KEI Europe comments on the European Commission’s roadmap for an Intellectual Property Action Plan

14 August 2020

Compulsory licensing in the Unitary Patent System.  There should be a provision for a unitary compulsory license in the unitary patent system, that is without prejudice to national compulsory licenses on the unitary patent right.  

Non patent market exclusivities.  Sui generis exclusive rights regimes, such as but not limited to regulatory test data exclusivity, orphan disease exclusivity, and all copyright like related rights, including for data or broadcasting, should have exceptions and compulsory licensing provisions that are at least as robust as for patent and copyrights. 

Transparency.  IP systems should be more transparent.  Patent landscapes on medical technologies should be transparent. Government funding of patents should be disclosed in patents.  All licenses of government funded patents should be fully transparent and available in a central repository.  Member states should implement the transparency provisions of the World Health Organization’s transparency resolution (WHA72.8).

Cross licensing public sector rights in inventions. EU member states should cross license public rights in government funded patents, and enter into agreements with non-EU countries for cross licensing such rights.

Artificial Intelligence. In establishing a European approach to intellectual property and artificial intelligence (AI), the European Commission should not set norms before understanding the ramifications. Policy makers need to consider the scale of AI-generated output, which is unprecedented, and which may create IP thickets. AI is also likely to involve substantial increasing returns to scale. Access to data by third parties, as an essential facility, may be necessary in order to prevent monopolization. Self-driving cars and search engines are but two examples. We will likely need less protection of data, not more, to avoid excessive and innovation-reducing concentration.

COVID-19 response  The EU should mandate deep technology transfer for any effective COVID-19-related vaccines, therapeutics or diagnostic tests, as well as rights in any test data needed to register products.

The EU should require all funding agencies to license patents, know-how, data on cell lines to the WHO’s COVID-19 Technology Access Pool (C-TAP), and to provide transparency of (1) all funding and procurement contracts (2) all clinical trial results and (3) information on the costs for all trials used to obtain regulatory approval, including public sector subsidies.

TRIPS Article 31bis.  The Commission should reverse an earlier decision to voluntarily opt-out of World Trade Organization (WTO) rules to enable WTO members to import medical technologies manufactured under a compulsory license in another country. 

Delinking incentives from prices and exclusive rights. The Commission should conduct a feasibility study to evaluate the design, cost, feasibility and efficacy of market entry rewards as an alternative incentive for development of medical products and services.

Cell and gene therapies. EU member states should not grant patent protection to CAR-T treatments, and they should be defined as a service or a medical procedure, rather than a product. 

Copyright terms. Copyrights and related rights not owned by authors or performers should be as short as is permitted by the WTO TRIPS Agreement.

News of the day.  Consistent with Article 2(8) of the Berne Convention, copyright and related rights protection should not apply to news of the day or to miscellaneous facts having the character of mere items of press information.

Controlled Digital Lending.  Exceptions to or the exhaustion of copyright and related rights should be robust enough to permit controlled digital lending of copyrighted works by libraries and archives.