What pharma should know about the European Unitary Patent in light of Brexit

October 2, 2017

What is the European Unitary Patent? What are the consequences of Brexit in the pharmaceutical market? What are the economic forecasts in this sector? You will find all your answers in this very interesting article from Pharmafile!

The departure of the United Kingdom from the European Union, dubbed “Brexit,” has sparked significant economic global uncertainty. Two Brexit-related issues especially relevant to the pharmaceutical industry are: 1) whether the UK will ratify the proposed European Unitary Patent System, and 2) whether London will still be the site of the thematic patent court dedicated to pharmaceutical patent disputes.


These issues are more critical than ever as the UK has officially invoked Article 50, the mechanism by which members of the EU withdraw from the union. Although the UK may still ratify and join the Unitary Patent System before officially leaving the EU, it cannot join the Unitary Patent System after withdrawing from the EU. Further, when the UK formally leaves the EU at a later date, it would no longer be covered by the Unitary Patent System unless the agreement is amended.


Conflicting information has created additional uncertainty regarding to what extent the UK will help facilitate the Unitary Patent System as it promised to do prior to Brexit, and whether the UK will ultimately join the Unitary Patent System at all. In this article, we explore the possible effects of Brexit and Article 50 triggering on the Unitary Patent System and address the real-world consequences for the pharmaceutical industry.


The Current European Patent System


Under the current European patent system, an applicant for patent protection has the option to file applications in individual European countries, but most applicants choose to file and prosecute a single European Patent application through the European Patent Office (“EPO”). Once granted, a single European Patent may be entered into multiple contracting states and immediately receive patent protection in each. However, even a patent obtained through the EPO must be enforced in each European country individually. Although the EPO system greatly streamlines the process for gaining patent protection in Europe, enforcement is still performed within the national court systems of each individual state, often requiring multiple simultaneous or overlapping litigations to effectively pursue infringers.


The Proposed Unitary Patent System


The Unitary Patent System proposes to further streamline enforcement of a European Patent by creating a Unitary Patent that can be enforced in a Unified Patent Court (“UPC”) system. Unitary Patents would concurrently provide patent protection to 25 of the member states of the European Union, and could only be enforced in the singular UPC system. Rulings by the UPC on a Unitary Patent would apply consistently to all 25 member states within the Unitary Patent System. Significant cost savings are expected with the Unitary Patent due to reduced translation costs, a single maintenance fee, and centralized enforcement for patent owners. Further, stability and predictability associated with a unified system would facilitate more effective patent strategies for technology-based companies like those in the pharmaceutical industry.


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