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Knowledge Ecology International Europe

KEI Europe

Knowledge Ecology International Europe (KEI Europe) is a non-profit organization focusing on the management of knowledge, including innovation and access to knowledge goods.

Lobbying Activity

Response to Compulsory licensing of patents

31 Jul 2023

Knowledge Ecology International Europe's (KEI Europe) comments on the Commission's proposal for a regulation on compulsory licensing addresses the following issues. The regulation should not be limited to an emergency. The exceptions for regulatory data protections and market exclusivity are important. The exceptions can be implemented under Article 44.2 of TRIPS, more efficiently than under Articles 31 or 31bis. The regulation should not be limited to an emergency. While having special flexibility during an emergency is important, it is hardly the only situation where exceptions to exclusive rights are important, or where a Union non-voluntary authorization to use patented inventions and regulatory exclusivities is appropriate and necessary. The Union currently has a mandatory compulsory-cross licensing program for cases where biotechnology patents and plant varieties protections cannot be developed without infringing on each other, and in the technology area, there is constant struggling to address the challenges of patent thickets, particularly as they relate to standards essential patents. There is extensive litigation over patents in the areas of advanced therapy medicinal products, including, for example, cell and gene therapies. There have been supply problems for some drugs that had implications for patent rights, for example, when Sanofis was unable to meet patient needs for its drug Fabrazyme, and the patent holder sought an injunction to remove Shires alternative protection Replagal. In that case, Shire sought a compulsory licence in Germany, and used that compulsory licensing procedure as leverage to obtain a voluntary licence. Excessive prices and unequal access to products due to high prices are also issues that should justify the possibility of a Union wide compulsory licence, particularly when a compulsory licence cannot be successful without the supplier having access to a large enough market to justify development and entry for the generic or biosimilar product. The exceptions for regulatory data protections and market exclusivity are important. All regulatory exclusivities, including those relating to regulatory data and orphan product, and other types of intellectual property protections, including in some cases, even confidential manufacturing know-how or access to proprietary biologic resources such as working cell lines, can be critical in achieving the Union objectives concerning access and or affordability. Regulatory exclusivities are also a problem for the EU-Med4all program, because it makes it impossible to use this program for products that are new and have uses in the EU. The exceptions can be implemented under Article 44.2 of TRIPS, more efficiently than under Articles 31 or 31bis. The proposal is modeled to address the TRIPS framework in Article 31 and 31bis. But alternatively the Commission should consider an approach similar to that used by the United States in the COVID 19 crisis, to limit the remedies to infringement subject to reasonable compensation, a solution that is possible under Article 44.2 of TRIPS. There are many advantages of the Article 44.2 approach, including no restrictions on non-predominate uses. The implementation of an Article 44.2 approach in the United States only requires a single sentence in a contract that invokes use of FAR 52.227-1 Authorization and Consent, and as the TRIPS Article is flexible, it is possible to tailor an implementation in ways that the EU finds appropriate.
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Response to Compulsory licensing of patents

29 Apr 2022

1. In the European Union (EU)’s revised framework for compulsory licensing of patents, the EU anticipates establishing an EU-level compulsory licence for use in a crisis, acknowledging that a patchwork of fragmented, national compulsory licensing laws are not fit for purpose in dealing with the pandemic response or other crises. The following are KEI Europe’s recommendations regarding this issue. 2. The EU should reverse its earlier decision to voluntarily opt-out of TRIPS Article 31bis as an eligible importer of drugs, vaccines or diagnostic tests manufactured under a compulsory licence in another country. The case for doing so is discussed in an April 7, 2020 letter to 37 WTO Members signed by more than 30 groups and three dozen experts on health, law and trade. https://www.keionline.org/32707 3. While an opt-in of Article 31bis as an importing country is a minimum step in cases of emergencies, the EU has other more efficient policy tools available, as well as complementary actions. 4. Among the complementary actions that are needed are clear exceptions in regulations and laws regarding exclusivities to rely upon test data to register products. Such exceptions should also be recognized in any bilateral or plurilateral trade agreement. 5. A second complementary measure is that the EU should ensure that countries have sufficient legal authority and leverage through coordinated procurement policies to require the transfer of manufacturing know-how and access to biological resources including working cell lines, when necessary to rapidly scale manufacturing of countermeasures. 6. The EU should include march-in or government use provisions in all government funded R&D grants and other subsidies, to address the need for non-voluntary use of technologies, inventions, know-how, biologic resources and data. 7. As to the legal mechanisms for compulsory licensing of patents, the EU should implement exceptions similar to those adopted in Germany in 2020, the Act on the Protection of the Population in the Event of an Epidemic Situation of National Importance, (Gesetz zum Schutz der Bevölkerung bei einer epidemischen Lage von nationaler Tragweite). This Act allowed the government to authorize the non-voluntary use of patented inventions subject to remuneration. 8. In general, the EU should adopt measures that eliminate the remedies for infringement during a crisis to adequate and reasonable compensation. This is allowed under Article 44.2 of the TRIPS Agreement, or alternatively under Article 30 of the TRIPS Agreement. For more on this topic, see: James Love, “The Quad WTO proposal on COVID 19 and TRIPS proposal is tied for the 5th best option for exports,” Medium. March 20, 2022.
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Response to European Health Emergency Response Authority

24 Feb 2021

Whilst calls for better coordination in the EU pandemic response are welcome, HERA must put the global right to health, rather than regional biosecurity concerns, at its heart. Rapid operationalisation, as demanded by global public health needs, must not and need not come at the cost of ossifying poor practices into governance frameworks. The EU should, when possible, require collaboration and sharing of knowledge and resources, rather than secrecy, hoarding of manufacturing know-how, and blocking access to biologic resources. The lack of global solidarity, particularly as developing countries, appears to be a common thread throughout this proposal, which is regrettable. Licensing practices The new voluntary licensing mechanism should not have a geographic limit. The EU needs to address its relationship to the WHO COVID-19 Technology Access Pool (C-TAP) and the work of the Medicines Patent Pool. In addition to the immense public investment through funding of early stage research, and de-risking of investments through advance purchasing agreements, HERA needs to attach clauses guaranteeing downstream access and affordability, as well as the transfer of manufacturing know-how to third parties to achieve greater scale and faster delivery of products. The EU should endeavor to be more inclusive as regards access, not just for member states, and to constructively address the disparities in access in developing countries, including by the transfer of manufacturing know-how globally. Public-private collaboration can be both useful and necessary. The licensing agreements should seek to achieve broad public rights in both foreground and background intellectual property, and when possible, enable data, inventions and know-how to immediately enter the public domain as global public goods. Licensing agreements should include adequate step-in rights in case of later breach of access protections, and when possible, reach-through clauses such that further licensing retains the aforementioned protections. The license should require the waiver of supplementary patent protections and excessive regulatory protections. Exclusive rights in regulatory test data should be waived by the licensee, but the licensing of rights in data can be remunerative on reasonable terms. Transparency Opacity of contracts generates information asymmetries that often benefit drug and vaccine companies the most, unduly protect government and Commission officials from criticism from the public if the negotiated instruments have shortcomings, and create uncertainty and mystery as regards important policies embraced. With the exception of Germany and Hungary, all EU member states have agreed to the WHO transparency resolution (WHA 72.8), and the specific transparency norms in the resolution should be honored, including transparency of net prices, patent landscapes, units sold, sales revenues, subsidies and incentives, registration status in countries, the costs of human subject clinical trials and the outcomes from trials. Technology transfer We support greater EU manufacturing capability, but implemented with the goal of enhancing development and capacity globally. Delinkage The role of HERA extends to well beyond the end of the COVID-19 pandemic. The EU needs to explore the future mechanisms to fund incentives to invest in the development of drugs, vaccines and other countermeasures, that are delinked from exclusive rights or high prices, and which are consistent with sharing access to manufacturing know-how and cell lines and rights in investments, data and inventions. And if the knowledge resources are to become global public goods, the financing of such incentives should also be global, or at least, among a community of like minded countries larger than the EU. WTO EU members need to notify the WTO they are opting back into TRIPS 31bis as importing countries. See: https://www.keionline.org/32707
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Response to Intellectual Property Action Plan

14 Aug 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.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

KEI Europe comments on the EU Pharmaceuticals strategy 07 July 2020 i) The COVID-19 response COVID-19 Technology Access Pool (C-TAP) Ensuring universal access to COVID-19 health technologies requires reforms of incentive systems, international cooperation, solidarity and deep technology transfer to facilitate competitive supply. In the COVID-19 response, the European Union should mandate deep technology transfer for any effective vaccines, therapeutics or diagnostic tests, as well as rights in any test data needed to register products. We request the European Union (EU) join the World Health Organization’s COVID-19 Technology Access Pool (C-TAP). As part of the EU’s commitment to solidarity and deep technology transfer in the COVID-19 response, we request you to: -License any potential vaccine, treatment, diagnostic, or other health technology (funded by the European Union or the European Commission) to the Medicines Patent Pool; -Provide transparency around the publication of all clinical trial results; -For all trials used to obtain regulatory approval, provide information on the costs, including public sector subsidies. Assignments of Intellectual property rights of COVID-19 technologies to WHO C-TAP should include existing and future rights in patented inventions and designs, regulatory test data, know-how, cell lines, copyrights and blueprints for manufacturing vaccines, diagnostic tests, devices, or therapeutics. B. Article 31 bis of the TRIPS Agreement The European Commission should reverse an earlier decision to voluntarily opt-out of World Trade Organization (WTO) rules to enable WTO members to import drugs, vaccines or diagnostic tests manufactured under a compulsory license in another country. Commissioner Phil Hogan’s response to MEP Bernd Lange in relation to Article 31bis was encouraging. “The Commission is monitoring the situation carefully, in close contact with Member States, and it will not hesitate to take the necessary action if the need arises, also as regards the EU’s non-importer status under Article 31 bis of the TRIPS Agreement.” ii) Cell and gene-therapies The European Commission should take specific actions and refine cost saving initiatives that avoid rationing of treatments. The EU needs to delink R&D incentives from the grant of monopolies and the price of products or services. The Commission should conduct a feasibility study to evaluate the design, cost, feasibility and efficacy of market entry rewards as the alternative incentive for development of new cell and gene therapies. The European Patent Office (EPO) should use the available policy space under the WTO TRIPS Agreement and the provisions of the European Patent Convention (EPC) to reject patent applications claiming CAR T methods of treatment, and educate policy makers on the alternative of market entry rewards as the incentive. The Commission should create a working group to examine the implications of Article 27.3(a) of the WTO TRIPS Agreement on the patentability of gene and cell-based therapies when treatment can be described as a service or a medical procedure, rather than a product. The working group should explore if certain cell and gene-based treatments are, in fact, exempt from patentability when a country has an exception that mirrors Article 27.3(a) of the TRIPS Agreement. The European Medicines Agency should not have to define cell and gene therapies as products to justify its regulatory activities.
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Response to Europe’s Beating Cancer Plan

3 Mar 2020

Cell and gene therapies are among the more promising innovations to treat cancer. Chimeric Antigen Receptor T-Cell (“CAR T” or “CAR T-cell”) treatments involve a combination of procedures that take place both in and outside of the body. Blood is taken from a patient, and T cells (a type of immune cell) are isolated and then modified, typically using a virus. The modified CAR T cells are cultured and multiplied, and a few weeks later, re-infused into the patient. The CAR T cells then bind to an antigen on the cancer cells and kill them. Several patents have been granted for CAR T therapies, but some governments are exploring the degree to which the technology is excluded from patentability. There are several problems associated with the CAR T monopolies. In June 2018, the European Medicines Agency recommended marketing authorizations for two CAR T therapies: 1) Kymriah (marketed by Novartis) - indicated for the treatment of acute lymphoblastic leukaemia, and 2) Yescarta (marketed by Gilead) - indicated for the treatment of diffuse large B-cell lymphoma. In Germany, Novartis introduced Kymriah at the price of 320,000 Euros. In Spain, the Hospital Clínic de Barcelona paid a unit price of 313,920 Euros per patient for Yescarta in 2019. In the field of gene therapy, Zolgensma has emerged as a striking example of the dystopian future that confronts us now. The Novartis gene therapy Zolgensma is approved for the treatment of spinal muscular atrophy (SMA); Zolgensma costs 1.9 Euros million per patient. The early development of Zolgensma was funded by the US National Institutes of Health (NIH), the French charity Généthon, and US-based charities including Sophia’s Cure, Getty Owl Foundation, Fighting SMA, Jason’s Dream Foundation, and Miracle for Madison. In light of the rise of these catastrophic health expenditures that drain health budgets, it is our view that the European Union may never achieve universal health coverage without the delinkage of R&D costs from the prices of drugs, vaccines and other health technologies. To achieve the goals of reducing cancer incidence and mortality rates as well as expanding access to life-saving cancer treatments, we recommend that the European Commission takes specific actions and fine tune cost saving initiatives that do not involve the rationing of life saving treatments. To accomplish successful steps towards the delinkage of R&D cost from the price of drugs, the Commision should conduct a feasibility study to explore new market entry rewards as the incentive for development of new CAR-T and other cell and gene therapies, which would operate in countries where the patentability of such treatments will not be granted. Furthermore, the Commission should create a working group to examine the implications of Article 27.3(a) of the WTO TRIPS Agreement on the patentability of gene and cell-based therapies including those involving autologous T-cell immunotherapy (CAR T), CRISPR and other technologies when treatment can be described as a service or a medical procedure, rather than a product. The working group should explore if certain cell and gene-based treatments are, in fact, exempt from patentability when a country has an exception that mirrors Article 27.3(a) of the TRIPS Agreement. Since EU actions must be based on evidence and understanding of the impacts of regulations, we request that the Commission require the following information regarding cancer therapies be collected and made public: a) annual reports on sales revenues, prices and units sold; b) annual reports on marketing costs incurred for each registered product or procedure; c) the costs directly associated with each clinical trial used to support the marketing authorization of a product or procedure, separately; d) all grants, tax credits or any other public sector subsidies and incentives relating to the initial regulatory approval and annually on the subsequent development of a product or service.
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Meeting with Maria Asenius (Cabinet of Vice-President Cecilia Malmström), Pedro Velasco Martins (Cabinet of Vice-President Cecilia Malmström) and

15 May 2018 · Access to medicines in poor countries