third parties from manufacturing and selling the product without the consent of
the innovator. However, patents do encourage and protect the development of
new ideas by the publication of new knowledge.
Originally each country issued its own patent laws, but by the mid-18th
century it was recognized that patent rights should extend beyond national
boundaries. The first international agreement was theParis Convention of
1883. This has been revised on numerous occasions, the current treaties in
operation being the Europeans Union’s European Patent Convention (EPC)
of 1978 and the Patent Cooperation Treaty (PCT) signed in Washington in
1970. The former is only open to European countries and administered by the
European Patents Office (EPO). The latter is open to all countries of the world
and is administered through the national patent offices of the country subscrib-
ing to the treaty.
The protection offered by a patent is of paramount importance to a company
at the research, development and production stages of drug production. It is
essential that a patent is filed as soon as new compounds have been made and
shown to have interesting properties. Otherwise, a rival company working in the
same field might pre-empt the patent, which means that a large amount of
expensive research work would be unproductive in respect to company profits.
In this respect, it is particularly important that the patent covers the relevant
field and does not give a rival manufacturer an exploitable loophole.
The time required for the development of a drug from discovery to produc-
tion can take at least 7–15 years. In many countries, patents normally run for 20
years from the date of application. Consequently, the time available for a
manufacturer to recoup the cost of development and show a profit is rather
limited, which accounts for the high cost of some new drugs. Furthermore, it
also means that some compounds are never developed because the patent
protected production time available to recoup the cost of development is too
short.
11.8 Regulation
The release of a new drug onto the market must be approved by the regulating
authority for that country. For example, in Britain this is the Medicines Control
Agency (MCA), in the European Union it is the European Medicines Evalu-
ation Agency (EMEA) and in the USA the US Food and Drugs Administration
(FDA). These bodies, which are essentially consumer protection agencies, issue
a so calledproduct licenceormarketing authority (MA)when they are satisfied
REGULATION 237