**1. Introduction**

The pioneering work of Cohen and Boyer in recombinant DNA (deoxyribonucleic acid) technology [1] gave birth to genetic engineering and the biotechnology industry. The related Cohen-Boyer patents [2-4] that protected the technology played a stellar role in the rapid rise of the biotechnology industry [5, 6]. The next landmark was the creation of a bacterial cell controlled by a chemically synthesized genome by Craig Venter and his group in 2010 [7]. More recently, Floyd Romesberg and colleagues in 2014 [8] reported the creation of a semisynthetic organism with an expanded genetic alphabet that has raised both hope and fear [9]. The new letters in the alphabet are artificially created nucleotides not found in Nature. Along with these breakthroughs, the great promise of CRISPR (clustered regularly interspaced short palindromic repeats), and in particular CRISPR-Cas9 gene editing technology pioneered by Feng Zhang in 2012 [10] as a new way of making precise, targeted changes to the genome of a cell or an organism (see Section 2.3) has set the stage for major advances in synthetic biology, which aims to design and construct new biological parts, novel artificial biological pathways, organisms or devices and systems including the re-design of existing natural biological systems for useful purposes.

Researchers are now focussing on developing tools and methods that would enable them to encode, in artificially created or natural DNA, basic genetic functions in novel combinations by design. The aim is to artificially create biological systems of increas‐ ing size, complexity, and tailored functionality. Currently synthesis capabilities far exceed design capabilities in the sense that we know how to build but not yet with clarity what to build [11]. Synthesis capabilities are developing at a pace where DNA synthesis can be automated and the desired DNA produced once the sequence is provided to vendors. This integration of biology and traditional engineering is occurring so rapidly, it appears likely that a couple of decades hence researchers may begin producing synthetic organisms that can produce not only pharmaceutical products but also industrial

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products such as bio-fuels on a commercial scale. Possible socio-economic benefits from synthetic biology research is thus enormous, but then so is the possibility of the technology's misuse. The concerns range from bioethical and environmental worries to bio-terrorism, say, by malicious release of genetically engineered viruses targeted at specific ethnic groups. The main concern here is the illegal creation and growth of bioweapons.

The socio-economic promise of synthetic biology has spurred both public and private invest‐ ments and made people introspect about its consequences and impact on human society. All players involved in creating and commercialising this knowledge-and-capital intensive emerging technology are obviously deeply interested in knowing how they would gain or lose from the intellectual property (IP) system in place and whether that system needs to be changed, replaced, or abolished from their respective perspective.

DNA as an information carrier gained currency in the 1950s with the discovery of the doublehelix structure of cellular DNA by James Watson and Francis Crick in 1953 [12]. Prior to that biologists talked of biological "specificity". In 1953, Watson and Crick noted: "...it therefore seems likely that the precise sequence of the bases is the *code* which carries the genetical *information*..." (Emphasis added) [13]. Now the language of information is pervasive in molecular biology—genes are linear sequences of bases (like letters of an alphabet) that carry information (like words) for the production of proteins (like sentences). The process of going from DNA sequences to proteins we use words like "transcription" and "translation", and we talk of passing genetic "information" from one generation to another. It is rather uncanny that molecular biology can be understood by ignoring chemistry and treating the DNA as a computer program (with enough input data included) in stored memory residing in a computer (the cellular machinery). It is this aspect that bioinformatics exploits. It is analogous to viewing Euclidean geometry not in terms of drawings but in terms of algebra. In our current understanding, DNA is an informational polymer. It is a vast chemical information database that *inter alia* carries the complete set of instructions for making all the proteins a cell will ever need. As Albert Lehninger lyrically put it, understanding the DNA is the study of "the molecular logic of the living state." [14].

The intellectual property (IP) system, as it stands, did not anticipate the convergence of the patenting of information carrying living matter, a knowledge-based global economic system, and the ascendancy of a research-centric and innovative biotechnology industry. Therefore, the IP system is already under great strain because biotechnology related IP has been patched onto an existing patent system in an *ad hoc* manner. For example, in the complex legal maze, intellectual property rights (IPR) related to DNA synthesis, which is at the core of synthetic biology, may be inadvertently infringed by DNA synthesis companies in terms of enforceable trade secret, trademark, copyright or patent laws, simply by constructing DNA sequences for their clients [15].

That the DNA is an information encoded molecule, makes the interpretation of IP laws that much more difficult by judges who are generally ignorant about the deep science that supports biotechnology. Indeed organisms are defined by the information encoded in their genomes, and since the origin of life that information is believed to have been encoded using a two-basepair genetic alphabet (A–T and G–C). Recent research has expanded the alphabet to include several man-made unnatural base pairs (UBPs) which can be efficiently PCR-amplified and transcribed in vitro and whose unique mechanism of replication has been characterized. Clearly, the expansion of an organism's genetic alphabet leads us into unknown scientific territory related to DNA replication, gene expression, unknown proteins, DNA repair, etc. [8]. While the core principles of synthetic biology are common to those of well-practised recombi‐ nant DNA techniques, the biggest differences lie in the size, scope, accuracy, and speed of genetic changes that can now be accomplished [16]. Note that genetic modification incorpo‐ rates DNA from one species into another; genome editing introduces new mutations into an organism's own DNA (similar to what Nature does or we do through selective breeding but on an accelerated time scale).

The critical IP issue in synthetic biology is determining, in an equitable manner, the nature of the IP rights to be allocated, to whom they should be allocated and the context in which they should be allocated for the overall socio-economic benefit of society. This chapter therefore briefly introduces synthetic biology and its relevance to human society, the intellectual property it may generate, equitable modes of protecting the generated intellectual property, and suggests changes to patent laws keeping in mind the changing socio-economic circum‐ stances in which it must operate.

This chapter is written for young researchers and students in synthetic biology for whom a basic understanding of IPR issues related to their subject has assumed great importance.
