CMS Expert Guide on Bolar Provisions

Bolar provisions, named after the US law enacted to overturn a court ruling which had held that the USA did not provide for a research exemption (see Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc., 733 F.2d 858 (1984)), are a powerful tool for generics and biosimilars drug manufacturers to overcome potential acts of patent infringement during the course of drug research and development.

Across the EU, countries have implemented their own versions of Directive 2001/82/EC and Directive 2001/83/EC by introducing Bolar provisions or amending existing Bolar provisions. Many European countries now have in place legal or research exemptions from patent infringement for certain acts relating to the development and submission of testing data to a regulatory agency or for experimentation, including the manufacture of patented products for generic, bioequivalent and/or biosimilar drugs. 

In this Expert Guide, we summarise the particularities of the Bolar provisions in each jurisdiction.

Bolar in the UPC is implemented by the UPC Agreement as one of the “limitations of the effects of a patent”, pursuant to Article 27(d). The UPC Bolar exemption will probably lead to a narrow application relating only to acts under Article 13(6) of Directive 2001/82/EC or Article 10(6) of Directive 2001/83/EC for patents covering the product within such meaning. Accordingly, the scope of the UPC Bolar exemption appears to be narrower than the broader exemption seen in Germany, France and the UK (in its broader ‘New Experimental Use Exemption’), where there is no distinction between marketing authorisations for generics and innovative drugs or where they are applied for, and broadly aligned with the Netherlands.

For both traditional European patents and for Unitary patents the UPC has the choice of national laws in which to interpret Article 27(d), but it may need to refer the matter to the CJEU in order to clarify the scope of the Bolar exemption in the future.