Browsing by Author "Rahnasto, Johanna"

The research discusses whether health rights can be used as a discretionary limitation in the grant of permanent injunctions for pharmaceutical patents in the EU. The method is predominantly legal dogmatic with some comparative law as well as law and politics. The research contributes to the discussions of what the role of the right to exclude is, whether courts should have discretion in granting injunctions after infringement has been established and what the relationship of intellectual property and human rights is. The traditional starting point of patent law is a strong right to exclude. This means that injunctions are issued as a matter of course when infringement has been established. In the case of pharmaceuticals the exercise of the right to exclude can sometimes result in a socially valuable product becoming unavailable to patients. It is therefore reasonable to ask whether the right to exclude should sometimes be overridden by public health concerns. Health rights refer to these public health concerns, including access to medicine and right to highest attainable level of health, as provided in various human rights instruments. The EU Enforcement Directive provides that courts must have authority to grant injunctions. It also says that remedies must be effective, proportionate and dissuasive. To fulfil all these requirements any particular remedy should be selected based on the facts at hand. In the USA, the Supreme Court's eBay judgment made granting injunctions entirely discretionary. Courts have kept issuing injunctions for pharmaceutical patents in most cases, but consideration of public interest factors has become more routine. Injunctive relief might be denied if the injunction would make a medically important product unavailable to a substantial patient population, for example if the infringing product were not entirely substitutable with other products. Taking into account the human rights framework of the EU, it seems that EU courts would have the authority to take into account these kinds of facts and exercise similar discretion. Health rights could in individual cases weigh more than the patentee's right to exclude. Despite this, the current practices are unlikely to change without the emergence of a landmark case that might be referred to the Court of Justice of the EU. As a conclusion, no legislative changes would be needed in the EU in order to adopt discretion in granting permanent injunctions. The lenient wording of the enforcement provisions, the principle of proportionality and the various human rights commitments of EU Member States provide sufficient legal grounds for exercising this kind of judicial discretion. In the light of the EU health rights framework the possibility to balance competing interest according to individual circumstances seems justified. Yet, the threshold for intervening with normal exercise of patent rights should be set quite high. In standard cases there would be no reason not to prioritize interests of the patentee. In the long run these interests also support public interests indirectly. Therefore the existence of discretion would not necessarily undermine exclusivity-based business models or incentives for pharmaceutical research and development.