The supplementary protection certificate: the recent decisions of the court of justice of the European union
The supplementary protection certificate: the recent decisions of the court of justice of the European union

Summary/Abstract: In recent years, public health systems in high-income countries have been heavily exposed to pressures due to high drug prices. High drug prices are affected by market monopolies that pharmaceutical companies have thanks to patents, i.e. the exclusive rights granted to them for drugs. An additional factor affecting high drug prices is the extended forms of intellectual property protection, including the extension of the exclusivity period after the expiration of a patent for medical devices. The supplementary protection certificate as a form of a supplementary protection for pharmaceutical products in the European Union is regulated by the Regulation 469/2009. This form of protection is also known in the national patent regulations. Since the entry into force of the Regulation 469/2009, there has been debated the question of whether the supplementary protection certificate should be available for new therapeutic uses of previously approved active ingredients. In addition, the subject of interpretation was also the Article 3(a) of the Regulation 469/2009 requiring that the “product” (i.e. the active ingredient or combination of active ingredients) being the subject matter of the SPC application, should be “protected by the basic patent”.The author analyzes several important decisions of the EU Court of Justice, with an emphasis put on the recent verdicts in both the “Santen” and “Royality Pharma” cases. In the grounds of these cases, there have widely been discussed the issue concerning the encouragements given to pharmaceutical companies being involved into medical researches in order to stimulate their investment into innovation treatments.

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