IP protection Archives - European Industrial Pharmacists Group (EIPG)

A new member within EIPG


The European Industrial Pharmacists Group (EIPG) is pleased to announce the Romanian Association (AFFI) as its newest member following the annual General Assembly of EIPG in Rome (20th-21st April 2024). Commenting on the continued growth of EIPG’s membership, EIPG President Read more

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

Lessons learnt to transition from Horizon 2020 to the new FP10

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by Giuliana Miglierini

The European Commission published the ex post evaluation of Horizon 2020 (H2020), the FP8 framework programme for research and innovation (R&I) run in years 2014-2020.

The report identifies several areas of possible improvement, which may be taken into account in the definition of the new FP10 (2028-2034) that will follow the current programme Horizon Europe (FP9). Among these are a broader participation, further simplification and reduction of the administrative burden, reinforcement of the dissemination, exploitation and deployment of results, support for the participation of women and enhancement of synergies with other initiatives at EU, national and regional level.

With a overall budget of € 75.6 billion, the main goal of H2020 was to support EU’s economic growth and excellence in science, industrial leadership and societal challenges. We summarise the main features of the report.

Key numbers of Horizon 2020
Calls under H2020 collected more than a million individual applications from 177 countries. Funded projects were more than 35,000, involving more than 40,000 organisations. The true impact of the programme cannot yet be fully appreciated, as 41% of projects were still active at the time of the final evaluation and are expected to yield further results.

Many new technologies in various domains of science were developed thanks to H2020 funding, i.e. mRNA vaccines, photonics and micro- and nanoelectronics, and novel hydrogen-fuelled transports. Sustainable development benefited from investments equal to 64.4% of H2020’s budget.

Activities run under FP8 led to almost 4,000 applications for protection of intellectual property (¾ patents and 12% trademarks). Peer-reviewed publications were over 276,000. Horizon 2020 had a significant effect in boosting employment (+20%) and increasing the turnover and total assets for participating companies (+30%). The mobility of approx. 50,000 researchers across countries and sectors was also supported. The programme allowed to improve the access to newly created or upgraded research infrastructures for more than 24,000 researchers and organisations.

According to the final report, some additional € 159 billion would have been needed to fund all the high-quality proposals submitted. Despite this, the long term impact of the programme is estimated to contribute an average annual increase of €15.9 billion to EU GDP (€429 billion for the period 2014-2040), and a net gain in employment levels of around 220,000 employees at its peak.

Co-investment led to a wide development of public-private partnerships and joint undertakings, with private partners contributing resources (in cash or in kind) two-three times the volume of EU funding. The development of the venture capital ecosystems and networks was also improved.

Key scientific and societal achievements
Medical sciences, quantum mechanics, chemical engineering and composite materials were among the main scientific domains targeted by actions run under Horizon 2020, together with climate change, health and food security and other societal challenges.

The relevance of scientific publications is acknowledged by the citation frequency, that according to the report is twice the global average. A significant number of papers (4%) are among the most cited worldwide, while more than 25% covered emerging and rapidly evolving R&I sectors. The great majority of publications (82%) were published as open access papers, thus greatly supporting the circulation of knowledge.

Emerging health crises were among the main research priorities related to improvement of public health, together with rare diseases and personalised medicine. Ebola and Zika epidemics were the first targeted emergencies, but the real test case was the Covid-19 pandemic: the final report indicates H2020 and the previous FP7 are recognised as the third most frequently acknowledged funding sources for Covid-19 related research in the world.

As for climate change, this field of research received 32% of H2020 funding to support, among others, the development of alternative and low-emission fuels. Other relevant lines of R&I included the development of a smart European electricity grid, automation, energy storage integration and the adoption of renewable energy sources.

As for the ongoing digital transformation, H2020 supported for example the development of safe and user-friendly robotics. Over 20% of the overall budget was dedicated to research in social sciences and humanities disciplines.

Elements to be improved
Horizon 2020 allowed to greatly expand the European network of research infrastructures. According to the final evaluation, access to these facilities may be further improved by enabling greater synergies between EU, national and regional programmes for research infrastructure. Despite H2020 saw improvements in the presence of women in evaluation panels (42%), the fixed target of 50% share of women in scientific advisory panels and as researchers in projects was not yet achieved (43% and 23% respectively).

As for financial aspects, the interim evaluation identified a notable gap in venture and growth capital in the EU to scale up innovations. The issue was addressed through the launch, in the last three years of H2020, of a pilot to run the European Innovation Council (EIC), which according to the report showed positive preliminary results both on the turnover and staffing levels of its beneficiaries, and in tackling the critical funding gap in high-risk areas where limited alternatives are available at national and regional levels.

Preparing for the next FP10
With Horizon Europe framework programme coming to an end in 2027, the final report on results achieved by H2020 represents a first basis to reason on new research targets and financial support to be part of the new FP10 2028-2034 (you can find comments here and here).

While some members of the European Parliament already called for a FP10 budget of at least € 200 billion (see here more), several academic and scientific organisations published their proposals to be considered in the drafting of the new programme.

The European University Association (EUA), Science Europe and the European Association of Research and Technology Organisations (EARTO) sent a joint open letter to EU Commissioner Iliana Ivanova, asking for a doubling of the FP10 budget to €200 billion. A higher budget stability and protection of funding from being shifted to non-R&I purposes are among other requests, together with rebalancing support across various stages of R&I (i.e. bottom-up basic research, applied research, development, and innovation). Sufficient national investments in R&I are also deemed important.

The European universities of science and technology represented by Cesaer also published a note to advance their suggestions, in line with the EU Commission’s goals of a more elaborate EU industrial policy, and the move towards EU-30+. Key elements should include the leadership in deep tech, clean-tech and biotech based on the full knowledge value chain, the use of open and competitive calls to select researchers and innovators and award funding across all parts of FP10, a stable financial environment with at least €200 billion investments and enacting the 3% GDP target to R&I agreed by the EU Council in 2002. An annual review mechanism of current performance and a ring-fence to protect the budget allocated to R&I are among the suggested actions.

Guiding principles proposed by EU-LIFE (the Alliance of research institutes advocating for excellent research in Europe) also address investments in the European Research Council, the bridging role of the European Innovation Council, the need to avoid additional pillars and fragmentation, and the development of a coherent impact approach by reducing the size of consortia and monitoring the impact of initiatives in Pillar 2.


The risk of a biosimilar void in Europe

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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 claiming the proposed reform would reduce the attractiveness of Europe for R&D activities, a recent report from Iqvia analysed the status of biosimilar competition. According to the document, not all biological medicines experiencing loss of exclusivity (LoE) in the next decade would automatically face competition by the corresponding biosimilars. This would result in the creation of a “biosimilar void” on the market, with many originators losing protection without seeing the parallel development of their biosimilar versions.

Competition is not guaranteed

Biosimilar competition is not necessarily guaranteed, and emerging dynamics pose a risk to conventional notions of medicines lifecycles, states the report since its very beginning. The analysis refers to biological medicines that will lose protection in the period 2023-2032.

Despite the approx. 8-fold expected increase in LoE opportunity by value between 2012 and 2032 (from €4.4 billion to €32.2 bln, as result of loss of exclusivity for 110 biological medicines), data show a declining trend for years 2021-2023 (€4.3 bln). According to Iqvia, more than a half (55%) of biologics with LoE in the period 2023-2027 might experience the lack of a biosimilar in development.

The report highlights five areas of common perception to be addressed to better define the issue. The increasing complexity of many biological medicines coupled to new barriers to entry is one of the factors making the development of biosimilars interesting only for products referred to originators with large market shares. According to Iqvia, 27% of the 26 high-sales products that will reach loss of exclusivity by the end of 2032 do not have yet a biosimilar candidate in development in Europe (vs 45% at the global level), corresponding to a potential loss of approx. €8 bln market opportunity. The number of biosimilar candidates in the pipeline for high-sales biologics is also expected to decrease from 2027 onwards.

Regulatory hurdles, therapeutic classes, and disease indication are expected to play a greater role in guiding decisions on biosimilar development, indicates the report. The attractiveness of the European market should also be considered. Oncology will remain the more interesting area, with 44% of all candidates in early to late development for LoE events occurring between 2023 and 2027. Immunology and ophthalmology are other therapeutic areas that might experience growing competition.

The current barriers to biosimilar development

According to Iqvia, the main constraints limiting the decision on biosimilars development are represented by cost and time. In the oncology area, for example, high costs have to be considered to purchase the reference comparator biologic medicine, and large patients populations are required to demonstrate relevant clinical endpoints. New therapeutic classes, i.e., PD-L1/PD-1 inhibitors, may also pose challenges for the design of pharmacokinetic and equivalence studies. From the manufacturing perspective, the increasing use of antibody-drug conjugates (ADC) would result in new barriers to entry.

According to Iqvia, the least attractive products for biosimilars development are those with less than €500 million annual sales in Europe. The report shows 93% of these products might fail to see biosimilar competition, compared to 27% of high-sales medicines. This negative trend would result in a “biosimilar void” corresponding to approx. €15 bln in lost savings. Iqvia also identified some exceptions that might experience a niche development, on the basis of specific technological and manufacturing know-how, platforms and market access excellence.

Another factor to be considered is reimbursement rate, that the report identifies in 51% for low-sales biologics with no biosimilar pipeline (approx. 30% lower than for products with a biosimilar pipeline). The management of the intellectual property referred to the originator should be also taken into consideration.

Orphan and one-off medicines

Despite the growing number of new biologics reaching marketing authorisation as orphan medicines, according to Iqvia biosimilar development is undergoing by now for only one product (eculizumab). No other orphan biologics are expected to face biosimilar competition in future, as annual sales of the 39 orphan medicines currently on the market are too low (approx. €105 mln).

A major factor limiting the development of biosimilars for orphan medicines is linked to the fact many of these therapies fall in the antibody-drug conjugates (ADC) and cell- or gene-therapies (ATMPs) categories (wave 3 biologics). This implies many challenges from the development and manufacturing point of view, higher upfront investments and a more complex setup for analytical and clinical testing.

According to Iqvia, there are currently 16 non-orphan biosimilar candidates under development, corresponding to wave 3 biologics. A limiting factor for this pipeline is identified in the still present fragmentation of the European regulatory system, e.g., reimbursement policies, incentives, and clinical standards. ATMPs, also referred to as one-off therapies, represent a particular case, being relatively young on the market. This leads to no expectation of LoE events in the next five years. The trend would then change, with some 10 products losing protection by 2040, but it should be considered together with the parallel declining of the number of eligible patients, as many of them might have been already treated with the one-off originator medicine.

Shifting standards of care

Another factor analysed by Iqvia is the impact on biosimilars development of the possible changes in the current standards of care, for example resulting from the availability of new and more user-friendly formulations of the originator (i.e., subcutaneous vs intravenous injections). The availability of second- and third generation versions of the original biologic should be considered as another factor limiting the possible market share of a biosimilar of the first-generation product. The picture is indeed furthermore complicated, as another frequent possibility, especially in the oncology area, sees the development of combination therapies based on the use of two or more biologics. As already said, some of them might be very costly (i.e. monoclonal antibodies and PD-1 inhibitors), and require a larger study population to demonstrate equivalence of the add-off effect.

The proposed solutions to fill the biosimilar void

The Iqvia report proposes several possible solutions to overcome the expected biosimilar void, starting from horizon scanning activities aimed at early identification of upcoming LoE events in order to prevent contractions in biosimilar development. Horizon scanning may also support market entry and granting of incentives based on demand. The development of biosimilars of orphan medicines might benefit of a default waiver of comparative efficacy studies, a suggested measure that according to Iqvia would not compromise the demonstration of biosimilarity. Improvements at the regulatory level might also help to streamline development, together with global convergence of regulatory guidance. Iqvia also suggests the adoption of clear regulatory pathways to incentivise the development of the next-generation, one-off biosimilar gene- and cellular treatments. Access might be improved by optimisation of market conditions, with incentives for clinicians combined with the introduction of prescription targets. New tender models would also be needed to favour multi-winner procurement practices.


Steps towards the final approval of the IP action plan

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By Giuliana Miglierini

The end of 2021 may see the final approval of many pieces of the new legislative framework announced in November 2020 by the European Commission. An important piece of this puzzle is represented by the IP Action Plan, governing the protection of intellectual property (IP); a step forward in this direction is represented by the resolution of 11 November 2021 on the Own-initiative report of the European Parliament.

The final text licensed in single reading is the result of the examination of the initial draft report – issued in May 2020 by the Committee for Legal Affairs, rapporteur Marion Walsmann – by several other Committees (IMCO, DEVE, CULT, AGRI).

The main points of the resolution

The resolution recognises the importance for the European economy of a balanced protection and enforcement of intellectual property rights (IPR). In years 2012-2016, the knowledge-intensive industries generated almost 30% of all jobs and almost 45% of total economic activity (in terms of Gross Domestic Product, GDP) in the EU; the IPR-intensive industries account for 93% of total EU exports of goods.

Europe’s recovery and resilience capacity is also highly impacted, as demonstrated by the pandemic when shortages of certain medicinal products and vaccines occurred. The EU Parliament acknowledges the role played by intellectual property in increasing the overall value of companies,especially the small-and-medium size ones (SMEs).

A current limitation to IP protection in Europe is represented by the still fragmented situation across different member states, which often leads to parallel national validation procedures and litigation for European patents. To this instance, the Parliament suggests the establishment of an IP coordinator at European level, to harmonise the approach to EU IP policy and enhance cooperation between the different bodies involved in the process (i.e. national IP authorities, Commission Directorates-General, EPO, EUIPO, WIPO, etc).

The Parliament also recognised the role IP plays in the pharmaceutical sector, where the availability of incentives greatly favours the development of new and innovative treatments. The resolution asks the Commission to support the innovative potential of European companies “on the basis of a comprehensive IP regime”, so to guarantee effective protection for R&D investments and favour fair returns through licensing. The availability of open technology standards has been valued as an important competitive element on the wider, global scenario.

Many different types of incentives are suggested by the Parliament’s resolution as useful to support micro-enterprises and SMEs in filing and managing their intellectual property, including IP vouchers, IP Scan and other Commission and EUIPO initiatives to support simple registration procedures and low administrative fees. The newly created European IP Information Centre may represents a fundamental reference point to increase knowledge in the field. The Parliament also suggests to introducing an EU-level utility model protection, not yet available, as a possible fast and low-cost protection tool to protect technical inventions.

Unitary patents and improved market competition

Still missing members states are urged to adhere to the enhanced cooperation scheme for the creation of a Unitary Patent Protection (UPP) and to ratify the Protocol to the Agreement on a Unified Patent Court on provisional application (PPA). The activation of this unique Court in charge of the examination of litigations would allow for a more efficient process and for lowering legal costs and improving legal certainty.

Fragmentation remains an issue also with respect to Supplementary Protection Certificates (SPCs): to this instance, the resolution asks the Commission to issue guidelines for member states and to provide a legislative proposal based on an exhaustive impact assessment. A major criticality to be solved is represented by the unitary patent not providing a unique SPC title valid across the EU; the own-initiative report also suggests the extension of the EPO’s mandate, so that examination of SPC applications could be carried out on the basis of unified rules.

Other important points needing attention to improve the presence of generic and biosimilar medicines in the EU are the abuse of divisional patent applications and patent linkage, which should also see an intervention by the Commission. The Parliament also opened the possibility of a revision of the Bolar exemption, which allows clinical trials on patented products needed to reach marketing authorisation of a generic or biosimilar version not to be regarded as infringements of patent rights or SPCs. This may also support the immediate market entry after the expiration of patent rights and SPCs. The Commission is called also to ensure the effectiveness and better coordination of compulsory licensing in order to provide access to medicines needed in case of health emergencies.

The resolution also addresses the theme of standard essential patents, which currently often leads to litigations, and it calls for the revision of the 20-years old system for design protection. Transparency on results obtained from publicly funded R&D is also recommended. The Parliament suggests artificial intelligence (AI) and blockchain technologies may play an important role in tackling counterfeiting practices and guarantee traceability of goods, as they may contribute to a better enforcement of intellectual property rights along the whole supply chain. The Commission should also work to establish clearer criteria for the protection of inventions created by the AI, without human intervention.

Comments from the industry

The European Parliament has clearly voted for a strong and fair IP system by underlining the importance of timely generic and biosimilar medicine competition. The misuse of divisional patents, the need to enlarge the scope of bolar to include API and all regulatory and administrative steps, and the long overdue ban anti-competitive patent linkage are well known problems that the Commission should address in the IP Action Plan. The Parliament has voted; the Commission must act.”, said Adrian van den Hoven, Director General at Medicines for Europe.

A major point in the implementation of the new European policies is represented by the review the Commission is going to conduct in 2024 to assess the effective achievement of goals of the SPC manufacturing waiver, which entered into force in July 2019 and is expected to start producing effects in the second half of 2022.

Many of the themes discussed in the Parliament’s resolution were debated during a webinar organized by Medicines for Europe, with the participation of representatives from the European Commission and the European Patent Office.

EFPIA, representing the innovator pharmaceutical industry, focused its attention on the impact of past EU Free Trade Agreements (FTAs) on drug spending, timing of countries’ access to new medicines after global launch, investments overall and in pharmaceuticals, and clinical trial participation. A report by IQVIA published in the Federation’s website addresses the impact of IP protection on these elements. Results confirm the central role of the pharmaceutical sector as the most R&D intensive industry in the world, with R&D spending averaging over 15% of revenue. A strong IP protection framework available at the level of EU FTAs favours the attractiveness for investments in the EU and its FTA partner countries. According to the report, an expanded IP protection appears not to be linked to the generation of a higher pharmaceutical spending; drugs’ share of healthcare spending is claimed to stay flat or fall after an FTA, and prices for medicines to rise more slowly than the level of inflation. A stronger IP index, adds IQVIA, is also correlated with increased clinical trial activity in a country, bringing both clinical and economic benefits.