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November 2019

Amendments to Poland Bolar provisions

An important change is coming to Polish patent litigation. Poland is about to adopt a more lenient approach to the Bolar provision. In most EU countries since 2004 the Bolar provision enables to conduct, during the patent protection term studies and trials necessary for obtaining pharmaceutical marketing authorization, to launch a new pharmaceutical product onto the market. The draft legislative reform decree of July 2019 will amend Article 69 of the Polish Industrial Property Law (patent section). The amendment will bring precision to the personal, subjective and territorial scope of the regulatory review defence.

It provides that one does not infringe a patent where usage of the patented invention is for the purpose of producing, using, storing, offering, placing on the market, exporting or importing in order to carry out activities that are required by law to obtain, also by a third party, registration or authorization as a condition for market authorization of certain products due to their intended use, in particular medicinal products on the territory of the European Economic Area or another country. Furthermore, Poland may adapt into domestic law a breeders' exemption. It would not be a patent infringement use of biological material for the purpose of breeding or discovering and producing new plant varieties.

Controversies over the "old" Bolar

The new provision is a result of a long-time industry battle over the ambiguous scope of the Bolar provision. The current provision has appeared flexible because it provides that it is not a patent infringement making use of the invention, to the extent necessary, to perform activities which are required by law to obtain registration or authorization which are a condition for the authorization of certain products on the market because of their intended use, in particular medicinal products. However, this leaves the unspecified personal scope, territorial reach or status of medicines and the kind of studies or trials exempt from patent infringements.

The decision of the Polish Supreme Court on 23 October 2013 confirmed a narrow scope of this regulatory defence as a result of complex litigation in Poland and Germany regarding the infringement of the Astellas' substance patent for Solifenacin by a Polish manufacturer of active ingredients. We have reported on this here and here. The Supreme Court ruled that the Bolar provision only applied to the entity conducting the experiments or trials, and did not allow infringing acts committed by third-party suppliers or manufacturers.

Some practical tips: what actions will "new" Bolar cover?

• The Bolar provision is without limitation of territorial scope which means that exempted activities should be covered by a local exemption regardless of where regulatory approval is ultimately sought and thereby export of manufactured substance is allowed.
• A third party which assists a primary party in carrying out preparatory work for regulatory approval (eg by contract manufacturing) should benefit from the Bolar exemption, provided that such third-party activities are clearly directed and limited to assisting the primary party in seeking regulatory approval.
• The Bolar exemption is limited to those activities that occur prior to regulatory approval. Activities that occur after a competing medicine is approved but while relevant patents that cover those activities are still in force do not implicate this purpose, but instead interfere with core patent rights and undermine the innovation incentives that patents were designed to provide.
• It applies to all qualifying activities, regardless of whether those activities relate to approval of a generic or biosimilar medicine or a new innovative medicine.
• Storage of test batches is covered by the Bolar exemption, but not storage of commercial batches for launch after patent/SPC expires.
• Clinical trials to investigate market potential exceed the Bolar provision.

Summary

It is expected that this amendment will come into force on the first part of 2020. The amended Bolar provision will broaden protection to additionally cover activities conducted for the purpose of obtaining a marketing authorisation anywhere in the world, including studies on biosimilar and innovative drugs.

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