The Drug development process - Pharmaceutical Biotechnology: Concepts and Aapplications - page 70

subsequent clinical trials, and then be approved for general medical use by the relevant regulatory
authorities.

4.9.1 What is a patent and what is patentable?

A patent may be described as a monopoly granted by a government to an inventor, such that only
the inventor may exploit the invention/innovation for a fi xed period of time (up to 20 years). In
return, the inventor makes available a detailed technical description of the invention/innovation so
that, when the monopoly period has expired, it may be exploited by others without the inventor's
permission.
A patent, therefore, encourages innovation by promoting research and development. It
can also be regarded as a physical asset, which can be sold or licensed to third parties for
cash. Patents also represent a unique source of technical information regarding the patented
product.
The philosophy underlining patent law is fairly similar throughout the world. Thus, although
there is no worldwide patenting offi ce, patent practice in different world regions is often quite
similar. This is fortuitous, as there is a growing tendency towards world harmonization of patent
law, fuelled by multinational trade agreements.
In order to be considered patentable, an invention/innovation must satisfy several criteria, the
most important four of which are:

• novelty

• non-obviousness

• suffi ciency of disclosure

• utility.

4.9.2 Patenting in biotechnology

Many products of nature (e.g. specifi c antibiotics, microorganisms, proteins, etc.) have been suc-
cessfully patented. It might be argued that simply to fi nd any substance naturally occurring on the
Earth is categorized as a discovery and would be unpatentable because it lacks true novelty or any
inventive step. However, if you enrich, purify or modify a product of nature such that you make
available the substance for the fi rst time in an industrially useful format, that product/process is
generally patentable. In other words, patenting is possible if the 'hand of man' has played an obvi-
ous part in developing the product.
In the USA, purity alone often facilitates patenting of a product of nature (Table 4.1). The US Pat-
ent and Trademark Offi ce (PTO) recognizes purity as a change in form of the natural material. For
example, although vitamin B 12 was a known product of nature for many years, it was only available
in the form of a crude liver extract, which was of no use therapeutically. Development of a suitable