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24 September 2015Big PharmaAnja Lunze and Paul England

SPCs: When a few days makes a difference

On September 10, Advocate-General (AG) Niilo Jääskinen delivered his opinion in a case concerning supplementary protection certificates (SPCs). The case (C-471/14) was brought by Seattle Genetics against the Austrian Patent Office (APO).

US biotechnology company Seattle Genetics had filed a European patent on July 31, 2003 covering “Auristatin conjugates and their use for treating cancer, an autoimmune disease or an infectious disease”. It was granted on July 20, 2011. In the same year, Takeda, which is based in the UK, applied for a marketing authorisation of a pharmaceutical product based on the patent’s active ingredient, brentuximab vedotin. Seattle Genetics’ product trades under the name Adcetris.

The European Commission granted the marketing authorisation on October 25, 2012, pointing out that the “validity of this marketing authorisation … is one year after the notification of this decision”. Takeda was notified of the marketing authorisation five days later—on October 30, 2012 and it was published in the Official Journal of the EU on November 30, 2012.

Following Seattle Genetics’ request in 2012, the APO granted an SPC and stated it would take effect when the basic patent expired; the SPC itself would expire on October 25, 2027, assuming that the date of the first marketing authorisation would be the date of the commission’s decision of October 25, 2012.

In 2014, Seattle Genetics filed an action with the High Court of Vienna seeking correction of the expiration date of the SPC by arguing that it should actually be five days later, ie, October 30, 2027, because the relevant date should be the date of the notification of the decision to Takeda, ie, October 30, 2012.

Questions for the court

In view of differing case law of EU member states, the High Court of Vienna referred the following two questions to the Court of Justice of the European Union (CJEU):

1. Is the date of the first authorisation according to article 13(1) of the SPC Regulation to be determined according to EU law or does this provision refer to the point in time at which the marketing authorisation takes effect according the law of the relevant member state?

2. In the event that the CJEU confirms that the determination of the relevant date underlies EU law, which is the relevant date: the date of the grant of the marketing authorisation or the date of the notification of the grant?

“The AG referred to the purpose of the SPC Regulation: to allow the patent owner to amortise its investments in pharmaceutical research.”

On the first question, the AG said that the term ‘date of the first authorisation’ is to be determined according to EU law. He pointed out that the legislator, by choosing the legal instrument of a regulation, expressed its intention to implement a standard system for SPCs on an EU level. The legal nature of the SPC Regulation therefore requires that its terms are interpreted autonomously and uniformly in Europe.

If the date on which a marketing authorisation entered into effect and the corresponding date of an SPC’s expiration would be determined by national law, the duration of an SPC could be different in different member states. This would significantly harm the intra-community parallel trade between member states if the SPC had expired in one member state, but was still in force in another—this would lead to a separation of markets, which would be contrary to the purpose of the SPC Regulation.

On the second question, the AG expressed his view that the date of notification of the grant to the applicant is the relevant date. While the date of the grant of the decision is mentioned in the ruling itself, the date of its notification to the applicant is always published in the Official Journal of the EU and can therefore easily be found by third parties. Both dates are therefore publicly accessible.

SPC owners will welcome the AG’s finding that the later date of notification is the relevant date for calculating an SPC term; the extension of exclusivity on a product for even a few days can have a significant commercial benefit. The AG referred to the purpose of the SPC Regulation: to allow the patent owner to amortise its investments in pharmaceutical research. The right to exploit a new pharma product by putting it onto the market and hence the amortisation can only start once the grant of the marketing authorisation has been notified to the applicant.

For this reason, only this date can be decisive for the duration of an SPC. Otherwise, the duration of an SPC would in practice be shortened by procedural aspects that the SPC applicant cannot influence and it would contradict the purpose of the SPC Regulation that intends an extension of the exclusive protection.

Seattle Genetics is the latest in a series of cases at the CJEU, most notably the AG’s opinion in Neurim Pharmaceuticals v Comptroller-General of Patents (C-130/11) and the CJEU decision that followed it, in which the purpose of the SPC regime is an important factor when interpreting the SPC Regulation (the ‘teleological’ approach).

Specifically, it is argued, the SPC Regulation should be interpreted in accordance with its purpose of assisting the investment in pharma products to be recouped. The present opinion suggests that this apparent liberalisation is still being explored.

It is to be expected that the CJEU, as usual, will follow the opinion of the AG. The CJEU has  announced that it will rule on the case on October 6.

Anja Lunze is a partner at  Taylor Wessing in Munich. She has more than ten years of experience in German and international patent infringement and revocation litigation. Lunze has experience in dealing with cross-border patent litigation, particularly in the pharmaceutical field. She can be contacted at: a.lunze@taylorwessing.com

Paul England is a senior associate at Taylor Wessing in London. He specialises in patent litigation, particularly in the life sciences sector, and has advised on a number of high-profile disputes. Before becoming a lawyer he was a scientist. He can be contacted at: p.england@taylorwessing.com

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