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

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.