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National application of the Seattle Genetics SPC decision




Margareta Oproiu and Raluca Vasilescu of Cabinet M Oproiu consider how Romania has applied the landmark Seattle Genetics decision on the expiry date of SPCs

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 Romania.

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 parties".

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 the parties".

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.

Corrections granted

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 notification.

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
  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, including biotechnologies.

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 certificates .

Raluca Vasilescu
  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 2015.


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