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CJEU – Royalty Pharma Collection Trust and Sandoz v. Searle / SPC

Posted: September 12th, 2019

Joined Cases C‑650/17 and C‑114/18, Royalty Pharma Collection Trust joined party Deutsches Patent- und Markenamt (Request for a preliminary ruling from the Bundespatentgericht (Germany)) and Sandoz Ltd, Hexal AG v. G.D. Searle LLC, Janssen Sciences Ireland (Request for a preliminary ruling from the Court of Appeal (England & Wales), Opinion of Advocate General Hogan, 11 September 2019

“In view of all the foregoing considerations, I consider that the Court should answer the questions referred by the Bundespatentgericht (Federal Patent Court, Germany) and the Court of Appeal (England & Wales) (Civil Division) as follows:

“The two-part test referred to in paragraph 57 of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585) and in the operative part of that judgment applies both to products consisting of a single active ingredient and products composed of several active ingredients;

“The concept of the ‘core inventive advance’ of the patent does not apply and is of no relevance in the context of Article 3(a) of Regulation No 469/2009;

“Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products does not preclude the grant of a supplementary protection certificate for an active ingredient which is covered by a functional definition or a Markush formula provided, however, that the two-part test set out in paragraph 57 of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585) and in the operative part of that judgment is satisfied;

“The two-part test referred to in paragraph 57 of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585) and in the operative part of that judgment must be applied from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent;

“The first part of the two-part test referred to in paragraph 57 of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585) and the operative part of that judgment is not satisfied and an SPC may not be granted in respect of a product if, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent, the claims in a patent in relation to that product are not required for the solution of the technical problem disclosed by a patent;

“The second part of the two-part test referred to in paragraph 57 of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585) and the operative part of that judgment requires that it be established that a person skilled in the art would have been able, in the light of all the information contained in a patent, on the basis of the prior art at the filing date or priority date of the patent in question, to derive the product in question. This is not the case where, in the light of all the information contained in a patent, a product or constituent element of the product remains unknown to a person skilled in the art on the basis of the prior art at the filing date or priority date of the patent in question.”

The entire opinion can be read here.

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