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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


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Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

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The EU Parliament voted its position on the Unitary SPC

April 8, 2024 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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.


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.