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First valid marketing authorisation clarified for SPCs

Ana-Maria Baciu, Adina Badarau and Anca Deaconu of NNDKP review recent judgments from the CJEU on the scope and term of SPCs

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 internal market.

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?

Case C-572/15

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 2014.

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 TFEU.

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.

Case C-471/14

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 Regulation:

  • 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.

Final remarks

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 case C-572/15).

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 handled.

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
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
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 engineering.

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
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 innovation support.

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 fields.

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