Brand-name drugmakers gain extra days of patent protection

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Brand-name drugmakers gain extra days of patent protection

Genéricos/General | Posted 23/10/2015 0 Post your comment

Brand-name drugmakers have gained some extra time, be it only days, for protection of their originator drugs after a ruling by the Court of Justice of the European Union clarified the date that drug patents expire.

The case in question was that of Seattle Genetics versus the Austrian Patent Office and concerned the supplementary protection certificate (SPC), which extends the duration of patent protection to compensate the patent owner for delays during the regulatory process required to issue a marketing authorization (MA). In Europe, SPCs have a maximum lifetime of five years, with an extra six months being granted for paediatric indications [1]. The total combined duration of market exclusivity of a general patent and SPC cannot normally exceed 15 years.

The Austrian Patent Office had calculated the term of Seattle Genetics’ SPC for its lymphoma treatment Adcetris (brentuximab vedotin) based on the date it issued the SPC, which was 25 October 2012. This would have given an expiration date of 25 October 2027. However, Seattle generics argued that a later expiry date should be calculated using the date on which its partner Takeda was notified of the grant of its centralized MA, which was 30 October 2012.

The court held that the date on which a centralized MA holder is notified of the grant of that MA is the relevant date for calculating the term of an SPC, and not the earlier date of the decision to grant that MA. This it said is due to the fact 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’ … and ‘not from the date on which that decision was adopted’. This change therefore extends the duration of Seattle Genetics’ SPC by five days to 30 October 2027.

The decision is in line with the approach to the calculation of an SPC’s term previously followed by the UK Intellectual Property Office and several other national Patent Offices. However, this has not been uniform across different EU Member States.

The decision therefore gives brand-name manufacturers a few extra days – estimated to be between three and five days – of protection for their products. Although this does not seem like much, in the blockbuster world of pharmaceuticals this is an important gain on the side of brand-name drug manufacturers and on the other hand a loss for generics makers.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Effect of patent filing and initiation of clinical trials on market exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 23]. Available from: http://www.gabionline.net/Policies-Legislation/Effect-of-patent-filing-and-initiation-of-clinical-trials-on-market-exclusivity

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Source: Curia,Europa, Lexology