Patenting life

An American biologist's race to create artificial life raises knotty ethical questions.

In the last 18 months or so, articles about "synthetic biology" have started to appear in scientific journals and been noted in the media. The most recent report is on American biologist Craig Venter's laboratory's efforts to "create" a life form with the minimum number of genes consistent with life.

Mr Venter is stripping down the genome of a living bacterium called Mycoplasma genitalium by removing its genes, one by one, to identify the essential components of its genome, without which it would be dead. He's reduced a 482-gene bacterium by 101 genes and with 381 genes it's still alive and able to replicate.

This kind of science fits within a new area being called "synthetic biology." It is not clearly defined, but involves applying engineering techniques to the elements of life forms to "build a better bug" or, even eventually, a higher animal.

The goals of synthetic biology include modifying or transforming biological systems by building them from the bottom up. Scientists want to make the design of life forms more predictable, like the design of a bridge. One of them put it this way: "We're talking about taking biology and building it for a specific purpose, rather than taking existing biology and adapting it... We don't have to rely on what nature's necessarily created."

I believe that we do not own life; rather, life owns us. That means there are ethical limits on what we may do to change life, in particular human life, and that we must hold life in trust for future generations, which also places limits on what we may do to life. Patenting life forms is inconsistent with the deep philosophical roots on which that view is based.

Synthetic biology can also encompass engineering from the top down, for instance, to identify the genes essential for life as Mr Venter is doing. (At this stage, we can only guess whether building up to the same 381 genes from scratch would result in the same living bacterium.) As well, some people see putting a gene from one species into another species as a "simple" form of synthetic biology, or even just splicing and recombining DNA.

So, turning to the ethics of synthetic biology, the primary, overriding question is: Should we be doing this at all?

Utilitarian-based ethicists would start their analysis in response to that question by asking whether the benefits outweigh the risks and harms.

As a principle-based ethicist, I would first ask another question: Is undertaking synthetic biology inherently wrong? That leads to yet another question: What does respect for nature, the natural and life require that we not do with synthetic biology, that we could do?

I don't believe using synthetic biology to fiddle around with bacteria, as Mr Venter is doing, is inherently wrong. (Whether it's ethical requires further analysis.) I'm much less certain of that if scientists were trying to create higher animals, especially ones that could never exist in nature. And I think it would be inherently wrong to use synthetic biology to try to create a "human entity." But what would constitute doing that?

For example, we share 98 per cent of our genes with a chimpanzee. If we engineered those "shared" genes, would we be dealing with chimps or humans? Is that determined by the gene’s source, whether chimp or human? Or is a critical factor the nature of the DNA that we use -- for instance, is that which codes for human brain cells different from that which codes for our hair?

Strong ethical objections have been raised with respect to putting DNA that codes for human brain cells into mice, with the resulting possibility the mice could have some form of human consciousness.

Let me be clear that I think it is inherently wrong to design a human. The question I'm addressing here is: What limits does the ethical prohibition of designing humans place on our use of synthetic biology?

Moving on, if what we plan to do using synthetic biology is not inherently wrong, the question for both principle-based and utilitarian-based ethicists becomes the same: Do the benefits and potential benefits outweigh the risks and harms? There is powerful disagreement in this respect, including as to what constitutes harms, risks and benefits.

Apart from the safety concerns raised by synthetic biology in general, including the accidental release of a novel virus or other infectious agent to which animals or humans would have no natural immunity, one of the really big worries is the so-called "dual use" dilemma. Like some other new technoscience, synthetic biology could be used, not only to advance beneficial scientific and medical knowledge, but also to deliberately inflict unprecedented harm. For instance, bio-terrorists could use it intentionally to create epidemics.

Synthetic biology has been used already to create a polio virus from scratch and to reconstruct the 1918 influenza virus. An example, often discussed in relation to possibilities for using synthetic biology for bio-terrorism, is smallpox. The smallpox virus is now extinct in the world except for two samples held in high security. But it could be constructed through synthetic biology.

And what if that virus were altered in some way to dramatically increase its lethality or contagiousness? Australian scientists working on mouse-pox virus (which is closely related to smallpox) to try to develop a mouse contraceptive, made a change to the virus that, to their surprise, made it lethal to all mice infected with it. They said that creating a vaccine to protect against the altered virus would be very difficult. Whether this research should be published was a matter of extensive debate, because of fear of its being used for bio-terrorism.

Such possibilities have added a new lexicon of terms to our language, for instance: bio-security; bio-safety; bio-defence; bio-warfare; and bio-weapons. The latter could include the horrific possibility of organisms that would uniquely target and harm certain racial or ethnic groups, leaving others unaffected. Other possibilities, such as inserting hyper-aggressivity genes, from an animal source, in human embryos to breed fearless soldiers, have also been discussed.

So, if scientists are going to proceed with synthetic biology, what sort of oversight and regulation are needed? How can we ensure that wisdom and accountability prevail?

Again there is strong disagreement. Scientists and industry want self-regulation and have been proposing codes to safeguard the research and its uses. Environmental and other lobby groups, concerned about potential harmful uses of the new synthetic biology, want external controls and not, as they perceive it, "the foxes guarding the hen houses." This debate continues today.

Finally, what about Mr. Venter's attempt to patent the "products" that result from synthetic biology? Quite apart from the general benefits and harms of patenting, to the extent that synthetic biology becomes a highly profitable, large-scale industry, it will be much more difficult to limit and control. We need only look at the "fertility industry" and its massive growth worldwide in the last five years (US$5 billion annually in the United States alone), to see a directly analogous example of that.

Taking Mr Venter's current research as an example, questions that patenting would present include whether reducing an organism's genes to the minimum necessary for continued life is a patentable invention? Has Mr Venter created a new life form or is this just a wounded or depleted Mycoplasma genitalium bacterium?

Or what if we were to make an exact copy of existing, natural DNA from the ground up? Did we invent that DNA or just copy the original? Or what if we start from chemical molecules and make DNA that we combine as genes that result in a never-before-seen living entity? That is probably an "invention" -- maybe a "creation" -- even though we didn't create the inanimate molecules that made up the DNA. But should these entities be patentable? That depends on our philosophy about the nature of life.

I believe that we do not own life; rather, life owns us. That means there are ethical limits on what we may do to change life, in particular human life, and that we must hold life in trust for future generations, which also places limits on what we may do to life. Patenting life forms is inconsistent with the deep philosophical roots on which that view is based.

For instance, patents apply to property and its ownership and control. Life is not property and should not be treated as such by patenting it.

Respect for life requires that it be "hors de commerce." Patenting life commercialises it and therefore breaches the required respect. That said, techniques that can be used to intervene on life may be patented, provided of course that the interventions they make possible are themselves ethically acceptable.

To conclude, synthetic biology faces us with three interrelated, major ethical questions, which will be among the most important we will need to address, not only in relation to synthetic biology but also in general, in the next decade or two:

* How can we develop an ethics of uncertainty? We make many ethical mistakes because we are frightened of uncertainty and try to convert necessary uncertainty to certainty, instead of applying wise ethical restraint in the face of uncertainty. We must learn to face and live more comfortably with uncertainty, if we are to avoid such mistakes. And we need ethics to help us to do that.

* What does an ethics of potentiality require? What are our obligations to future generations to hold life and our world in trust for them? In deciding what we will and will not do with the new technoscience, we must ask ourselves: Can the future trust us?

* And what does an ethics of complexity demand? We are the first humans to have the extraordinary powers science has placed in our collective human hand to change life itself. With great power comes great responsibility. Fulfilling that responsibility will require an ethics of sophistication, depth, insight, creativity, imagination and complexity equal to those same characteristics in the science it addresses.

Together, these three ethical inquiries can help us to build a comprehensive ethics of responsibility.

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Comments (8)

Michelle Martin said...

I really appreciate the articles that Ms. Somerville has written on bioethics-- it helps to equip oneself to discuss these issues intelligently and with reference to current research.

Canada | Friday, 22 June 2007 at 2:54 am

Teen from Ontario, Canada said...

I think that synthetic biology is a great and interesting idea, and building stone for the future. Nature has clearly already done some fabulous and miraculous work, so it is not all to be messed with, but after all, we as humans are apart of nature too, so i think it is ok for us to experiment and try to make things better if we could, just as long as we dont ruin any of natures perfect balances, or take an animal out of the food chain, because doing that would have many consequences.

Canada | Friday, 22 June 2007 at 4:28 am

MTM said...

“I don’t believe using synthetic biology to fiddle around with bacteria, as Mr Venter is doing, is inherently wrong. (Whether it’s ethical requires further analysis.)”

I would love to hear more about this aspect of your thinking…

“And I think it would be inherently wrong to use synthetic biology to try to create a “human entity.” But what would constitute doing that?

For example, we share 98 per cent of our genes with a chimpanzee. If we engineered those “shared” genes, would we be dealing with chimps or humans? Is that determined by the gene’s source, whether chimp or human? Or is a critical factor the nature of the DNA that we use—for instance, is that which codes for human brain cells different from that which codes for our hair?”

This seems a problematic line of reasoning for principle-based ethics, does it not?  What do we make of the starting point of this line of inquiry, when we note that it precludes an immaterial animating principle for “human entities”?  That is, would it not be a materialist argument to try to discern the human on the basis merely of genes--at least while this is still theorhetical (which I suspect it may always remain)? 

Also, it would seem that “genes” would need to be teased out with respect to inserting them into mice: are these “genes” part of someone who was or is someone or are they an manufactured copy of a gene pattern?  Is that even possible, or must we always harvest genes from a human person?  If that is the case then I see the point, but if there is some method of photocopying genes, then what problem would there be with inserting them into mice IF the material does not dictate the IS-ness of the entity?  Is there something intrinsic about human-like (not human, of course) genes that they can’t be experimented with?  Or is it the dignity of the species of mouse that would then be the concern?

My head is, as you can read, swimming…

United States | Friday, 22 June 2007 at 7:38 am

Silvername said...

Its ok to genetically engineer a plant or animal to make it better bigger or tastier( like rice or chickens)

But to make entirely new lifeforms, that is just plain old playing-god.

And that is immoral and must never be allowed or tolerated.

The mad -scientists still haven’t gotten over their god-complex, they are no better than satan and the other demons who fancied themselves gods.

There is no god other than the one true God, Our Father in Heaven.

These mad scientists should stop wasting time talent and money trying to make new lifeforms and should just make good use of their time talent and funding by maker bigger tastier and faster growing food, like shrimps, lobsters etc.

Philippines | Friday, 22 June 2007 at 1:28 pm

auntdottie said...

Man is a tinkering animal.  Curiosity leads us to try many things, just to see what will happen.  Tinkering with life can lead to improvement or devastation, healing or a living hell.  We are manufacturing babies in test tubes and may soon grow them in artifical wombs and raise them with robots.  I wonder how that will turn out...and I worry.  Already much of our foodstuffs are genetically modified and we buy and eat them, not knowing what they will do in our bodies.  The plants grow bigger, are disease-resistant in the fields, but - where are the long term studies as to their effect on humans?  Why are the bees disappearing?  Maybe the nectar from genetically-modified plants doesn’t agree with them???  It’s probably because of SOMETHING man is doing, but no one knows what.  I worry. We tinker with God’s work, trying to do it better.  Can we?  Should we?  We need serious prayer.

United States | Sunday, 24 June 2007 at 6:14 am

meso said...

Dear MTM,
I must say that your obervation :

“This seems a problematic line of reasoning for principle-based ethics, does it not?  What do we make of the starting point of this line of inquiry, when we note that it precludes an immaterial animating principle for “human entities”?  That is, would it not be a materialist argument to try to discern the human on the basis merely of genes--at least while this is still theorhetical (which I suspect it may always remain)? “ is highly thought provoking. Once more we’re before the problem of scientifically verifying that there is more to man than molecules of carbon, hydrogen and oxygen. If this trascendence argument is true, then whatever is done with material components of man shouldn’t be of much worry then, should it?

But then again man is such an intimately united being of these co-principles -body and soul- that it is practically impossible to say where in the continuum we are when handling such biological pieces as are genes, reproductive cells, etc. When can we say with all certainty that we are handling biological bits that are only and solely material and absolutely discontinuous with ‘humanness’?

Behold the problem.

This fear alone, is more than enough, in my opinion to halt all such limit case investigations until things are a bit clearer. No risks are worth the grave disorder that they could cause.

Nigeria | Monday, 25 June 2007 at 3:31 am

Tim Roberts said...

Oh dear!

Clearly, modern biotechnology raises ethical questions.  Some of the answers are (should be) straitforward.  Others are difficult.  Raising non-questions`spreads confusion.

You can’t patent ‘life’.  The first and most important requirement to patent something is that it be new. Life has been around for maybe three billion years - make that 6000 years if you’re a biblical literalist.  Either way it isn’t new.

Can you patent particular new lifeforms (and if so, should you?)?  Why not?  Because it’s wrong to own them?  But we’ve been owning lifeforms since the dawn of history.  Domestic animals, seeds and harvests were among the first property owned by anyone.  If we can own these, why not other forms of life?  (Not that patenting something means you own it, exactly, but it gives strong exclusionary rights). 

It sounds well to talk about ‘life owning us’, but what does it mean, if anything? I fully agree with the conclusion, that there are limits to what we can do with living organisims (humans particularly) but it hardly follows compellingly from a dubious premise.

But should we allow patenting of things that might be used for evil ends? Yes, absolutely!  All innovations can be used for evil ends (from fire to nuclear fission).  Nearly all can be used for good as well.  You can rarely tell in advance whether the evil will outweigh the good - neither side of the equation is foreseeable (or for that matter necessarily calculable, even with hindsight). 

This needn’t mean that everything should be patentable regardless of ethics.  We shouldn’t allow patenting of seriously evil means.  But then we shouldn’t allow any other uses of seriously evil means, either.  And we shouldn’t ask Patent Offices to decide what is so seriously evil that it shouldn’t be allowed.  They don’t have the neccesary experience or training.  Who does? It’s particularly difficult when we don’t have agreement in society about what are serious evils and what aren’t.

United Kingdom | Monday, 25 June 2007 at 4:20 am

Ikechukwu Odibo said...

The diversity of human interest is such a curious thing. Man has not solved the problem of hunger and poverty and is fiddling with synthetic biology. I can neither see the head nor tail of such a research, judging from the wisdom of hindsight. Since it is impossible to determine to what end man would put the fruits of such researches, the wisdom of hindsight suggests that it be discontinued. Those who researched on nuclear/atomic bombs probably wanted it a merely an academic breakthrough but invariable the wickedness of man put it to use and we all are witnesses to its untold adeverse effect on man and how it has made the world most unsafe by fuelling terrorism. Like all vices the synthetic biology research rather than solve the problems of man will add to the already worrisome heap. Whether man will survice the next humdred years is a question reasonable people are beggining to ask, amd here I renew it with an urgency invited by the on-going but unwanted synthetic bioligical research.

Nigeria | Monday, 25 June 2007 at 4:23 pm

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