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23 February 2015
The IP Court has granted a supplementary protection certificate (SPC) for a second medical use, despite the existence of a previous SPC for the same product and the same basic patent, and contradicting the practice of the Portuguese Patent Office.(1)
Boehringer applied for SPC 511 in reference to the medicine Pradaxa (dabigatran etexilate in the form of a mesylate) and in respect of basic patent EP1485094 to protect the medical use of dabigatran etexilate for the prevention of cerebrovascular accidents and systemic embolism in adult patients with non-valvular atrial fibrillation.
The Patent Office refused SPC 511, holding that it did not comply with Article 3(d) of the EU SPC Regulation (469/2009). It ruled that SPC 511 was not associated with the first marketing authorisation for the same product, since an SPC based on the same patent and active ingredient had already been applied for (SPC 490).
Boehringer appealed the Patent Office decision, claiming that SPC 490 applied to use of the active ingredient dabigatran etexilate (as mesylate) for primary prevention of venous thromboembolic events in adults who have undergone hip or knee replacement operations, while SPC 511 was intended to protect the use of the same active ingredient for the prevention of cerebrovascular accidents and systemic embolism in adult patients with non-valvular atrial fibrillation. Consequently, Boehringer contended that since the therapeutic use was different, it could not be said that there was more than one SPC for the same basic patent.
The IP Court allowed Boehringer's appeal and revoked the Patent Office's refusal decision. The IP Court cited European Court of Justice (ECJ) jurisprudence, particularly Case 130/2011, which held:
"like a patent protecting a 'product' or a patent protecting a process by which a 'product' is obtained, a patent protecting a new application of a new or known product, such as that at issue in the main proceedings, may, in accordance with Article 2 of the SPC Regulation, enable an SPC to be granted and, in that case, in accordance with Article 5 of the regulation, the SPC confers the same rights as conferred by the basic patent as regards the new use of that product."
Considering ECJ case law, the IP Court held that since the new therapeutic use of the drug Pradaxa – for the prevention of cerebrovascular accidents and systemic embolism in adult patients with non-valvular atrial fibrillation – was attached to the active ingredient protected by the basic patent of SPC 511, this therapeutic use was covered by no previous marketing authorisation and, therefore, SPC 511 must be granted.
The decision illustrates the harmonisation of Portuguese jurisprudence with ECJ jurisprudence on SPCs. It serves as an important precedent for the Patent Office to change its practice relating to SPCs for second medical uses.
For further information on this topic please contact Paulo Monteverde at Baptista Monteverde & Associados by telephone (+351 213 806 530), fax (+351 213 806 531) or email (firstname.lastname@example.org). The Baptista Monteverde & Associados website can be accessed at www.bma.com.pt.
(1) Boehringer Ingelheim Pharma GmbH & Co KG v Instituto Nacional da Propriedade Industrial (Case File 300/13.0HYLSB).
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