Drug companies can increase their profits by extending the life of their patents. In the EU, extensions can be granted with an ‘SPC’. However, these need to be applied for and their award is governed by the rules laid down in the EU’s ‘SPC’ Regulation 469/2009. In this case, a drug company applied for an SPC but it failed to provide a required document, and instead enclosed a different piece of paper. Does the omission kill the application? And if so, then is the application really dead? Can it be reanimated by dint of the fact that when the company had made its application the document did not exist but the company had offered to supply it at some point in the future?
Merck Sharp & Dohme (MSD) is a company that makes pharmaceuticals. One of its products is Atozet. For years, this product had been protected by a European Patent (with a UK designation). However, the day before this patent was due to expire, MSD applied to the relevant UK body for an SPC certificate to extend the life of the patent.
Five days later, the UK body turned down MSD’s application. The reason was that MSD’s application lacked one specific obligatory document – a valid UK marketing authorisation for Atozet. This document was required by dint of Article 3 of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products, which stipulates:
3. A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
MSD appealed the UK body’s decision to the High Court of England and Wales.
Its first argument was that in place of a valid UK marketing authorisation for Atozet, the relevant authority in Germany had already issued a document known as an ‘end of procedure notice’ in respect of the drug. According MSD, since the document came from Germany – the ‘reference Member State’ – this was therefore equivalent to a marketing authorisation for all national authorities. Mr Justice Arnold, who was hearing MSD’s case, did not know whether ‘an end of procedure notice’ could be relied upon in lieu of a valid UK marketing authorisation so that would be his first question to the CJEU.
If MSD would lose that argument, then MSD had raised a second one. MSD recalled that when it had made its application, there was no UK marketing authorisation; consequently, it had asked the UK body if it could supplement its application by supplying a copy of the UK valid marketing authorisation at a later date, namely, at the moment when the UK marketing authorisation was granted. The UK body had in effect said it could not do that. According to the UK body, the defect in MSD’s application arose from Article 3(b) of the Regulation and not Article 3(c) so the application could not be saved by Article 10(3) of the Regulation (which is limited to Article 3(c)). However, MSD sought to get around that literal understanding of the EU’s SPC Regulation. It cited a judgment from the Court of Appeal of England and Wales (E I du Pont de Nemours & Co  EWCA Civ 966). In that judgment, the Court of Appeal had allowed a defect in an application to extend an SPC to be cured by Article 10(3) in circumstances where updated marketing authorisations had subsequently become available.
Mr Justice Arnold did not know if MSD’s application was still curable under Article 10(3) of the EU Regulation so he decided to ask the CJEU about this too.
The official version of the questions has not yet been published on the Curia website. Fortunately, the Bailii website contains a copy of Mr Justice Arnold’s decision to make a preliminary ruling, and it concludes with these words:
50. I will hear counsel as to the precise wording of the questions, but in essence the questions are as follows:
(1) Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation?
(2) If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?
This MSD pharma reference comes at a time when the CJEU already has a set of pesticide references in its In-Tray which also concern the potentially extinctive effect of EU rules on authorisation applications made to national regulators. Curiously, those pesticide cases also turn on whether companies can get around the EU rules by relying on national law; see further, Case C-293/16, Sharda Europe – Deadline missed? Schade!
The issue of an SPC application and a functional equivalent to a definitive marketing authorisation was in the background to Case C-210/12, Sumitomo Chemical.
Update – 15 January 2017
Mr Justice Arnold has made another preliminary reference to the CJEU concerning SPCs. It has yet to be docketed by the CJEU so my summary of it is parked here for the time being.
Case C-XXXX/YYYY, Teva – the patent protected ingredient A so no SPC for products using ingredients A+B
A company possessing a European Patent will still need EU marketing authorisations before it can sell its patent-protected drugs. Obtaining these takes time. Fortunately, EU law offers patent holders a ‘Supplementary Protection Certificate’ (an SPC) to extend the commercial life of the patent. Yet there is no automatic right to one. Article 3(a) of the EU’s ‘SPC’ Regulation 469/2009/EC requires the active ingredient in the medicinal ‘product’ to be ‘protected’ by the patent. In this case, the patent covered active ingredient ‘A’ but the product is using ‘A’ combined with active ingredient ‘B’ and ‘B’ was not even mentioned in the patent – so is the product is ‘protected’ by the patent?
In 2003, Gilead Science was granted a European Patent. This covered the use of a certain active ingredient to treat human and animal viral infections. Patent pocketed, Gilead then set about obtaining the obligatory marketing authorisations which it would need before it could sell any of its viral infection treatments. This naturally took some time and invariably shortened the commercial life of the patent. Consequently, Gilead applied for an EU ‘Supplementary Protection Certificate’ (SPC) to extend the life of the patent. Eventually, it got one for its HIV treatment product, ‘Truvada’.
However, the legality of the decision to grant the SPC is being challenged by several generics companies including ‘Teva’. They point out that there is no automatic right to an SPC. To qualify, Article 3(a) of the EU’s ‘SPC’ Regulation 469/2009/EC requires the product to be ‘protected’ by the patent. They say that requirement has not been satisfied. This is because Truvada combines ‘tenofovir disoproxil’ with ‘emtricitabine’ but the patent made no mention of emtricitabine. Therefore, no SPC should have been granted.
The judge is unsure what the word ‘protected’ means for the purposes of the EU Regulation. To start with, he does not know which rules to apply in order to work out the patent’s protective scope. On the one hand, there are European Patent rules in a body of law flowing from the European Patent Convention but that Convention is not a plank of EU law. On the other hand, there was a plan for EU patent law but this was never enacted into EU law – although it did make its way into English law and the laws of several other Member States. So which rules are applicable?
His next uncertainty arose from trying to understand the CJEU’s ‘SPC’ case law. Conceivably, even if a product fell within the scope of the patent using the law of the European Patent Convention, then it would still be possible for EU law to decide that a product was not ‘protected’ by the patent – so a company would still have no legal right to one of the EU’s SPCs. That seemed to be hinted at in the CJEU’s judgment in Case C-443/12 Actavis Group PTC ehf v Sanofi ELCI:EU:C:2013:833 but the judge had particular difficulty comprehending the CJEU’s reasoning.
Undeterred, the judge proposed a solution to the present case before him. The judge thought that if the patent mentioned ingredient A but not the combination of A plus ingredient B, then the inventive advance of the patent was ingredient A. If someone subsequently discovered that A+B was good to treat HIV, then a different patent could be obtained on that combination. Since it was the combination that would be the inventive advance of the latter patent, an SPC could be granted in respect of a product that used that combination. But that was not the case here.
According to a copy of his judgment published on the Bailii website, Mr Justice Arnold has asked:
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?
Update – 17 January 2017
Mr Justice Arnold has made another SPC preliminary reference to the CJEU. It too has yet to be given a number by the CJEU so it is parked here temporarily.
The question in this case is whether for the purposes of Article 3(d) of the EU’s ‘SPC’ Regulation 469/2009/EC, a company can be granted an SPC for a product that is but a new formulation of an old active ingredient.
A cancer treatment drug known as ‘nab-paclitaxel’ was protected by a European Patent. Abraxis applied for an SPC for its product ‘paclitaxel formulated as albumin bound nanoparticles’, a product which it also calls ‘nab-paclitaxel’.
Abraxis’ application was turned down by the UK’s Comptroller-General of Patents. The Comptroller-General decided that since the active ingredient in nab-paclitaxel was paclitaxel, that was not a new drug. Paclitaxel had already been made and sold in various trade marked drugs.
However, Abraxis challenged the correctness of his decision. It claims that nab-paclitaxel is not paclitaxel. Consequently, the earlier marketing authorisations given in respect of the older trade mark paclitaxel drugs are not relevant – what matters is that Abraxis possessed a marketing authorisation in respect of its nab-paclitaxel drug ‘Abraxane’, and that was a new and inventive formulation of the old ingredient, paclitaxel. Since Abraxane is the ‘first authorisation’ for the purposes of Article 3(d) of the EU’s ‘SPC’ Regulation 469/2009/EC, it should be granted an SPC.
According to the Bailii website, Mr Justice Arnold would like to know:
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?
The final wording of the Abraxis question would be discussed with the parties’ lawyers.