Contrary to expectations (see Autumn 2012 Patent issues) the Intellectual Property Bill is silent on the issue of exempting infringement for clinical drug trials. We expected the so-called "Bolar" exemption would be expanded beyond merely allowing generic drug companies to obtain regulatory approval for drugs that are about to go off-patent, to also exempting clinical and field trials using innovative drugs, and even permitting studies required for a patented drug's health technology assessment. The United States and Germany, for example, have broader such exemptions, and the UK Government is very keen to encourage the business of running clinical trials in the UK.
A problem is the chicken-and-egg situation in the Unitary Patent Court Agreement. That agreement defines patent infringement of a unitary patents and European patents and allows only the "narrow" Bolar exemption. Furthermore, Article 2(2) of the EPC requires a European patent to have the same effect as a national patent, so it does not appear to be open to member states to have different laws in relation to patent infringement, even for national patents.
We understand that the expansion of the Bolar exemption may yet be introduced into the Bill. Even if the UPC Agreement does not countenance it, there are two good reasons for proceeding now. The first is that there may be an interim period before the UPC Agreement comes into effect, during which an expanded exemption may be politically attractive, and the second is that if sufficient states follow the lead from Germany and the UK, there may be a consensus for an amendment to the UPC Agreement, which may be an easier instrument to amend than an EU Regulation or the EPC.
Bolar Exemption in Germany
German Patent Act, Section 11, No. 2b
The effects of a patent shall not extend to: . . . studies and trials and the resulting practical requirements necessary for obtaining a marketing authorization to place a medicinal product on the market in the European Union or marketing approval for a medicinal product in the Member States of the European Union or in third countries.