Schedule A2 of the Patents Act 1977 (which implements the Biotechnology Directive (98/44/EC) provides that although biological products and processes are not, per se, unpatentable, certain biological subject matter cannot constitute patentable inventions.
The most important exclusions are-
Â· Animal or plant varieties or essentially macrobiological processes.
Â· So, although animal and plant varieties are not, per se, patentable, because of theÂ very narrow definition of what a plant variety is, careful drafting of patent claims can help theÂ patent application avoid this problem.
Â· The distinction between a microbiological process (which is patentable) and aÂ macrobiological process (which is not) is not clear, but microbiological processes are said to beÂ processes using micro-organisms to make or modify products.
Â· The formation and development of the human body and mere discoveries of elements of the
human body are not patentable inventions.
The exclusion of plant varieties is usually explained on the basis that when the EPC was drafted there was a ban on dual protection in the International Convention of New Varieties of PlantsÂ (UPOV). However, the fact that there is no equivalent treaty for animal varieties has led to someÂ to question why animal varieties were also excluded.
However, case law has indicated that so long as a claim encompasses more than one variety it isÂ potentially patentable. The Novartis case (2000) said that Âwhere specific plant varieties areÂ not individually claimed the claim is not excluded from patentability, even though they mayÂ embrace plant varieties.Â