A supplementary protection certificate (SPC) is a sui
generis industrial property title that is based on a
granted patent protecting biologically active agents such as
plant products or human or veterinary medicaments.
At the EU level a special patent term extension system was
created to remedy the deficiency existing in the national
patent law of each member state with respect to pharmaceutical
research and to prevent any disparities amongst the national
laws, thus ensuring a uniform practice in the member states.
This system provides for special Regulations in the
pharmaceutical and plant protection fields.
The cases of the Court of Justice of the European Union
(CJEU) further clarified some issues raised by EU Regulation
469/2009 (the SPC Regulation) for pharmaceutical products.
Prior to the accession of a new member state to the EU, SPC
protection was already provided under different national patent
laws in some of the new accession member states. The SPC
Regulation provides for special transitional provisions for
SPCs granted pursuant to this national legislation.
The SPC Regulations was designed not only to establish
similar conditions for granting additional protection to
companies investing in research and development in the
pharmaceutical field, but also to compensate for the loss of
exclusivity as a result of the time required for obtaining a
valid marketing authorisation (MA).
In the absence of full patent law harmonization in the EU,
there is a still divergent practice at the national level as to
how some of the provisions of the SPC Regulations, in
particular that for medicinal products, applies. For instance,
there are still questions about how Article 3 of the SPC
Regulation for medicinal products should be interpreted,
although the CJEU has ruled in various cases on this aspect.
Also, there are divergent national decisions related to the
calculation of the SPC term in the accession countries.
The scope of an SPC, which starts on the expiry date of the
relevant patent protection period, is to help the
pharmaceutical company obtain effective patent protection by
offering an additional five years of extra protection, plus
potentially six months for paediatric extension, to compensate
for the time dedicated to testing the products and obtaining
the authorisation to place the products on the market, which
would be likely to restrain the free movement of goods in the
Pursuant to Article 13 of the SPC Regulation and the CJEU
jurisprudence, it was established that the duration of the
certificate is calculated based on the first MA issued in the
European Economic Area (EEA). What about the new accession
countries to the EU? Was it possible to obtain an SPC on the
basis of the first MA issued pursuant to the national
provisions? Was it necessary to make a difference between the
first national MA obtained prior to the accession date and the
first MA that was issued in the EEA, which could result in a
significantly different expiry date?
The CJEU case C-572/15 – F Hoffman–La
Roche AG v Accord Healthcare OÜ issued on October 5
2016 provided some guidance as to how the term of SPCs in
accession countries should be calculated.
Roche, a Swiss multinational healthcare company, had an SPC
in Estonia, obtained under the national SPC law, for the
product capecitabine, marketed under the name of
Xeloda. The SPC was issued by the Estonian Patent Office on
October 24 2001, based on the patent granted on April 15 1998,
several years prior to Estonia's accession to the EU.
Accord, a healthcare company based in Estonia, obtained a MA
for a generic version of Xeloda, also containing capecitabine
as the active ingredient, and it further obtained the national
authorisations to be included on the list of medicinal
products. This inclusion had as a direct effect the cost
reduction of the innovative product. Accord's generic product
was planned to be placed on the Estonian market on December 15
Roche filed an action before the Harju District Court,
Estonia, seeking to obtain a decision by which Accord would be
ordered to refrain from and/or cease conduct infringing its
exclusive rights conferred by the SPC relating to Xeloda, and
to prohibit Accord from marketing, offering for sale, selling
and advertising in Estonia until the expiry date of the SPC,
which according to Roche, was June 8 2016. The Estonian court
allowed the applicant's request for protective measures.
Accord challenged that decision, arguing that Article 13 of
the EU Regulation 469/2009, in conjunction with recital 9
thereof, must be interpreted as "meaning that it is not
permitted for the holder of both a patent and an SPC to rely on
the entire period of validity of the certificate, calculated in
accordance with Article 13 thereof, in a situation in which, by
relying on such a period of validity, it would enjoy an
exclusive right in relation to an active substance for more
than 15 years from the time when the first MA in the European
Union was granted for a medicinal product consisting of that
active substance or containing it".
In this case, Roche obtained the first MA in the EU for a
medicinal product containing capecitabine on June 10 1998.
Thus, Accord argued that Roche's SPC should not extend beyond
June 10 2013, calculating 15 years from June 10 1998, and thus
Roche could not enjoy exclusive rights for
capecitabine until June 8 2016, as it claimed.
The Harju District Court decision was appealed and further
adjudicated by the Tallinn Court of Appeal, which set aside the
order delivering the protective measures.
Roche appealed this decision and the case was referred to
the Estonian Supreme Court. Taking into consideration the
arguments raised by Roche, the Estonian Supreme Court decided
to stay the proceedings and to refer the following two
questions for a preliminary ruling to the CJEU:
1) Must Article 21(2) of Regulation No
469/2009 … be interpreted as shortening the duration of
[an SPC] issued in a Member State which was issued under
national law before the accession of the State in question to
the European Union and whose duration in relation to an active
substance, as stated in the [SPC], would be longer than 15
years from the time when the first [MA] in the Union was
granted for a medicinal product consisting of the active
substance or containing it?
2) If the answer to the first question is in
the affirmative, is Article 21(2) of Regulation No 469/2009
compatible with European Union law, in particular the general
principles of European Union law on the protection of acquired
rights, the principle of the prohibition of retroactive effect
of law, and the Charter?"
The CJEU stated that Article 21(2) of the SPC Regulation
must be interpreted as meaning "that it applies to an SPC,
relating to a given medicinal product, granted by a Member
State prior to its accession to the European Union. To the
extent that that medicinal product was the subject, within the
EEA, of an marketing authorisation before that granted in that
Member State, and, as the case may be, before its accession to
the European Union, only the first marketing authorisation must
be taken into account for the purposes of determining the
duration of validity of that SPC".
In its answer to the second question, the Court stated that
it did not have jurisdiction to rule on the validity of Article
21(2) of the SPC Regulation, in accordance with Article 267
By this ruling, the CJEU confirmed the earlier case law
establishing that the owner of both a patent and an SPC should
not be able to enjoy more than 15 years of exclusivity for an
active ingredient from the time of the first the MA obtained in
the EU for a medicinal product consisting of that active
ingredient – case C-555/13, Merck Canada Inc v
Accord Healthcare Ltd and others.
Although setting the date of the first MA for a medicinal
product has been the subject of numerous preliminary rulings to
the CJEU (C-617/12, C-195/09, C-207/03), this topic has not yet
been fully exhausted. There are still several sufficient issues
that need to be clarified in order to harmonise the national
practice with the EU Regulations in the field of SPCs.
One of the CJEU cases that brought additional clarification
on the date that should be considered for calculating the
duration of an SPC was C-471/14, detailed below.
CJEU case C-471/14 Seattle Genetics Inc v
Österreichisches Patentamt concerned the "date of the
first authorisation to place the product on the market in the
European Union". The judgment in this case clarified which
first MA date should be taken into account when the SPC
duration is calculated.
Seattle Genetics, a biotechnology company based in the
United States, filed with the Austrian Patent Office an
application for an SPC on the basis of its patent EP 1545613
and on the first MA for the product Adcentris –
brentuximab vedotin. The product was developed by
Takeda Global Research and Development Centre and then
transferred to Takeda Pharma A/S, a licensee of Seattle
Genetics using the basic patent.
The decision to grant the centralized MA for Adcentris was
final in October 25 2012, but the notification of the decision
for granting the MA to Takeda was communicated to the applicant
only on October 30 2012.
The Austrian Patent Office granted the SPC taking into
consideration the date when the MA was issued, that is, October
25 2012. For obtaining a re-calculation of SPC duration,
Seattle Genetics brought proceedings against the Austrian
office and claimed a new expiry date, namely October 30 2017,
calculated as five years from the date when the notification of
the MA decision was communicated, namely October 30 2012.
Noting that the practice of other patent offices in the EU
member states diverged with respect to this topic and the
provisions of Article (13) of the SPC Regulation, the Higher
Regional Court of Vienna, hearing the case filed by Takeda
against the Austrian Patent Office, decided to suspend the
proceedings and to refer the following questions to the CJEU
for a preliminary ruling:
1) Is the date of the first authorisation to
place the product on the market in the EU pursuant to Article
13(1) of Regulation determined in accordance to EU law or that
provision refers to the date on which the authorisation takes
effect under the law of the Member State in question?"
2) Which date must be taken into account for
establishing the SPC duration – the date of
authorisation or the date of notification?
Before the CJEU judgment in this case, there were two
possible dates that could have been considered for establishing
the duration of an SPC, pursuant to Article 13(1) of the SPC
- the decision date – which
represents the date when the centralised MA was granted;
- the notification date – which
represents the date when the centralised MA was
communicated/notified to the applicant.
The CJEU ruled that Article 13(1) of the SPC Regulation is
to be interpreted as meaning that the "date of the first
authorisation to place the product on the market" is determined
by EU law and that "the date of the first authorisation to
place the product on the market in the EU […] is the
date on which notification of the decision granting marketing
authorisation was given to the addressee of the decision".
Essentially, the CJEU's decision in this case clarifies that
the date to be taken into account when determining the duration
of a SPC is the date when the applicant is notified with the
approval of the marketing authorisation.
Following the decision of the CJEU, Article 13(1) of the SPC
Regulation received a uniform and autonomous interpretation,
based on EU law, and therefore its interpretation will no
longer depend on the national legal provisions of each member
state. This decision put an end to the inconsistent practices
within the member states and contributed to the extension of
the duration of the SPCs for which the date when the MA was
granted was taken into account.
Therefore, the decision in case C-471/14 allowed applicants
who had a pending SPC application or new applicants for an SPC
to request that the calculation of the duration their eventual
SPC be made in accordance with the CJEU decision, while the
term of already granted SPCs may be recalculated.
The decisions made by CJEU in the cases presented here
confirm that, for the purpose of calculating the duration of an
SPC, the MA to be taken into account is the MA first granted in
the EU or inside the EEA, even if this was granted before the
accession date in a new member state (for example, Estonia for
While case C-572/15 confirms the previous jurisprudence
relating to the first MA in pre-accession member states, in the
Seattle case, the Court's judgment clarifies which
date of the first MA is to be taken into account when the SPC
duration is calculated.
The CJEU decision in case C-471/14 contributed to changes in
national patent offices' practice regarding calculation of the
SPC's term. Nevertheless, this ruling gives no guidelines on
how the retroactive calculation of the SPC's term should be
The jurisprudence of the CJEU seeks to prevent the issuance
of contradictory decisions of the national courts and patent
offices issued for cases related to the first MA and its date,
having in mind that SPCs are after all national IP rights. A
uniform approach in the member states would lead to more legal
certainty the innovative pharmaceutical companies, holders of
patents and corresponding SPCs and for generic companies
bearing in mind that even few extra protection days have an
significant economic impact on their business.
||Ana-Maria Baciu has 18
years of experience in international and domestic
business law. She is a partner and heads the
firm’s IP and pharmaceuticals and healthcare
practices and co-heads the gaming and consumer protection
practices. She advises clients in various industries
(automotive, gaming, industrial and manufacturing,
pharmaceuticals and healthcare, retail and consumer
goods, technology, tobacco and telecommunications and
media). She is a regular contributor to specialised
publications and lectures on IP and gaming matters. A
licensed European trade mark and design attorney, she is
a member of the Romanian National Council of Industrial
Property Attorneys and the Bucharest Bar.
Her professional affiliations include the International
Trademark Association (member of the Anti-counterfeiting
Committee), International Association for the Protection
of Intellectual Property, European Communities Trademark
Association and MARQUES.
||Adina Badarau is a
patent attorney, with particular expertise in chemistry;
her practice focuses on patent prosecution,
freedom-to-operate and validity opinions, as well as
infringement and nullity actions in the fields of
chemistry, pharmaceutical science and chemical
A member of the Romanian National Chamber of Industrial
Property Attorneys, Adina worked as an examiner with the
Romanian State Office for Inventions and Trade Marks, and
practised as a patent attorney in a reputed national IP
firm prior to joining NNDKP.
||Anca Deaconu joined
NNDKP in April 2017. Over the past seven years of
professional activity, she has worked as an engineer for
an international construction company in the energy field
and subsequently joined the State Office for Inventions
and Trade Marks where she started as a patent examiner,
continued as head of the electricity – physics
department and was subsequently promoted to the position
of director of the department of patents inventions and
Anca advises clients on all aspects of IP rights, with
particular focus on issues related to patents in the IT
and computing, electrical engineering and associated