INNsight articles by Duncan Curley, April 09

Supplementary Protection Certificates (SPCs) are intended to provide an extension to the life of a basic patent for a medicinal product.  The rationale behind Council Regulation (EEC) No. 1768/92 (‘the SPC Regulation’) is to compensate a patentee for ‘patent term erosion’ for medicinal products, i.e. the lost period of exclusivity that a patentee would have had, if the regulatory approval process had not held up the marketing authorisation for the product in question.  The European requirements for safety and efficacy testing of drug products were sought to be harmonised in 1965 (in Council Directive 65/65/EEC) and the relevant regulations have since been updated.  Some Member States introduced the regulatory requirements contained in Council Directive 65/65 progressively, over time.  For example, Germany did not implement all of the measures in Council Directive 65/65 until the late 1970s.    

A recent UK case has concerned the SPC on the API memantine.  The relevant drug product - Akatinol - was developed by Merz Pharma GmbH & Co. KgaA (‘Merz’) in the late 1960s/early 1970s and authorised and placed on the market in Germany long before the SPC Regulation came into force in the European Community (on 2 January 1993).  In Germany, products that were already on the market on 1 January 1978 were automatically granted a continuing authorisation to remain on the market, subject only to notifying the relevant authority.  Akatinol was treated as having gone through the authorisation procedures required by Council Directive 65/65/EEC, even though it had not.  Later, on 19 September 1983, the Luxembourg Ministry of Health granted a further authorisation to place Akatinol on the market in Luxembourg.  The Luxembourg Ministry of Health simply relied upon the authorisation to place the product on the market in Germany, in accordance with its Law of 11 April 1983 regulating the introduction on to the market of pharmaceutical products (which complied with Directive 65/65/EEC). 

Finally, in 2002, Merz obtained community authorisations for the drug product EBIXA®, which also contains as the API memantine.  EBIXA® is now used to treat moderate to severe Alzheimer’s disease.  According to NICE in the UK (in a technology appraisal guidance note issued in November 2006 and amended in September 2007), the recommended maintenance dosage of EBIXA® is 10 mg twice daily and prices were £69.01 for 56 tablets of 10 mg, equating to £899.59 per year for treatment (in September 2005).      

Given that memantine is such an old API, it is perhaps not surprising that the IP protection around EBIXA® has been the target of litigation from the generic sector.  The original Lilly patent on memantine was filed in the 1960s and so it has long since expired.  However, Merz applied for and was granted a ‘second medical use’ patent for memantine, European Patent (UK) No. 0,392,059 B1 entitled “The use of adamantine derivatives in the prevention and treatment of cerebral ischemia”.  The SPC Regulation allows for any patent to be designated as the ‘basic patent’ in an application for a SPC.  It has been the UK Intellectual Property Office’s policy to allow second medical use patents to qualify as ‘basic patents’, pursuant to Article 1(c) of the SPC Regulation, which defines a ‘basic patent’ as meaning a patent which protects an active ingredient as such, a process to obtain such an active ingredient or an application of an active ingredient.  So, although the ‘059 patent expired on 13 April 2009, Merz applied for and obtained a SPC in the UK, no. SPC/GB02/046, based on the ‘059 patent and their 2002 authorisation for EBIXA®, for “Memantine and its pharmaceutically acceptable salts”.  The UK SPC will not expire until 14 April 2014.     

Synthon decided to attack the validity of Merz’s UK SPC, arguing that it is either invalid and should not have been granted or that its term should be zero years.  The hearing took place on 3rd March 2009 before Floyd, J.  Synthon argued that the SPC Regulation only applies to drug products that have had to undergo the full administrative authorisation procedures laid down in Directive 65/65/EEC.  They maintained that any product that has been placed on the market without having undergone that procedure is outside the scope of the SPC Regulation.  This was in fact the conclusion of the Bundespatentgericht in a previous case concerning the SPC for the same product in Germany (which decision is presently under appeal). 

Synthon argued that the European Court of Justice has already stated (in the Hässle case) that the purpose of Article 19 of the SPC Regulation is to prevent the grant of SPCs for old products that were first marketed in the Community a long time ago.  Article 19 is a transitional provision, negotiated on a country by country basis, that cuts out of the SPC scheme certain older drugs that were already authorised in the European Member States when the SPC Regulation came into force.  The ‘cut off’ date for Germany in Article 19 was 1 January 1988.  In the famous Hässle case, the German SPC that had been granted for omeprazole was revoked when it became apparent that the drug was too old to qualify for an SPC in Germany.  Synthon also relied on the Novartis case, in which a marketing authorisation issued in Switzerland was deemed to be a relevant marketing authorisation for the purposes of calculating the duration of a SPC.  Synthon argued that the Novartis case demonstrates that a marketing authorisation does not have to be a Directive 65/65/EEC ‘compliant’ authorisation in order to set the clock running in calculating the duration of a SPC (as specified in Article 13 of the SPC Regulation). 

Merz argued that it had to go through a Directive 65/65/EEC compliant authorisation procedure in order to get their central (2002) authorisation for EBIXA®.  Merz claim that they are deserving of a SPC, because they have carried out the clinical trials necessary to get an authorisation for the Alzheimer’s indication for the drug and their application for a SPC ‘ticked all the boxes’, in terms of the formal requirements in Article 3 of the SPC Regulation. 

The Judge in the UK came to the conclusion that he needed to refer questions on the legal interpretation of the SPC Regulation to the European Court of Justice for clarification of the position.  One of the questions posed by the Judge in his judgment dated 2nd April 2009 was as follows:

“Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in Council Directive 65/65/EEC within the scope of Council Regulation (EEC) No. 1768/92 [as defined in Article 2]?”

Other questions of interpretation of the SPC Regulation were also referred to the European Court of Justice.  Synthon initially opposed the idea of a reference, because they wanted an immediate decision from the Court that would presumably have given them a commercial ‘first to market’ advantage.  Decisions from the European Court of Justice can typically take 2-3 years (unless the decision is expedited) and although the Judge noted in his judgment that a reference would harm Synthon (commercially), he felt that his hands were tied.