EU Court Rules New Formulations of Authorized Products Do Not Qualify for SPCs
The Court of Justice of the European Union (CJEU) last week handed down a preliminary ruling rejecting drugmaker Abraxis’ argument that its cancer drug Abraxane (paclitaxel protein-bound) should qualify for a supplementary protection certificate (SPC).In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse between when the patent application is filed and when marketing authorization is granted.
Abraxane was first granted marketing authorization by the European Medicines Agency in 2008 and its active substance, paclitaxel coated with albumin, is protected by European Patent EP0961612. While Abraxane’s formulation allows the product to pass through cell membranes more effectively, paclitaxel has been previously marketed as the active ingredient in other products in the EU.
In 2016, the UK’s Comptroller General of Patents rejected Abraxis’ application for an SPC for Abraxane, arguing that the drug did not meet the requirements set out in Regulation (EC) No 469/2009 for obtaining an SPC.
Specifically, the Comptroller General of Patents argued that Regulation (EC) No 469/2009 does not extent SPC protection to new and inventive formulations of active ingredients that are already on the market.
Abraxis appealed the Comptroller General of Patents’ decision to the High Court of Justice of England and Wales, which in turn stayed the proceedings and referred the question to the CJEU for a preliminary ruling on the matter.
In the judgement issued by the CJEU last Thursday, the Court backs the Comptroller General of Patents’ decision to reject Abraxis’ request for an SPC for Abraxane.
According to the Court, Regulation (EC) No 469/2009 defines a product as “the active ingredient or combination of active ingredients of a medicinal product” in Article 1(b) and specifies in Article 3(d) that an SPC shall be granted if the authorization “is the first authorization to place the product on the market as a medicinal product.”
“‘Product’ is understood to mean an active ingredient in the strict sense and that minor changes to the medicinal product such as a new dose, the use of a different salt or ester or even a different pharmaceutical form will not lead to the issue of a new SPC,” the Court writes.
Because the active ingredient paclitaxel has already been authorized under other marketing authorizations in the EU, the Court says it does not qualify for an SPC. The Court also determined that the addition of a nanoparticle coating to paclitaxel does not constitute a combination of active ingredients, and thus does not qualify as a new product in that sense either.
Additionally, the Court notes that the intent of the SPC regulation is not to protect all pharmaceutical research, “but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product.”
CJEU