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Novel formulations are not new 'products' under the SPC Regulation, says the CJEU

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United Kingdom

The CJEU has recently ruled in the Abraxis Bioscience case that SPCs may not be granted for new formulations of old active ingredients.

Summary

In 2016, the UK IPO rejected Abraxis Bioscience's application for a Supplementary Protection Certificate (SPC) for its product sold under the trade mark, Abraxane, on the grounds it did not comply with Article 3(d) of the SPC Regulation.

Abraxis challenged the IPO Comptroller General's decision before Arnold J in the High Court, who made a request for a preliminary ruling to the CJEU regarding the interpretation of Article 3(d). In its recent decision (Case C-443/17), the CJEU has now confirmed that SPCs may not be granted for new formulations of old active ingredients, confirming Arnold J's own preliminary view.

Background

An SPC extends the period of exclusivity for a medicinal product by up to five years after patent expiry. To be validly granted, an SPC application needs to satisfy the conditions set out in Article 3 of the SPC Regulation, including:

  • Article 3(b), which provides that a marketing authorisation (MA) must have been granted in respect of the product; and
  • Article 3(d), which provides that the MA referred to in Article 3(b) must be the 'first authorisation to place the product on the market as a medicinal product'.

Under Article 1(b) of the SPC Regulation, 'product' is defined as the "active ingredient or combination of active ingredients of a medicinal product".

Abraxis' SPC application

Abraxane is a medicinal product containing paclitaxel coated with albumin, which Abraxis refers to as 'nab-paclitaxel'. Paclitaxel has been marketed by other companies for some time and is used for the treatment of certain cancers. The addition of albumin has been shown to give nab-paclitaxel greater efficacy than paclitaxel and other earlier formulations.

Abraxis obtained an MA for nab-paclitaxel in 2008. It subsequently applied for an SPC, which was rejected by the IPO's Comptroller General on the basis that the MA for nab-paclitaxel was not the first MA to place the product on the market, as paclitaxel was the subject of an earlier MA.

Arnold J had held in the first instance judgment that it was clear that nab-paclitaxel was not the active ingredient of Abraxane within the meaning of Article 1(b) of the SPC Regulation. Instead, paclitaxel was the active ingredient and albumin was a carrier. In his view, it was therefore not necessary to seek further guidance from the CJEU as to the interpretation of Article 1(b) since the interpretation of that provision was acte clair.

Having reviewed previous case law on Article 3(d), Arnold J considered it appropriate to refer the following question to the CJEU to determine whether the MA for nab-paclitaxel could be considered to be the first MA under Article 3(d) of the SPC Regulation:

"Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the MA referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?"

CJEU decision

The CJEU considered previous case law and the rationale behind the creation of the SPC system and came to the following conclusions:

  1. What is the extent of the definition of product under Article 1(b)?

The CJEU has confirmed its previous position in other cases that the definition of 'active ingredient' does not extend to substances which have no therapeutic effect on their own. The same applies to a substance which acts as a carrier, such as albumin in Abraxane. The combination of the old active ingredient, paclitaxel, and the carrier which has no therapeutic effect, is therefore not a new product within the meaning of Article 1(b).

In arriving at this position, the CJEU also referred to paragraph 11 of the Explanatory Memorandum to the SPC Regulation and the fact that the term 'product' is meant to be strictly interpreted and that minor changes to medicinal products such as "a new dose, the use of a different salt or ester or a different pharmaceutical form will not lead to the issue of a new certificate".

  1. Can an MA for a new formulation of an old active ingredient be regarded as being the first MA granted for that product?

The CJEU has held that where an MA has already been granted for an active ingredient, an MA for a new formulation of that active ingredient cannot be regarded as the first MA.

The CJEU noted 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".

 On this basis, the CJEU provided the following answer to the question posed by the High Court: 

"Article 3(d) of [the SPC Regulation], read in conjunction with Article 1(b) of that regulation, must be interpreted as meaning that the MA referred to in Article 3(b) of that regulation, relied on in support of an application for an SPC concerning a new formulation of an old active ingredient, cannot be regarded as being the first MA for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of an MA as an active ingredient."

Comment

The CJEU's response to the referred question aligns with the original view expressed by Arnold J. He acknowledged that, while the primary purpose of the SPC Regulation is to reward innovative research and compensate patentees for delays in obtaining MAs, it is also intended to provide a simple and predictable system that can be operated in a uniform manner. To achieve the objective of balancing the interests of patentees with those of other stakeholders, Arnold J considered it necessary to have "bright-line rules even if they sometimes deprive meritorious inventions of extended protection". In addition, it would be inconsistent with a strict interpretation of Article 1(b) to interpret Article 3(d) as permitting SPCs to be obtained for new formulations of old active ingredients.

In this ruling, the CJEU has confirmed that the approach taken in Neurim (see our 2012 blog - Will Neurim decision lead to more SPC applications or more CJEU references?) does not apply to new formulations of old active substances. It also vindicates the approach adopted by the UK IPO and other IP offices across the EU in rejecting SPC applications for new formulations. The extent to which the impact of Neurim will be further limited to its particular factual matrix will be considered in the Santen case – the first preliminary reference to the CJEU on the interpretation of the SPC Regulation from the Court of Appeal of Paris.

With special thanks to trainee, Charley Guile, for her contribution to this article.

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