Baby Steps on Gene Patents

When I suggested in my book Who Owns You? that unaltered genes, such as “disease genes” like that responsible for Canavan’s Disease, ought not to be patentable because they are not in the least bit inventive, I was attacked as a pariah by the minions of the IP-Industrial Complex.  Gene patents, specifically on merely “isolated” genes, are particularly insidious perversions of the patent law’s ever expanding breadth, and they are also tremendously valuable to any company that happens to get them.  These patents encompass the sequences of genes known, for instance, to cause a propensity for a certain disease.  Identifying them through a genetic test involves significant consequences for individuals.  Companies that tie up these sequences by patent can “own” the exclusive right to test for the presence of that gene.  The most famous example is Myriad, which owns patents on the BRCA1 and 2 genes known to increase one’s propensity for breast and ovarian cancers.  This patent enables Myriad to prevent anyone else from performing clinical tests for the BRCA1 and 2 genes, and so in the absence of competition they can charge the ludicrous monopolistic price of nearly $3000 US for a test that costs less than $400 to perform.  This sort of patent is particularly offensive, not merely because of the consequences, but because of the “theory” behind them.  While we ordinarily consider patents to apply to “inventions,” they can also apply to new “discoveries” as well.  This nasty little ambiguity has been extended through painfully strained reasoning to allow patents on synthesized, but otherwise naturally-occuring molecules like adrenaline and now, unmodified (but “isolated”) genes.  Defenders of the practice say that by “isolating” a gene from the 3 billion base-pair string that is the human genome, something “new” has been created, and as a new composition of matter, it is somehow patent-eligible.  In my book, and ever since, I have analogized this to drawing a boundary around the Devil’s Tower and claiming to have invented the Devil’s Tower.  Nature defines the boundaries of genes even more precisely than natural boundaries around physical features, because at the end points of genes are well-known markers called “promoter” and “stop” codons.  Because of the value of gene patents, there has been a gold-rush of sorts to identify and claim ownership of genes, and this has had a real effect on the progress of basic research.  Worse, it defies all reason and awards the right to exclude others from basic, natural facts and phenomena.

But the tide may be turning.  The ACLU sued Myriad last year and won a surprising summary judgment which is now being appealed.  The court reasoned that the mere isolation of a naturally-occurring mutation to a gene was not sufficiently inventive to warrant a patent.  The decision was of course derided by patent attorneys, but it seems to have presaged a general shift in thinking about this issue.  Public opinion has been firmly against these sorts of patents for some time, and now even the US government (outside of the PTO) is beginning to push back.  Early this year, the The Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) for the Department of Health and Human Services (HHS)  issued a report that called for scaling back a bit  the practice of granting patents over isolated genes.  Even more significantly, the Department of Justice filed a surprise amicus brief  last week in the Myriad lawsuit, siding with the plaintiffs and arguing that patents on unmodified (but merely “isolated”) genes are contrary to the purposes of patent law and ought to stop.

You can bet that this issue will not die down soon, and it will be fascinating to see how this all plays out given that the PTO clearly disagrees with the DoJ’s position, but it is good to see movement, however slight, in the right direction.