On 23 December 2014, the Intellectual Property Miscellaneous Provisions Act 2014 was signed into law, enacting an amendment designed to broaden Ireland’s ‘Bolar’ exemption.
This development will be of interest to pharmaceutical companies operating, or intending to invest, in Ireland.
Background of the Bolar Exemption
The Bolar exemption has existed in Irish law since 2006 and has its basis in two Directives -Directive 2004/27/EC amending Directive 2001/83 relating to medicinal products for human use and Directive 2004/28/EC on veterinary medicinal products. The exemption acquired its name from a US case Roche Products v. Bolar Pharmaceutical, in which the US Court of Appeals ruled that the experimental use of a drug for the purposes of obtaining regulatory approval for a generic version of a patented pharmaceutical product constituted a patent infringement. Following this case, US patent law was amended to include an exemption to permit such activities and the EU followed suit as part of the reform of the then current pharmaceutical legislation in the directives referred to above.
Medicinal and veterinary products require a marketing authorisation before they can be placed on the market, whereby the Health Products Regulatory Authority at national level, or by the European Medicines Agency at EU level. In order for a generic or biosimilar medicinal product or veterinary product to gain a marketing authorisation, the manufacturer must perform certain studies, tests and trials on its product in order to generate the data necessary to demonstrate the safety and efficacy of the product. In the absence of an exemption, the manufacture of the patented product pre –expiry as part of these tests, studies and trials would constitute infringement and the exemption enables the generic producer to obtain this marketing authorisation in preparation for the expiry of the patent.