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.
Highlights
The patent is the right to the intellectual property which gives the inventor the exclusive right to production, distribution, import and use of the invention protected by the patent (Lasić, 2014, p. 178)
SPC exists with the aim of prolonging the validity of the patent
In the greatest number of countries the patent lasts for twenty years
Summary
The patent is the right to the intellectual property which gives the inventor the exclusive right to production, distribution, import and use of the invention protected by the patent (Lasić, 2014, p. 178). The patent is valid for 20 years since the day of submitting the patent application, which means that the competition to the patent’s inventor is prevented from economic exploitation of the invention protected by the patent This is understandable and justifiable, bearing in mind for example great expenses which pharmaceutical companies invest in the research and development of the new medicine A special emphasis will be placed on the court practice in EU Court of Justice about the additional protection for the second medical use This question has especially become an important issue after the recent verdict of the Court of Justice in the “Santen case” which has brought about different comments both by the experts and by the pharmaceutical products manufacturers
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