Another raft of questions concerning patent term extensions (SPCs) referred to the CJEU
The CJEU has been busy recently answering questions concerning the SPC Regulation, which is aimed at providing a patent term extension in Europe, known as a supplementary protection certificate (SPC) which compensates patentees for the regulatory delays experienced in bring pharmaceutical products to the market.
The extension can last for up to 5 years after patent expiry, with a further 6-month paediatric extension if paediatric studies are completed.
In order to apply for an SPC, (a) a patent must have been granted that protects a product containing an active ingredient or combination of active ingredients; and (b) a marketing authorisation must have been granted in Europe for the product, and that authorisation must be the first for that product in Europe.
In the latest set of questions, the CJEU has been asked:
- What are the criteria by which it should be decided whether or not the patent “protects” the (authorised) product, as required by the SPC Regulation?
- Should an SPC be granted where the marketing authorisation is the first authorisation within the scope of the patent in question to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?
Both questions arise from the previous CJEU decisions where the court is seeking clarification on how to apply the guidance in practice. In essence, the court is seeking more guidance on the tests to be applied and whether the CJEU’s previous guidance should be given a broad or narrow interpretation.
Background to the referred questions
The first question was referred in Teva UK Limited & Ors v Gilead Sciences Inc  EWHC 13 (Pat).
Teva challenged the validity of Gilead’s SPC to the combination product, Tenofovir disoproxil together with Emtricitabine, which is an anti-retroviral medication for HIV marketed under the name Truvada® by Gilead.
Gilead argued that the combination product described in the SPC was protected by European Patent (UK) No. 0 915 894, but Teva disputed this. The patent claimed new compounds by their formulas, in particular, Tenofovir disoproxil, but there was no claim or disclosure specific to Emtricitabine. There was, however, a general claim (claim 27) reciting:
A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.
Gilead argued that this was enough for the patent to protect the combination of Tenofovir disoproxil with other therapeutic ingredients such as Emtricitabine.
The court was left to decide whether the patent protected the given combination based on previous CJEU case law, in particular, Medeva (C-322/10), which found that an SPC should only be granted for an active ingredient or combination of active ingredients which are “specified in the wording of the claims”. However, the CJEU had not set out the criteria for determining whether a product was “specified” or not.
Therefore, the judge (Justice Arnold) proposed to refer the above first question to the CJEU and asked for guidance on the criteria to be applied.
The second question was referred in Abraxis Bioscience LLC v The Comptroller-General of Patents  EWHC 14 (Pat).
Abraxis had appealed against the refusal of their SPC application by the UK-IPO for “paclitaxel formulated as albumin nanoparticles” (“nab-paclitaxel”), the formulation of Abraxis’ anti-cancer drug Abraxane®.
Abraxis argued that nab-paclitaxel is a different active ingredient to paclitaxel such that they are different “products” under the SPC Regulation. This was rejected by both the UK-IPO and the Court based on the narrow interpretation taken by previous case law.
Abraxis’ alternative argument was based on a previous CJEU decision in Neurim (C-130/11) where it was held that the existence of an earlier authorisation for a medicinal product, whether for an earlier veterinary or human use, does not preclude the grant of an SPC following the grant of a later authorisation, provided that the earlier authorisation would not fall within the limits of the patent relied upon as the basis for the SPC application. Abraxis argued that this principle extends to new formulations of previously approved medicaments as well as new indications. The UK-IPO rejected this argument and this was the main subject of their appeal. The UK-IPO felt that Neurim was intended to be limited to new therapeutic uses for old active ingredients and that other CJEU case law, namely MIT (C-431/04), GSK (C-210/13) and Forsgren (C‑631/13), suggested that SPCs cannot be granted merely for new formulations.
However, the appeal court found that this issue remained unclear, and in particular, highlighted the conflicts between some of the previous CJEU decisions. Therefore, the judge (Justice Arnold) proposed to refer the above second question to the CJEU and asked for a simplified approach.
These referrals will hopefully give some clarity to the previous CJEU decisions and indicate how broadly their decisions should be interpreted.
Until then, we suggest seeking advice from our Life Sciences and Chemistry team at Forresters who are well versed in the complexities of these SPC cases and can advise on a claim drafting strategy.