日期: 17 October 2017
By Dr. Edward Rainsford
The "Bolar exemption" allows the use of patented products for the purposes of providing the clinical trial and experimental evidence required for obtaining regulatory approval. This allows a pharmaceutical manufacturer to obtain regulatory approval for a generic version of a patented drug prior to expiry of the patent. The manufacturer is therefore able to sell the approved generic drug immediately after expiry of the patent rights. As reported here, different countries within the European Union have taken different approaches to implementing the European Directives relating to the Bolar exemption. In 2014, the UK made a major change to its approach to the Bolar exemption to allow not just testing for generic versions of patented drugs but also testing for innovative drugs.
Ireland also broadened its approach to the Bolar exemption in recent years. However, despite initially being proposed, an exemption for health technology assessment was not implemented.
A summary of the differences between different European countries is set out in the table below:
Exemption is limited to activities relating to marketing approval of generic medicines, bioequivalents and biosimilars
Broader exemption for any act required for marketing approval, as well as acts relating to innovative medicines
Further exemption for Health Technology Assessment (e.g. for drugs that already have marketing approval)
Marketing authorizations in the EU only
Belgium, Cyprus, Greece, Netherlands and Sweden
Bulgaria, the Czech Republic, Estonia, Finland, France, Hungary, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Slovenia, and Spain
Marketing authorizations inside or outside the EU or European Economic Area (EEA).
Austria, Germany, Denmark, Ireland, Italy and UK
One grey area relating to the Bolar exemption is whether a company is free to market and sell a generic version of a patented drug explicitly for use in testing under the Bolar exemption. The Düsseldorf Appeal Court in the case of Astellas Pharma Inc v Polpharma S.A. Pharmaceutical Works referred several questions relating to this issue to Court of Justice of the EU (CJEU) in case C-661/13. However, these questions were withdrawn prior to being answered by the CJEU.
It has now been reported in the Wall Street Journal that the UK National Health Service (NHS) has secured a supply of a generic version of the anti-HIV drug Truvada from Mylan NV at a much reduced price than that of the patent owner Gilead Sciences Inc. The reason this is allowable is because the NHS is supplying the drug to patients as part of a clinical trial. This move has been noted by some commentators as unconventional for the NHS and it has been speculated that it may have been sparked by the NHS losing a UK Court of Appeal case in which the NHS was deemed to have the resources to pay for Truvada and was compelled to start providing the drug.1)
The Bolar exemption is set to remain an important issue for European pharmaceutical companies.
If and when the unitary patent system comes into effect, there is the possibility that these differences in national implementation of the exemption will give rise to different outcomes depending on the residence of the applicant. A unitary patent shall have the same effect across all participating member states (UP Regulation Art. 5.2), but what that effect is in a given state depends not on the law of that state but on the law of the state of residence of the applicant (Arts 5.3 and 7.1). It is possible that the legislative intent of the states with broad exemptions may be circumvented by applying for European patents in the name of a company registered in a state with a narrow exemption and declaring such patents as having unitary effect.
1) In National Aids Trust v National Health Service Commissioning Board (NHS England) (Rev 1)  EWHC 2005, Mr Justice Green ruled that NHS England had "erred in deciding that it has no power or duty to commission" pre-exposure prophylaxis (PrEP), a treatment which involves HIV negative people taking an antiretroviral drug to avoid getting HIV. The NHS appealed and lost.
For questions about this matter or related issues, please contact our Associate Dr. Edward Rainsford(email@example.com).