Team:MIT bioethics

The last half century has witnessed pivotal advances in the life sciences, ranging from the elucidation of DNA's structure to the mapping of the human genome. It can be argued, however, that none has had a greater impact on our standard of living or economy than the discovery of restriction enzyme technology and its product, recombinant DNA. Facilitating innovations ranging from pharmaceutical products synthesis to gene therapy, these tools of genetic engineering birthed the biotechnology industry. Yet, the industry and its life changing products would not have been possible without the input of pioneering entrepreneurs and their own key enabling technology- patents. Through the provision of a limited monopoly, patents provided incentives not only for further research by inventors but also development from early entrepreneurs to bring their products to market.  

Thus secured a financial foundation, pioneering entrepreneurs quickly subscribed to the motto “clone a gene, make a million,” anticipating support from biopharmaceuticals and the traditional venture capital community. Indeed, commercial biotechnology started with high hopes. "There's no question that [...] the entrepreneurs who began biotechnology businesses had very broad, grand ideas and big visions," says Jim Vincent, former chairman and CEO of Biogen, Inc. With patents securing compensation on the most promising products, money poured into biotechnology startups such as Amgen, Genzyme, and Biogen, forming a $30 billion industry with over 160 drugs and vaccines on the market and another 370 currently undergoing clinical trials. With a market capitalization of over $300 billion and 200,000 employees working for 1,500 companies in the US alone, biotechnology's rise directly follows from the increased mapping and staking of biological intellectual property space.  Co-founder, president, and COO of Advanced Tissue Sciences, Inc., Gail Naughton made it a point to secure core technology. "We have very strong patents that we defend," says Naughton. "Getting the patents was always among the first three issues on which we spent a lot of time and talent. We kept abreast of all the new inventions at universities.”  

However, the very same bioprospecting that made biotechnology so spectacularly successful cannot be said about its latest conception: synthetic biology. The life sciences' next transformative innovation, synthetic biology facilitates not just the transferring of segments of DNA among organisms but the complete redesign and construction of biological systems via entirely artificial genetic circuits from a toolkit of standardized biological parts. Through the rational and systematic design of biological systems to display functions not found in nature, synthetic biology promises to produce pharmaceuticals, cure cancer, and generate post-petroleum fuels- all remarkable assertions reminiscent of those made a generation ago at the start of the biotechnology boom. This time, however, inventors and entrepreneurs cannot simply rely on patents to facilitate industry growth.  

The emergence of such a new technology raises the question of whether the patent system, historically designed to protect mechanical and chemical products, is suitable to protect inventions in fields as new as synthetic biology. Adopting common practice in other engineering disciplines, synthetic biology standardizes genetic analogues to logic gates, oscillators, and circuit components. This process of standardization lays the template for the creation of truly artificial, man-made biological circuits to act in a rationally designed way. DNA is used to make parts; parts are assembled into devices; devices are assembled to make systems. This hierarchy in design introduces roadblocks in a product's path to commercialization. “A product generated by synthetic biology [...] can involve hundreds of different parts that [...] might all be protected by different patents that are probably held by several rights holders, thereby creating a so-called patent thicket,” wrote Berthold Rutz, a patent examiner specializing in synthetic biology. Specifically, as new technologies build upon old technologies, they become necessarily more complex, and as a result, are often subject to the protection of multiple patents, spanning both the new and old technologies. This effect, known as the tragedy of the anticommons, guarantees that everyone- the patent holders, manufacturers, and consumers- who could have benefited from the technology loses.  

Moreover, the interdisciplinary nature of synthetic biology requires patent offices to be proficient in a multitude of technical domains from computer science to nanotechnology, resulting not only in a shortage of synthetic biology examiners but also a general confusion and concern as to what constitutes patentable material. Rick Johnson, who heads up an OECD group on synthetic biology, has called the field “an IP law professor’s dream final examination problem,” arguing for a complete overhaul of US patent laws regarding the field. Legal experts also agree that something needs to be done. "Synthetic biology presents a particularly revealing example of a difficulty that the law has frequently faced-the assimilation of a new technology into... existing intellectual-property rights," wrote Arti Rai and James Boyle, from Duke University in North Carolina, in a recent paper. "The way that US law has handled software on the one hand and biotechnology on the other could come together in a 'perfect storm' that would impede the potential of the technology."  

The confusion clouding synthetic biology has led groups, such as Synthetic Genomics, founded by scientist and industrialist Craig Venter, to file patents on the very foundations and principles on which the field is built, potentially freezing progress in both research and commercialization by others. “Some of the patents being filed are astoundingly basic, the equivalent of patenting Boolean algebra right at the birth of computer science,” wrote Boyle. The disturbing ease of this sort of patenting has  garnered the attention of synthetic biology's founding fathers. "You can take any device from the Texas instruments TTL catalogue, put 'genetically coded' in front of it without actually demonstrating it in practice, and you have a good chance of getting a patent," says Drew Endy, professor of bioengineering at Stanford. Tom Knight of MIT calls such patent claims, “absurdly, ridiculously broad.” The problem is aggravated by the fact that unlike in the biotechnology industry, the one molecule-one patent rule  does not apply to synthetic biology. Instead, because it so intrinsically relies on a single standard upon which all future improvements are made, the field is particularly susceptible to patent trolls and entities who are seeking financial gain, but not pursuing product development.  

As was throughout the biotechnology industry's growth, patents will play a key role in determinating the future of its latest product, synthetic biology. However, because of the inescapable differences between traditional biotechnology and synthetic biology, what was once a prime mover in the direction of innovation and commercialization has proven to be a double-edged sword. The premises originally established to stimulate progress may result in the very opposite effect. When synthetic biology's potential paths of innovation or stalemate are juxtaposed, there is an inescapable coupling of disappointment and appreciation of how patent law intersects our most promising sciences. Patents then, may indeed be our most transformative invention of all.