patent linkage 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

The EU Parliament voted its position on the Unitary SPC

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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 SPC Regulation (EC) 469/2009. The unitary SPC system will apply also to plant protection products (under different regulations), and it will allow for the obtainment of up to 5 years IP protection beyond the life of the patent.

The new system will complement the unitary patent system, as part of the overall “EU patent package” announced in 2023, and which also includes the proposed regulation on compulsory licensing (we wrote about this last week) and the one on standard essential patents. According to the EU Parliament, the procedure on unitary SPCs will now stop after the European elections.

A report on the potential impact of the unitary supplementary protection certificates on access to health technologies, prepared by the Policy Department for Citizens’ Rights and Constitutional Affairs for the Parliament’s Committee for Legal Affairs, is also available.

The main amendments to the Commission’s proposal

The text adopted by the Parliament on 28 February 2024 (together with the legislative resolution on the recast of the SPC regulation) refers to the proposed new regulation amending Regulation (EU) 2017/1001 (EU trademark), Regulation (EC) 1901/2006 (medicinal products for paediatric use) and Regulation (EU) 608/2013 (custom enforcement of intellectual property rights).

The report of the rapporteur, Tiemo Wölken, specifies the entities or people that provided him with input in the preparation of the document, among which are also EFPIA and Medicines for Europe.

The amended text highlights the importance of pharmaceutical research in ensuring the EU’s competitiveness, but also the difficulty of establishing a direct link between this and the rules aimed to support research in innovative medicinal products. The point is that “authorised medicines from third countries are equally eligible to receive all Union incentives, just as Union-based innovative companies can equally benefit from incentives in third countries”. This may lead to companies moving their activities in other countries offering greater protection.

The adopted text better specifies cases for which manufacturing is possible in the EU in presence of a still valid unitary SPC, i.e. export to a third country, where protection does not exist or has expired, or storing the product in order to be ready to enter the EU market upon expiry of the corresponding SPC (the so-called EU “day-one” entry).

To obtain granting of the unitary SPC, the product should fall within the scope of one or more claims of the basic patent. To this instance, the Parliament made specific reference to the description and drawings of the patent, and to the skilled-on-the-art “person’s general knowledge in the relevant field and of the prior art at the filing date or priority date of the basic patent”. The same applies also to active ingredients in combination products, each of which needs to be specifically identifiable. The approved text removes any reference to the concept of “therapeutic equivalence”.

The Parliament specified that the information on granted unitary SPCs provided in the register should not be used for patent linkage or other administrative decisions related to generics or biosimilars. The text also clarifies how to consider “economically linked” parties, that are not entitled to obtain multiple SPCs for the same product.

A single procedure and a digital-by-default process

The main objective of the unitary SPC system is to allow the submission of a single application to obtain extension of the IP protection in all European countries which are part of the EU’s unitary patent system. The digital-by-default principle should guide the entire procedure leading to the grant of a unitary SPC, starting from the submission of the application to the European Intellectual Property Office (EUIPO) using a format to be made available by the EUIPO itself. Combined applications for supplementary protection certificates should also be made possible.

The application for a unitary SPC would be based on an already existing centralised marketing authorisation issued by EMA. Information on any direct public financial support received for research related to the development of the product for which the SPC is requested should be also provided.

In charge of the examination would be a new SPC division created within the EUIPO. The examination would be run by an examiner from the Office and two examiners from national competent authorities, with sufficient expertise (at least one examiner with a minimum of five years’ experience in the examination of patents and supplementary protection certificates).

The examination opinion should be issued within six months of the publication of the application. A new amendment has been introduced to allow for an expedited examination (4 months) in case, for example, of imminent expiry of the basic patent. Should multiple oppositions be filed against an examination opinion, they should be jointly dealt with by the EUIPO, with issuing of a single decision. The Parliament has maintained the pre-grant opposition procedure, which attracted many criticisms as it might result in increased uncertainty for patentees.

From a market perspective, access to products covered by unitary SPCs should be favoured in countries where the right-holder does not have the intention to launch them, by mean of voluntary agreements to licence the corresponding rights in those markets. A new Recital underlines the importance of a timely entry of generics and biosimilars in the UE market in order to increase competition, reduce prices and ensure sustainability of national healthcare systems and access to affordable medicines.

Comments from Medicines for Europe

The European association of the generic and biosimilar industry, Medicines for Europe, published a note highlighting the possible impact the new unitary SPC may have, due to the significant geographical extension of the IP protection also in countries where the concerned medicines are not normally launched or launched very late.

It would be very important to prevent a possible misuse of the system, is the request of the industrial association. To this instance, the safeguards identified by the Parliament for the examination of applications before the granting of a unitary SPC are considered adequate, as for transparency and quality of the procedures. Furthermore, according to Medicines for Europe, the pre-grant opposition mechanism included in the Parliament’s position should prove useful to prevent invalid (non-innovative) SPCs from being enforced and ultimately invalidated in Court.

The explicit ban of the patent linkage is also considered very important, and it should be coupled to transparency of SPC expiry dates in the register so to ensure these data would not be misused to implement unlawful and anti-competitive patent linkage strategies.

The position of the Parliament goes in the right direction and rightfully bans patent linkage. The pre-grant opposition will ensure a timely grant of SPCs for innovative drugs (a maximum 14 months or 12 with an expedited procedure) and prevent monopoly extensions for those drugs that do not have a legal right to an SPC because they are not innovative. The ban of patent linkage will serve access to medicines by preventing pricing and reimbursement or tender procedure delays for generic and biosimilar medicines at SPC expiry. Medicines for Europe will engage constructively with the EU institutions to ensure the most efficient, quality, and fair SPC system possible for the future.”, said Adrian van den Hoven, Director General of Medicines for Europe, commenting on the report.

You can find here more comments on the approved and deleted amendments.


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

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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 revise the current SPC Regulation (links to the document and the procedure).

On the dedicated pages of EP’s website, you can also find the opinion issued by the Consultative Working Party, according to the Inter-institutional agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts.

A document analysing the potential impact of the Unitary SPC on access to health technologies was also prepared by the Policy Department for Citizens’ Rights and Constitutional Affairs Directorate-General for Internal Policies in September 2023.

We summarise the main features of the EP’s draft positions, which were discussed in the 7 November meeting of the JURI Committee.

The revision of the current SPC Regulation

The JURI Committee (Rapporteur Tiemo Wölken) moved to Recital 2 the statement that “medicinal products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research”. Recitals 3 and 5 of the original proposal have been deleted, the last one referring to the risk research centres located within the EU might move to countries offering greater protection. The new Recital 2 makes now reference to the difficulty of establishing a direct link between favourable protection rules and EU competitiveness. If, on the one hand, it would be true that the attractiveness of EU markets might benefit from favourable protection, on the other it should be taken into account that European incentives can be granted also to authorised medicines from third countries. Furthermore, UE-based innovative companies can equally benefit from incentives in third countries.

Recital 13, referring to the request of a marketing authorisation for a biological medicinal pro-duct identified by its International Nonproprietary Name (INN), has been amended to indicate that the protection conferred by the SPC should extend to all biosimilars (and not to therapeutically equivalent products, as previously indicated).

A reference to Article [86] of the new Directive (EU) …/… [2023/0132(COD)] to be approved has been introduced in Recital 24, concerning fees that can be charged by the European Union Intellectual Property Office (EUIPO) with reference to centralised application for SPCs for paediatric medicinal products.

The newly inserted Recital 41 a highlights the importance of the timely entry of generics and biosimilars in the EU market, as it may support competition, reduction of prices, sustainability of national healthcare systems and access to affordable medicines.

Several amendments have been proposed for Recital 45. Among the main ones is the reference to the opportunity “to restrict the protection conferred by a supplementary protection certificate in accordance with Regulation (EU) 2019/933 so as to allow making for the exclusive purpose of export to third countries and any related acts in the Union strictly necessary for making or for the actual export itself […]”. The JURI Committee referred to “related acts” as those that “could include the possession, supply, offering to supply, import, using or synthesis of an active ingredient for the purpose of making a medicinal product containing that product, or temporary storage of the product or advertising for the exclusive purpose of export to third-country destinations”.

A phrase was added to Recital 60 on the centralised SPC register to deny the possibility to use the hereby contained information to support patent linkage, regulatory or administrative decisions related to generic or biosimilars, pricing and reimbursement decisions or tender bids. Article 35 – paragraph 11 a further emphasises this concept with reference to public authorities, that should not use such information for refusal, suspension, delay, withdrawal or revocation of marketing authorisations.

The JURI Committee also modified the definition of medicinal product contained in Article 2 – paragraph 1 – point 1 of the proposed Regulation, making reference to “‘any substance or com-bination of substances that fulfils at least one of the following conditions”. These include properties for treating or preventing disease in humans, the possibility to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

The new Article 2 – paragraph 1 – point 12 a defines the meaning of the wording ‘economically linked’ with reference to “different holders of two or more basic patents protecting the same product, that one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder”.

The JURI Committee also introduced the new Article 8 – paragraph 1 – point d b, stating the need to provide information on any direct public financial support received for research related to the development of the product.

The new Article 26 – paragraph 4 – point c a mentions the inclusion of any evidence in the notice of opposition in support of the opposition itself. According to the amended Article 26 – paragraph 6, the opposition panel should communicate its decision together with the reasoning for it. The same applies to the EUIPO (Article 26 – paragraph 9). The Office should also issue a single decision with reference to several oppositions filed against an examination opinion (Article 26 – paragraph 9 a). Undue delays are repeatedly discouraged.

Article 28 – paragraph 3 – point a was amended to indicate that examiners of patents and SPCs should possess relevant expertise and sufficient experience in the assigned tasks. Article 45 – paragraph 3 adds experts shall be verified for the absence of any conflict of interest.

Amendments of the Unitary SPC proposal

Many of the amendments made by the JURI Committee to the Unitary SPC proposal correspond to the ones seen above for the SPC recast. Among the distinctive ones is the new Recital 14 a, focusing on the “digital by default” principle and consequent electronic applications for unitary and combined applications for supplementary protection certificates. Article 8 – paragraph 4 a adds that the electronic application for a unitary SPC should use the formats made available by EUIPO. Other articles regulate the entire procedure to occur by exchange of electronic documentation.

Amended Recital 22 now makes explicit reference to the possibility to produce and store in the EU “in view of entering the market of any Member State upon expiry of the corresponding certificate (‘EU Day-one entry’) and any acts related thereto”.

The new Article 22 – paragraph 1 – point c b defines cases where the applicant shall waive the SPC rights for markets where the medicinal product has not been launched, i.e., the medicinal product is not placed on all Member States or a Member State market covered by the unitary certificate or combined centralised SPCs.

Comments from Medicines for Europe

The first drafts of the EP position on the SPC and SPC Regulation recast are a step in the right direction for access to medicines across Europe, according to Medicines for Europe. The association particularly appreciated the identification of the necessary safeguards for scrutiny of the SPC application before granting, to prevent invalid (non-innovative) SPCs from delaying access to generic and biosimilar medicines. The undue use of SPC expiry dates in the register to implement unlawful and anti-competitive patent linkage strategies were also deemed positive.



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.