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What are Intellectual Property Rights?
Patents and intellectual property (IP) rights apply as much to biotechnology
and genetics as to any other area of technology. In the field of health care,
innovation coupled with meaningful IP protection has long been recognized as
the driving force that brings new drug therapies and preventive measures to
patients.
The patent system was developed to promote the progress of the sciences and
useful arts to the benefit of all. Its aim is to encourage innovation and commercial
development so that new and useful products are available to society at large.
The system provides a balance between public and private interests by allowing
inventors limited exclusionary rights in exchange for full disclosure of their
inventions. This quid pro quosolution not only provides the incentive for private
sector investment into research and development of innovative products, but
promotes the dissemination of knowledge and information which otherwise would
be kept secret. Broad access to this knowledge fuels further research, innovation,
and development. This underlying philosophy and public policy has stood the
test of time, successfully producing the intended social benefits.
Intellectual property protection of gene sequence information and genetic materials
is a subject of at times ardent heated public debate. In Europe, this debate
has led to the development of a Directive on the Legal Protection of Biotechnology
Inventions (98/44/EC) to be implemented by European Union member states. In
the U.S., this debate has contributed to changes in the way the United States
Patent and Trademark Office (PTO) evaluates genomic inventions.
What is a patent?
To obtain a patent, it is not enough to simply describe the material or method;,
rather, an inventor must show that the invention is (i) novel and (ii) non-obvious
or containing an inventive step (: that is meaningless that the invention was
not made nor described or discovered before the inventor filed a patent application;
and that the invention is not obvious from the prior work of others). Further,
the inventor must show that the invention is (iii) useful (i.e., it has an “(industrial
application”)) and is (iv) described in such detail (“sufficiency
of disclosure”) that a person skilled in the field of the invention would
be enable (“enablement”)d to make and practice the invention. In
other words, the inventor must show that the invention has a real-world use,
and how it can be made and put to use.

Legislative issues
There are many important legislative initiatives being developed in Europe and
internationally in the area of Intellectual Property Rights and which EuropaBio
members are closely following through the
Intellectual Property Rights Working Group. The day to day monitoring is carried out
by specialised working groups in order to prepare the Implementation of existing
intellectual property rights legislation such as Dir 98/44/EC and initiation
of infringement procedures by the Commission at an earlier stage and, a centralized,
cost-effective and simple-to-obtain Community Patent.
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