CJEU refuses to allow SPC for new formulation of existing active ingredient (Abraxis Bioscience LLC v. Comptroller General of Patents)

"An SPC cannot be granted for a new formulation of an old active ingredient."

Before a medicinal product enters the market, the manufacturer must apply for a market authorisation (MA), which can be a lengthy administrative process. The patent application for the active ingredient has usually already been filed in the meantime, so that this administrative red tape can eat into the duration of the patent. To compensate for the loss of running patent time, Regulation 469/2009 provides for the grant of supplementary protection certificates (“SPC Regulation”). According to Article 3 (d) of this SPC Regulation, an SPC can only be obtained if the market authorisation is the first authorisation to place the product on the market as a medicinal product. Unfortunately, this condition has given rise to divergent interpretations. Moreover, in the pharmaceutical industry, products are constantly improved (e.g. alterations in chemical formulas, dosing regimes etc.). What if a product is granted several MAs, one for each (patented) modification? Can each MA be considered as the required MA ex Article 3 (d) of the SPC Regulation? Or is only the very first MA concerning the medicinal product considered as the “first” MA?

There are two ways to interpret Article 3 (d) of the SPC Regulation. Under a straightforward, literal interpretation, the required MA has to be ‘the first authorisation to place the product on the market as a medicinal product’ without further qualification. Alternatively, a teleological interpretation is possible, in the sense that the required MA has to be ‘the first marketing authorisation covering the product as a medicinal product and falling within the scope of the protection conferred by the basic patent’. The 2012 judgment of the CJEU in the Neurim case (C-130/11) did not address this issue in relation to a new formulation of an existing active ingredient.

The European Court of Justice (“CJEU”) now resolved this debate in its recent Abraxis Bioscience LLC v. Comptroller General of Patents judgment. In this case, Abraxis requested an SPC for Abraxane®, a cancer treatment product consisting of a new formulation of the old active ingredient, paclitaxel, in the form of nanoparticles coated with albumin which acts as a carrier for paclitaxel. This new formulation allows the active ingredient to release its therapeutic effects with increased efficacy. An MA had previously been granted in respect of paclitaxel for the treatment of cancers. However, paclitaxel as such was not covered by the basic patent relied upon for the SPC application.

In August 2016, the UK Intellectual Property Office (“UKIPO”) turned down Abraxane’s SPC application on the grounds that it did not comply with Article 3 (d) of the SPC Regulation. The UKIPO held that, although that provision permits the grant of a new SPC for a new and inventive therapeutic use of an old active ingredient (as per the Neurim judgment), its scope does not extend to a new and inventive formulation of an old active ingredient.

Abraxis, who argued in favour of the second, more teleological interpretation described above, appealed the UKIPO’s decision with the High Court of Justice for England & Wales, who decided to stay the proceedings and refer a question for preliminary ruling to the CJEU.

The CJEU confirmed its preference for the first interpretation. In light of the definition of the scope of ‘product’, namely the active ingredient or combination of active ingredients of a medicinal product, a literal interpretation of Article 3(d) of the SPC Regulation presupposes that “the first MA for the product as a medicinal product” within the meaning of that provision actually means “the first MA for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue”. The CJEU explained that the intention of the legislator in establishing the SPC regime was to encourage research into medicinal products, while also taking into account all interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector. The SPC Regulation intends to protect not all pharmaceutical research giving rise to a granted patent and the marketing of a new medicinal product, but rather to protect research leading to the first putting on the market of an active ingredient or a combination of active ingredients as a medicinal product. The Neurim judgment cannot be relied upon in the case of an MA for a new formulation of a previously approved active ingredient, even if the MA for that new formulation was the first to come within the scope of the basic patent relied upon for the SPC application for that new formulation.

This is disappointing news for pharma innovators but a welcome judgment for the generic industry, who will no longer be confronted with an extension of the patent life for a new formulation of an existing active ingredient.