By Jaydee Hanson, Eric Hoffman

Synthetic biology - the design and construction of new biological parts, devices and systems that do not exist in the natural world and the redesigning of existing biological systems to perform specific tasks - will bring the next wave of patents on living organisms. Synthetic biology not only poses new challenges to biosafety and biosecurity but also to our patent system. Discussions on gene patents must include synthesized DNA lest technology again jumps ahead of our patent system and we spend decades trying to play catch-up.

Instead of inserting genes from one species into another, what is considered "traditional" genetic engineering, synthetic biologists claim that they aim to "create" life from scratch with computer-synthesized DNA or without the use of DNA entirely. Much of what is called "synthetic biology," however, does not achieve this level of change.

Nonetheless, in May 2010 J. Craig Venter and his team announced they had "created"   the world's first organism with a synthetic genome. The success of Venter's team may be more in the area of patents that will apply to his new techniques than in actually having "created" synthetic life.

Dr. David Baltimore, a leading geneticist at Caltech, described the work to the New York Times as "a technical tour de force" but not breakthrough science, but just a matter of scale ... He has not created life, only mimicked it."

The Venter team could not get the cell to reproduce without placing the synthetic genome in a preexisting cell, which was naturally inclined to make sense of the transplanted DNA and to turn genes on and off. In effect, the bacteria did what they have done for eons: swap DNA.

Still, this was the first time much of the public had heard of synthetic biology and was a wake-up call to many that current regulations around biotechnology are already outdated. Unfortunately, while Venter's team may have only copied the genome of a goat pathogen, their intellectual tour de force includes patenting each of the steps in the process that they used to make the copy. Nobel Prize winner, John Sulston, has argued that Venter is interested primarily in patenting the process to exclude 'free research' by others.

In 1980, the Supreme Court ruled in Diamond v. Chakrabarty that genetically engineered life forms could be patented. The case was referring to more traditional genetic engineering (in this case, bacterium that was engineered to eat crude oil), but the court's ruling will undoubtedly be extended to the products of synthetic biology. The ruling states "...the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature's handiwork, but his own: accordingly it is patentable subject matter."[4] Venter's inclusion of additional DNA to mark the synthetic genome as his own is an additional step that makes clear that his 'invention' does not exist in nature.

Since then patents on naturally occurring genes and DNA sequences have been granted, despite the Court's clear message that naturally occurring DNA is not patentable. Currently, over 20% of the human genome has been patented as well as thousands of plant, animal, virus, and bacteria DNA sequences that have naturally evolved over billions of years but were pulled out of the commons into private hands through patents and intellectual property rights. The U.S. Patent and Trademark Office currently argues that the mere act of "isolating" DNA is an inventive step worthy of a patent. While the Department of Justice has argued in a brief to the court that merely isolating DNA is not sufficient for a patent, the Venter team's work goes beyond isolating DNA to actually writing the sequence and getting it to "boot up" (their words!).

Now, with synthetic biology, mere "isolating" is not even necessary. One could theoretically upload a DNA sequence onto a computer, "print out" an exact copy of that DNA sequence, and patent the synthetic DNA sequence as an invention. Less theoretical-and with many more commercial applications-is creating copies of natural DNA and making slight tweaks to the genome as the inventive step worthy of a patent. In effect, synthetic biologists are able to "evolve" organisms through computer algorithms and create novel DNA sequences that can be then be "printed" out and inserted into an organism.

Patents have already been granted on many of the processes and products involved in synthetic biology, including patents on methods for building synthetic DNA, synthetic genes and DNA sequences, synthetic pathways, synthetic proteins and amino acids, and novel nucleotides that replace the letters of DNA.

For example, in 2007 the J. Craig Venter Institute applied for a frighteningly broad patent of its "minimal bacterial genome" called Mycoplasma laboratorium. This organism was an attempt to create life with the minimum number of genes by cutting out as many DNA sequences as possible without removing its ability to reproduce or survive. U.S. patent numbers US2007 0264688 and US2007 0269862 describes creation of the first-ever, entirely synthetic living organism-a novel bacterium whose entire genetic information is constructed from synthesized DNA (but whose genome is a near-replica of a naturally occurring genome).

This patent claims exclusive monopoly on the genes in the minimal bacterial genome, the entire organism made from these genes, a digital version of the organism's genome, any version of that organism that could make fuels such as ethanol or hydrogen, any method of producing those fuels that uses the organism, the process of testing a gene's function by inserting other genes into the synthetic organism, and a set of non-essential genes. These patents are not restricted to any specific cell type-it currently applies to prokaryotes and eukaryotes - or size of a synthetic genome.

While these patents have yet to be granted, the claim shows the extent to which some synthetic biologists are testing the limits in the battle to control the fundamental building blocks of life and actual living organisms. While it is likely this specific patent application's scope will be limited to cover only bacterial cells, such a patent would still grant Venter and company an exclusive license to create synthetic fuel-producing bacteria and the tools to create such organisms. Conveniently, Venter's company, Synthetic Genomics, has contracts with both Exxon Mobile and BP to produce "next-generation" biofuels from synthetic cells (or at least genetically engineered cells that contain synthetic DNA sequences).

Amyris Biotechnologies is a synthetic biology company that used genetically engineered yeasts that contain synthetic DNA to break down sugarcane to produce isoprenoids-which are then being converted to biofuels, industrial chemicals, among other products. Patent US 7,659,097, granted to Amyris in February 2010, covers the production of many different isoprenoids created though a number of different microbes. Amyris already has deals with major oil and chemical companies to turn Brazilian sugarcane into high-value commodities. Again, Amyris' "biosynthetic pathways" are near-copies of metabolic pathways found in nature with some "tweaking" of the DNA pathways to allow the yeast to do some things that traditional genetic engineering could not accomplish.

The novel challenge created by the emerging field of synthetic biology is that not only can natural or synthesized DNA be patented, but the processes used to synthesize DNA and create synthetic organisms can also be patented. Furthermore, the living organisms created with synthetic DNA are covered in these patents, as are the products they are engineered to produce.

Take Amyris as an example again. Through their patent, they own the process of engineering microbes with their synthetic DNA, the synthetic DNA, the microbes themselves, and any products the microbes produce. If these microbes escape and contaminate wild-type relatives, their synthetic DNA could pass on and Amyris would theoretically own those new microbes that have been contaminated with synthetic DNA.

There is a significant battle going on here. At stake is whether the knowledge of how life works at its most basic level should be a common property of all, or whether it should be controlled by a few. This is nothing short of intent to further own and control the building blocks of life.

What must be done

While it is clear to us that current court rulings would likely support the patenting of synthetic genomes as developed by Venter's lab and other researchers, Congress should prevent the patenting of DNA sequences that simply copy naturally occurring DNA. To do otherwise would in effect allow another way to patent natural occurring organisms and their DNA-just make synthetic copies of them. That is in no one's interest but the patent holders'.                                                  

Eric Hoffman is Biotechnology Policy Campaigner with Friends of the Earth U.S.

Jaydee Hanson is Policy Director with the International Center for Technology Assessment.

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