Patent Docs: In Support of Gene Patents - Sent Using Google Toolbar

Patent Docs: In Support of Gene Patents

In Support of Gene Patents

    By Kevin Noonan

Once again, the popular press, aided and abetted by academics more interested in career advancement than the facts, have sounded the clarion call against patenting genes (see "Gene Patenting in the News Again").  For anyone interested in a reasoned debate on an important topic, the resulting articles are disheartening.  For those interested in advancing progress and U.S. economic interests, they are infuriating.

The latest jeremiad comes courtesy of Parade magazine, a popular component of Sunday section in many local newspapers.  It is helpful at the start to set out (and refute) the many factual misstatements in the article:

  • "A fifth of your genes belong to someone else."  Besides being contrary to the 13th amendment (banning having a property right in a person), no patent in the U.S. (or anywhere else) claims ownership of "your" genes.  All U.S. patents require that compositions of matter comprising "genes" are "isolated and purified."  So no one is going to knock on your door and ask for a royalty for using your genes.
  • "No one should own a disease" - and no one does.  There have been patents on isolated microorganisms, but this is not new: Louis Pasteur had patents on yeasts useful for wine and beer-making, and before the genetics revolution of the last half century, the only way to make useful antibiotics was to isolate the microorganism that happened to make the drug.
  • "Countries where they haven't patented genes have better genetic testing."  Correction: cheaper genetic testing, not better.  Where did the genetic test come from?  Not France, because they can't protect their genetic inventions in France.  The U.S. leads the world in biotechnology and is responsible for most of the "better genetic testing" that now exists.  There are many reasons why, but one important reason is that the companies that have developed those tests could get the economic support needed to take a scientific discovery and turn it into a useful test.  This is so because of patent protection.  If France can offer a cheaper test, it's because the French government permits companies in France to use technology without paying for it.  This is a good deal only if someone else is paying for it; Dr. Andrews' comments are a little like parents who don't get their children vaccinated, and then benefit from the vaccination of all the other kids in the neighborhood.
  • "Researchers are claiming they don't have to report deaths from genetic studies, calling them 'trade secrets'" and "[s]ome companies are willing to put people at risk to have an advantage."  Unlikely to be true.  But even if it is, human testing is not within the purview of the patent system.  The Food and Drug Administration controls clinical trials, and human testing in a university setting is governed by several levels of review boards enforced by Federal granting agency oversight.  The University of Illinois hospitals lost all Federal funding several years ago because they hadn't maintained proper records (i.e., paperwork); it is irresponsible to imply that people are dying without any evidence that it is so.
  • "You don't even have control over your own tissue or blood once it's donated for research."  The falsity of this statement is evidenced in the very next line of the article: "What can the public do?  Read consent forms at the hospital and doctor's office, and specify that you don't want your blood or tissue used for patented genetic research."  If you don't want your DNA to be used to fight diseases, by all means refuse to consent.  But then don't complain that your particular illness is an "orphan" that no one is interested in.
  • "Gene patenting is like someone owning the alphabet and charging you each time you speak."  In reality, since gene patents are all limited to isolated and purified DNA, the information contained in DNA is freely available.  No gene patent owner can "charge" you for using the genetic sequence - which is the key to the scientific information contained in your genes - in any way you wish.  Paradoxically, the economic interest and value produced in permitting companies to protect their investment in genetic technology has had the consequence of producing the greatest increase in biological knowledge in history.  The information generated on genes from humans, primates, mice, dogs, cats, horses, cows, pigs and many other species, including both useful and harmful microorganisms, is provided without charge to any researcher, capitalist or homemaker having and interest and a computer.  It is the equivalent of having publicly-accessible the blueprints of every machine ever made.

The problem with the misinformation contained in these articles is that they ignore important limitations imposed by the patent system.  As mentioned, individuals cannot be patented.  Human "body parts" can't be, either, just like it is illegal to sell a kidney.  (Ironically, in one of Dr. Andrews' books she advocates people having a property right in their DNA.  By that thinking, there is no legal justification to prevent an individual from deciding to sell a kidney, since it is his or her "property.")  No one owns your genes, or anyone else's.

Moreover, the patent right is finite - it expires.  That's one of the beauties of the patent system, since it is a limited right, and one of those limitations is time.  Presently, a U.S. patent expires 20 years from its earliest filing date.  For many of the earliest gene patents, that day is or soon will be here.  For the vast majority of gene patents, expiration will occur by 2020.  The biological reality is that, given the immense number of new genes identified (and still being identified), and publication of the genetic sequences of these genes in databases around the world, patent protection will expire before we have determined the usefulness of most of human genes.

Just as in the generic drug debate, there is a balance to be struck between rewarding companies and universities that expend vast amounts of money, time and resources in discovering the genetic information necessary to produce a genetic test, and the cost of those tests to the public.  The answer is not to declare the underlying technology off-limits to patent protection.  That way leads to a real "tragedy of the commons" where no one has the economic incentive to develop a test that can be stolen by a competitor without compensation.  There are many ways to make testing available to those who cannot afford it; for those who can afford to pay, objections to paying for such testing is a fancy variant of "free-riding" on the time, efforts and accomplishments of others.  (At least those Americans looking for cheaper genetic testing in France can afford to support the airline industry in going there.)

There are many facets to the legal implications of the revolution in genetics, including many included in the "Genetics Bill of Rights."  It does a disservice to the civil libertarian aspects of the debate - freedom from discrimination, freedom from prosecution, privacy rights over having yourself or your tissues used in research - to conflate them with gene patenting.  It is even more of a disservice to reasoned debate on the topic to misstate the issues to make political or rhetorical points, particularly when those misstatements are willful rather than misinformed.  Gene patenting is not a scourge and does not impose undue burdens on the public.  In fact, it is an important contributor to results desired by all: better technology to provide better prevention and treatment for human diseases.  It is a shame that some will obscure the facts to sell books or make headlines.