20% figure originated in a 2005 article:  Kyle Jensen & Fiona Murray, Intellectual Property Landscape of the Human Genome, 310 SCIENCE 239, 239 (2005).  Holman obtained the data set that Jensen and Murray used.  They found that 20% of known gene sequences (or the corresponding protein sequences) are “explicitly mentioned” in US patent claims.  Jensen and Murray’s set consisted of 4270 patents; Professor Holman reviewed 533.  Holman divided the set into three categories:

Category 1:  140 of the patents don’t contain a claim that could be infringed by genetic testing. (e.g. one claims a non-naturally occurring version of hemoglobin (the protein, not the gene encoding hemoglobin))

Category 2:  366 of the patents contain product claims covering DNA molecules (most of the claims limited to isolated or recombinant DNA).  In looking at this category, the likelihood of infringement by whole genome sequencing depends on what “isolated” DNA means.  These patents might or might not be impacted by sequencing.  Many of the claims are directed to full length cDNA sequences (and cover the use of the gene to produce protein), and most likely would not be infringed by conventional genomic DNA sequencing.

Category 3:  48 patents contain methods of sequencing that might be infringed by some form of genetic testing (but not necessarily by all forms of gene sequencing, particularly next-generation genome sequencing technologies that do not require DNA amplification).

Professor Holman concludes that Category 1 claims are of no concern, as well as the Category 2 claims on full length cDNA.  He finds the main areas of potential concern are those patents from Category 2 that cover gene fragments as well as those with broad method claims from Category 3.

I think Holman’s research suggests that while it is not clear to what extent gene patents ultimately will impact whole genome sequencing, it is likely less than academics previously believed.  (http://holmansbiotechipblog.blogspot.com/2011/08/will-gene-patents-impede-whole-genome.html).

Brenda Simon

Non-Resident Fellow, Center for Law and the Biosciences

Associate Professor of Law, Thomas Jefferson School of Law