Section 18.3. Open Source Biology

18.3. Open Source Biology

With present pharmacoeconomic trends unlikely to change in the immediate future, the path toward a sustainable drug industry remains as elusive. There is also a widening understanding that today's pharmaceutical companiesfocused on disease managementmay not have consumers' best interests in mind. Today there are few incentives for companies to improve any drug (at least until patent protection nears expiration) or to develop biological technologies that might lead to either prevention or cure.

In this light, some have begun to openly question whether there are other viable paths to drug development. At the heart of alternative routes is IP management. Since the passage of Bayh-Dole, scientists have been presented with two options for sharing research: publication; or patent and license with optional publication. The latter choice, heavily favored for discovery with commercial potential, has resulted in the current biotechnology industry. The alternativeopen, unrestricted publicationhas never been seriously considered a path to commercial development in the life sciences.

Now, open source, mainly used to develop computer software, has yielded strong evidence that open development may in fact be economically viable. OSS projects, including the Linux operating system and Apache Web Server, have become prominent examples that open strategies can result in robust, commercial-grade offerings. Open source has also emerged as an economic force, resulting in the formation of new companies like Red Hat, or adding revenues to the top line of others, like Sun and IBM. This success has encouraged speculation that similar results could be produced in biological development, if OSB could be made to work.

Recently, lawyers Stephen Maurer and Arti Rai and computational biologist Andrej Sali published a paper titled "Finding cures for tropical diseases: Is open source an answer?" to discuss how OSB might work. They suggest that OSB could organize many small research and development efforts toward the manufacture and testing of tropical disease drugs, reducing the final point-of-sale cost. Whether such a scheme would work in practice is unknown. However, there is no a priori reason why non-software products like drugs cannot be made using open source methods: it is not unreasonable that a community of open drug developers could produce open drugs. The unanswered question is whether, without IP, this development could be made economically sustainable enough to attract investors.

Any R&D effort, drugs or software, will consume resources that have real dollar costs. OSS developments are economically sustainable in part because these costs are kept very low. Geographic location, time zones, and physical facilities are not factors. Similarly, legal fees, product distribution costs, communication charges, and travel costs are also essentially zero. Few salaries are paid. OSS works because overhead is minimized while the aggregated value of donated developer time keeps growing over time. OSB faces a different economic reality. Any life sciences project, even an open source one, would come attached with physical constraints and very large costs. Laboratories are required. Millions of dollars of reagents, equipment, and testing are necessary. Realistically, before any OSB effort could yield a commercial product, the real dollar cost of biological R&D would need to be greatly reduced.

The Internet is helping to do this. The Web has already dropped the direct cost of doing scientific research, while also encouraging IP freedom. It has become an important repository for scientific information, much of it accessible openly and for free. Open access journal sites like the Public Library of Science (PLoS) and BioMedCentral now deliver peer-reviewed articles online at no charge and without copyright restrictions. Databases of DNA sequence data, human variation data, and, more recently, clinical trial results are available online. Sophisticated tools that link research datasets and support complex queries are beginning to appear. Science Commons, recently launched by the nonprofit Creative Commons, hopes to further interaction by making it easier for scientists, universities, and industries to share data and other IP. Overall, the Internet now allows most individuals, professionals or not, and even those in developing nations, free access to a wealth of high-quality scientific information. The main challenge for OSB to work, then, is to translate this research data into sustainable real-world open development projects.

New development strategies are beginning to emerge. Although not strictly open source, the company OneWorld Health appears to have found one successful path to reducing both IP and development charges. Based in San Francisco and billing itself as the first U.S. nonprofit pharmaceutical company, OneWorld assembles donated IP, expertise, and funds to further therapeutic development for diseases common in the Third World. It is working on drugs for malaria, leishmaniasis, and Chagas disease (a parasitic disease that can lead to heart failure), among others, and expects to launch its first product in 2005. However, while OneWorld's efforts are to be praised, its model is limited to drug molecules and markets not considered interesting to its proprietary partners.

The Biological Innovation for Open Society initiative (BIOS, http://www.bios.net), the brainchild of plant biologist Richard Jefferson, is also working to reduce the cost of biological development, and is willing to challenge proprietary groups to do so. Launched in 2004 and supported by a Rockefeller grant and technology from IBM, BIOS provides researchers with tools to share, manage, and navigate biotech IP, with an eye to facilitating open agricultural biotechnology. Keen on open source, Jefferson intends to create a patent commons and seed it with a broad method that allows plant researchers, public or private, to sidestep proprietary gene transfer technologies that restrict genetically modified (GM) crop development. Crops created with this community IP would be more affordable by growers throughout the world and be easier to manage than proprietary offerings. Meanwhile, the open patent commons would provide a defensive shield against proprietary challenges to their use.

Yet neither of these development models resembles the archetype OSS project, with an online platform, simple IP structure, and low overhead. For this reason, support is being found for a simpler model, a direct way for open source biology to follow in the footsteps of open software. The idea is to treat DNA, the foundation of virtually everything biological, for what it already is widely recognized in biology to bea programming language. Virtually anything related to biology on this planet, living or not, can be reduced to this common denominator: a sequence of DNA bases that specifies its form and metabolism. DNA in a cell is no different from the 0s and 1s in a computer program. DNA is biological source code.

If OSS works, and DNA is software, don't reinvent: adapt. Allow genetic engineering to be done in the same way that software is engineered today, on computers with specialized software tools. In this way, OSB could closely parallel the strategies and, perhaps, realize the same advantages of open source software. Furthermore, since the DNA molecule can be a commercial product unto itself, and can direct biological synthesis of many bioproducts in vivo, circumventing the need for large production facilities, genetics can shorten the distance between research and development considerably. Because of these features, DNA code holds great potential to make OSB a reality, and also the possibility of developing a wide range of open biological products economically. Today a new science called synthetic biology is allowing researchers to move beyond mere speculation of this potential to practically test these ideas in reality.