1. Patent enforcement in Poland – Hot topics
Changing IP in Changing Europe Trilateral Seminar of the French, German and Polish Groups of AIPPI Paris, 5 April 2019
Patent enforcement in Poland – Hot topics
Freitag, 5. April 2019

2. Is there a theory of equivalence in Poland ?
The good old days - strict, literal interpretation
Judgement of Polish Supreme Court of 16 January 2014, (ref. IV CSK 219/13)
Changing perspective - patent claims should be interpreted like any legal act
Judgement of the Court of Appeal in Lodz of 9 November 2012 (ref. I ACa 612/12)
Judgement of Polish Supreme Court of 10 December 2015 (ref. V CSK 149/15)
Issues as related to the mosaic approach:
parallel legal regimes for the interpretation of patent claims (Polish and European patents)
European Life Sciences Forum - e-Medication in Austria

3. The Bolar exemption – some guidelines from Poland (I)
Territorial Scope: Bolar exemptions without limitation of territorial scope - exempt activities should be covered by a local exemption regardless of where regulatory approval is ultimately sought.
Application to Third Parties: A third party which assists a primary party in carrying out preparatory work for regulatory approval (e.g. 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.
Limitation to Pre-Approval Activities: the exemption should be limited to those eligible activities which occur prior to regulatory approval. Activities which occur after a competing medicine is approved but while relevant patents which cover those activities are still in force do not implicate this purpose, but instead interfere with core patent rights and undermine the innovation incentives which patents were designed to provide.
European Life Science Forum - e-Medication

4. The Bolar exemption – some guidelines from Poland (II)
Stockpiling and Clinical Trials to Investigate Market Potential: commercial activities not directly connected to obtaining regulatory approval, such as stockpiling or clinical trials to investigate market potential, should not be covered by the exemption.
Application to Innovators as well as Generics: the application of the exemption to all qualifying activities, regardless of whether those activities relate to approval of a generic medicine or a new innovative medicine
Application for Diagnostic Tests: tests should be covered under the exemption if they are used in order to obtain marketing approval of a competing or further developed test, either alone or in connection with a companion drug treatment. Use of such tests solely as tools in the research and development process (i.e. for the commercial purposes for which those tests were designed) should not, in my view, be covered by the exemption.
European Life Science Forum - e-Medication

5. Controversy in Poland about Teva drug pricing
dispute between AstraZeneca and Teva launched in September / October 2018 over the decision to reimburse issued on 1. July 2018
Interim injunction granted
A River Runs Through It : The Bolar exemption, iminent patent infringement and patent-free actions)
The clash of AstraZeneca with the Polish Ministry of Health
A new hope – let’s balance interests :
Public health to be more important than patent rights?
Will the Polish government issue the first compulsory license n Poland ?
European Life Science Forum - e-Medication

6. Thank you for your attention!
Dr. Agnieszka Sztoldman
Senior Associate heading Life Sciences, Taylor Wessing Warsaw
European Life Sciences Forum - e-Medication in Austria

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