Moreover, if and when the Agreement on a Unified Patent Court (UPCA) enters into force, the scope of the exemption will also depend on the nature of the relevant patent and whether the UPC has jurisdiction. This is because the UPCA contains a narrow Bolar exemption and refers to the provisions of the Human Medicines Directive and the Veterinary Medicines Directive. As a consequence, unitary patent and European patents litigated before the UPC would be subject to a narrow exemption.
There is also a lack of clarity over whether the Bolar exemption is applicable in the context of outsourcing. Specifically, some clinical studies and trials that are directly covered by the Bolar exemption rely on the supply of API from third parties. It is unclear whether the supply of API in this context is within the scope of the exemption, and therefore if the third-party supplier – that does not conduct the studies and trials itself – is covered.
The Supreme Court of Poland considered the issue in 2013 and decided that the third-party supplier could not rely on the Bolar exemption under Polish law in such a situation. In parallel proceedings in Germany the Düsseldorf District Court took the same view but the Düsseldorf Court of Appeal referred the question to the Court of Justice of the EU (CJEU). However, the case was subsequently settled and the CJEU did not issue a ruling on the matter.
The research exemption
In most EU countries, the Bolar exemption is complemented by a more general research exemption, which is often referred to as the experimental use exemption, which exempts from infringement certain research activities.
Unlike the Bolar exemption, the research exemption does not have a basis in EU law and its scope vary significantly from a country to another.
The SPC manufacturing waiver
In the field of SPCs, EU law makers recently introduced a new waiver which permits manufacturing of generic and biosimilar products as well as related activities in the EU that would otherwise require consent of an SPC holder where they are undertaken for the purpose of exporting the goods to territories outside of the EU.
The waiver, the eligibility for which is subject to a series of notification, due diligence and labelling requirements, also allows producers of generics or biosimilars to stockpile products in the EU during the last six months that the SPC is valid so as to be ready for release on the EU market upon the expiry of an SPC.
Contrary to the Bolar and research exemptions, the SPC manufacturing waiver covers activities that have a direct commercial purpose. It is aimed at boosting the competitiveness of Europe's pharmaceutical industry compared to countries or regions where pharmaceutical products enjoy a shorter effective patent protection period.
The exemption, however, only applies to SPCs, and manufacturing activities exempted under waiver may remain at risk in relation to secondary patents covering aspects of the product, such as a particular process or dosage.
Due to transitional rules for its application, the SPC manufacturing waiver is not expected to be effectively available until at least mid-2022.
Options for reform
Reform of the Bolar exemption is being explored by the European Commission in the context of the pharmaceutical incentives review.
In 2017, the European Commission published a roadmap of its initiative in relation to optimising the intellectual property legal framework on SPCs and patent research exemptions.
The introduction of the SPC manufacturing waiver was one of the options it listed for reform, as was the potential extension of the scope of the Bolar and research exemptions.
The Commission's stated objectives for reform include creating a level playing field for EU-based manufacturers of generic and biosimilar medicines by comparison with firms based in non-EU countries, increasing business predictability, legal certainty and potentially provide additional incentives for innovation, and maximising certainty and the benefits of the Bolar exemption. In this latter regard, it said this should include reducing fragmentation in relation to the application of the Bolar exemption in the EU single market.