More referrals to the CJEU on SPC matters

January 2017

2017 has started with two new referrals from Mr Justice Arnold to the CJEU on the subject of supplementary protection certificates.  These coincide with a European Commission Tender regarding a “STUDY ON THE ECONOMIC IMPACT OF SUPPLEMENTARY PROTECTION CERTIFICATES, PHARMACEUTICAL INCENTIVES AND REWARDS IN EUROPE”.

In Teva UK Ltd & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) “Teva” and Abraxis Bioscience Llc v The Comptroller-General of Patents [2017] EWHC 14 (Pat) “Abraxis”, both handed down on 13 January 2017, questions of interpretation of Articles 3(a) and (d) of European Parliament and Council Regulation 469/2009/EC respectively were referred.

Teva UK Ltd & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat)

In the Teva case, the Claimants challenged the validity of the Defendant's SPC for a product described in the SPC as "Composition containing both Tenofovir disoproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine". The SPC covered a product which is marketed by Gilead under the trade mark Truvada.  Truvada is an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV).   It is a combination product consisting of two active ingredients.  Gilead contended that the product described in the SPC was protected by a European Patent (UK) No. 0 915 894, but the Claimants disputed this.  Accordingly, the Claimants contended that the SPC did not comply with Article 3(a) of the SPC Regulation.

After a thorough review of the Regulation itself, and case law of the CJEU on the interpretation of Article 3(a), Mr Justice Arnold concluded that the test to be applied in order to determine whether a product is "protected" by a basic patent within the meaning of Article 3(a) of the SPC regulation remained unclear.  Mr Justice Arnold has in fact asked the question regarding the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of the SPC Regulation previously, in Actavis Group PTC EHF & Anor v Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat) (20 September 2012).  Referring to that case, he offered his own answer on his referral “in the hope that it will assist the Court of Justice to provide a clear answer this time”.  His own interpretation was that  a patent claim claiming a specific active ingredient, plus “any” other therapeutic use may not confer enough protection to enable the granting of an SPC; an active ingredient, or a combination of active ingredients, should embody an inventive advance (or technical contribution) of the basic patent.

Abraxis Bioscience Llc v The Comptroller-General of Patents [2017] EWHC 14 (Pat)

In the Abraxis case, Abraxis were appealing against the decision the UK Comptroller-General of Patents to refuse Abraxis' application for an SPC for a product described as "paclitaxel formulated as albumin bound nanoparticles" on the ground that it did not comply with article 3(d) of the SPC regulation. 

Abraxis contended that the active ingredient of the medicinal product authorised by the Abraxane MA is not paclitaxel, but nab-paclitaxel.  It was common ground that, if this was correct, the Abraxane MA was the first marketing authorisation for nab-paclitaxel and that the Application complied with Article 3(d) of the SPC Regulation.  However, the UKIPO hearing officer held that the active ingredient of the medicinal product authorised by the Abraxane MA was in fact paclitaxel; so the Abraxane MA was not the first marketing authorisation for paclitaxel and the Application did not comply with Article 3(d). 

Mr Justice Arnold considered it was not clear how far the CJEU reasoning in Neurim (C-130/11, [2012] RPC 23) extends and whether is applicable to new formulations of old active ingredients and how this could be aligned with the earlier MIT, GSK and Forsgren decisions that SPCs cannot be granted merely for new formulations.  The judge therefore referred the following question to the CJEU:

"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?"

Mr Justice Arnold offered his own answer as follows:

“While I fully acknowledge the force of counsel for Abraxis' argument that the primary purpose of the SPC Regulation is to reward innovative research of the kind that led to the development of nab-paclitaxel and to compensate patentees for delays in obtaining marketing authorisations of the kind that Abraxis experienced with Abraxane, it must be recalled that the SPC Regulation was intended to provide a simple and predictable system that could be operated by the competent authorities of the Member States, and in particular the national patent offices, in a uniform manner. Moreover, as discussed, the SPC Regulation aims to balance the interests of patentees with those of other stakeholders. To achieve those objectives, it is necessary to have bright-line rules even if they sometimes deprive meritorious inventions of extended protection. Article 1(b) is such a rule, and the Court of Justice has held that it should be strictly interpreted. In my view 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. If Article 3(d) were to be interpreted in that way, it would be likely to lead to uncertainty and inconsistency as to the circumstances in which SPCs for new formulations could be obtained, as the existing case law illustrates. For example, could an SPC be obtained where the basic patent protected a key ingredient in the new formulation other than the active ingredient (as in MIT, the first application in GSK and Forsgren), rather than the new formulation containing the active ingredient (as in the second application in GSK and the present case)? Moreover, I agree with the Comptroller that paragraphs 11 and 12 of the Explanatory Memorandum appear to indicate that SPCs should be available for new applications (i.e. new therapeutic uses) of old active ingredients, but not for new formulations. Accordingly, I would answer the question no.”

The CJEU decision will be important for pharmaceutical companies engaged in expensive clinical research and development involving re-profiling of know actives.

Given the continued diverging interpretations of the SPC Regulation in recent years, it is not surprising that the purpose of the recent EU Tender  is stated as follows:

“The contractor shall conduct an economic evaluation of the incentives and rewards for pharmaceutical innovation, in particular an economic evaluation of national SPC systems in Europe and provide an economic analysis of the functioning, use and effects of the incentives for pharmaceutical products, in particular, SPCs for pharmaceutical uses (human and veterinary) and plant protection, data protection and market exclusivity for medicinal products for human use, in order to provide answers to the following issues:

  • Overall economic effect of SPCs as well as data protection and market exclusivity on innovation, accessibility and availability of medicines in the EU
  • Specific challenges related to SPCs
  • Specific challenges related to incentives and rewards under the EU pharmaceutical legislation including data and market exclusivity”

2017 is set to be another interesting year for SPCs.

This update was prepared by Mike Nelson,  Partner.

If you would like further advice on this or any other matter, please contact Mike Nelson at mnelson@hgf.com or your usual HGF representative or visit our Contact Page to get in touch with your nearest HGF office.

 

 

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