Archive for the ‘Life Science’ Category

Feb, 10th, 2011

Against the background of a dispute over the criteria for classification of borderline products – PART TWO

The principle of trust to state authorities A great part of designations placed on packaging of food products constitutes protected elements – trademarks – granted by public administration organs, namely The Patent Office of the Republic of Poland. The process of trademark registration, conducted in accordance with Polish Industrial Property Law, stipulates a refusal to [...]

Jan, 31st, 2011

Against the background of a dispute over the criteria for classification of borderline products – PART ONE

Although at the decline of the year 2009, the transition period for products fulfilling the criteria of both a medicine and other preparation – in the majority of cases a dietary supplement or a cosmetic – elapsed (from the beginning of the year 2010 these products can be introduced on the market exclusively as medicines), [...]

Dec, 13th, 2010

Advertising or information? In search of more clarity on Polish pharmaceutical market

‘Advertising of medicinal products’ by definition under Article 86 of Pharmaceutical Directive 2001/83/EC (and implemented into the Polish Pharmaceutical Law accordingly) includes both inducement and information activities if they are designed ‘to promote the prescription, supply, sale or consumption of medicinal products’.  ECJ ruling on advertising definition Over a year ago the European Court of [...]

Dec, 1st, 2010

ONE STEP BACK BY INNOVATORS IN THEIR LEGAL BATTLE AGAINST GENERIC APPROVALS

For the last six years we have been watching the activities of innovative product companies, trying to institute invalidation proceedings against generic marketing authorizations (MAs). This long-lasting struggle is not about the merits of those actions but is limited to innovator’s right to be a party in such proceedings. It was only last week when some further decisions were taken in the matters. The decisions are particularly interesting as they refer to two cases which are most advanced in the whole group of the pending proceedings.