BRIEFING

EU Legislation in Progress

Unitary supplementary protection

certificate for plant protection
products
OVERVIEW
The supplementary protection certificate (SPC) is a specific intellectual property right that extends
the basic patent's market exclusivity for plant protection products. The unitary patent became
operational in the EU on 1 June 2023, unifying patent protection in all participating Member States.
Despite this significant change, SPCs, which are inseparable from patent protection, remain
regulated at national level. This fragmented regulatory approach has proven ineffective, leading to
excessive administrative costs for SPC applicants, who have to navigate the national laws of each
Member State where they seek SPC protection. To address this issue, on 27 April 2023 the
Commission submitted a proposal for a regulation introducing a unitary SPC for plant protection
products as a complement to the protection offered by the unitary patent. This proposal, coupled
with a parallel proposal for an SPC for plant protection products of the same date, seeks to
harmonise the process of granting SPCs for plant protection products in the single market.
In Parliament, the proposal was assigned to the Committee on Legal Affairs (JURI), with
Tiemo Wölken (S&D, Germany) as rapporteur. Following the approval of the reports on the two
proposals by the Parliament plenary at first reading, Parliament adopted its position for the
interinstitutional negotiations. The Council has yet to agree on its negotiating mandate.
Proposal for a regulation of the European Parliament and of the Council on the unitary
supplementary protection certificate for plant protection products and for a regulation of the
European Parliament and of the Council on the supplementary protection certificate (recast).
Committee responsible: Legal Affairs (JURI) COM(2023)221
27.4.2023
Rapporteur: Tiemo Wölken (S&D, Germany) 2023/0126(COD)
Shadow rapporteurs: Javier Zarzalejos (EPP, Spain) COM(2023)223
Adrián Vázquez Lázara (Renew, Spain) 27.4.2023
Marie Toussaint (Greens/EFA, France) 2023/0128(COD)
Emmanuel Maurel (GUE/NGL, France) Ordinary legislative procedure
(COD) (Parliament and Council on
equal footing – formerly 'co-
decision')
Next steps expected: Trilogue negotiations

EPRS | European Parliamentary Research Service

Author: Kamil Baraník with Hugo Carmona Bas
Members' Research Service
PE 762.281 – April 2024 EN
EPRS | European Parliamentary Research Service

Introduction
In 2023, the European Commission submitted the patent legislative package, which consisted of six
proposals aimed at reforming the supplementary protection certificates (SPCs) for patented
medicinal and plant protection products, the standard essential patents and the EU's compulsory
licensing regime. The main goals of the package were to establish a more transparent, effective and
futureproof intellectual property rights framework, eliminate the remaining barriers within the
single market, reduce red tape for businesses, enhance efficiency and complement the unitary
patent system, effective since 1 June 2023.
The patent legislative package includes two proposals on SPCs for plant protection products (PPPs):
a proposal for a regulation on the unitary supplementary protection certificate and a parallel
proposal for a regulation on the supplementary protection certificate (a recast of Regulation (EC)
No 1610/96 of the European Parliament and of the Council on the supplementary protection
certificate for plant protection products). These proposals aim to reinforce the single market for
agrochemicals and support the twin digital and green transitions. They seek to establish a unified
SPC granting procedure and introduce a unitary SPC. These goals were set in the Commission work
programme for 2024.

Context
Supplementary protection certificates (SPCs) are sui generis intellectual property (IP) rights that
provide exclusive rights for the active substance or combination of active substances in a plant
protection product (PPP) available in the EU. These rights constitute a separate and distinct title of
legal protection. The current SPC regime for PPPs in EU is outlined in Regulation (EC) No 1610/96 of
the European Parliament and of the Council of 23 July 1996 concerning the creation of a
supplementary protection certificate for plant protection products.
The main purpose of SPCs is to extend the legal protection of a patent for a PPP that has been
authorised by regulatory authorities. This extension is seen as a way to prevent market failure, as the
standard 20-year term of plant protection may not be sufficient. An additional incentive for the
existence of an SPC regime in the Member States is the fact that other countries, such as the USA,
Canada, Israel, Japan and Korea, have various models for extending patent protection.
SPCs are at an intersection between economic and societal interests. Furthermore, they influence
the availability of PPPs in the agricultural sector, as well as companies' competitiveness and
incentives to invest in the research and development (R&D) of PPPs.
SPCs are designed to compensate for the substantial time loss in patent protection for PPPs as a
result of the compulsory lengthy testing and trials required before regulatory marketing approval
for these products is obtained. A valid marketing authorisation for a PPP grants the right to place it
on the EU market. This process usually takes several years and consumes a significant portion of a
patent's lifespan. Therefore, the EU legislator designed SPCs as an additional form of market
exclusivity to compensate for the investments made in PPPs. The SPC term is calculated as the time
between the date on which the application for a patent was lodged and the date of the first market
authorisation minus a period of 5 years. An SPC can last for up to 5 years. The exclusivity attached to
IP protection serves as compensation for the investment. The period covered by an SPC is of
significant economic importance to inventors.1 The main objectives of SPCs include encouraging
global R&D in the area of new active ingredients of PPPs, attracting R&D centres and jobs to the EU,
preventing R&D relocation, and fostering common regulatory standards.
The scope of the SPC Regulation is limited to products that are protected by a European patent with
unitary effect ('basic patent') and are subject to an administrative market authorisation procedure
in the individual Member States prior to being marketed. Therefore, the SPC is inseparable from the
patent to which it relates, meaning the grant of a SPC is contingent on the existence of a basic
patent. A patent is a legal title that can be granted for any invention with a technical character,

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provided it is new, involves an 'inventive step' and is industrially applicable. A patent can cover how
things work, what they do, what they are made of and how they are made. The individual or entity
with a patent possesses the exclusive right to prevent others from creating, employing or marketing
the invention without their explicit consent.
SPCs are distinct IP rights granted specifically for patented PPPs. SPC protection confers the same
rights and obligations as the basic patent. However, unlike the basic patent, an SPC does not extend
the protection conferred across the entire scope of the patent claims but will only protect the
product covered by the authorisation to place the corresponding medicinal product (or plant
protection product) on the market and any use of that product as a medicinal product (or plant
protection product) that has been authorised before the expiry of the SPC.' 2
Plant protection products (PPPs) 3 are active substances and preparations containing one or more
active substances intended to protect plants (or plant products) against harmful organisms or to
prevent the action of such organisms. They can also influence the life processes of plants, preserve
them, destroy undesirable plants or parts of plants, and check or prevent undesirable growth of
plants. They play a vital role in safeguarding crops and plants throughout various stages of
production, storage and transportation. As a subgroup of pesticides, PPPs are designed to shield
crops and desirable plants in agricultural, forestry, horticultural and home garden settings. These
products contain active substances that control pests or diseases, influence plant life processes,
preserve plant products or deter undesired plant growth.
Before being integrated into PPPs within the EU, active substances undergo rigorous evaluations
and peer reviews by Member States and the European Food Safety Authority to ensure compliance
with EU regulations. This approval process highlights the importance of safety and efficacy in
agricultural practices. While the terms 'pesticide' and 'plant protection product' are often used
interchangeably, pesticides encompass a broader spectrum, including non-plant or crop uses such
as biocides. In essence, PPPs represent a specialised category within the realm of pesticides,
specifically tailored to meet the demands of modern agricultural practices and environmental
sustainability.

Existing situation
An SPC should effectively extend a patent right for a maximum of 5 years. Therefore, the holder of
both a patent and an SPC should be able to enjoy a maximum of 15 years of exclusivity from the
time the PPP in question first obtains authorisation to be placed on the market in the EU.
The introduction of a unitary patent system in 2023, designed to serve as a centralised platform for
patent protection and enforcement within the EU, has brought to light the limitations of the
national nature of SPCs. Currently, SPCs are national, territorially restricted rights granted by
national offices. This means that there is no unitary SPC that complements a patent with a unitary
effect (unitary patent). Therefore, a unitary patent can only be extended through national SPC
protection. The discrepancy between the newly introduced unitary patent system and the approach
of granting SPCs nationally prevents the unitary patent holder from obtaining unitary protection
during the combined protection period conferred by the unitary patent and the (national) SPCs.
Consequently, an applicant seeking to extend the protection offered by a unitary patent must go
through the national procedure in each Member State.
In the 2020 intellectual property action plan, the European Commission acknowledged that the
fragmented (national) nature of the regulatory framework governing SPCs undermines their
effectiveness. This fragmentation also generates legal uncertainty, red tape and extra costs for
businesses, particularly small and medium-sized enterprises (SMEs). Additionally, national
examination and authorisation procedures further added to the additional administrative burdens
faced by businesses.

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The European Commission calculated that 'to obtain SPC protection in the whole EU for the
maximum term of 5 years, applicants need to comply with 27 different procedures at national patent
offices and pay various national application and maintenance fees totalling €192 000'. Historically,
approximately a quarter of applications for the same product resulted in different decisions
regarding SPCs. Therefore, the current fragmented SPC regime leads to complex and costly
application procedures and legal uncertainty, as one Member State may grant the SPC while another
rejects the application.
Currently, certificates are granted by the national patent offices (NPOs) and litigated before the
national courts. The jurisdiction of the Court of Justice is limited to the proceedings envisaged under
Article 267 of the Treaty on the Functioning of the European Union (TFEU).

Parliament's starting position

In November 2021, Parliament stressed that the SPC regime in the EU was suffering from fragmented
implementation across the Member States. It therefore asked the Commission to issue guidelines
for the Member States and to propose legislation that could help to address this fragmentation and
the resulting legal uncertainty. This request came after a full impact assessment had been
conducted. The same year, through another resolution, Parliament called on the Commission 'to
evaluate the added value of the SPC' system for the medical sector. Highlighting the existing
differences in the validity of patents and SPCs among the Member States, Parliament called on the
Commission: 'to revise the use of SPCs on the basis of technological and scientific advances'.
Additionally, Parliament requested an evaluation of the potential impact that a proposal for a
unitary SPC would have on the market entry of generic and biosimilar medicines. Following this
valuation, Parliament suggested proposing a unitary SPC where appropriate.

Council starting position

The patent package was presented to the Council Working Party on Intellectual Property in
May 2023. In June 2023, the European Council welcomed 'the entry into force of the Unified Patent
Court Agreement for the participating Member States, and the consequent entry into operation of
the unitary patent, which will help boost innovation and competitiveness'.
In 2020, the Council adopted conclusions on intellectual property policy and the revision of the
industrial designs system in the EU. The Council invited the Commission to put forward initiatives to
enhance the protection of intellectual property 'including with regard to the supplementary
protection certificate system'. Additionally, the Council emphasised the importance of creating
affordable procedures tailored to SMEs in particular.

Preparation of the proposal

In 2018, the Max Planck Institute for Innovation and Competition conducted a study on the legal
aspects of SPCs in the EU for medicinal and plant protection products. The study's main conclusion
was that stakeholders and national patent offices (NPOs) agree that the system 'fulfils its purposes'.
However, there are legal uncertainties that could jeopardise the smooth functioning of the SPC
regime. Specifically, inconsistencies and unclear interpretations by the Court of Justice regarding
key provisions in two SPC regulations – on medicinal and plant protection products – pose
challenges for NPOs in aligning their practices with evolving case law that substantially influences
the protection afforded by the regulations (these ambiguities occur, for instance, through the
provision of broad definitions of what exactly is covered by the SPC regimes and the provision of
clarity on the various exemptions in the SPC regimes and the duration of the certificate). As
companies align their practices with evolving case law, this may result in discrepancies with past
practices or those of other NPOs. Originator companies express confidence that the system would
self-correct over time, while generic manufacturers argue for a comprehensive overhaul to achieve
a more balanced approach. The latter group underscores the need for a rebalancing due to

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perceived limitations in the granted rights, which it believes are too narrowly tailored for an effective
response to heightened global competition challenges. The study concludes that all concerned
parties concur on the need to reform the current SPC system.
In 2020, the European Commission released its evaluation report on existing SPC regulations. It
praised the role of SPCs in research on new active ingredients and found that they remained fit for
purpose. The report concluded that SPCs were coherent with patent legislation and had brought
added value to the EU. However, it also stated that national SPC management undermined the
effectiveness and efficiency of the SPC system. The report assessed that the national SPC system
created legal uncertainty, red tape and extra costs for businesses, especially SMEs, and national
administrations.
In March 2022, the European Commission initiated a consultation calling 'for evidence' regarding
the necessity of proposing regulations governing SPCs. The consultation aimed to explore the
feasibility of implementing a unitary SPC regime and/or a single ('unified') procedure for granting
national SPCs. The consultation concluded in April 2022, receiving 59 valid contributions, with
30 coming from companies and business associations. The feedback indicated that while
participants considered that a unitary SPC system would be effective, potential discrepancies in its
management and enforcement across EU countries could lead to inefficiencies.
In August 2022, the Max Planck Institute released a study on the options for a unified SPC system
in Europe. The study identified several shortcomings, primarily focusing on the scope of a unitary
SPC, its relation to the unitary patent, and the legal protection granted by the Unified Patent Court.
Additionally, the study highlighted the main reasons for reforming the SPC granting system: 1) the
complexity of legislation and case law; 2) the absence of uniform expertise among the national
agencies; and 3) differing approaches to examining SPCs leading to inconsistent decisions and
fragmentation of the single market. The study concluded that even a moderately unified procedure,
where a central body would assess regional applications and provide an opinion on SPC eligibility
while NPOs would decide whether to grant or refuse the certificate, would still improve the current
fragmented situation of SPC granting.
In April 2023, the European Commission conducted an impact assessment (IA) (with an executive
summary) on a reform of the EU's SPC regime, consisting of a proposal for a regulation creating a
procedure for the centralised examination of SPC applications and a proposal for a regulation
creating a unitary SPC. The IA resulted in an endorsement for a centralised procedure that would
grant national SPCs in some or all EU countries and/or a unitary SPC covering those EU countries
where the basic unitary patent has effect. The IA also recommended that the EU Intellectual Property
Office become the central examination authority for SPCs.
The most recent document addressing the adoption of the new SPC system for medical products
and PPPs was a 2023 EPRS implementation appraisal. This briefing highlights the results of the
European Commission's assessment, discrepancies in implementation among Member States, and
the complexity of balancing between various interests.

The changes the proposal would bring

On 27 April 2023, the European Commission proposed a comprehensive reform of the SPC regime,
consisting of two legislative proposals regarding PPPs. The first proposal would establish a new
unitary SPC system for PPPs, while the second proposal would create a centralised procedure for
granting national SPCs (recast) for PPPs.
The legal basis for regulating the unitary SPC for PPPs is Article 118(1) TFEU, under which the
ordinary legislative procedure applies (as defined in Articles 289(1) and 294 TFEU).
The proposed unitary SPC system for PPPs aims to complement the unitary patent system, which
has been effective since June 2023. Currently, a unitary patent can only be extended by a national
SPC, meaning it is not done in a unitary manner. Not only does this fragmented procedure require

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the applicant to file a separate SPC for PPP application in the national language of each Member
State but it also poses a risk of SPCs being granted in some Member States and denied in others. The
proposed regulation on a unitary SPC system centralises the granting procedure in order to achieve
complete consistency. It relies on the same substantive provisions relevant for granting the national
certificates introduced in the parallel recast proposal on the SPC for PPPs (COM(2023)223). In other
words, the proposed changes do not aim to modify the substantive rules for acquiring SPCs but seek
to introduce new, harmonised procedural provisions for the granting of SPCs.
A unitary SPC should provide uniform protection and have an equal effect in all Member States
where the patent it relies upon has unitary effect. Being an object of property right, a unitary
certificate should be treated as a national certificate of the Member State determined by the law
governing the basic patent, in its entirety and in all Member States in which it takes effect. Therefore,
the unitary SPC should effectively complement the unitary patent.
The new (harmonised) regulatory regime would allow applicants to file a combined application for
a unitary SPC and a national SPC. It would be possible to file the application in any official EU
language. If the SPC examination is successful, the procedure would result in the granting of both a
unitary SPC (currently applicable in 17 Member States) and a national SPC for those Member States
not covered by the unitary patent. However, it would not be possible for a single product to be
protected by both a national SPC and a unitary SPC in the same Member State.
The unified procedure should significantly reduce administrative burden and costs, such as
application, renewal and translation fees. At the same time, the revamped SPC system would
increase transparency and provide more predictability, ensuring manufacturers are better informed
about the protection status of their products across the EU. Combining the unitary SPS and unitary
patent should encourage innovation and promote growth and jobs in affected sectors. Thus, the
SPC reform is anticipated to boost the utilisation of the unitary patent.
The proposed regulation identifies the European Union Intellectual Property Office (EUIPO) as
the central examination authority to assess the formal admissibility of the unitary SPC. The EUIPO
panels would review applications. The proposed procedure would involve close cooperation
between EUIPO and Member States' national IP offices, as each panel would consist of a member
from EUIPO and two qualified examiners, who are experienced in SPC matters, from two NPOs in the
Member States.
The first step in evaluating an application for a unitary SPC certificate would involve assessing its
formal admissibility. 4 If it meets these requirements, the EUIPO will publish the application in a
register. This register would serve as a single access point providing information on applications for
unitary certificates, granted unitary certificates, and their status. The register should be available in
all official languages of the EU.
Within 3 months of the application's publication, i.e., in the early stages of the process, third parties
(any natural or legal persons) would be able to submit written observations to the EUIPO
regarding the eligibility for supplementary protection of the product to which the application
relates in one or more of the Member States where the basic patent has unitary effect.
Subsequently, the EUIPO would assign the substantive examination of the application to a panel.
This panel would be composed of an EUIPO member and two qualified examiners, experienced in
SPC matters, from two different national patent offices in the Member States.
The unitary SPC would be granted on the basis of a basic patent, if in each of the Member States
where that basic patent has unitary effect, at the date of the application, all of the following
conditions are met: 5 a) the product is protected by the basic patent in force; b) a valid authorisation
to place the product on the market as a plant protection product has been granted in accordance
with Regulation (EC) No 1107/2009; c) the product has not already been the subject of a certificate
nor a unitary certificate; d) the authorisation referred to in point b) is the first authorisation to place
the product on the market as a plan protection product.

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After examining the application, the EUIPO would issue an examination opinion stating whether
the application meets the applicable criteria. After the final decision on the merits, the EUIPO would
either grant a unitary SPC or reject the application.
Any person could file a notice of opposition to the examination opinion regarding an application
for a unitary certificate with the EUIPO within 2 months of its publication. Opposition could be based
on one or more conditions not being met for one or more Member States where the basic patent
has a unitary effect. The various EUIPO examination panels would review the opposition within
6 months.
Once the deadline for filing an appeal or opposition may be filed has passed without any
submissions, or after a final decision on the merits has been made, the EUIPO would either grant a
unitary certificate or reject the application for a unitary certificate.
Any party involved in the proceedings who is adversely affected by a decision of the EUIPO,
including the adoption of an examination opinion, would be able to challenge a negative opinion
before the EUIPO's Board of Appeal. Filing an appeal would have a suspensive effect and would
have to be done in writing within 2 months of the decision's notification date. Where an appeal
results in a decision that is not in line with the examination opinion, the EUIPO Board of Appeal may,
through its decision, annul or modify the opinion.
Subsequently, an action might be brought before the General Court against a decision of the EUIPO
Board of Appeal in relation to appeals within 2 months of the date of notification of that decision.
This action can be based on grounds such as infringement of an essential procedural requirement,
infringement of the TFEU rules, infringement of the proposed regulation or of any rule of law related
to their application, or misuse of power. The action would be available to any party involved in
proceedings before the EUIPO Board of Appeal who has been adversely affected by its decision. The
General Court would have the authority to annul or modify the contested decision.
Ultimately, under Article 256(2) TFEU, the General Court's decision might be exceptionally subject
to a review by the Court of Justice under the conditions and within the limits laid down by the Rules
of Procedure of the Court of Justice.

Advisory committees
The European Economic and Social Committee (EESC) issued its opinion on the proposed
regulation and the other Commission proposals included in the patent package on
25 September 2023. The EESC report generally supported the Commission's initiative to establish a
centralised SPC for both European and unitary patents, considering them essential for establishing
a more harmonised patent system within the EU. However, the report also mentioned several
potential complications of the proposal. Most importantly, it considered the proposed 'all EU
languages' regime for centralised SPC applications enormously challenging. Additionally, the report
considered the processes that involve assessing the scope of protection of a given patent to
determine whether a product falls under a basic patent (for SPCs) difficult to execute. Given the
technical nature, high level of sophistication, and insufficient number of experts, this language
system would increase the complexity of implementing the proposed regulation.

National parliaments
The deadline for submitting reasoned opinions on subsidiarity was 23 October 2023. The Czech
Chamber of Deputies examined four proposals and supported the Czech government's position
on the issue. The Irish Houses of Oireachtas considered that the proposal did not warrant further
scrutiny. The Committee on Rural Affairs of the Lithuanian Seimas concluded that the proposal
complied with the subsidiarity principle. The Slovenian National Assembly was generally in favour
of the proposal but recommended a balanced approach. It furthermore advocated 'a non-binding
regulation [for] the participation of national examiners in the centralised procedure for testing the

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conditions for the grant of SPCs'. It argued that a binding regime would overload the Slovenian
Intellectual Property Office.

Stakeholder views 6
In June 2023, the European Data Protection Supervisor (EDPS) released an opinion under
Article 42(1) of Regulation 2018/1725, which states that the Commission must consult the EDPS
when a proposal for a legislative act impacts the protection of individuals' rights and freedoms
regarding the processing of personal data. The EDPS acknowledged that launching an application
for an SPC or a unitary SPC involved the processing of personal data. Therefore, the opinion focused
'on the provisions requiring publication of personal data, as well as the proposed storage duration'.
Among other things, the EDPS requested clarification on the purposes for which personal data may
be disclosed and the mechanism for accessing them. The opinion recommended clearly articulating
the specific purposes for which personal data may be made available and considering providing a
mechanism that allows access only to parties that have demonstrated a legitimate interest linked to
the proposal's objectives (i.e., this data should not be publicly available). Additionally, the EDPS
provided observations regarding the retention period for all entries in the register and an
administrative database.
The proposals on the SPC for PPPs have been the least controversial parts of the patent package,
especially when compared to the proposals dealing with the SPC for medical products or even more
so, to the compulsory licencing regime. This lack of controversy is evidenced by the limited number
of studies and research articles on the topic. Currently, none of the stakeholders have opposed the
stated aims of the SPC for PPPs proposals: to simplify and harmonise the current framework around
SPCs, increase transparency, and address the omission of a unitary SPC from the unitary patent
system. The SPC for PPPs proposals have been broadly welcomed by stakeholders and are expected
to progress relatively smoothly through the legislative process. It remains to be seen how the
proposed changes to the provisions of the basic SPC Regulation will affect the scope of rights
available under SPCs for PPPs (and how national patent offices and courts will interpret these rights
following such changes).

Legislative process
The two proposals under examination in this briefing, one on the unitary SPC for PPPs (the unitary
SPC proposal) based on Article 118 TFEU and the second one on the SPC for PPPs (the recast SPC
proposal) based on Article 114 TFEU, are subject to the ordinary legislative procedure, requiring the
support of both the Council of the EU and the European Parliament. In the Parliament, both
proposals were referred to the Committee on Legal Affairs (JURI), with Tiemo Wölken (S&D,
Germany) as rapporteur.
Under Rule 56 of Parliament's Rules of Procedure, the Committees on Agriculture and Rural
Development (AGRI) and on the Environment, Public Health and Food Safety (ENVI) were asked to
give opinions. The AGRI committee decided not to give an opinion as the proposal would not
substantially modify the existing regime for SPCs. On 29 August 2023, the ENVI committee decided
not to give an opinion on these legislative files, without giving any reasons.
The rapporteur presented his draft report on the unitary SPC proposal on 13 October 2023. The
key recommendations of the report included defining the concept of 'economically linked' for
holders of multiple patents; holding applicants accountable for the accuracy of the information they
submit; making it possible for the EUIPO to collectively address multiple oppositions filed against
an examination opinion; appointing examiners based on expertise; prioritising expertise over
geographical balance in examination panels; setting a 3-month decision deadline for the EUIPO,
requiring evidence-supported appeals; ensuring expert neutrality; and obligating the Commission
to report the main findings on the establishment of a central authorisation procedure to the
European Parliament and the Council after 5 years.

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The draft report on the recast SPC proposal, published on 16 October 2023, suggested minor
changes, aimed at refining the text and unifying the terminology and procedures with those from
the unitary SPC proposal.
The deadline for tabling amendments in the JURI committee was set for 10 November 2023. Some
98 for the first proposal and 57 amendments for the second one were tabled. Ultimately, five
compromise amendments were tabled for the unitary SPC proposal. For the recast SPC proposal,
three compromise amendments and one amendment were tabled. On 24 January 2024, the JURI
committee voted in favour of both legislative reports, adopting all compromise positions except
for amendment 47 to the recast proposal, which was rejected.
The approved reports mainly contain technical amendments, addressing various aspects, including:
 the examination of the unitary and centralised SPC applications,
 the opposition procedure,
 the role of national authorities,
 the combined applications,
 the formation of examination panels,
 the appellate process.
The reports were tabled for the February II plenary session. Parliament voted in favour of both
reports, including the JURI committee's amendments, by an overwhelming majority. It thus adopted
its first-reading positions for the proposals on the unitary SPC for PPPs and on the recast SPC for
PPPs for the interinstitutional negotiations.
In the Council, the Working Party on Intellectual Property (Patents) is responsible for handling the
proposals. On 29 September 2023, the preliminary written comments of the national delegations
were distributed among the members of the Working Party. On 16 October 2023, several (non-
public) working papers were distributed among the delegations. The Council held a debate on the
proposal on 22 December 2023, at which the Member States shared their views. The Council has yet
to agree on its mandate for negotiating with Parliament.
EUROPEAN PARLIAMENT SUPPORTING ANALYSIS
Baraník K., Supplementary protection certificates for plant protection products, 'plenary at a glance' note,
EPRS, February 2024.
Frizberg D., Intellectual property: Revising legislation on supplementary protection certificates, initial
appraisal of a European Commission impact assessment, EPRS, November 2023.
Huemer M.A., implementation appraisal on Revision of the Supplementary Protection Certificate
Regulations for medicinal and plant protection products, EPRS, May 2023.
Mildebrath H.A. with Carmona H., Compulsory licensing of Patents for Crisis Management, EPRS,
legislative briefing, February 2024.

OTHER SOURCES
Legislative trains on the Unitary SPC for PPPs and on the SPC for PPPs (recast), EPRS, European Parliament.
Ridderbusch O. and Von Uexküll A. (eds.), European SPCs Unravelled: A Practitioner's Guide to
Supplementary Protection Certificates in Europe, Second Edition, Wolters Kluwer International, 2021.
Stief M. (ed.), Supplementary Protection Certificates (SPC): A Handbook, Second edition, Verlag C.H. Beck
oHG; Verlag C.H. Beck oHG, 2021.
Supplementary protection certificate for plant protection products. Recast, Legislative Observatory
(OEIL), European Parliament.
Unitary supplementary protection certificate for plant protection products, Legislative Observatory
(OEIL), European Parliament.

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ENDNOTES
1
'A. Purpose, History and Legal Character of the Certificate', in Marco Stief (ed), Supplementary Protection Certificates
(SPC): A Handbook, Second edition (© Verlag C.H. Beck oHG; Verlag C.H. Beck oHG 2021) pp. 4-12.
2
https://e-courses.epo.org/wbts_int/litigation/SPCs.pdf
3
See Article 2 of the proposal on the unitary SPC for PPPs.
4
See Articles 8, 9, and 29(1) of the proposal on the unitary SPC for PPPs.
5
See Article 3 of the proposal on the unitary SPC for PPPs.
6
This section does not intend to serve as an exhaustive account of all different views on the proposal.

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© European Union, 2024.
eprs@ep.europa.eu (contact)
www.eprs.ep.parl.union.eu (intranet)
www.europarl.europa.eu/thinktank (internet)
http://epthinktank.eu (blog)

First edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative
procedure.

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