Council Regulation (EEC) number 1768/92 (EC) of June 18 1992
concerning the creation of a supplementary protection
certificate for medicinal products (codified as the Regulation
(EC) number 469/2009 of the European Parliament and of the
Council of May 6 2009), and respectively the Regulation (EC)
number 1610/96 of the European Parliament and of the Council of
July 23 1996, concerning the creation of a supplementary
protection certificate for plant protection products, entered
into force in Romania on January 1 2007, the date when Romania
joined the European Union.
On the same date, Regulation (EC) number 1901/2006 on
medicinal products for paediatric use entered into force in
From 2007 until now, the number of SPC applications filed
with the Romanian PTO increased yearly, from about 20 in 2008
to about 55 to 60 in 2015-16.
After October 6 2015, the Examining Commission of the
Romanian Patent and Trade Mark Office has decided that the
expiry date for all SPC applications under examination will be
calculated taking into account the date of the notification of
the first marketing authorisation, in compliance with the
judgment of the CJEU in case C471/14.
In short, the judgment of the CJEU in case C471/14 deals
with the recalculation of the expiry term of SPCs and is also
known as the Seattle Genetics decision.
The Seattle Genetics decision
In case C471/14, the Oberlandesgericht Wien decided to stay
proceedings and to refer two questions to the CJEU for a
preliminary ruling (paragraph 21 of the decision): (1) if the
date of the first authorisation to place the product on the
market in the [European Union] should be determined by EU law
or by national law and (2) if this date is to be determined by
EU law, which date must be taken into account – the
date of authorisation or the date of notification.
The response of the CJEU as mentioned in the judgment is
that the applicable law for determining the date of first
authorisation to place the product on the market in the EU is
determined by EU law and that this date is the date on which
notification of the decision granting marketing authorisation
was given to the addressee of the decision.
The Seattle Genetics judgment is obviously
favourable to holders of SPCs, who can benefit not only from an
extended term of protection as a result of the recalculation
but also from a uniform and coherent way to calculate the term
of protection as extended by the SPC.
Recently, the Romanian Patent Office decided to apply the
Seattle Genetics judgment to SPCs granted before
October 6 2015 based upon a first marketing authorisation
issued by the EMEA and granted before October 6 2015. This
decision has been taken having in view requests filed by
holders of SPCs that fulfil the condition stated above.
Consequently, at the request of the SPC holder, the SPC
expiry date can be re-calculated in Romania on basis of the
date of marketing authorisation notification.
The application of the CJEU judgment was made by the
Romanian Patent Office according to the provisions of Article 4
of the Treaty on European Union (to which Romania adhered on
January 1 2007, the Adherence Treaty being signed on April 25
2005), Article 17 of Regulation (EC) 1610/1996
and Articles 18 and 19 (1) of Regulation (EC) 469/2009, in
conjunction with Article 5 of the new Civil Code, respectively
providing that "in the issues regulated by the present Code,
the rules of the Law of the European Union are prevailing
applicable, regardless the quality or the status of the
And Article 5 of the new Civil Procedure Code, which
provides that "in the issues regulated by the present Code, the
compulsory rules of the Law of the European Union are
prevailing applicable, regardless the quality or the status of
From a procedural point of view, in the absence of special
internal regulation regarding SPCs, the two EC Regulations
governing SPCs apply together with provisions of the Patent Law
(for procedure) that can be adapted for this field. In case of
corrections to the term of protection, these follow the
procedure of appeal before the Re-examination Commission, as
provided by Article 51 (7) of the Implementing Regulations to
the national Patent Law: "Any modifications requested after the
communication of the decision to grant shall be carried out
only by appeal, according to Article 51 of the Law and subject
to payment of the legal fee."
A request for appeal is filed by the holder of the SPC,
accompanied by all documents, and a hearing is established. The
representative of the holder of the SPC has the opportunity to
present the case before the Commission, which issues a
decision. In the event of a negative decision, it can be
further appealed before the Municipal Court of Bucharest.
The first applications for correction of the expiry date of
SPCs were filed in June 2016. So far, the correction was
granted for numerous cases of well-known medicine products such
as those commercialized under the trade marks Emend, Previcox,
Silgard/Gardasil, Aerinaze, Noxafil, Januvia, Isentress,
Zactran, Cancidas and Avolve/Duagen.
An interesting case is represented by medicine products
Avolve/Duagen, corresponding to "Dutasteride optionally in form
of a pharmaceutically acceptable solvate". The question in this
case was that, although the date of notification of the
decision granting the marketing authorisation was clear now in
light of the CJEU judgement, the notion of notification was not
defined, namely what constitutes the date of such
In the case of dutasteride, the first marketing
authorisation in the European Economic Area consisted of two
documents issued by the Medicine Agency from Sweden and dated
July 19 2002. The initial validity term of the SPC was from
September 17 2014 to July 19 2017.
A request was filed to correct the expiry date from July 19
2017 to July 23 2017 having in view the date when the two
authorisations were received, namely July 23 2002. The request
was accompanied by evidence as follows:
- the two marketing authorisations from Sweden whose date
was July 19 2002;
- the covering letter of the Swedish Medicine Agency dated
July 22 2002, this being the date of notification of the
marketing authorisations accompanying them;
- an excerpt from the internal registrar of the holder of
the authorisations bearing a record that the two marketing
authorisations were indeed received on July 23 2002.
At the date of authorisation (2002), the Swedish Medicine
Agency did not publish the date of notification of said
authorisations, therefore it was not possible to attach to the
request an official document of the agency proving this, as it
was possible in case of centralised medicine agencies.
For this reason the holder of the marketing authorisation
submitted the excerpt from the internal registrar and a
declaration of the head of the department in charge of
authorisations from the holder's company certifying the
accuracy of the entries in the registrar.
However in the end, the Romanian Patent Office ignored the
mentions in the registrar made on July 23 2002, but agreed to
accept the date of notification of July 22 2002 as valid, hence
decided to correct the expiry date of the SPC from July 19 to
July 22 2017.
Creating case law
This decision is important and may create case law for all
future cases in which at the date of issuing the marketing
authorisation no procedure was in place in that jurisdiction
for the publication of the notification.
As a conclusion, the decision of the CJEU in case C471/14 is
uniformly implemented in Romania for SPCs granted either before
or after the date of its issuance, satisfying the spirit of the
Community rules. This means all manufacturers of medicinal
products benefit from the same additional term of protection
for their SPCs.
||Margareta Oproiu is the
senior partner and a patent and trade mark attorney with
Cabinet M Oproiu.
Oproiu has a PhD in physics from the University of
Bucharest and has spent 15 years in research in the field
of plasma physic applied to several technologies,
After passing the patent attorney examination in the
first session organized in the early 1990s in Romania,
she became a patent attorney and opened Cabinet M Oproiu
in 1995 as one of the first agencies in private practice.
Today, Oproiu is one of the most experienced Romanian
patent attorneys, her cutting edge being in cancellation
and infringement proceedings before the Patent Office and
the courts. She is well experienced in conducting all
procedures related to supplementary protection
||Raluca Vasilescu is a
patent and trade mark attorney at Cabinet M Oproiu, which
she joined in 1996; she qualified as a European patent
attorney in 2003. She is the author of the Romanian
chapter in the Vrins/Schneider book "Enforcement of
Intellectual Property Rights through Border Measures"
published by Oxford University Press in 2012 and a
contributor to Haselblatt book of commentaries on the EU
Trade Mark Regulation published by C H Beck Hart Nomos in