Companies of all sizes rely on predictable and reliable intellectual property (IP) frameworks. The European Union has proposed changes to the Compulsory Licensing (CL) Regulation in order to address the existing gaps in Europe’s IP environment. As the deadline for amendments on this Regulation approaches, policymakers must account for the need for independent judicial oversight. Most importantly, there should be a standstill period that allows the parties involved to assess the impact and – if required – ask for an accelerated review by the General Court to define whether the CL granting is lawful. There are precedents where the Court has acted very fast on those types of decisions, an important aspect given the fact that these decisions will have to be made in crisis situations. This consideration, among others outlined in the attached documents, would ensure a fairer and more workable IP system in Europe.
Compulsory licensing of patents
Related items
Letter: Concerns over the European Parliament's on the compulsory licensing of patents
Companies of all sizes rely on predictable and reliable intellectual property (IP) frameworks. The European Union has proposed changes to the Compulsory Licensing (CL) Regulation in order to address the existing gaps in Europe’s IP environment. As the trilogues on the Regulation begin, the American Chamber of Commerce to the EU wishes to highlight key concerns with the current text of the regulation, specifically with the position of the European Parliament. Although the European Parliament’s position seeks to include certain safeguards on trade secrets, strong concerns remain regarding the potential mandatory disclosure of trade secrets and know-how. If implemented, such disclosures would irrevocably harm innovators. AmCham EU urges policymakers to take these considerations into account, as well as others outlined in the letter, to ensure a fairer and more workable IP system in Europe.
Public consultation: Intellectual property - revised framework for compulsory licensing of patents
Innovative companies of all sizes rely on predictable and reliable systems of intellectual property protection. Given the recent global crises, there is hardly any evidence to justify the introduction of a Compulsory Licensing (CL) system at EU-level in addition to the existing national CLs system. Thus, it is crucial that – if implemented – this legal framework is established with adequate judicial oversight, with a clear definition for what triggers the CL procedures and what constitutes as ‘crisis’ and in compliance with the TRIPS Agreement.
Expansion of the waiver of intellectual property protections afforded under the TRIPS agreement
The US international Trade Commission (ITC) is currently conducting an investigation to decide whether to extend the Intellectual Property (IP) waiver from COVID-19 vaccines to COVID-19 diagnostics and therapeutics. This extension would not improve access but would undermine research and development efforts of industry in the continued fight against COVID-19 and future pandemics. Therefore, AmCham EU recommendations to policymakers would be to facilitate open trade and address regulatory barriers (including measures to reduce tariffs, limit export restrictions and support developing countries in enhancing their supply chains) and build robust delivery of vaccines and therapeutics addressing bottlenecks.
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