8.1.4 Definition of the person skilled in the art in the field of biotechnology

The person skilled in the art in the field of biotechnology is well defined by the case law of the boards of appeal. The skilled person’s attitude is considered to be conservative. However, this must not be seen in the sense of being reluctant or opposed to modify or adjust a known product or process, but rather in the sense of being cautious. The skilled person would never go against an established prejudice, nor try to enter into "sacrosanct" or unpredictable areas nor take incalculable risks. However, they would readily seek appropriate, manifest changes, modifications or adjustments which involved little trouble or work and no risks or only calculable risks, especially for the sake of obtaining a more handy or convenient product or of simplifying a procedure. In particular the skilled person would perform a transfer of technology from a neighbouring field to their specific field of interest, if this transfer appeared to be easy and to involve no obvious risks, for example involving routine experimental work comprising only routine trials (T 455/91, OJ 1995, 684; see also T 500/91, T 387/94, T 441/93, T 1102/00, T 867/13). If, on the other hand, the skilled person would expect to have to perform scientific research rather than routine work in order to transfer a technology previously set up in one field of research to a neighbouring field, then inventive step could be acknowledged (T 441/93).

From the notional skilled person nothing more can be expected than the carrying out of experimental work by routine means within the framework of the normal practice of filling gaps in knowledge by the application of existing knowledge (T 886/91, T 223/92, T 530/95, T 791/96).

In T 60/89 (OJ 1992, 268) the board took the view that the skilled person in genetic engineering in 1978 could not be defined as a Nobel prize winner, even if a number of scientists working in this field at that time actually had been awarded that prize. Rather the skilled person should be assumed to be a scientist (or team of scientists) working as a teacher or researcher in the laboratories which made the transition from molecular genetics to genetic engineering at that time. See also T 500/91, in which the board ruled that the development of the art normally expected by the notionally skilled person – who may be represented by a team of appropriate specialists (T 141/87) – did not include solving technical problems by performing scientific research in areas not yet explored (see also T 441/93).

In T 223/92 the board had to consider the knowledge and capabilities of the notional skilled person in the field of genetic engineering as at October 1981, more than one year later than was the case in T 500/91. By this time, a considerably greater number of genes had been made the subject of cloning and expressing methods, and skills and experience in this technical field were developing rapidly. The knowledge of the notional person skilled in the art had to be considered as that of a team of appropriate specialists who knew all the difficulties still to be expected when considering the cloning of a new gene. However, the skilled person had to be assumed to lack the inventive imagination to solve problems for which routine methods of solution did not already exist.

In T 207/94 (OJ 1999, 273) the board stated that it had to be assumed that the average skilled person would not engage in creative thinking. Yet the average skilled person could be expected to react in a way common to all skilled persons at any time, namely that an assumption or hypothesis about a possible obstacle to the successful realisation of a project must always be based on facts. Thus, in the board's view, an absence of evidence that a given feature might be an obstacle to carrying out an invention would not be taken as an indication that this invention could not be achieved, nor that it could.

In T 455/91 (OJ 1995, 684) the board held that the skilled person in this field was well aware that even a small structural change in a product (e.g. a vector, protein, or DNA sequence) or procedure (e.g. a purification process) could produce dramatic functional changes. Therefore, the skilled person would constantly be conditioned by the prior art and, before taking action, would carefully ponder any possible modification, change or adjustment against the background of the existing knowledge. See also T 867/13.

In T 412/93 the patent related to the production of erythropoietin. The parties agreed that in this particular case the skilled person should be treated as a team of three, composed of one PhD researcher with several years' experience in the aspect of gene technology or biochemistry under consideration, assisted by two laboratory technicians fully acquainted with the known techniques relevant to that aspect. The composition of the team might vary depending on the knowledge and skills required by the particular aspect dealt with.

The board in T 387/94 distinguished T 455/91, in which the modification necessary was small and the neighbouring fields were very close. In the case in hand the technical situation was much less well defined. Little information was available at the relevant priority date on the mechanisms of gene expression in plant and animal cells and the implications of this knowledge in the case where the genes to be expressed were not an intrinsic part of the genomes of said cells had not been researched. The reasoning used in decision T 455/91 could not therefore be applied.

In T 493/01 the invention related to a protective antigen potentially useful in a vaccine against whooping cough. The board noted that in T 455/91 (OJ 1995, 684) the skilled person in the field of biotechnology had already been defined as being cautious and conservative. The board said this did not mean her skilled person would refrain from considering information because it did not concern the mainstream of research in their field of specialisation or because it applied only to some parts of the world. The skilled person’s skill and knowledge were not geographically limited; in fact they would have a global point of view. Thus if, as in the case in point, a pathogen constituted a known threat in some restricted parts of the world, the skilled person would not refrain from taking prior knowledge about that pathogen into consideration or from using it as a basis for their activities.

In T 867/13, in the board's view, it was not conceivable that in the case of the treatment of a potentially lethal disease the motivation of the skilled person to search for further - or alternative - treatments stopped solely because one treatment existed, even if it was perceived as satisfactory at the time.