Patent Expert Issues: Biotechnology

Biotechnology generally concerns the application of cellular and molecular biology to make or modify products or processes. It includes scientific and industrial disciplines focused on understanding and manipulating living or biologically-active material at the molecular level, often involving DNA techniques and the analysis of genetic information. Modern biotechnology is expected to lead to important breakthroughs in many fields, such as health, food, energy, and the environment.

While the patentability criteria prescribed in patent laws apply to inventions in all fields of technology in the same manner, the application of patent law to biotechnological inventions has to deal with a number of particularities that may not exist in the same way in other areas of technology.

One set of issues relates to the scope and legal standards of patent protection. While in principle, in accordance with the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), patents are available for any invention in any and all fields of technology, the issue of the patentability of biological materials, isolated or derived from naturally occurring living organisms, has triggered widespread discussions. Some argue that such biological materials are mere “discoveries”, and therefore not patentable, while others argue that they are man made “inventions”.

With respect to industrial applicability (usefulness) and sufficiency of disclosure, the exclusive patent rights may be granted only where an appropriate level of concrete and practical use of the biotechnological invention is disclosed in the patent application. The debate addresses the importance of ensuring that claims are not broader than is justified by the invention disclosed in the patent application, in particular, where it is an early and fundamental stage of innovation or a new gene with its future application still not determined. The application of the patentability criteria has further implications on licensing and other issues related to the exploitation of patents. In this context, exceptions and limitations to patent rights, in particular, research and experimental use exception, has been considered important for down-stream innovation.

In addition, a number of typical issues relating to biotechnological inventions result from the fact that biological material is capable of reproducing itself. This specific characteristic requires determination of law as to, for example: (i) the scope of legal protection of future generations; (ii) exhaustion regimes; (iii) special rules, if any, for plant and animal breeders or farmers. Further, the development of genetic engineering resulted in the possibility of overlap between plant variety and patent protection even in countries where patent protection for plant varieties is excluded. While each of these systems provides a scope of protection and rights as well as limitations that are distinct from each other, the interplay between the two systems is under scrutiny. Other relevant issues, such as the conservation of biodiversity and ethical dimensions of the protection and commercialization of biotechnological inventions, have been discussed in many fora, for example, the World Trade Organization (WTO), the Convention on Biological Diversity (CBD), and the Food and Agriculture Organization (FAO). As to biodiversity, reference is made to the issue of genetic resources, including “disclosure requirements” and prior art databases.