Certain biological subject matter is unpatentable

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-

· Animal or plant varieties or essentially macrobiological processes.

· So, although animal and plant varieties are not, per se, patentable, because of the very narrow definition of what a plant variety is, careful drafting of patent claims can help the patent application avoid this problem.

· The distinction between a microbiological process (which is patentable) and a macrobiological process (which is not) is not clear, but microbiological processes are said to be processes using micro-organisms to make or modify products.

· 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 Plants (UPOV). However, the fact that there is no equivalent treaty for animal varieties has led to some 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 is potentially patentable. The Novartis case (2000) said that “where specific plant varieties are not individually claimed the claim is not excluded from patentability, even though they may embrace plant varieties.”

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