Will patents give Craig Venter a monopoly over synthetic life?

So Craig Venter has created the first synthetic cell, but should he be able to patent it? The short answer is yes. But his patent applications are too broad.
Written by Boonsri Dickinson, Contributing Editor

When I met J. Craig Venter last year, he talked about how he was close to creating synthetic life.

Even then, I could sense his anticipation of making this very announcement:

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.

His track record after all is remarkable — he was one of the pioneers in the quest to sequence the human genome a decade ago.

I knew that the synthetic life feat would happen. It was only a matter of time.

There’s been some discussion over what to call Venter’s discovery because labeling it "artificial life" might scare the public — as it ultimately changes our fundamental understanding of what life is.

Some people have asked him why he is playing God (simply saying this makes me cringe). Others have downplayed Venter's invention — saying he has not created life from scratch, therefore it can not be considered an artificial life-form. Well that's true, Venter created an organism with a synthetic natural genome inside of a bacterium called Mycoplasma mycoides.

It may seem trivial, but the name and classification of this synthetic cell matters. Just as careful descriptions have been made in stem cell research, in calling early stage embryos "blastocysts" and "pre-embryos". How people classify Venter's synthetic cell will influence how it is accepted into society and how much opposition it attracts.

Life might have been like a box of chocolates for Forrest Gump. But for Venter, life is like a computer -- and some chemicals that you can string together and watch self-replicate.

The process isn’t quite that simple, clearly as it took Venter’s team at J. Craig Venter Institute 15 years to get it right. And even now, he’s only inserted a synthetic genome into one type of bacteria. The price tag of the research was on the order of $40 million.

This modified version of the naturally occurring bacterial genome looks like the real deal to microbiologists, only DNA sequencing would expose it as synthetic, Venter told The Wall Street Journal.

Indeed, it is the first self-replicating, synthetic bacterial cell. More importantly, this discovery could be used to fuel the alternative energy sector and enhance vaccine development.

Once you accept at the fundamental level what Venter's synthetic cell has taught us about what life is, the potential industrial applications include producing algae that could consume carbon dioxide and produce oil.

Microorganisms "have the potential to provide all the transportation fuel we need in the U.S.," Venter told Businessweek. "I joke that I'm going from the gene king to the oil king."

This translates to a potential jackpot of money. Not surprisingly, Venter filed a few patent applications for his invention.

After DNA was removed from a bacterium, Venter’s team inserted it with synthetic DNA — and it replicated with more than a billion copies. This self-replicating ability is critical to life.

This is a big deal because it fundamentally shows that life is the result of chemicals reactions — all you really need is a computer, a bacteria, a DNA synthesizer, and four chemicals.

“Copy the chemical code that controls cell reproduction – the equivalent to a computer's software – put that code into a cell, and voilà! The cell reproduces itself. It is alive. And if it works for the cells of bacteria, it will work for our cells, too,” Alasdair Palmer wrote in The Telegraph.

The patent applications are publicly available here. Venter filed two patent applications in the U.S. in 2005 — US2007 0264688 and US2007 0269862 — but they were published in 2007. This is typical of the patent system. There’s usually an 18-month lag time between the time a patent is filed and when it is published.

The first patent application relates to inserting a synthetic genome in a cell, says patent attorney Gordon Wright at Elkington and Fife LLP. “It is fantastically broad. It is not restricted to cell type and it is not restricted to the size of the genome. And it applies to prokaryotic and eukaryotic organisms,” Wright says.

Furthermore, it would be "mind boggling" if it were allowed, but it won’t be, says Wright. The whole patent process is transparent, he adds.

Wright explains that “the two families are based on WO 2008/024129, Synthetic Genomes and WO 2008/016380, Installation of Genomes or Partial Genomes into Cells or Cell-like Systems. Neither of these two patent applications has yet been granted by either of the US PTO or the European Patent Office (EPO). Examination, is however, underway. The process is entirely open to public inspection.”

“When I was a child, people used to make bead necklaces. I’m sure if your parents bought you a million beads, you would have made a necklace. You’d have a necklace day. But the better thing to do is invite your friends over and make necklaces with 1,000 beads and then pop them together. It’s how you stick it together that matters,” explains Wright. "That is what it seems Venter is claiming in the first of his applications. When it comes to making long stretches of DNA, that technique is not new."

“Venter isn’t entitled to [claiming] anyway to make a synthetic cell. If somebody invented the wheel that would have been pretty inconvenient. Venter invented [the equivalent of the] modification of the wheel. But at the moment he is claiming the wheel. I don’t think he will get these broad claims. Although, he might a patent to his modifications,” he adds.

Don't worry, Venter’s patent applications will likely be reduced in its scope before the patent is granted and probably be limited to a bacterial cell.

The thought of Venter patenting this process leaves a bad taste in professor John Sulston's mouth. Which is not all that surprising because Sulston has a long beaten history with Venter as they both raced to sequence the human genome.

Venter led the private sector and championed charging to obtain data about the human genome, but The University of Manchester’s Sulston was part of the public effort and wanted the information to remain public and available to scientists.

Now Sulston has warned that granting Venter's team a patent on their synthetic cell would stifle research in genetic engineering.

"I've read through some of these patents and the claims are very, very broad indeed," professor Sulston told Pallab Ghosh at BBC News. "I hope very much these patents won't be accepted because they would bring genetic engineering under the control of the J Craig Venter Institute (JCVI). They would have a monopoly on a whole range of techniques."

In many ways, if Venter’s patent applications are granted, it would mirror the patent granted for gene splicing. The 1973 gene splicing discovery launched the biotech industry and also brought in $200 million in royalties for Stanford and the University of California at San Francisco.

“[The gene splicing patent] didn’t restrict research and the owners of the patent had a pragmatic licensing policy,” says Wright. Generally, the patent system is there to reward people who make a full disclosure of a new and useful invention, by giving them the right to stop others from using that invention for up to 20 years.

“This system will not always get it right, but it is becoming more and more transparent. I welcome the role that the public can play in making sure that the patent system delivers what it sets out to do – to provide an incentive to make new and inventive products and processes,” says Wright. “Without such incentives, much of commercial research might dry up – and society will lose out on new medicines and new diagnostic tests.”

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