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CJEU DECLINES OPPORTUNITIES TO RELAX SPC REQUIREMENTS: NO SPC FOR GSK’s ADJUVANT AND A TOUGH LINE ON AZ’s EARLIER AUTHORISATION

02 December 2013

(1) In GlaxoSmithKline Biologicals (GSK) v Comptroller-General of Patents (Case C-210/13), the CJEU concluded that an adjuvant does not fall within the definition of an ‘active ingredient' and also that the combination of an active ingredient having therapeutic effects on its own and an adjuvant does not fall within the definition of a ‘combination of active ingredients', thus precluding the grant of an SPC under a patent that protects the adjuvant and combination of active ingredient and adjuvant.

GSK had two patents: the first protected an adjuvant known as AS03 and the second related to a vaccine comprising the combination of an antigen and AS03. GSK applied for an SPC directed to AS03 under the first patent, and an SPC directed to an influenza virus antigen from a strain associated with a pandemic outbreak in conjunction with AS03 under the second patent. Both SPCs were based on the same MA for a pre-pandemic influenza vaccine called Prepandrix®.

Article 1(b) of the SPC Regulation 469/2009 defines the ‘product' that is the subject of the SPC as ‘the active ingredient or combination of active ingredients of a medicinal product'. Article 1(b) has been interpreted narrowly in the past, notably in Massachusetts Institute of Technology (MIT; C-431/04) in which the CJEU decided that the concept of ‘combination of active ingredients of a medicinal product' did not include a combination of two substances, only one of which has therapeutic effects of its own for a specific indication, the other rendering possible a pharmaceutical form of the medicinal product which is necessary for the therapeutic efficacy of the first substance for that indication. GSK sought to distinguish MIT on the ground that the MIT case concerned only an excipient which had no physiological effect on the body, whereas AS03 did have physiological effects on the body and thereby enhanced the therapeutic effects of the antigen. On the other hand, the UK Comptroller-General considered that AS03 did not have a therapeutic effect of its own, and pointed out that adjuvants are listed as "excipients" in the EU legislation governing the grant of a MA. In its reasoned order, the CJEU essentially followed the Comptroller-General's arguments.

(2) In AstraZeneca (AZ) v Comptroller-General of Patents (case C-617/12), the CJEU concluded that a Swiss MA starts the clock for SPC term calculation even if the MA was suspended and subsequently reinstated.

Article 13 of the SPC Regulation sets the term of an SPC as a period equal to the time that elapsed between the date on which the basic patent was filed and the date of the first authorisation in the EEA to place the product on the market, reduced by a period of five years, provided that the duration of the SPC may not exceed five years. In July 2002 AZ submitted an application for a MA to SwissMedic for the medicinal product Iressa® which was granted in March 2004. By virtue of a customs union the Swiss MA was automatically recognised in Liechtenstein (which, unlike Switzerland, is an EEA member). The MA was suspended by SwissMedic in October 2005 with the result that from that date it was no longer possible to distribute Iressa® in Switzerland or Liechtenstein. In January 2003 AZ submitted an application for a MA for Iressa® to the EMA, but withdrew it in January 2005 because the EMA requested further supporting data. In May 2008, AZ resubmitted its application to the EMA supported by further studies and the Iressa® MA was granted in June 2009. In June 2008, AZ requested SwissMedic to lift its suspension of the Swiss MA having submitted further studies (i.e. those that were also present in the EMA submission), and the suspension was lifted in December 2010.

AZ contended that the EMA MA dated June 2009 should be considered the first MA for the purposes of Article 13 of the SPC Regulation on the grounds that the SwissMedic MA is valid only in respect of the customs union between Switzerland and Liechtenstein, and not the legal order of the EU. They also argued that the grant of the SwissMedic MA was based on clinical data that was deemed insufficient for the purposes of granting an EMA MA, and so should not be counted for that reason. On the other hand, the Comptroller-General considered that the SwissMedic MA dated March 2004 was the relevant authorisation for calculating the SPC term, and that this was clear from earlier CJEU decisions in Novartis and Others (C-207/03 and C-252/03). In essence, the CJEU agreed with the Comptroller-General's position and, in particular, noted that if AZ was correct it would have meant that they would have received >15 years of exclusivity in part of the EEA (i.e. Liechtenstein) in contravention of one of the main purposes of the SPC Regulation.

Reasoned orders

That the CJEU decided both cases by reasoned order (i.e. without hearing the parties) means that it considered that the answers to the questions referred for a preliminary ruling may be clearly deduced from existing case law. However, the fact that the cases were referred at all to the CJEU (by Mr Justice Arnold of the Patents Court of England and Wales) means that the referring court had doubts on the correct interpretation of the SPC Regulation. In the AZ case, Arnold J was persuaded to make a reference because some patent offices had agreed with AZ and granted SPCs with a five year term, whereas others, including the UK patent office, had granted SPCs with the shorter term.

Despite these unfavourable (to the applicants) decisions, it seems likely that applicants will continue to test the boundaries of the SPC Regulation in order to try to maximize the supplementary protection available for their products. Although it may not have helped GSK in their case, it is helpful for patent attorneys to be involved in the regulatory submission in order to achieve alignment between the active ingredient(s) and therapeutic indication(s) of the medicinal product and the claims of the patent. Our SPC & Regulatory team has a wealth of experience of contentious SPC matters, including involvement in four CJEU references, and SPC filing strategies, and will be pleased to discuss any SPC matters that you may have.

Further CJEU decisions due

The decisions in the Georgetown University (C-484/12), Actavis v Sanofi (C-443/12) and Human Genome Sciences v Eli Lilly (C-493/12) cases are due to be handed down by the CJEU on 12 December 2013. The first two cases relate to whether or not it is possible to get more than one SPC per patent, and the latter two cases reconsider the question of how to determine whether or not a ‘product' is protected by a patent. We shall inform you of the outcome of these fundamentally important cases in due course.

If you require further information about SPCs, please contact Michael Pears or John Miles of our SPC & Regulatory group.    

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