SUPPLEMENTARY PROTECTION CERTIFICATES (SPCS)
Supplementary Protection Certificates (SPCs) are governed by EU law and provide an extension of the patent term for medicaments and plant protection products. It is intended to compensate for delays due to regulatory approval. After a relatively calm period, the last few weeks saw several referrals from national courts to the Court of Justice of the European Union (CJEU), seeking clarifications on the SPC regulation. Two referrals, both originating from the UK, stand out for their possibility to seriously affect the interpretation of the SPC regulation. The decisions could impact the possibility for obtaining patent term extensions on combination products and new formulations.
Teva v Gilead
The product underlying the court proceedings is Gilead’s Truvada for the treatment of HIV. Truvada contains a combination of tenovir disoproxil and emtricitabine. The SPC application was based on a European patent on tenovir disoproxil (further referred to as the monotherapy patent). This patent does not mention emtricitabine. A European patent on the combination of tenovir disoproxil and emtricitabine was revoked in opposition.
Gilead also markets tenovir disoproxil as a monotherapy (Viread). However, as it would not have provided a real benefit, Gilead did not request an SPC extension for the monotherapy European patent based on this monotherapy drug.
An important criterion for obtaining an SPC is that ‘the product is protected by a basic patent in force’ (Article 3(a) of the SPC regulation). The monotherapy patent contained a claim covering tenovir disoproxil and optionally other therapeutic ingredients. While that claim generically embraces the combination with emtricitabine, the referring judge doubts if that is enough to conclude that the combination is protected by the patent within the meaning of the SPC regulation. Reference is also made to among others previous CJEU decisions that state that the product should be “identified” or “specified” in the wording of the claims. The question referred to the CJEU is therefore “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’”.
The referring judge provides his own suggested answer. In his opinion, one should look to the “inventive advance” of the basic patent. Where the product is a combination product (such as Truvada), the combination should embody the inventive advance of the basic patent (instead of only one ingredient of them as is the case in the monotherapy patent). It remains to be seen if the CJEU will follow this suggestion or take another approach.
Abraxis identified a new way of formulating paclitaxel (a known anti-cancer therapeutic). By formulating it as albumin bound nanoparticles, it behaves materially different (increased effectiveness, better tolerability,…). Abraxis obtained both a patent and a marketing authorization for this formulation (Abraxane), resulting in the question if SPC extensions are available for new, inventive formulations of old active ingredients.
While several CJEU decisions suggest that it would not be possible to obtain an SPC extension on a new formulation of an old active ingredient, Abraxis referred to the Neurim decision to cause doubt (we previously discussed the potential impacts of the Neurim decision here: http://ipimediaworld.com/extending-your-patent-on-a-new-application-for-an-old-drug/). While that case allowed an SPC extension on a new therapeutic use of an old active ingredient, Abraxis contended that it similarly applies to new formulations of old active ingredients. The CJEU will now have to decide if that is indeed the case.
Other SPC referrals
Incyte (C-492/16) concerns the rectification of SPC expiry dates in view of the Seattle Genetics (C-471/14) decision.
In Merck (C-567/16), the question at stake is if an SPC extension requires a Marketing Authorization or if an End of Procedure Notice suffices and if this can be rectified retrospectively.
Pfizer (C-681/16) relates to the interaction of an SPC with a specific mechanism to prevent importation from accession states into Germany.
LC Patents is closely monitoring these and other SPC-related decisions. Do not hesitate to contact us for more information.