CJEU issues judgment on SPCs to new formulations of old active ingredients

In Abraxis (C-443/17), the CJEU confirms that an SPC is not available for a new formulation of an old active ingredient.

The Court of Justice of the European Union (CJEU) has just issued its judgment (available here) in the Abraxis SPC case (C-443/17) confirming that an SPC is not available for a new formulation of an old active ingredient. This appears to be a significant restriction to the types of invention that may be eligible for an SPC. However, several questions remain unanswered, especially on the precise interpretation of Article 3(d) SPC Regulation according to Neurim (C-130/11).

Overview

The Abraxis case concerns the medicinal product Abraxane, which contains nanoparticle albumin-bound paclitaxel (nab-paclitaxel) for the treatment of certain breast, pancreatic and lung cancers. Abraxis applied for an SPC in the UK based on its Abraxane marketing authorisation (MA) to nab-paclitaxel. However, paclitaxel per se had already been authorised under previous MAs, which raised the question whether the Abraxane MA was the “first authorisation to place [paclitaxel] on the market as a medicinal product” required by Article 3(d) SPC Regulation. Abraxis contended that Article 3(d) was satisfied, arguing that (on a broad interpretation) Neurim (C-130/11) permits SPCs for “different applications” of old active ingredients, which in this case was a new formulation of an old active ingredient. More detailed background to the case is discussed in our first report, here.

The judgment

The CJEU’s answer to the referred question (reproduced in full below) has confirmed that an SPC is not available for a new formulation of an old active ingredient:

“Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, read in conjunction with Article 1(b) of that regulation, must be interpreted as meaning that the marketing authorisation referred to in Article 3(b) of that regulation, relied on in support of an application for a supplementary protection certificate concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorisation for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of a marketing authorisation as an active ingredient.”

Emphasising that Neurim is a narrow exception under Article 3(d), the majority of the CJEU’s reasoning focusses on the strict requirements to identify the active ingredient under Article 1(b) of the SPC Regulation. This is despite the fact that these issues under Article 1(b) had already been determined by the UK Court and were neither referred to the CJEU, nor further appealed by Abraxis. In this, nab-paclitaxel was considered not distinct, for SPC purposes, from paclitaxel and thus constituted the same “product” under Article 1(b) of the SPC Regulation.

Neurim

It is the CJEU’s comments concerning the interpretation of Neurim that seem more significant, but these are rather brief. What can be derived from the judgment is that Neurim does not extend to all “new formulations” of known active ingredients, but is not overturned entirely either. The middle ground between these two extremes remains open to question - albeit the decision makes clear that the middle ground remains narrow.

In particular, the judgment states 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, 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…Such an objective would be jeopardised if… it were possible to take into account, in respect of a new formulation of an old active ingredient, solely the first MA to be covered by the scope of the basic patent protecting that new formulation and to disregard an MA which had been granted previously in respect of the same active ingredient in another formulation.”

Thus, while the CJEU acknowledges that Neurim is “an exception to the narrow interpretation of Article 3(d)”, it emphasises that the exception is limited, in that Neurim “does not, in any event, refer to cases of a new formulation of the product at issue. That exception [ie Neurim] cannot, therefore, in any event, be relied on in the case of an MA granted for a new formulation of an active ingredient which has already been the subject of an MA, even if the MA for that new formulation was the first to come within the scope of the basic patent relied on in support of the SCP application for that new formulation.”

Despite the above, the CJEU did not explicitly refer to the 4 possible interpretations of Neurim put forward in the Advocate General’s (AG) opinion of December 2018 (discussed here). In essence, these interpretations had proposed an increasingly narrowing cascade of possible interpretations for approaching Article 3(d); ie that Article 3(d) might allow an SPC for:

  1. Any new formulations (or therapies) of known active ingredients, on the condition that the MA is the first to fall within the scope of protection conferred by the basic patent (advanced by Abraxis)
  2. Any new therapeutic uses of known active ingredients, but not formulations, on the condition that the MA is the first to fall within the scope of protection conferred by the basic patent (advanced by the UK Government and European Commission)

  3. The first therapeutic use in human medicine of a known active ingredient, where any previous MA only covered a therapeutic use in veterinary medicine, and the MA for human use is the first to fall within the scope of protection conferred by the basic patent (advanced by the Czech, Dutch and Polish Governments), or

  4. Only the first MA for the active ingredient in all situations, according to a strict literal interpretation of Article 3(d) (advanced by the Hungarian Government). This interpretation would have the effect of overturning the judgment in Neurim.

Following the CJEU’s judgment in Abraxis, it seems above options 1 and 4 are rejected. However, options 2 and 3 appear to remain open. While the CJEU does discuss Neurim in the context of its facts (which would suggest option 3 above), the CJEU does not explicitly reject above option 2, where an SPC could be granted to any new therapeutic uses of known active ingredients without the need for a shift between veterinary and human uses.

This distinction is likely to be significant for a number of other pending and granted SPCs which rely on Neurim, such as those based on new indications for a human therapeutic. These questions may be answered by another referral to the CJEU by the French Court of Appeal, in Santen (C-673/18). Indeed, the first question in Santen refers specifically to the scope of Neurim and whether it should be limited to its facts, which may prompt a more definitive answer from the CJEU. Given its referral in October 2018, the earliest we could expect a decision or an opinion to be handed down in Santen is later this year.

It will be interesting to consider further developments in this area, given the timing of the Santen referral and (from a UK-perspective) the continuing uncertainties surrounding Brexit. Since the CJEU has handed down its judgment before 29 March 2019 (or an extended date), it would become enshrined in English law after Brexit as Supreme Court precedent under the European Union (Withdrawal) Act 2018.

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