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January 2017

As we have previously reported, there is a lack of clarity about the requirements for the grant of a supplementary protection certificate ("SPC") and interpretation of aspects of Regulation 469/2009/EC ("SPC Regulation"). It is in this context, that Mr Justice Arnold has in three cases before the English Patents Court considered the correct interpretation of articles 3(a), (b) and (d) of the SPC Regulation. Incomplete reasoning in previous cases decided by the Court of Justice of the European Union ("CJEU") and diverging approaches across Europe has led in each case to the referral of further questions to the CJEU for a preliminary ruling.

Article 3(a)

Teva UK Limited and three other claimants challenged the validity of an SPC held by Gilead Sciences Inc ("Gilead") that covers its anti-retroviral treatment Truvada. The claimants argued that the product (Truvada) is not protected by the basic patent for the purposes of Article 3(a) of the SPC Regulation. The result is a referral to the CJEU on the question of the criteria to be applied when considering Article 3(a), although the requirement would not be satisfied in this case on the basis of the "inventive advance" test supported by Arnold J.

Truvada is a combination product used in the treatment of HIV that consists of tenofovir disoproxil fumarate and emtricitabine in a fixed dose tablet. The basic patent relied on by Gilead (EP 0 915 894) claims a range of compounds that includes tenofovir disoproxil. Claim 27 claims a pharmaceutical composition of a compound of the earlier claims (i.e. including tenofovir disoproxil) "together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients". The basic patent does not refer to emtricitabine by name.

The test when applying Article 3(a) has been the subject of successive references. In Medeva¸ the CJEU did not identify the criteria to be applied but gave the overall answer that an SPC cannot be granted for "active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application."¹ The answer given in University of Queensland was the same except that "identified" was used instead of "specified" in the CJEU's reasoning. In Lilly v HGS the CJEU referred back to the answer from Medeva and added that the grant of an SPC was possible if the active ingredient was identified by a functional definition in the claims but the "claims relate, implicitly but necessarily and specifically, to the active ingredient in question". In the absence of a workable set of criteria and diverging national decisions on this SPC application and other products, the UK Patents Court has again requested a preliminary opinion from the CJEU on the following question:

"What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation?"

While Actavis v Sanofi and Actavis v Boehringer were decided without the CJEU answering the questions referred to it on Article 3(a), Arnold J considered the language in these decisions carefully. The CJEU described the objective of the SPC Regulation as "to compensate for the delay to the marketing of what constitutes the core inventive advance that is the subject of the basic patent"², and further acknowledged the need to balance the interests of pharmaceutical industry and public health. In the context of the requirement for a basic patent to protect an active ingredient 'as such', the CJEU decided that the "active ingredient must constitute the subject-matter of the invention"³.

The final two pages of the judgment set out Arnold J's suggested answer to the proposed referral question. Previous case law has identified two relevant approaches to the interpretation of Article 3(a): the "Extent of Protection Rules"⁴ and the "Infringing Act Rules"⁵. The decision concludes from prior case law that the Extent of Protection Rules should apply, but that the mere application of these rules would result in a greater monopoly than intended by the SPC Regulation. The suggested answer is to consider the "inventive advance" or technical contribution of the basic patent. A product would satisfy Article 3(a) if "it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent". When applied to the facts of the case, the combination of agents comprising Truvada does not embody the "inventive advance" of the basic patent. Arnold J considers that such an assessment is consistent with the objectives of the SPC Regulation and would meet the need to encourage and reward innovation in medicinal products. The adoption of such a requirement would require national authorities to make their own assessment of the "inventive advance" of the basic patent when considering SPC applications and this may not be straightforward in every case. The test draws upon the wording in the CJEU's decisions in both Actavis references and industry and commentators will eagerly await the CJEU's next instalment.

Articles 1(b) and 3(d)

In Abraxis Bioscience LLC ("Abraxis") v the Comptroller of Patents the English Patents Court considered (i) the definitions of "product" and "active ingredient" under the SPC Regulation in light of recent CJEU case law, and (ii) the scope of protection intended by the reasoning of the CJEU in Neurim.

Abraxis markets nab-paclitaxel under the trade mark Abraxane and the product comprises paclitaxel formulated as albumin bound nanoparticles. There are several advantages of Abraxane over the existing form of paclitaxel. According to Abraxis, nab-paclitaxel is the single active ingredient of Abraxane due to the tight association of paclitaxel to albumin.

"Product" as defined in the SPC Regulation⁶ means "the active ingredient or combination of active ingredients of a medicinal product". The UKIPO refused Abraxis' application for an SPC as it concluded that paclitaxel was the active ingredient of nab-paclitaxel and the Abraxane marketing authorisation ("MA") was not the first authorisation of that product. In light of the authorities (in particular MIT, GSK and Forsgren) Arnold J concluded that Article 1(b) is to be interpreted narrowly and that an active ingredient is a substance which produces a pharmacological, immunological or metabolic effect of its own. Arnold J agreed that the role of albumin did not change that paclitaxel was the active ingredient of nab-paclitaxel. The case law on Article 1(b) was considered sufficiently clear that no reference was required on this point.

Abraxis further argued that, in light of the policy considerations relied on in Neurim, Article 3(d) of the SPC Regulation was capable of protecting a new formulation of an old active ingredient. In Neurim, the CJEU held that "the mere existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which an MA has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC."⁷ The CJEU followed the Opinion of Advocate General Trestenjak who proposed a teleological rather than literal interpretation of Article 3(d): the rationale of the SPC Regulation is to compensate for the insufficiency of the term of patent protection to cover the investment made into pharmaceutical research. Arnold J previously observed⁸ that the CJEU's reasoning in Neurim did not make clear how its decision should be reconciled with previous case law.

Due to the uncertainty of the how far the reasoning in Neurim should be applied Arnold J has referred the question to the CJEU. However, Arnold J's view was that it would be inconsistent with a strict interpretation of Article 1(b) - see above - to interpret Article 3(d) as permitting SPCs to be obtained for new formulations of old active ingredients. Arnold J emphasised the need for a simple and predictable system that can be implemented by national patent offices in a uniform manner. Arnold J expressed the view that to achieve this "it is necessary to have bright-line rules even if they sometimes deprive meritorious inventions of extended protection."

Finally, it will be helpful if the CJEU takes up the suggestion at paragraph 44 of Arnold J's judgment, to expressly state when earlier decisions are no longer to be regarded as authoritative or to be limited to particular facts.

Article 3(b) – valid authorisation

The third SPC issue on which the English Patents Court has referred questions to the CJEU relates to whether an "end of procedure notice" is equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation. Merck Sharp & Dohme Corporation v The Comptroller-General of Patents, Designs and Trade Marks was handed down in July 2016 and the UKIPO recently sought comments from the public to assist in its role in advising the UK government on possible submissions to the CJEU in this reference. Although the conclusions drawn by Arnold J would have the effect of upholding the decision of the UKIPO, two issues have been referred to the CJEU for a preliminary ruling.

In September 2013 Merck Sharp & Dohme Corporation ("MSD") applied for an MA for Atozet (a fixed dose combination of ezetimibe and atorvastatin) via the Decentralised Procedure. Under this route the application is assessed by one member state (referred to as the Reference Member State or "RMS") which co-ordinates the process for approval of the MA on behalf of other nominated member states (each a Concerned Member State or "CMS"). Once the RMS issues its final assessment report and closes the procedure the CMSs adopt a decision on the basis of the report which becomes binding in that member state.

MSD applied for an SPC on 12 September 2014, one day before its basic patent covering a combination of ezetimibe and atorvastatin expired. Two days before MSD's application, the competent authority of the RMS (BfArM) issued an "End of Procedure communication of approval" in respect of the application but the MHRA did not grant an MA for Atozet until 10 October 2014.

For an SPC to be granted, Article 3(b) of the SPC Regulation requires, at the date of the application, the grant of "a valid authorisation to place the product on the market" in accordance with the Directive 2001/83/EC or Directive 2001/82/EC. Arnold J gave an opinion that the "end of procedure notice" was not equivalent to an MA for the purpose of the SPC Regulation and therefore the UKIPO hearing officer's decision not to grant an SPC was upheld. In particular, even after the closure of the DCP procedure it remains necessary for each individual member state to the grant the MA. Together with the specific references to "granted" MA in the SPC Regulation this suggests a strict interpretation of this provision is required.

The Court also considered whether the absence of an MA was an irregularity that could be cured under Article 10(3) of the SPC Regulation. Arnold J expressed a view that the subsequent grant of an MA could not remedy the deficiency that existed at the application date.

Like Gilead's application discussed above, MSD's SPC application has led to inconsistent results across the EU. Portugal and Sweden have adopted the same approach as the UK and refused to grant the SPC. On the other hand, Denmark, Greece, Italy and Luxembourg have granted the SPC and the Netherlands has accepted that an "end of procedure notice" is equivalent to a granted MA for this purpose. This was further justification for a CJEU referral in this case.

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.

¹At [28].

²Actavis v Sanofi at [41].

³Actavis v Boehringer at [38].

⁴Article 69 of the European Patent Convention sets out the extent of patent protection should be determined by the claims and the "Extent of Protection Rules" is directed at the wording of the claims.

⁵This assessment asks whether the product would infringe the basic patent under the relevant national infringement law.

⁶Article 1(b).

⁷at [27]

⁸AstraZeneca AB v Comptroller-General of Patents, Trade Marks and Designs [2012] EWHC 2840 (Pat) at [52]-[53].

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