Patents involving human stem cell lines
The introduction to the Guide
to the Deposit of Microorganisms under the Budapest Treaty
(World Intellectual Property Organisation, 2006 edition) states
that "a fundamental requirement of patent law is that the
details of an invention must be fully disclosed to the
public". This means that an invention must be described
in sufficient detail such that a person skilled in the art can
repeat the effect of the invention. In practice this means
that the average experts with access to the appropriate facilities
can reproduce the invention themselves.
Disclosure is normally achieved through the provision of a
written description supplemented where necessary by plans.
However, disclosure of inventions involving the use of new
micro-organisms present problems of disclosure in that
repeatability often cannot be ensured by the provision of a written
According to the Guide, the term microorganism is not defined in
the Treaty so that it may be interpreted in a broad sense.
Whether an entity technically is, or is not, a microorganism
matters less than whether a deposit of the entity is necessary for
the purpose of disclosure. Thus for example tissue cultures
and plasmids can be deposited under the Treaty, even though these
are not technically microorganisms in the strict sense of the
word. The same applies to stem cell lines.
Because of the potential problems involved in ensuring
repeatability, many countries including the United Kingdom, either
require or recommend that the written disclosure of an invention
involving the use of a new microorganism be supplemented by the
deposit of the microorganism in a recognised culture
collection. The culture collection is then charged with
making the microorganism available to the public at the appropriate
point in the patenting process.
Under the auspices of the World Intellectual Property
Organisation (WIPO), the Budapest Treaty 1978 (amended 1980) was
drawn up. The essence of this treaty was an agreement between the
signatories that certain culture collections should be recognised
as International Depositary Authorities (IDAs) and that a deposit
made with any one of them should be recognised as valid for patent
purposes by all the countries involved.