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Friday 10 July 2009

Generics (UK) Ltd v Synaptech Inc - on what first authorisation means

In the relatively recent decision of Generics (UK) Ltd v Synaptech Inc [2009] EWHC 659 (Ch), 20 May 2009, the England and Wales High Court has held that the term "the first authorisation to place the product on the market" should be interpreted wherever it occurs in the European supplementary protection certificate (SPC) Regulation as referring to the first authorisation compliant with Directive 65/65/EEC. This meant that the Intellectual Property Office had correctly granted an SPC with a term calculated on the basis of a first Directive 65/65/EEC authorisation in 2000, rather than earlier non-compliant authorisations.

In the case in question, Synaptech Inc. obtained European patent EP (UK) 0236684 which protected galantamine or analogues thereof for treating Alzheimer's disease. The patent expired on 16th January 2007. Galantamine has been on sale in Europe as a medicine for more than 40 years. There was a marketing authorisation for it as a treatment for polio in the 1960s under the trade mark "Nivalin" in Austria prior to its accession to the EEA. Nivalin went on to be authorised in West Germany in 1978.

Synaptech obtained an SPC (SPC/GB00/033) which is due to expire on 15th January 2012. They argued that the first authorisation was a Swedish authorisation granted in 2000 in accordance with Directive 65/65.

Generics (UK) Limited contended that the SPC ought to have expired, at the latest, on 31st December 2008 because previous marketing authoriations in Germany and Austria.

In his decision, Roger Wyand QC, sitting as a Deputy High Court Judge, reviewed the case law around the calculation of SPC terms, including the ECJ decision in Hässle AB v Ratiopharm GmbH, Case C-127/00 and Novartis v Comptroller-General Case, C-207/03. In the Hässle case, the ECJ held that the expression "first authorisation to place [a product] on the market as a medicinal product in the Community" in Article 19(1) of the SPC Regulation referred solely to the first authorisation required under the EC provisions on the authorisation of medicinal products, and suggested that the words had the same meaning wherever they appeared in the Regulation. Even though the court in Hässle was considering a different argument, Roger Wyand held that the wording of the judgment was clear and binding. He also held that he Novartis case was not directly relevant here, because the Swiss authorisation in that case was treated as Directive 65/65/EEC compliant under the 1992 EEA Agreement.


Anonymous said...

In view of the regulation's wording of Art. 2 ("prior to being placed in the market as a medicinal product"), the fact that a new indication does not render the product novel, and the German authorization of 1978, it seems that galatamine should not have been subject of any certificate. However, Art. 2 does not constitute a reason for invalidity under Art. 15, so, I wonder how this should be handled by national courts. Any comments by anybody?

Anonymous said...

This seems to cover the same issue as in the Synthon vs. Merck case reported earlier http://thespcblog.blogspot.com/2009/04/breaking-news-synthon-v-merz-ruling.html.
Rather interesting to see one UK judge calling the matter clear in view of ECJ C-127/00, and the other UK judge not clear at all and referring it to the ECJ.

Anonymous said...

Re: "the fact that a new indication does not render the product novel"

I don't see the relevance of this statement. Novelty of the product, i.e. active substance, is not a requirement for an SPC. The second indication patented might be the first indication authorised (in particular in accordance with Dir. 65/65). This is rare but not impossible.

Anonymous said...

Re: "I don't see the relevance of this statement."

I would have thought that this is more than clear: Since the different indication does not render "the product" novel, the product that was finally authorized under 65/65 and the one of the early West German authorization are the same. Hence, the authorization under 65/65 was filed after (not "prior to") the product was placed on the market and the regulation was not applicable (or, at least, should not have been applied).