The 2014 Act will be of particular interest to the pharmaceutical sector because it expands the scope of the statutory exemption from patent infringement in respect of acts done in carrying out the studies, tests and trials that are required to obtain regulatory approval for a medicinal product (human or veterinary). This type of exemption is known as a ‘Bolar’ exemption.
Prior to the 2014 Act, the ‘Bolar’ exemption under Irish law (set out in Section 42(g) of the Irish Patents Act, 1992 as amended (the “Patents Act”)) extended only to acts done in conducting studies, tests and trials for the purpose of obtaining regulatory approval for a medicinal product under any of the ‘abridged’ application procedures provided for under EU law . This limited the scope of the exemption to only those studies, tests and trials that were carried out for the purpose of obtaining regulatory approval in the EU for a generic, bioequivalent or a biosimilar product.
The 2014 Act inserts a new Section 42(h) into the Patents Act which in essence provides that, in addition to the above, the following acts carried out in Ireland will also be exempt from patent infringement:
- Acts done in conducting studies, tests, and trials with a view to satisfying the application requirements for a marketing authorisation (or similar instrument) outside the EU; and
- Acts done in conducting studies, tests, and trials with a view to satisfying the application requirements for a marketing authorisation (or similar instrument) for an originator/innovative product.
The new Section 42(h) also makes it clear that acts done in conducting ‘experiments’ are covered (if done with a view to satisfying the requirements for obtaining any regulatory approval) and that ‘trials’ includes clinical trials and field trials.
This legislative change brings Ireland’s ‘Bolar’ exemption closer in line with a number of other EU countries, who for some time have adopted a broader ‘Bolar’ exemption than applied in Ireland, and also with the UK who have recently implemented similar changes to their ‘Bolar’ exemption.
The Minister for Skills, Research & Innovation, Damien English has yesterday welcomed the legislation saying that it will make it easier for pharmaceutical companies to develop new medicinal products in Ireland, making it more attractive for research and development investment.
The 2014 Act also introduces a number of amendments to the Trade Marks Act, 1996 are necessary to allow Ireland to ratify the Singapore Treaty on the Law of Trademarks.
Where a person becomes the new owner or a licensee of an Irish trade mark under a transaction that is registrable under the Trade Marks Act, 1996 they are required to register the particulars of that transaction in the Irish Trade Mark Register. The amendments in the 2014 Act relate to the consequences of non-registration of such transactions.
- Prior to the 2014 Act, a licensee could not benefit from Section 34 and 35 the Trade Marks Act (which set out the respective rights of a non-exclusive and an exclusive licensee, including the scope of their right to take action against infringers) until such time as the licence was registered on the register. The amendment introduced by the 2014 Act means this restriction no longer applies.
- Prior to the 2014 Act, the Trade Marks Act provided that the Court must not (save in certain circumstances) award damages or an account of profits to a proprietor and licensee who had failed to register the relevant transaction in accordance with the statutory requirements in respect of any infringement of the registered trade mark occurring after the date of the relevant transaction and before the date of the application for registration of that transaction. The amendment introduced by the 2014 Act means that this provision has now been substituted with a potentially less onerous one which provides for the relevant sanction to apply not in respect of an award of damages or an account of profits but instead to an award of the costs of proceedings.
Amendment to the Competition Acts 2002 to 2014
- In addition the Act includes amendments to the Competition and Consumer Protection Act 2014 (which amended the relevant provisions of the Competition Act 2002).