Masterarbeit

Development of generics during patent protection. Legal and regulatory framework in the EU and North America /USA and Canada/, consequence for the Candidate countries

Dr. Adriana Ivanova Vladimirova (2003)

The patent has to promote and protect the technological progress by providing icentive to create new invention. Each country can decide to provide patent protection on his territory. The worldwide trend follows the need of harmonisation of the national laws, concerning patent protection. The World Trade Organisation's Agreement (TRIPS) provides the internatinal standarts for patent protection. The lates date for the implementation of the TRIPS Agreement's principles into the national legislation of the Member countries was/is 1996 for the developed countries, 2000 for the developing countries, 2006 (during the WTO Meeting in Doha it has been aggreed to extent this to 2016) for the laest-develping countries. Under the TRIPS Agreement, the Member States can implement the "Bolar provision" in to their legislation. The "Roche-Bolar" exemption is related to low-wight chemical molucules, protected by patent and allows generic companies to prepare data nacessary for marketing authorisation during the patent protection of the original medicinal product. This provision exists in the legislation in some countries, which are WTO Member: USA, Canada, Bulagaria, Hungary.

Currently the patent protection in the EU is not a part from Acquies Communitaire and the experimental work during patent protection depends on the national legislation and court's interpretation in the EU Member States. The European Commission proposed the possibility for test, which will support generic medicine authorisation in advance of the expiry of the patent protection, to be implemented in the EU legislation. The existence and implementation of the "Bolar" provision into the national legislation of the Candidate Countries for EU membership will be in complince with the TRIPS Agreement and with European Commision's proposal, related to the pharmaceutical legislation and Community patent. It will benefit the economical development of this counties, where the pharmaceutical industry is presented by generic sector.

Pages: 69