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Jaisree Moorthy & Dennis Fernandez

Feb. 1, 2008 | In recent years, biotechnology has undergone a major paradigm shift, the focus moving from understanding nature to engineering nature. This new synthetic biology approach seeks to go further than biomimetics and transcend nature’s limitations by rewiring signaling and metabolic pathways in cells, potentially creating an entire organism from scratch.

These modifications coax living cells to function as factories for producing drugs, as scavengers to breakdown waste, as fuel cells or as computational and electronic units. Due to its diverse applicability, synthetic biology will impact many industries such as pharmacology, bio-energy, agriculture, and electronics.

The intellectual property (IP) portfolio — an essential component of any business including patents, copyrights, and trademarks — plays a key role in synthetic biology, as it addresses issues in biological systems as well as those of computers and electronic circuits and other forms of micro-machinery. Various biological parts, such as oligonucleotides, gene products, functions of the engineered system, simulation software and biomedical devices may be patented. Genomic-based patents straddle the thin line between definitions of natural and man-made; the argument in favor of synthetic biology is that the genes are entirely man-made.

The U.S. Supreme Court ruling in favor of patenting engineered organisms in Chakrabarty’s case in the early 1980’s set precedence for organism ownership. LS9 and Amyris Biotechnologies are some of the companies that have modified the genome of organisms to function as biofactories.

A recent challenge that arose was the patenting of engineered biological systems such as the patent filed by J. Craig Venter on the “minimal bacterial genome” (20070122826), which describes trimming the genome of the smallest known bacteria (Mycoplasma genitalium). This particular patent is in the limelight and under sharp scrutiny by the GeneWatch UK and Canada-based ETC Groups because the claims are very broad. A danger in any nascent field is that broad claims could be issued which would thwart further progress in the area because the patent owner now acts as a ‘gatekeeper’ and can monopolize the market.

Synthetic biology is now at the crossroads of IP-protected and open biology — analogous to the open source model in software engineering (e.g. Linux). Some of the drawbacks of IP protection in this field are high license costs, making it difficult for a start-up to thrive, and monopolization of information by a few companies. For example, Venter’s minimal genome patent application was described in Science last year as “the start of a high-stakes commercial race to synthesize and privatize synthetic life forms.” In addition, Venter’s plan to develop an operating system for biologically based software adds to the controversies in this area.

Shared Resources
In the open biology approach, scientists share engineered genetic codes, referred to as biobricks, through public domains (including the Registry of Standard Biological Parts hosted by MIT). The argument for this path is that biological tools and parts can be developed quickly without competition among the researchers and companies.

A concern against the open model is that there are no economic returns for developing expensive parts that involve long-term research resulting in quick fixes becoming the norm and the overall products suffering from quality assurance. A combination of IP-protected and the open model could address the issues in economic growth in synthetic biology.

One idea, proposed by J. Henkel and S. M. Maurer (TUM Business School and Goldman School of Public Policy at the University of California, Berkeley), is to reduce the duration of the patent so that the inventor is awarded the expenses incurred, after which, the inventor may deposit the biological part into the public domain and share with other researchers.

Recently, the Patent Reform Act of 2007 proposed changes that could adversely affect innovation and economy of this industry. For instance, the reform is not supportive of licensing the patent, especially when the patent holder is not involved in product development. This change will greatly affect universities that license the technology to industries and use the revenue to fund further research in this area.

Another drawback is that this reform act proposes to change to “first-to-file” policy rather than “first-to-invent,” which deters independent inventors from entering the market.

Synthetic biology promises novel ways to solve global health, food, and energy problems. But as with any new technology, synthetic biology presents potential dangers such as epidemics caused by engineered organisms and uncontrollable changes to the ecosystem.

Granting patents in ignorance of the above concerns could pave the way for an industry that could step over ethical barriers, both in context of society and in its relation to the environment. Synthetic biology is still in its infancy and therefore will require rules, regulations, and moral guidelines to help it mature into a full-fledged industry. 

Jaisree Moorthy, is at the Bioengineering Department, University of Pennsylvania & Dennis Fernandez is the senior managing partner of Fernandez & Associates LLP.

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 This article appeared in Bio-IT World Magazine.
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