By Jane Calvert

In recent times, and particularly during the Royal Commission of Inquiry into Genetic Modification, many have voiced reservations about the patenting of life forms and natural products. These reservations have tended to be based on concerns surrounding whether ownership or control of naturally-occurring substances by way of a patent should be allowed.
It is timely to revisit the extent to which one can obtain patent protection for naturally occurring entities and to address some of these reservations.

Utility requirement for naturally occurring entities

Naturally occurring novel products of organisms and biological compounds including DNA fragments or sequences that have been isolated or cultured to a particular degree of purity and that have been found to be useful for some purpose are patentable. This means that a patent application cannot be based simply on the discovery of a naturally occurring substance. Some underlying utility or purpose must also be determined. Novel processes for isolating or purifying compounds or DNA sequences from their natural environments are also patentable, as well as a genetically modified product such as an animal or plant.

However, any resulting patent protection for these naturally occurring substances does not extend to provide any rights to these products when simply found in their naturally occurring state or environment. New Zealand's Patents Act 1953 specifies that "where a [patent] specification claims a new substance the claims shall be construed as not extending to that substance when found in nature."

The Taxol® example
How the system works in practice can be exemplified by considering the developments that led Bristol Myers Squibb to seek patent protection for paclitaxel or Taxol®, a natural product from the Pacific yew tree (Taxus brevifolia). Although this compound was discovered in 1962, it was five years later before the active compound was isolated from the bark of the yew tree. The useful anti-cancer properties were then identified. It was the isolation and research that led to the finding that paclitaxel had anti-cancer properties that amounted to the invention.

The discovery of the compound in 1962 alone was not sufficient to amount to an invention. Patent applications were subsequently filed for the compound paclitaxel. However, the resulting patents did not extend to give Bristol Myers Squibb commercially exclusive rights in every Pacific yew tree in existence.

The reservations about the legitimacy of "owning" and being involved commercially with naturally occurring substances need to be put into context. The protection of life forms has been known in New Zealand since farming practice was established. Society accepts that farmers have rights to own, trade, and protect their livestock or crops for commercial gain. In fact, some aspects of farming-based ownership can be more extensive than a patent right, which suggests to us that these patent/ownership reservations are based on a misunderstanding of the patent system as a whole.

A patent right, while providing a commercially exclusive right to use an invention, does not last indefinitely. A trade secret on the other hand may afford protection indefinitely, if not disclosed to the public. The right granted by a patent is essentially a reward for the inventive effort involved in developing an invention, which is given in exchange for a full disclosure of the invention to the public. A patent right is no guarantee that commercial returns for the invention will be made by the patentee. Any patent right is always open to challenge during its lifetime, for example if the scope of the patent is too wide, or if any other contestable ground is argued successfully.

There are inherent commercial risks in the patent system and there is nothing absolute about the rights granted by a patent. It is incorrect to say that an individual or corporation has absolute ownership rights to a naturally occurring substance by way of patent rights.

This article has also been published in Chemistry NZ, vol 65(2), September 2001.

This is a general summary only and should not be taken as a substitute for specific advice.

Web site: Baldwin Shelston Waters
Email: email@bsw.com

September 2001