No supplementary protection for a new form of an active substance
In a judgment of 21 March 2019 (C-443/17) the CJEU reiterated the need for a precise and concise interpretation of the term “protected product” under Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products. The CJEU stressed that this term only applies to an active ingredient of a medicinal product, and not combination with other substances that do not have an independent therapeutic effect.
The purpose of a supplementary protection certificate (SPC) is to extend a patent for medicine. An additional exclusivity period (of a maximum of five years) is intended to compensate a patent holder for shorter market exclusivity. Upon registering a patent, a holder often still has to conduct long-term testing and comply with marketing authorisation procedures, while the 20-year protection period for the invention has already begun.
To obtain an SPC, the holder has to make use of patent coverage for a product or new method of administering the product (the basic patent), while there has to be marketing authorisation for the product (active ingredient) as part of a medicinal product. At the same time, this has to be marketing authorisation issued for the first time, not previously covered by an SPC.
Protection under an SPC falls within the protection enjoyed under a basic patent, but is limited to a product that is an active ingredient of a medicine authorised for placement on the market.
The pharmaceutical company Abraxis sells a medicinal product under the name “Abraxane”, for treatment of tumours. The active substance that the holder has specified for this medicine is “nab‑paklitaksel”, nanoparticle albumin-bound paclitaxel, registered under EP 0961612. Within this substance, albumin and paclitaxel are closely linked, which means that they penetrate the cell membrane as a single unit. Abraxane was approved for placement on the market in 2008 by the European Medicines Agency (EMA). Prior to that date, paclitaxel was sold in different form (without albumin) by other companies on the basis of the relevant marketing authorisations. Nab‑paklitaksel has been found to be more efficacious than the previous forms of paclitaxel.
Abraxis applied for SPC on the basis of the basic patent held for nab‑paklitaksel and the marketing authorisation for Abraxane. This application was denied, as SPC would be applicable to a substance that was already known, now merely taking on a different form.
Abraxis contested that decision, and the court submitted a prejudicial question to the CJEU, asking whether SPC can be granted under Regulation EC 469/2009 when the marketing authorisation is the first authorisation for a product within the limits of a basic patent, and the product is a new form of an already known active substance.
The initial assumption made by the CJEU was that the application for SPC concerned a new form of the already known active ingredient nanoparticle albumin-bound paclitaxel. Albumin was only acting as a carrier increasing the therapeutic efficacy of paclitaxel.
The active substance and the carrier constituted the product sold as Abraxane. This medicinal product was authorised for placement on the market, which essentially was the first authorisation under the basic patent (covering the new form of paclitaxel, as mentioned). Nevertheless, as such, paclitaxel was sold prior to the date of issue of marketing authorisation of Abraxane as the active substance of other medicinal products previously approved for placement on the market.
As a result, the CJEU found that the combination of the active substance and the carrier was not a separate product from the product formed from the same active substance. The term “product” should be understood solely as an “active substance” or “active ingredient”. A combination of an active substance with a substance that does not have an independent medical effect, and only increases the therapeutic efficacy of the active substance, cannot, in this case, be deemed to be a new product that is separate from forms of the active substance already known in trade.
The CJEU also ruled that marketing authorisation for medicine comprising a new form of active substance cannot be considered the first marketing authorisation for that product. The first marketing authorisation was the previous marketing authorisation for a medicinal product containing the active ingredient under consideration, in a previously known form.
The CJEU emphasised that when pursuing the goal of Regulation EC 469/2009, which is to encourage continuing of research by enhancing protection, the interests of other firms in the public health sector must be respected. This goal would be endangered if SPC could also be granted for a new form of a known active ingredient. The CJEU made a basic assumption, in line with the views of the advocate general, who stated in an opinion that the legislature intended, in establishing the SPC regime, to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product on the market, 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.
For this reason, the CJEU found that placement on the market of a new form of a known active ingredient such as nab‑paklitaksel could not be considered the first placement on the market, being grounds for granting protection under SPC rules.
The CJEU’s ruling confirms an approach adopted in past adjudications towards application of Regulation EC 469/2009. This was the view taken by the CJEU for instance in a ruling of 14 November 2013, in the Glaxosmithkline Biologicals and Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma case (C‑210/13). A precise and concise interpretation reduces the notion of a product to the active ingredient (mixture of active ingredients). The CJEU reiterated that substances that do not have an independent therapeutic effect do not determine that a product is new and eligible for supplementary protection. This view will probably not be good news for pharmaceutical companies working to improve the form of an active substance or improve its therapeutic efficacy by combining it with other substances.
Norbert Walasek, adwokat, Intellectual Property practice, Wardyński & Partners