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.

Comments

[Tim]

Well said Kevin -- I couldn't agree more. If you haven't already, I suggest sending this to the editors of Parade magazine and the article's author.

[Mark Banner]

I'm glad you wrote this. We need people to continuously push back on those who distort the patent system and its impact on society.

[crs]

There's certainly a danger in misguided attempts to vastly oversimplify complex issues for public consumption. Happens often in the occasional news article about things patent. A whole lot more people read Parade than this blog. Also, most people are unwilling or unable to spend a lot of time gathering information and thinking about it. By all means contact Parade - but if the eds publish your correction letter, make sure to keep it as simple as you can!

[bert]

Genes are not inventions. A simple and formal argument.

[I.P. Occasionally]

bert: To me your argument is a bit too simple (or too formal?). What is your opinion about plant-based drugs that are useful for treating various medical conditions? They exist in a plant, so maybe one could gnaw on its bark or leaves and realize some beneficial results. But what about someone taking the time and effort to purify and isolate the active compound, characterize it structurally, characterize it mechanistically, and provide it to the public as a pure, more safe (thanks to the FDA), more effective, and more accessible drug formulation? Can't that be considered an invention? Doesn't the public derive some benefit from that work?

To me, that situation is clearly similar to the state of gene patents. Kevin took time and effort to lay out the argument in favor of gene patents, and to reply to his article with a conclusory statement does nothing to persuade people to your side of the issue.

[Ted Lemon]

No offense, but you haven't actually said why gene patents are good. You've said why they aren't as bad as these articles claim, and you've asserted that "my genes" aren't patented, but you've said nothing to support that assertion - to draw a clear distinction between what can be patented and what can't.

You've asserted that the ability to patent genes has provided incentives for developing better gene sequencing technology, which may well be true, but you haven't said why people were motivated to support development of these tools - only that they had a financial incentive.

"Why" is an interesting question. In order to engage in informed debate on this topic, it is necessary to consider both the pros and the cons. You seem to be saying there are no cons. Is that really what you think?

[Kevin E, Noonan]

Ted:

Well, I did support the statement that "your" genes aren't patented, when I said that a gene must be "isolated" or "isolated and purified." Your genes are where they have been since you were conceived, inside your cells in your body. My point was that many authors raise the red herring that somehow a patent holder would lay claim to "your" genes as a dishonest way to raise the emotional temperature of the debate. Nothing could be further from the truth.

As to whether gene patenting is a "good" thing, I wonder if you are old enough to remember when the US was depicted as an aging, rust-belt wreck that would soone be surpassed by those gleeming new post-WWII economies. Didn't happen, and one of the reaons (certainly not the only one) is that those countries were very slow in permitting biotechnology patents to be granted. (In fact, there is a University of Sussex report issued recently thar points out that both Europe and Japan still lag very far behind the US in gene patenting.)

In addition, if you look at any financial page regarding big pharma, where are they going for new drugs? Biotech companies, who in many instances have been able to protect their franchise and obtain the funding they needed to survive and continue their research.

Moreover, a great deal of "gene" patents come from the university, and universities have been able to obtain licensing fees (that they use for many other things, including new research) from commercial ventures. Prior to 1980, this work would have been expropriated free of charge by companies (foreign and domestic), to all our detriment.

And finally, companies like Amgen and Genentech have provided drugs that otherwise would have been unavailable (Epogen, TPA, human growth hormone, human insulin) if they had not been able to protect the genes that were the bases for producing these drugs.

Thanks for the opportunity to clarify.

[tyrone brown]

People shoulnt be alowwed

[tyrone brown]

People shoulnt be alowwed

[tamz]

hi i would like to know where do the good genes come from when they get rid of the bad one because they say they will replace it with a good oe but where does come from also can someone sell there good genes like if they had good eye sight can they sell that good gene if so then where thankyou.

[Jack]

Let's say pharmaceutical company A gets a patent on the genes for a form of cancer. what happens if pharmaceutical company B wants to research said cancer, taking a different approach to dealing with this cancer? Is B allowed to do their research unhindered, allowing them to come up with solutions that A never would have thought of (that they can then patent), for the betterment of mankind? or does A have a monopoly on this cancer now?

[Kevin E. Noonan]

Dear Jack:

Good question. Here is the answer (with the understanding that we are dealing merely with a claim to an isolated gene).

Company B would need to identify a tumor or a tumor cell line that expressed the gene. This wouldn't require isolation of the gene, merely identifying the gene's expression. So far, so good. Then, for example, Company B can test compounds to find ones that cause the expression of the gene in the cells to decrease. Again, no need to isolate the gene to do that. Finally, Company B would do studies in animals (perhaps bearing human tumors) to see if treating the animals with the compound reduces tumor growth etc. Again, no need to isolate the gene. Conclusion: no inhibition on cancer research.

Now, there may be other claims that might be a problem, but that's where the debate goes off the tracks a little - this post was concerned with gene patent claims themselves, which have been important in developing biologic drugs, for example. There may be arguments for or against other types of claims, but the arguments raised against claims on isolated genes are, as I say in the post, simply wrong.

Thanks for the comment.