SPCs for new formulations?

An update on the UK Supplementary Protection Certificates (SPC) referral in Abraxis which is progressing towards the Court of Justice of the European Union (CJEU). The UK Intellectual Property Office (IPO) is now asking for comments on this significant case concerning the interpretation of Article 3(d) of the SPC Regulation.

Back at the start of 2017, the UK Patents Court (Mr Justice Arnold presiding) handed down two judgments on the same day referring multiple questions to the CJEU to clarify the interpretation of the SPC Regulation (Regulation EC 469/2009): namely in Teva v Gilead (C-121/17) and Abraxis (C-443/17).

The UK IPO has recently published the Abraxis case referral seeking comments by 06 September 2017 on the question in issue:

"Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation 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?"

This confirms that the question is the same as the one postulated in the original UK judgment and follows the call for comments in the Teva v Gilead case earlier this year in April (despite the CJEU turning down the application for expedition in that case, it nonetheless proceeded to this stage more quickly).

To recap, the Abraxis case relates to paclitaxel (taxol), which is the active ingredient of Abraxane (nab-paclitaxel), a medicinal product marketed for the treatment of various cancers.

Abraxis applied for an SPC for "paclitaxel formulated as albumin-bound nanoparticles", relying on: (1) its marketing authorisation for Abraxane; and (2) its patent, which claims (claim 33) "paclitaxel (taxol) coated with a protein, namely, albumin,…and part of the paclitaxel is contained within the albumin coating and part is associated with free albumin associated with the coating".

At the UK IPO, the hearing officer refused Abraxis' SPC application on grounds that the active is simply “paclitaxel”, and nab-paclitaxel was therefore a new formulation of paclitaxel. This meant that in order to obtain its SPC, Abraxis had to avoid earlier authorisations for paclitaxel to prevent them being deemed the “first” authorisation in accordance with Article 3(d). Abraxis sought to do so by relying on the principles of the well-known Neurim case, which allowed an innovative and different application of an "old" active ingredient to avoid an earlier authorisation for the same "old" active ingredient applying under Article 3(d). The UK IPO rejected Abraxis’ arguments and held that the principles in Neurim are confined only to instances where the new application is a new therapeutic use.

Mr Justice Arnold did not disagree with the UK IPO but considered the law to be sufficiently unclear so to merit a referral to the CJEU. This draws an interesting contrast to his decision in the Neurim case itself, in which he originally rejected the SPC application and held that the law was acte claire before being overturned by the Court of Appeal, which then made the referral to the CJEU resulting in the grant of Neurim’s SPC. A further factor in this referral was the inconsistent outcome of Abraxis’ SPC applications across Europe, which according to the UK decision had been granted (in Austria, Denmark, Finland, Greece, France, Italy, Luxembourg, Portugal and Spain) and rejected (in Sweden and the UK).

Coincidentally, the SPC granted in Neurim expired this year in April 2017, but the questions about its scope continue to be raised. The advancement of Abraxis’ case to the CJEU is testament to the importance of the Neurim decision and the uncertainty as to how far-reaching its principles might (or should) be. Abraxis therefore provides the opportunity for the CJEU to address some interesting questions, such as: Is Neurim confined to new therapeutic uses? Can it be extended to new formulations? If Neurim can be extended to new formulations, might it be extended further still?

Rather unusually for a referral it might be said, the CJEU decision in Neurim was very fact-specific and so even if Abraxis get their SPC, the full potential and scope following Neurim may remain unclear.

However, as usual, it is tempting to consider whether, if Abraxis succeeds, this will open the floodgates to further “formulation SPCs” and perhaps other categories of SPCs. Looking at the SPC applications made in the UK since this referral in January 2017, at least one appears to be raising similar issues concerning new forms/formulations of an "old" active ingredient, namely SPC application SPC/GB17/043. This application was based on a patent for “Liposomes useful for drug delivery” and the authorisation for Onivyde®, a medicinal product containing irinotecan, which has otherwise been marketed since the early 2000s. It will be interesting to see whether Abraxis impacts on this application and other SPC applications which seek to test how far the boundaries of Neurim extend.

This case will also develop within the same timeframe as the Commission’s investigations into the European SPC regime, which has posed similar questions concerning the scope of what new innovations should qualify for SPC protection.

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