xtock-shutterstock-com-2
xtock / Shutterstock.com
6 October 2015Europe

CJEU: SPCs begin on notification, not authorisation, date

The Court of Justice of the European Union (CJEU) has ended the uncertainty over the term of supplementary protection certificates (SPCs) by ruling that they begin once a party is notified of a marketing auth orisation for a drug.

The case concerned a referral from the High Court of Vienna after Seattle Genetics challenged a decision by the Austrian Patent Office (APO) that had said its SPC was due to expire on October 25, 2027.

Seattle Genetics applied for a European patent covering “Auristatin conjugates and their use for treating cancer, an autoimmune disease or an infectious disease”, in 2003 and it was granted on July 20, 2011.

Takeda had applied for an authorisation earlier that year to market a new active substance under the trade name Adcetris (brentuximab vedotin), which it had developed using the patent.

The European Commission authorised Takeda’s application on October 25, 2012, but the pharmaceutical company was not informed until October 30.

In November 2012, Seattle Genetics applied for an SPC at the APO. The APO then set the date for the expiry of the SPC at October 25, 2027, based on the date that Takeda’s product was authorised by the commission to enter the market.

The commission had taken the view that the date of the first authorisation to place the product on the market within the meaning of article 13(1) of Regulation (EC) No. 469/2009 was the date of its decision on marketing authorisation.

Takeda transferred the marketing authorisation for Adcetris to Takeda Pharma, a licensee of Seattle Genetics, in October 2013.

Seattle Genetics filed a lawsuit against the APO at the Vienna high court in 2014 requesting that the date of the SPC’s expiry to be extended to October 30, 2027.

The high court stayed the case and referred two questions to the CJEU. First, does article 13(1) of regulation 469/2009 state that authorisation is to be determined by EU or national law?

And second, if it is EU law that determines the date of when a product enters the market, at what date does the SPC term begin—from when the product is authorised or when the party has been notified?

On the first question, the CJEU said the date of authorisation is determined by EU law. To rule otherwise, the CJEU said, the “objective of establishing a uniform solution at EU level would be undermined”.

On the second question, the CJEU said an SPC term begins when a party has been notified.

“Since the EU legislature’s intention was to give the holder of an SPC adequate effective protection, the calculation of the duration of supplementary protection cannot be carried out without taking into account the determination of the date from which the recipient of an SPC is in fact able to enjoy the benefit of his marketing authorisation by marketing his product.

“It is clear that the holder of an SPC is entitled to market his product only from the date on which he is given notification of the decision granting the marketing authorisation in question, not from the date on which that decision was adopted,” the court added.

The CJEU’s judgment follows the opinion of Advocate-General Niilo Jääskinen, who last month recommended that SPC protection should begin on the date a party has been notified of a marketing authorisation.

Mark Sandbaken, vice president for IP at Seattle Genetics, said: "The CJEU’s ruling will benefit all those at Seattle Genetics, its partner Takeda, and other companies who have invested significant time and efforts in the development of many innovative products that benefit patients."

Marie Manley, partner at law firm Bristows and representing Seattle Genetics, added: "This is a decision of significant importance for the innovative pharmaceutical industry which invests millions in developing a medicinal product.

"As such, the duration of SPC protection is essential for their medicinal products. Importantly the decision provides certainty to both innovative and generic pharmaceutical companies by clarifying when SPCs expire."

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Big Pharma
8 October 2015   The CJEU’s decision on how an SPC term is to be determined is likely to be welcomed by applicants and owners, but the court has left them to work out how to apply the ruling, say Natalia Wegner-Cribbs and Daniel Wise of Carpmaels & Ransford.

More on this story

Big Pharma
8 October 2015   The CJEU’s decision on how an SPC term is to be determined is likely to be welcomed by applicants and owners, but the court has left them to work out how to apply the ruling, say Natalia Wegner-Cribbs and Daniel Wise of Carpmaels & Ransford.

More on this story

Big Pharma
8 October 2015   The CJEU’s decision on how an SPC term is to be determined is likely to be welcomed by applicants and owners, but the court has left them to work out how to apply the ruling, say Natalia Wegner-Cribbs and Daniel Wise of Carpmaels & Ransford.