Author(s) Roberta Silva Melo Fernandes
Advisor(s) Luís Couto Gonçalves
Year 2013
Synopsis Pharmaceutical industry has specificities distinguishing it from other industries. In addition to social and economical implications involving the industry, R&D activities require considerable investment (set-off by patent concession). Stemming from the complexity of the pharmaceutical industry the best way to promote it resides in legal mechanisms that provide the protection of results and reach beyond mere patent concession. In the pharmaceutical patent system lies a subsystem related to specificities that may integrate patent requests, especially with the consequences of analyses outcomes (relatively rigid) of patent concession requirements. This is an issue mostly involved with the fact that a considerable part of medications currently launched in the market contain few innovative elements, or, at times, none. Nowadays it is frequent that a same active principle receives a new patent every time there is a small change in presentation, dosage, composition (different salt or ester or new therapeutic indications). The industry is vulnerable to imitation and many of the new drugs can be copied at a minimum cost. This industry is also unique for patent concession in itself does not authorize the medication to be commercialized. Before that happens several licences are required and granted by an agency different from the one conceding the patent rights. Thus, the petitioning company undertakes the obligation to perform pharmaceutical, toxicological, pre-clinic and clinical tests of a new chemical entity or involving new therapeutic applications. In some cases the Company will also be required to determine the highest retail market price in addition to a co-participation percentage in national health systems. By reason of this specificity, another differentiating factor arises consisting in the protection involving confidential pharmacological, toxicological, preclinical and clinical data of new chemical entities introduced to regulatory authorities for registration obtainment of the submitted pharmaceuticals. This requirement significantly reduces the time of exclusive marketing rights Marketing Authorization. These tests and experiments differ from the ones performed in the patent obtainment concession procedure. Resulting from this significant reduction of exclusive marketing rights and the high cost of the Marketing Authorization some countries are adopting practices to extend the exclusive marketing right period. Examples of this consist of the supplementary protection certificate concession and the protection of data deposited with the health authority. There is also the consideration that as a result of drug price regulation by the public bodies, as well as the difference in pricing procedures of different countries, parallel trade of drugs has come into play. This fact generates issues related to rights depletion and parallel importation. As for the pharmaceutical industry another characteristic should be highlighted. By reason of this temporary exclusive trading right, industrial property rights holders are more easily placed into control. Competition restrictions in the pharmaceutical industry operate in different ways and are mostly protected by the shield of legality. Nevertheless, analysis related difficulties in general occur because the objective concept of competition restriction is not limited to legislation. On the contrary, there are complex situations in which this concept becomes more comprehensive due to assumptions based on circumstances related to the behavior of economic agents. It is also characterized by the possibility of compulsory license regimes, especially in the superseding of exclusive rights (legal monopoly) or industrial privileges opposing governmental objectives. Last, but not the least, there must be a distinction between pharmaceutical companies trading drugs by trademarks and pharmaceutical industries companies producing and trading medication by active principle. The difference is not only related to the objective of the company involved but first and foremost focused on pricing. The difference between industries trading medication by brand and the ones trading medication by active principle promotes tension extrapolating marketing issues and involving administrative and legal issues. Related tension, contradictions and disagreements are the object of this paper.
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Author(s) Roberta Silva Melo Fernandes
Advisor(s) Luís Couto Gonçalves
Year 2013
Synopsis Pharmaceutical industry has specificities distinguishing it from other industries. In addition to social and economical implications involving the industry, R&D activities require considerable investment (set-off by patent concession). Stemming from the complexity of the pharmaceutical industry the best way to promote it resides in legal mechanisms that provide the protection of results and reach beyond mere patent concession. In the pharmaceutical patent system lies a subsystem related to specificities that may integrate patent requests, especially with the consequences of analyses outcomes (relatively rigid) of patent concession requirements. This is an issue mostly involved with the fact that a considerable part of medications currently launched in the market contain few innovative elements, or, at times, none. Nowadays it is frequent that a same active principle receives a new patent every time there is a small change in presentation, dosage, composition (different salt or ester or new therapeutic indications). The industry is vulnerable to imitation and many of the new drugs can be copied at a minimum cost. This industry is also unique for patent concession in itself does not authorize the medication to be commercialized. Before that happens several licences are required and granted by an agency different from the one conceding the patent rights. Thus, the petitioning company undertakes the obligation to perform pharmaceutical, toxicological, pre-clinic and clinical tests of a new chemical entity or involving new therapeutic applications. In some cases the Company will also be required to determine the highest retail market price in addition to a co-participation percentage in national health systems. By reason of this specificity, another differentiating factor arises consisting in the protection involving confidential pharmacological, toxicological, preclinical and clinical data of new chemical entities introduced to regulatory authorities for registration obtainment of the submitted pharmaceuticals. This requirement significantly reduces the time of exclusive marketing rights Marketing Authorization. These tests and experiments differ from the ones performed in the patent obtainment concession procedure. Resulting from this significant reduction of exclusive marketing rights and the high cost of the Marketing Authorization some countries are adopting practices to extend the exclusive marketing right period. Examples of this consist of the supplementary protection certificate concession and the protection of data deposited with the health authority. There is also the consideration that as a result of drug price regulation by the public bodies, as well as the difference in pricing procedures of different countries, parallel trade of drugs has come into play. This fact generates issues related to rights depletion and parallel importation. As for the pharmaceutical industry another characteristic should be highlighted. By reason of this temporary exclusive trading right, industrial property rights holders are more easily placed into control. Competition restrictions in the pharmaceutical industry operate in different ways and are mostly protected by the shield of legality. Nevertheless, analysis related difficulties in general occur because the objective concept of competition restriction is not limited to legislation. On the contrary, there are complex situations in which this concept becomes more comprehensive due to assumptions based on circumstances related to the behavior of economic agents. It is also characterized by the possibility of compulsory license regimes, especially in the superseding of exclusive rights (legal monopoly) or industrial privileges opposing governmental objectives. Last, but not the least, there must be a distinction between pharmaceutical companies trading drugs by trademarks and pharmaceutical industries companies producing and trading medication by active principle. The difference is not only related to the objective of the company involved but first and foremost focused on pricing. The difference between industries trading medication by brand and the ones trading medication by active principle promotes tension extrapolating marketing issues and involving administrative and legal issues. Related tension, contradictions and disagreements are the object of this paper.
See more here.