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On March 21, the Court of Justice of the European Union (CJEU) issued a ruling in response to a request for a preliminary ruling by Abraxis Bioscience LLM (“Abraxis”), in relation to the interpretation of article 3.d) of Regulation 469/2009, concerning the supplementary protection certificate for medicinal products.

As the Spanish Patents and Trademarks Office explains, a supplementary protection certificate (SPC)

“is an industrial property certificate that, for a maximum of five years, gives the protection conferred by a patent to an active ingredient or a combination of active ingredients that are found in a pharmaceutical or phytosanitary product after the patent has expired.”

The SPC is a mechanism designed for patents concerning a pharmaceutical or phytosanitary product that requires a prior marketing authorization (“MA”). The marketing authorization causes a delay to product launch, reducing the period in which the rights holder can exclusively enjoy the rights given by the patent (20 years). Therefore, SPCs “resuscitate” the patent after it expires, with the same inherent rights, for a certain period of time.

Regulation 469/2009 creates the requirements for issuing an SPC. In particular:

  1. The product must be protected by a basic patent.
  2. The product must have an MA.
  3. The product must never have been previously subject to a supplementary protection certificate.
  4. The MA must be the first one given to the product as a medicine.

In the case at hand, the pharmaceutical company Abraxis was selling Abraxane, which contains the active ingredient paclitaxel, for which it obtained the corresponding MA.

Abraxis created a new form of paclitaxel called nab-paclitaxel, which was protected by a basic patent that Abraxis used as the basis of its SPC request. However, the UK Comptroller General of Patents rejected its request. Therefore, the following question was referred to the CJEU for a preliminary ruling:

“Is Article 3(d) of Regulation [No 469/2009] to be interpreted as permitting the grant of an SPC where the [MA] referred to in Article 3(b) [of that regulation] is the first [MA] 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?”

In its ruling, the CJEU followed the conclusions of the advocate general, Mr. Saugmandsgaard, submitted on December 13, 2018.

He begins by indicating that Regulation 469/2009 does not define what an active ingredient is, and so it must be understood in the general context in which it is used. The CJEU also clarified that a substance that is associated with another cannot lead to a composition of active ingredients:

“a new formulation of an old active ingredient, which, such as nab-paclitaxel, consists of that active ingredient and a carrier that has no therapeutic effect on its own linked together in the form of nanoparticles, cannot be regarded as being a product distinct from the product consisting solely of that active ingredient even if such a formulation allows that active ingredient to exercise its therapeutic effect with increased efficacy.”

Regarding Abraxane, it adds that “only the authorization in respect of the first medicinal product placed on the market, consisting of the product concerned, may be regarded as the first MA”.

The court’s conclusion is clear: the purpose of the SPC is to foster the protection of research leading to the first marketing of an active ingredient or a combination of active ingredients as a medicine. Therefore, the MA issued for a new formulation of an old active ingredient, as is nab-paclitaxel, cannot be considered to be the first MA for that product as a medicine, if that active ingredient has already been subject to an MA.

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