Source: https://pharmaintelligence.informa.com/resources/product-content/cjeu-ruling-could-prove-problematic-for-gileads-truvada-spc
Timestamp: 2019-04-26 10:40:23+00:00

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The Court of Justice of the EU has ruled that a supplementary protection certificate (SPC) can be granted to a medicinal product comprising more than one active ingredient only if each of those ingredients is “specifically identifiable” in the basic patent on which the SPC is based.
The ruling is significant in that it revolves around a UK SPC awarded to Gilead Sciences for its HIV combination product, Truvada, which contains tenofovir disoproxil (TD) plus emtricitabine (case C-121/17). The validity of the SPC was challenged in the English High Court by Teva and other generics firms on the grounds that the basic patent on which the SPC was granted does not specify the combination of ingredients in Truvada, only the TD element.
The CJEU ruling is on a specific point of EU law, and does not say whether or not the Truvada SPC should not have been granted – this is a matter that the High Court will have to decide.
Teva et al claimed the SPC did not meet the condition laid down in Article 3(a), which requires the product to “be specified in the wording of the claims.” They said the wording does not specify emtricitabine, and that the expression “other therapeutic ingredients” does not specify any active ingredient, whether structurally or functionally, so the TD/emtricitabine combination “cannot therefore be considered to be protected by a basic patent in force,” the CJEU noted.
By contrast, Gilead contends that the expression “other therapeutic ingredients” relates “implicitly but necessarily to emtricitabine” and so satisfies Article 3(a).
The High Court noted that despite several earlier judgments having been delivered by the CJEU on the interpretation of Article 3(a), the meaning of the provision was still unclear, and divergent decisions had been taken by different EU member states on the issue.
The ruling is broadly in line with the opinion of Advocate-General Melchior Wathelet, which was handed down in May. The matter now goes back to the English court for a decision as to whether the Truvada SPC meets the Article 3(a) criteria.
The CJEU, does however, appear to “venture a step farther in its decision than merely proposing a framework for the construction of Article 3(a), as it seems to suggest in paragraph 56 that Gilead’s Truvada SPC does not fulfil the criteria laid out by the CJEU in its decision,” law firm Kromann Reumert points out.
“It will be interesting to follow the developments with the national courts,” Kreumann Ruemert says.
Snodin said it was “likely (though perhaps not certain) that the new Article 3(a) test established by the CJEU will resolve the dispute relating to the validity of the SPC to the combination of tenofovir disoproxil and emtricitabine."
It also raises other questions such as whether the new test relates only to combination products, and what “specifically identifiable” means – for example, the precise form of the active ingredient(s) in the product or a more generic description of the relevant active ingredients.
Future CJEU judgements likely to come in the next 12 months “could well provide answers to at least some of the unresolved questions outlined above,” he continues.

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