The team is joined by Guest Kats Rosie Burbidge, Stephen Jones, Mathilde Pavis, and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Hayleigh Bosher, Tian Lu and Cecilia Sbrolli.

Thursday, 7 December 2017

BREAKING: CJEU holds that SPCs cannot be obtained on the basis of an "end of procedure notice" pursuant to Article 3(b) SPC Regulation

The AmeriKat's new tattoo 
Back in July last year right, at the end of the Court's Trinity Term, Mr Justice Arnold referred two questions to the CJEU on the SPC Regulation in Merck Sharp & Dohme v Comptroller-General of Patents [2016] EWHC 1896.   Today, the Court of Justice of the European Union responded to Arnold J's questions in Case C-567/16 holding that an end of procedure notice does not amount to a granted marketing authorization for purposes of Article 3(b).  The AmeriKat summarized the background of the dispute, parties' arguments and referred questions in this post - but for ease she repeats the background for readers below.

The problem and the questions to be referred

What do you do if your patent is about to expire, but despite notice that Member States (MSs) have agreed to grant your marketing authorization (MA) under the decentralized procedure, a MS has not yet taken the step to actually grant it? You still make your SPC application, of course.

What happens after that was subject to a reference to the CJEU (form of questions below).

The SPC Regulation

Nothing makes the AmeriKat happier than SPC law (as far as "legal happiness" goes). For those who have better things to do with their time than to understand the wonderful world of SPCs or to follow the myriad of national and CJEU decisions in this area, the key points are as follows:
  • By law, before a medicinal product can be placed on the market, it requires a MA. Getting a medicinal product to this point cant take upwards to 15 years.
  • By the time a MA for a medicinal product is granted, much of the term of the patent that protects the product will have expired. This means that the effective protection under the patent is insufficient to cover the investment in R&D (see Article 4 of the SPC Regulation).
  • For this reason, a new right - the Supplementary Protection Certificate (SPC) - was introduced by the SPC Regulation in order to address that problem.
  • SPCs provide an additional period of protection - up to a maximum of 5 years - for a product (i) subject to a valid MA at the date of the application (Article 3(b)) and protected by a patent (basic patent) in force at the date of the application (Article 3(a)).
  • National courts and the CJEU have spent many years wrangling with the interpretation and application of the SPC Regulation. 
Oh, why did the SPC Regulation have to
be that clear?  
What's the product?

Atozet is the medicinal product which contains the active ingredients of ezetimibe and atorvastatin. It is used to lower cholesterol. Claim 17 of EP(UK) 0 720 599 (the basic patent) protects a pharmaceutical composition comprising ezetimible and atorvastatin (this was not in dispute). MSD applied for a SPC for the "product" on the basis of this patent for:
"ezetimibe and atorvastatin or pharmaceutically acceptable salts thereof, including atorvastatin as atorvastatin calcium trihydrate". 
The problem was that at the time of the SPC application, there was no granted MA in the UK.

The Facts

MSD obtained a MA and SPC for the mono product - ezetimibe - in 2003. It then obtained a MA and SPC for a combination of ezetimibe and simvastin - in 2004 and 2006, respectively (Merpel was struck by the relevance of this in the decision given that Article 3(c) objections were not in dispute, save for in the Dutch court).

In September 2006, MSD began development of the fixed dose combo of ezetimibe and atorvastatin. However, it encountered formulation difficulties. Seven years later, in September 2013, MSD filed MAs for Atozet in a number of Member States using the decentralized procedure (DCP) of obtaining a MA. MSD designated Germany as the reference Member State (RMS). As the RMS, the German medicines regulatory authority - Bundesinstitut für Arzneimittel und Medizinprodukte - coordinated the approval process, preparing the draft documents and, most importantly, the draft summary of product characteristics (SmPC) on which the other Member States comment. All Member States' respective regulatory bodies need to be happy with the documents before the procedure is closed. Thereafter, once agreement is reached, each Member State has 30 days to grant the MA.

The German medicines authority did not accept that MSD had filed a valid application until 13 February 2014. On 12 September that year - a single day before the patent expired (remember the basic patent has to be in force under Article 3(a)) - MSD applied for its UK SPC at the UK Intellectual Property Office (IPO). However, MSD did not have a granted UK MA. Instead, MSD submitted, with their SPC application, a copy of the end of procedure (EoP) notice from the German medicines agency stating that the DCP had ended with approval. MSD explained that the effect of the EoP notice was that concerned Member States, including the UK, had agreed to grant a MA for Atozet. MSD therefore asked the UK IPO for permission to supplement their application when their UK MA was granted.

Five days later, the UK IPO's examiner said MSD's application did not comply with Article 3(b) because at the time of filing their SPC application, they did not have a valid UK MA. The EoP notice did not satisfy that requirement. The IPO also objected to the application on Article 3(c) grounds. Three weeks later, the UK MHRA granted the MA on 10 October 2014. MSD submitted a copy of the UK MA, together with the first EU MA (from France) and asserted that these documents would rectify any irregularities in the application. The examiner maintained her objections, leading to a hearing in which the hearing officer agreed that Article 3(c) was satisfied but the SPC application fell foul of Article 3(b) which could not be cured under Article 10(3).

The path to a granted SPC under the DCP
The Questions and the Answers

The final form of the questions referred to the Court and the CJEU's answers are set out below:
1. Is an end of procedure notice issued by the reference Member State under Article 28(4) of Directive [2001/83] before expiry of the basic patent to be treated as equivalent to a granted marketing authorisation for the purpose of Article 3(b) of [the SPC Regulation], such that an applicant for [an SPC] in the Member State in question is entitled to apply for and be granted [an SPC] on the basis of the end of procedure notice?  
No - an end of procedure notice issued by a reference Member State in accordance with the DCP is not to be treated as equivalent to an MA.  The natural reading of the word "granted" in Article 3(b) is that the action has to have been completed.  The grant of an SPC is linked to the grant of a MA so an SPC can only be granted if an MA has been granted.  After setting out the specific procedure of the DCP, the CJEU turned to the crux of the issue.  It stated that the adoption of an end of procedure notice under Article 28(4) of Directive 2001/83 represents an intermediate stage in the DCP.  The notice does not have the same legal effect as a "valid" MA.  Although the notice has features of an MA (guaranteeing safety, identifying the product, etc), it importantly does not not permit an applicant to place on the market the medicinal product - an MA does.  This is the "essential feature " of a MA.   
The Court cited Forsgren (C-631/13) on the basis that that Court stated that a patented product may not give rise to the grant of an SPC unless the medicinal product has been granted a MA.  
2. If the answer to question 1 is no: in the circumstances in question, is the absence of a granted marketing authorisation in the Member State in question at the date of the application for [an SPC] in that Member State an irregularity that can be cured under Article 10(3) of [the SPC Regulation] once the marketing authorisation has been granted?
No.  Article 3(b) states an SPC is to be granted "if...a valid authorization to place the product on the market as a medicinal product has been granted".  There needs to be a granted MA in the Member State concerned.  If this condition is not met, then the SPC should be rejected by the relevant MS's authority.  Article 10(3) only relates to irregularities relating to the application for the SPC.  An absence of an MA does not constitute an irregularity of the application - it is "an irregularity in connection with the product, as a medicinal product, not an irregularity in connection with the SPC application."  Essentially Article 10(3) is for curing defects relating to paperwork, not defects relating to the conditions of grant.   
On the strict literal wording of the SPC Regulation, the AmeriKat can understand the reasoning of the Court.  But why should an applicant be penalized because (i) it takes longer to prove the safety and efficacy of a formulated medicinal product and (ii) a national medicines agency's speed may slow the DCP leading to a granted MA? Isn't this time loss exactly why we have an SPC Regulation?  This may be a hangry rant, but the AmeriKat is left searching for the justice of a telelogical approach amongst the black and white interpretation of the drafting of the SPC Regulation in this decision.  Merpel also finds irony in that, seemingly for once, the SPC Regulation is too clear.

5 comments:

Anonymous said...

A marketing authorisation is a marketing authorisation. There are no shades of grey about it. If you sell a product with just an end of procedure notice you're in breach of the law.

If the applicant wanted an SPC so badly they should have submitted their marketing authorisation application sooner. According to the Orange Book the (now withdrawn) US product received approval on 3 May 2013.

Mr Blobby-Obvious said...

When are lawyers going to put the law before their business development activities?

Yes, the law is clear in this case, unfortunately for the wealthy Merck, and more unfortunately for the greedy lawyers.

Proof of the pudding said...

Are you suggesting that the CJEU adopts a (politically) "selective" approach to the (non-)application of teleological principles for interpreting legislation? Perish the thought!

Pseudonymous said...

teleological approach only applies when the text is not clear. EU law 101.

Proof of the pudding said...

@Pseudonymous

Really? You might want to tell the CJEU about this. They clearly did not get that message in decisions such as C-482/07.

Subscribe to the IPKat's posts by email here

Just pop your email address into the box and click 'Subscribe':