**10. Conclusions**

biosafety, bioethics, and environmental health and sustainability. Their answers will require consultation with engineers, scientists, attorneys, innovators, teachers, students, policymak‐ ers, and ordinary citizens. However, before doing so society must decide how synthetic biology as a scientific discipline is to be handled. That is, establish rules and regulations of ownership, diffusion, and access to the knowledge the discipline generates and accumulates. Concurrent‐ ly, to further the bio-economy, it must establish global engagement and collaborative models, mentor and nurture young leaders, create next-generation manufacturing facilities, and

**•** When do basic research results benefit society most if placed in the public domain as

**•** When it is appropriate for industry to seek private ownership of inventions derived from

**•** When is an open innovation policy in synthetic biology likely to discourage industry from

Johnson [66] notes that synthetic biology needs "public policies and collaborative mechanisms that promote broad and robust pre-competitive openness, sharing, and access" and "strong and robust IPR" to enable "later-stage economic value creation, IPR-enabled commercializa‐ tion, and market-based investments". They will indeed help in aligning international invest‐ ments, in framing lab-to-market policies, and in creating global manufacturing and marketing

There are serious obstacles to globally harmonizing patent laws [67]. Disparate national laws have caused a number of complicated cross-border IP disputes and multiple infringement suits. For example, software and business method patents are permitted only in some coun‐ tries. Even when patent laws are similar in two countries, their interpretation by the courts may vary widely. Patent laws operate on the principle of territoriality and the needs of individual nations. Thus in a globalized, knowledge-driven economy, technologically advanced nations support strong patent protection to spur innovation, while the less advanced see it as barriers erected to restrict their access to new goods and dilute their welfare programs. Current national patent laws embody premises and concepts that were shaped by the Indus‐ trial Revolution; they are not malleable enough for the knowledge and information-driven age that has given rise to such exotic technologies as nano-technology, information technology, biotechnology, and robotics (and in the future, possibly bio-robotics). Today's inventor is frequently university educated or a researcher or a member of a large R&D team rather than an artisan or a technician. There is thus an acute need for harmonization of patent law and its enforcement. The assumption is that a uniform legal system would reduce legal uncertainties, cost of litigation, and barriers to trade. Other potential benefits include liberalized technology transfer and increased foreign direct investment from developed countries to the developing and underdeveloped countries and thus raise living standards globally. Ideally, harmoniza‐

address standards-related issues. The crucial questions are:

opposed to limited period IP monopoly of those results?

developing commercially viable products and processes?

the results of open innovation?

policies to facilitate global commerce.

**9.3. Harmonization**

224 Biotechnology

The genetic uniqueness of each individual implies the existence of numerous undiscovered non-trivial interactions in the human genome that would make linking individual factors to a disease condition highly complex. These interactions, due to inheritability, must account for family history to correctly interpret genotyping results to provide personalised medical treatment. Indeed, they must go beyond and ask how a given genome copes with a dynamic environment. The magnitude of this task has propelled the convergence of life sciences with other fields, *e.g.*, physics, chemistry, mathematics, computing, engineering, social sciences, etc. in search of new and innovative solutions. A recent NRC study notes [68]:

The scientific opportunities enabled by convergence—the coming together of insights and approaches from originally distinct fields—will make fundamental contributions in our drive to provide creative solutions to the most difficult problems facing us as a society. This convergence provides power to think beyond usual paradigms and to approach issues informed by many perspectives instead of few.

Synthetic biology makes personalised medicine appear within reach in terms of developing personalized drugs and diagnostics, minimizing adverse drug reactions, and personalising treatments by enabling people to make personalized health decisions. However, to take research results from the lab to the patient's bedside, to the community (translational appli‐ cation) and finally make it accessible to every human on Earth is a colossal endeavour that calls for a very high level of convergence. The time has come for governments to frame policies that would enable the desired convergence. The U.S. government, *e.g.*, is discussing a "mod‐ ular" policy [69] with public participation. A module, *e.g.*, may include education, basic research, and infrastructure; another that promotes market-oriented innovation through R&D tax credit, intellectual property policies, etc.; and yet another for catalysing breakthroughs in such areas as clean energy, biotechnology, nanotechnology, advanced manufacturing, information technology, and space technologies.

Genomics researchers are the new super-stars of science. A Thomson Reuters report provides a listing of authors who have written multiple highly cited reports and have thereby demon‐ strated their tremendous influence on ongoing research in their respective fields. Out of the seventeen hottest researchers a dozen belong to genomics [70]. Not surprisingly, the US sits atop the genomics-related patent filings heap, trailed by Europe and Asia, indicating the dominance of the U.S. both in research and its translation. [71]. An enigmatic world order is in the making.
