JCVI Creates World’s First Genetically Engineered Self-Replicating Synthetic Bacterial

By Gene Quinn
May 20, 2010

J. Craig Venter, PhD., Founder, Chairman & President of JCVI

Researchers at the J. Craig Venter Institute (JCVI), a not-for-profit genomic research organization, recently published results describing the successful construction of the first self-replicating, synthetic bacterial cell. The team synthesized the 1.08 million base pair chromosome of a modified Mycoplasma mycoides genome. The synthetic cell is called Mycoplasma mycoides JCVI-syn1.0 and is the proof of principle that genomes can be designed in the computer, chemically made in the laboratory and transplanted into a recipient cell to produce a new self-replicating cell controlled only by the synthetic genome. This research will be published by Daniel Gibson et al in the May 20th edition of Science Express and will appear in an upcoming print issue of Science.

According to the Wall Street Journal, this synthetic, self-replicating, one-cell organism was created at a cost of $30 million, and will open the way to the manipulation of life on a previously unattainable scale. Funding for this research came from Synthetic Genomics Inc., a company co-founded by Drs. Venter and Smith. While the announcements do not mention patent applications or issued patents, the Synthetic Genomics website does clearly say that it has its own intellectual property portfolio and also has “exclusive access to new inventions and discoveries in synthetic genomics research developed by the JCVI under the Sponsored Research Agreement between both organizations.” Not that I begrudge anyone who invents, protects and exploits, but can you imagine the firestorm that a genetically modified, self-replicating, synthetic bacterial cell will cause among the anti-patent movement? Given that it would not exist without substantial human intervention, and funding, as long as this organism is new and nonobvious (which is seems like it must be)  it will be patentable. I can already picture the frenzy, and the foaming at the mouth!

[Bio-Pharma]

Here are some quotes from the scientists involved in the research, which were obtained through the Press Release issued by JVCI earlier today.

“For nearly 15 years Ham Smith, Clyde Hutchison and the rest of our team have been working toward this publication today–the successful completion of our work to construct a bacterial cell that is fully controlled by a synthetic genome,” said J. Craig Venter, Ph.D., founder and president, JCVI and senior author on the paper. “We have been consumed by this research, but we have also been equally focused on addressing the societal implications of what we believe will be one of the most powerful technologies and industrial drivers for societal good. We look forward to continued review and dialogue about the important applications of this work to ensure that it is used for the benefit of all.”

***************************

According to Dr. Smith, “With this first synthetic bacterial cell and the new tools and technologies we developed to successfully complete this project, we now have the means to dissect the genetic instruction set of a bacterial cell to see and understand how it really works.”

***************************

Dr. Gibson stated, “To produce a synthetic cell, our group had to learn how to sequence, synthesize, and transplant genomes. Many hurdles had to be overcome, but we are now able to combine all of these steps to produce synthetic cells in the laboratory.” He added, “We can now begin working on our ultimate objective of synthesizing a minimal cell containing only the genes necessary to sustain life in its simplest form. This will help us better understand how cells work.”

***************************

According to Dr. Hutchison, “To me the most remarkable thing about our synthetic cell is that its genome was designed in the computer and brought to life through chemical synthesis, without using any pieces of natural DNA. This involved developing many new and useful methods along the way. We have assembled an amazing group of scientists that have made this possible.”

I am smiling ear to ear.  You just couldn’t make this stuff up.  A team of humans creates genetically altered and a self-replicating synthetic cell using a computer.  I suspect that computer was running some pretty powerful and sophisticated software.  So the anti-patent crowd should be sufficiently whipped into a frenzy over this story top to bottom.  It hits all the hot button issues, life, genetics, software, ethics and it rolls them all into one.  But while we might relish the anguish of those in the anti-patent community, this type of scientific advance should not be taken lightly because it has the potential to fire up those with an anti-patent agenda and could also fire up religious groups as well.  The coming together of such strange bedfellows would result in an alliance with enormous political power.  So innovators need to pay attention and be vigilant.

JCVI believes that the knowledge gained by constructing this first self-replicating synthetic cell will give rise to wider use of this powerful technology. This will undoubtedly lead to the development of many important applications and products including biofuels, vaccines, pharmaceuticals, clean water and food products.  So this might just be a revolutionary, break-through technology that provides clean energy for the world, allows for the creation of targeted vaccines and drugs, and it might just be useful for feeding the planet and ending world hunger.  Of course, this is all well down the road, but such an fundamentally important technology will undoubtedly keep the anti-patent folks (who would prefer no innovation and an agrarian society) up at night!

Of course, there are ethical considerations. JVCI is continuing in its ongoing mission to drive and support ethical discussion and review. Starting back in 1995 the team’s work has undergone continual ethical review, first by a panel of experts at the University of Pennsylvania. Subsequently, JCVI’s policy team, along with the Center for Strategic & International Studies (CSIS), and the Massachusetts Institute of Technology (MIT), were funded by a grant from the Alfred P. Sloan Foundation for a 20-month study that explored the risks and benefits of this emerging technology, as well as possible safeguards to prevent abuse, including bioterrorism. After several workshops and public sessions the group published a report in October 2007 outlining options for the field and its researchers. Most recently in December of 2008, JCVI received funding from the Alfred P. Sloan Foundation to examine ethical and societal concerns that are associated with the developing science of synthetic genomics. The ongoing research is intended to inform the scientific community as well as educate our policymakers and journalists so that they may engage in informed discussions on the topic.

Dr. Venter and the team at JCVI continue to work with bioethicists, outside policy groups, legislative members and staff, and the public to encourage discussion and understanding about the societal implications of their work and the field of synthetic genomics generally.

I for one see no reason not to pursue development of new technologies such as this one. If the technology and resulting innovations are new, nonobvious and can be adequately described they should be patented. Those who seek to end scientific pursuit in the name of learned self awareness are neither learned nor self aware. They are no different than that litany of individuals and institutions that we rightly ridicule today as a result of their narrow minded approach to science, having persecuted some of the greatest scientific minds the world has ever produced.

The world is not flat and the Earth is not the center of the solar system or of our galaxy or universe. Evolution is a theory that makes sense and doesn’t need to remove God or any creator from the equation. Just because we can explain things that happen, notice that they are happening and accurately describe the physical and chemical phenomena occurring does not mean anything other than we are advancing our scientific understanding of the physical universe that surrounds us. We should not cut off at the base any scientific endeavors, which would be the case if patents are not available because despite what the anti-patent crowd wants to pretend Governments and Universities can only fund so much. Private capital, frequently lots of it, is necessary for at a minimum translational research and commercialization of innovations.

This innovation breathes new importance into the Bilski case and into the Federal Circuit ultimately reversing Judge Sweet’s decision invalidating the Myriad Genetics patents, which we all know they will do. The new battle will likely be the policy front, confronting the flat-earth society who at times are well funded in their lobbying efforts. In the meantime, as science advances and pushes the envelope into Jurassic Park territory we need to have open, frank and honest discussions as those occurring at JVCI and funded by the Alfred P. Sloan Foundation. A bunch of Chicken Little’s running around and assaulting the patent system and innovators is not helpful, particularly given the economic realities facing the international community.

The Author

Gene Quinn

Gene Quinn is a Patent Attorney and Editor and President & CEO ofIPWatchdog, Inc.. Gene founded IPWatchdog.com in 1999. Gene is also a principal lecturer in the PLI Patent Bar Review Course and Of Counsel to the law firm of Berenato & White, LLC. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 15 Comments comments.

  1. pop May 20, 2010 11:57 pm

    Of course patents are going to be an issue in all this, it wasn’t the first or even second thing to come to mind when I heard this story . I was taken back by the sheer awe such a discovery invokes. I’m much more concerned with the scientific implications of this than the economic implications.

    I think that Universities and other research groups should be exempt from patents on this issue. I have no problems with patents on this as long as it is limited to only those entities that are going to make money. I also don’t see the software being an issue or patentable for this kind of thing. I mean, there really isn’t anything to it probably that is new. Programs to store, manage, and manipulate DNA on the computer have been around for a long time. I’m not sure what the software would do that is all that special that software like it hasn’t done in the past.

    I’m sure there could be method patents to come out of this, but really the discovery here is that it works and that it self replicates and that is the part that is least likely to be patentable

  2. Mark Nowotarski May 21, 2010 6:46 am

    Synthetic Genomics patent and patent applications http://bit.ly/at51ku

  3. Mark Nowotarski May 21, 2010 6:48 am

    J. Craig Venter patents and patent applictions http://bit.ly/bbKRYE

  4. Blind Dogma May 21, 2010 10:07 am

    should be exempt from patents on this issue

    Why?

  5. Gene Quinn May 21, 2010 10:20 am

    POP-

    You say: “but really the discovery here is that it works and that it self replicates and that is the part that is least likely to be patentable”

    That is actually the most likely thing to be patented. Despite what Judge Sweet and the ACLU might want to think, this is even more clearly patentable than the Myriad Genetics patents relating to isolated DNA. In Diamond v. Chakrabarty the United States Supreme Court unequivocally held that a living human-made micro-organism is patentable subject matter under 101. So a living synthetic self-replicating cell will definitely be patentable subject matter unless Congress steps up and amends the patent laws, which has about as much chance of happening as snow in Hawaii.

    -Gene

  6. Bill Ralston May 21, 2010 12:05 pm

    Gene, while I agree that Congress isn’t anxious to make any amendments to the patent laws, it regularly snows on top of Mauna Loa & Mauna Kea on the big island of Hawaii.

  7. Gene Quinn May 21, 2010 1:36 pm

    Bill-

    Of course it does! LOL. What I was trying to do was come up with something that wasn’t impossible, just pretty darn remote. Maybe that is exactly the right analogy. The big island is pretty remote, and the top of those mountains even more remote. So if Congress were to do something to amend the patent laws it would be remote.

    OK… I tried. Thanks for keeping me honest.

    -Gene

  8. David Koepsell May 21, 2010 3:21 pm

    I completely agree, clearly it’s patentable as it doesn’t occur in nature. Who could disagree?

  9. Gene Quinn May 21, 2010 5:27 pm

    David-

    Just wait and watch. I would bet dollars to donuts that patentable subject matter will be under assault once again. While the Courts should easily get this one right there will be many who object to the patenting of this type of invention and will take their case to Congress. What an irony it would be if Congress would ignore the needs of innovators for so long and then take up a purely political matter.

    -Gene

  10. pop May 21, 2010 11:19 pm

    I have no problem with the specific methods they used to create this cell being patented, but a broader patent on any cells created artificially seems ridiculous as it is obvious. It isn’t obvious how to do it, so as I have said, the methods used should be patentable, but it isn’t like the concept hasn’t been around for a while.

  11. Blind Dogma May 22, 2010 9:29 am

    pop,

    It seems that you could be called a reductionist. That is, it seems that you think that patents should be reduced to only those things that completely break new ground.

    But patent law does not work like that.

    I think I may understand you more if you supply an answer to my question above: Why?

    I also think that you are misapplying the term “discovery”. That term is usually used when finding something existing in nature. the “item” here was not existent in nature. The theological implication here, while tremendous (Man joins God as creator of life), is subsumed entirely within patent law. Generally speaking, when such religious tenants are subsumed, people can get pretty upset – just ask Galileo.

  12. Gena777 May 24, 2010 4:27 pm

    Great minds think alike; I’ve been following this story and just posted my own version to PatLit. I’m wondering whether anyone has any information on the status of the ETC Group’s challenge to the patent on Synthia (that’s what this synthetic life form is nicknamed)? I find this issue fascinating — obviously, it could have far-reaching effects on patent law in general, the Myriad case in particular, and many other biotech issues … not to mention bioethics, the future of humankind, etc.
    http://www.generalpatent.com/media/videos/general-patent-corporation-helps-patent-owners-enforce-their-ip-rights

  13. David Koepsell June 1, 2010 11:26 am

    Venter altered the genome of this organism, omitting the pathogenic genes, making it engineered rather than a product of nature. I have long supported the patentability of engineered life forms. This differs from the Myriad case in which the patent is on a naturally-occurring genetic sequence, non-engineered, and non-altered. Synthia is an invention, although its current use is apparently only as a proof of concept.

  14. Skeptical June 1, 2010 12:35 pm

    Myriad case in which the patent is on a naturally-occurring genetic sequence, non-engineered, and non-altered.

    David Koepsell,

    Kevin Noonan over at Patent Docs would like a word with you.

    Actually, I think that he would like you to actually read his words already shared on the subject. He has explained in detail and with rather nice graphics just why the Myriad case exhibits engineered and altered subject matter.

  15. David Koepsell June 1, 2010 3:38 pm

    Skeptical

    Yes, Kevin and I have sparred plenty. He’s wrong, IMHO, and the thousands of actual scientists who agree with me on the matter think likewise. I’m not interested in rehashing that debate here or elsewhere. It’s old hat. Now, let’s see what the courts say on that. Suffice it to say that Synthia is clearly engineered, no question.

    Best,
    David