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The risk of a biosimilar void in Europe


by Giuliana Miglierini The undergoing revision of the pharmaceutical legislation aims, among others, to redefine data protection to better support competitiveness of generics and biosimilars and to favour the timely access of patients to treatments. While the innovator pharma industry is Read more

The drug shortage situation - EIPG's point of view


by Maurizio Battistini The shortage of medicines has been a major concern in the countries of the European Union, and elsewhere, for more than 10 years, so much so that the Economic Community has devoted a great deal of effort Read more

EP’s draft position on Unitary SPC and SPC Regulation revision


by Giuliana Miglierini The Committee for Legal Affairs (JURI) of the European Parliament released the draft amendments to the Commission’s proposals aimed to establish a Unitary Supplementary Protection Certificate (SPC) (links to the document and to the procedure) and to Read more

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The proposals of the EU Commission for the revision of the IP legislation

May 12, 2023 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

By Giuliana Miglierini

In parallel to the new pharmaceutical legislation, on 27 April 2023 the EU Commission issued the proposal for the new framework protecting intellectual property (IP). The reform package impacts on the pharmaceutical industry, as it contains proposals on Supplementary Protection Certificates(SPCs) and compulsory licensing (CL) in crisis situations. It also includes a new Regulation on Standard Essential Patents(SEPs).

The proposed reform, which is part of the EU Industrial Strategy, will now undergo the scrutiny of the European Parliament and Council. It aims to improve European competitiveness, innovation and technological sovereignity, with a special attention to the role played by SMEs. The proposal is based on comments received during the consultation on the Action Plan on Intellectual Property issued in November 2020. The IP legislative framework will complement the Unitary Patent system, that will fully entry into force on 1 June 2023.

Supplementary Protection Certificates

Central to the reform of the SPC system is the creation of a unitary SPC to complement the Unitary Patent. The aim is to reduce the current fragmentation in the issuing of SPCs at the national level, which often leads to complex interpretation of patents’ expiry dates, and consequent legal uncertainty. The new system would not replace the existing national SPC schemes.

Procedures should be simplified, with a single application to be submitted to the EU Intellectual Property Office (EUIPO), which would be responsible for its central examination in close cooperation with EU national IP offices. The process would lead to national SPCs granted for each of the designated member states (MS), plus a unitary SPC if required by the applicant (here the Q&As).

According to the Commission, approx. 25% of current SPC procedures have contradictory outcomes. The mean number of annual SPC applications is 81 per MS, with a total cost of €192,000 over the 5 years of duration (compared to roughly €3,000 in the US and €4,200 in Japan). Savings from the new procedures may amount to up €137,000 for the EU27 wide, five years long SPC protection. A central SPC database is also planned in order to increase transparency.

The proposed reform is comprehensive of a Regulation specific to medicinal products and a second one focusing on plant protection products, plus parallel recasting regulations to review the current legislative provisions (i.e. Regulation (EC) No 469/2009). Innovators would be incentivised to use unitary SPCs, since otherwise a unitary patent could be extended at higher costs only by means of national SPCs. Infringements of unitary SPCs would fall under the judgement of the UPC Court.

The Commission expects the development and access to generic medicines will be facilitated. In particular, SMEs will be able to submit observations during the examination of a centralised SPC application, and to file an opposition in order to centrally challenge the validity of the SPC protection, if justified. The new framework complements the proposed pharmaceutical legislation, for example on the Bolar exception. This should allow the generic industry to perform research and testing for preparing regulatory approval also while a patent/SPC is still in force.

Compulsory licensing

Compulsory licensing may be used during crisis in order to provide access to relevant products and technologies, should result in impossible (or not adequate) to close voluntary licensing agreements with owners of IP rights. The current fragmentation of procedures at the national level results in a wide legal uncertainty (see also the published Q&As). The new framework would complement other EU crisis tools, such as the Single Market Emergency Instrument, HERA regulations and the Chips Act.

According to the proposal, a Union compulsory licence can only be granted after activation of an emergency or crisis mode at EU level. Instruments to trigger this fundamental passage are listed in an Annex, so to improve legal certainty. A remuneration scheme for IPR holders is also included, on the basis of successive steps in the activation and termination of compulsory licensing.

The existing national frameworks on compulsory licensing will continue to operate, and they may be used to manage local crisis. Compulsory licensing of exported products would not be allowed.

Standard Essential Patents

SEPs refer to technologies essential for the implementation of a technical standard adopted by a standard developing organisation. They are typical of the ITC industrial sector, and central to building the Internet of Things.

To improve the transparency and legal certainty of SEPs, the proposal aims to ensure innovation would be run in the EU by both EU SEP owners and implementers. End users would benefit from products based on the latest standardised technologies at fair and reasonable prices. SEPs licensing is based on the FRAND scheme (fair, reasonable and non-discriminatory) for the remuneration of patent holders.

Comments from the stakeholders

EFPIA granted positive feedback on the simplification and harmonisation of the SPC system and to the opportunities offered by the unitary SPC. On the other hand, the proposals on compulsory licensing didn’t find the agreement of the research-based pharmaceutical industry.

According to a note, voluntary licensing would be the preferred instrument for innovators, as it allows for the choice of the best-positioned and trusted partners to speed up production and distribution of medicinal products during health crisis. On the contrary, compulsory licensing is seen as a threat to investment stability of the EU’s IP system and to the overall innovation pipeline.

“Protecting the EU’s intellectual property framework could not be more important if we are to close the investment gap between Europe, the US and increasingly China and continue to offer patients the best possible treatments. Yet we are seeing multiple proposals emerging from the European Commission in the pharmaceutical legislation and patent package which tend towards the opposite”, said EFPIA Director General Nathalie Moll.

Medicines for Europe (MfE), on behalf of the generic and biosimilar industry, said that while “voluntary licensing agreements are relevant for health crises, we will contribute constructively to the EU-wide compulsory licensing system”. The request to the Commission is to make it a remedy also for anti-competitive abuses of the patent system, according to art. 31(k) of the TRIPS Agreement.

As for new SPCs, MfE highlights the new regime would extend their geographical scope from the current 20 out of 27 MS covered on average. “The proposal for a reform in the SPC system has the potential to reduce fragmentation in Europe but the legislation must ensure improved quality and transparency of granting procedures to prevent misuse by right holders to delay competition”, said MfE Director General Adrian van den Hoven.

Critics of the proposed scheme for compulsory licensing also came from EUCOPE, representing pharmaceutical entrepreneurs. According to the Confederation, the Commission’s proposal would further weakening the value of intellectual property rights within the EU. “Together with the proposal on the revision of the general pharmaceutical legislation, it is another indicator that the development of an innovation-friendly environment is not a priority, contrary to statements in the Intellectual Property Action Plan”, it states in a note.

For EUCOPE, the proposed SPC regime would not amend the substantive elements of the current system. Furthermore, a centralised SPC application would only be possible on the basis of a European patent, including a unitary patent, and for products with a centralised marketing authorisation. EUCOPE position goes for an optional EU-wide SPC, so to allow flexibility for IP owners in deciding their strategy for the protection of IP rights.


The Made in Europe partnership for manufacturing

March 18, 2022 , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The availability of a robust framework to support a sustainable European manufacturing system is undoubtedly a priority in the challenging times we are experiencing. In the pharmaceutical sector, the reshoring of productions of both active ingredients and finished medicinal products is already a key point of the new EU Pharmaceutical Strategy and of the consequent ongoing revision of the legislation governing the sector.

A broader action addressed to the entire European industrial system was launched in 2019 within the framework programme Horizon Europe (HE) 2021-2027: the Made in Europe manufacturing partnership aims to become the main driver for sustainable manufacturing in Europe. The partnership was modelled with the contribution of the European Commission, member states and the European Factories of the Future Research Association (EFFRA); the latter is also the leading entity in charge of coordinating the initiative, which include all actors taking part to the manufacturing ecosystem (i.e. academia, industry, non-governmental organisations and the public sector).

The main goals of the Made in Europe partnership

The two themes of ecological and digital transitions central to the policies of the von der Leyen Commission are the main source of inspiration for the Made in Europe partnership. The availability of a European manufacturing environment able to compete on global scenarios thanks to its technological leadership is the main objective of the initiative. Many challenges need to be faced to reach it, especially in the field of the integration of technologies based on artificial intelligence to fully exploit the potential of industrial data, the reshaping of a circular economy and a high flexibility in response to emerging trends and issues.

The Made in Europe partnership represents a common platform for national and regional manufacturing technology initiatives, including the required disciplines and technologies. The principles governing its actions are described in a guidance document available at the EFFRA website; a Strategic Research and Innovation Agenda (SRIA) is also available.

According to the guidance document, manufactured goods represented in 2018 83% of EU exports, and accounted for a annual trade surplus of 286 billion euro. Despite this very high surplus, the document warns it may be not sufficient to cover deficits arising from the purchase of non-manufactured goods and services. Also considering these factors, the balance moved from a surplus of € 22 billion in 2017 to a deficit of € 25 billion in 2018. This situation may now dramatically evolve further, due to the high increase of costs of energy and raw materials experienced in the last month, as a consequence of the war occurring at the Eastern boundaries of the EU. A situation that might make harder for the EU to also face the competition of Asiatic economies.

The guidance document identifies twelve challenges to be faced by the European manufacturing industry, starting from the need to strongly reduce to the minimal level its environmental impact. To this instance, optimisation of resource efficiency and the carbon intensity of the entire supply chains are among the main factors to be addressed, leading to the opportunity for European-made environmental-friendly but high-priced products. This switch also supports the development of circular models for the economy, and the use of next-generation sustainable materials and products, requiring to manage profound changes if the manufacturing systems and related supply chains. Recycling and re-manufacturing may play in the future an important role in redefining products’ life cycle. The resilience and agility of the European manufacturing industry shall be also tackled, in order to limit the impact of sudden crisis, as occurred with the Covid-19 pandemic or now with the Ukraine war. This goal calls for the availability of flexible and reconfigurable production lines within a country or region, suggests the document. The pharmaceutical sector already experienced criticalities during the Covid-19 arising from the dependence from extra-EU supplies; the same applies to all European industrial sectors, and according to the Made in Europe partnership it should be faced through achieving manufacturing sovereignty and technological leadership in key areas and critical value chains. A very challenging objective, that requires a coordinated European effort on manufacturing.

As for competition from other economies, the document warns that big public-private manufacturing partnerships are being launched also in Asia and America (i.e. Made in China). Environmental and social aspects should be jointly considered in the location/relocation of manufacturing companies, to account for the environmental sustainability of the businesses coupled to the requirements arising from a EU’s population mainly living in urban areas.

The challenges of digitalisation

Many of the above-mentioned targets identified by the Made in Europe partnership may benefit from the potential offered by the implementation of digital technologies to accelerate innovation and industrial transformation, thus leading to the improvement of the overall efficiency of manufacturing. Data are becoming a central driver for the creation of value, but companies are called to better understand the data economy also from a non-technological point of view. Cybersecurity should be also carefully addressed, as digitalisation is reflected by a higher vulnerability to cyber attacks.

Digitalisation also impacts on the availability of new business models, such as “manufacturing-as-a-service” and “collaborative product-service engineering”. Automated systems governed by artificial intelligence are now widely available in many industrial plants, and attention should be paid to modes of interactions between collaborative robots and human operators. Nevertheless, the availability of trained and skilled human staff is considered as a major barrier and threat by the Made in Europe partnership, particularly for SMEs.

The planned actions

Six different calls for actions in the field of green and digital transitions were launched by the Made in Europe manufacturing partnership within the Horizon Europe work programme 2021-2022. The total available budget is around € 1 billion. Topics of interest included AI enhanced robotic systems for smart manufacturing, zero-defect manufacturing towards zero-waste, laser-based technologies for green manufacturing, manufacturing technologies for bio-based materials, advanced digital technologies for manufacturing, and data-driven distributed industrial environments.

The Made in Europe partnership was also involved in calls about reconfigurable production process chains, products with complex functional surfaces, excellence in distributed control and modular manufacturing, intelligent work piece handling in a full production line, ICT Innovation for manufacturing sustainability in SMEs, and digital tools to support the engineering of a circular economy.

A consultation on possible topics to be included in the HE work programme 2023-2024 is still open to comments and can be accessed by the dedicated webpage at the EFFRA website. A summary document is also available presenting potential recommendations and discussion topics received up to now. New possible lines of actions may address the availability of “excellent, responsive and smart factories & supply chains” , how to achieve a circular products and climate- neutral manufacturing, new use models referred to new integrated business, product-service and production approaches, and models for a human-centered and human-driven manufacturing innovation.