Bolar exemption in Europe

The Bolar exemption is governed by European Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Article 10(6) excludes from infringement of patent rights or supplementary protection certificates (SPCs): “Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4.” Paragraphs 1-4, i.e. Articles 10(1)-(4) of the Directive, concern the provision of data during the marketing approval process.[1]

The exact language, scope and interpretation of Bolar exemptions vary across Europe. Generally speaking, countries can be divided into two categories, (1) those countries where the exemption is limited to activities relating to marketing approval of generic medicines, bioequivalents and biosimilars, such as Belgium, Cyprus, Ireland, Netherlands and Sweden; and (2) those countries that more broadly exempt any act required for marketing approval, as well as acts relating to innovative medicines, such as Austria, Bulgaria, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Slovenia, the UK, and Spain, as well as non-EU states Norway and Switzerland.[2]

Bolar exemptions in Asia

Bolar-type exemptions are prevalent in the national patent laws of many Asian countries. The scope of exemption varies significantly from state to state. For example, Pakistan provides Bolar-type provisions for research intended to be submitted to authorities in the country, while India more broadly exempts acts relating to the development and submission of information required by law “in India or in a country other than India.” A similar exemption is also available in the Philippines in the Universally Accessible Cheaper and Quality Medicines Act of 2008. In contrast, the scope of the Bolar defense is narrower in Singapore, and is limited to clinical testing to meet requirements for marketing approval in that country alone.[3]

The types of products covered by Bolar-like legislation also vary across Asia. Some countries limit the exemption to drugs and medicines — such as Malaysia, the Philippines, and Thailand. Others, such as Vietnam extend the exemption to any product requiring regulatory approval, while Chinese law expressly covers a “patented medical apparatus” as well as a patented medicine.[4]

Australia and New Zealand also have Bolar exemptions. Australia’s exemption does not include medical or therapeutic devices, but does include acts undertaken to obtain regulatory approval in a foreign country. Similarly, New Zealand legislation exempts acts related to the development and submission of information required under New Zealand law or the law of any other country, but more broadly covers any regulated product.[5]