Law No. 62/2011, of 12 December, subjected the resolution of industrial property rights disputes concerning reference drugs and generic drugs to necessary arbitration.
Under that scheme, the legislator intended to create a mechanism by which – in a short period of time – a decision on the merits could be obtained as to the infringement (or lack thereof) of industrial property rights in respect of such medicinal products, replacing the national courts in the assessment of these disputes.
The question of the jurisdiction of the arbitral tribunal to assess the validity or otherwise of a duly registered patent that grants rights incompatible with the marketing authorisation of the generic medicinal product has been raised.
Two opposing theories have emerged both in the courts and in legal writing, namely a limited one and a broader one. The subject was examined for the first time by the Supreme Court of Justice in its judgment of 14 December 2016, which decided to follow the more limited one, since allowing the incidental deduction of the peremptory plea of nullity of the patent would imply an undisputed dysfunctionality.
Without prejudice to the value of each of the opposing theses, it is understood (in line with the judgment referred to in point IV) that the one best suited to the aims and interests in question – according to the elements of interpretation of the law which must prevail (Art. 9 of the Civil Code) – will be the one that sustains the inadmissibility of the analysis by the arbitral tribunal of the validity of the patent in purely incidental terms, by way of exception, even if only inter partes effects.
The Supreme Court held that since there is unanimity in the sense of Art. 35(1) of the Industrial Property Code granting a reservation of exclusive substantive competence to the Court of Intellectual Property in relation to the declaration of nullity or of annulment of the patent, with erga omnes effectiveness, the best solution will be to deny jurisdiction of the necessary arbitral tribunal to judge on such validity or invalidity, even if it is invoked as a mere peremptory exception and with limited effects on the file.
Notwithstanding the value of the reasoning of the Judgement by the Constitutional Court of 24 May 2017 (until now the only judgement issued on the matter) – which concluded that the interpretation that prevented the incidental analysis of the validity of the patent by the necessary arbitral tribunal was unconstitutional – we consider the advocated solution as it derives from the explicit reasoning of the Supreme Court of Justice’s decision mentioned in point IV which we follow, does not disproportionately restrict the right of defence of the holder of the marketing authorisation. This is because the possibility of lodging a claim for declaration of nullity or annulment is an effective alternative to guarantee the defence of the applicant for a marketing authorisation.
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Official summary/headnotes. Translated by Nuno Sousa e Silva.
Editor’s note: In this translation, inaccuracies in the numbering of articles and laws in the original manuscript have been corrected.
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AA UK Limited and AA Unipessoal Lda v. BB Farmacêutica Lda Civil Code (CC), Art. 9; Industrial Property Code (CPI), Art. 35 No. 1; Industrial Property Rights Dispute Settlement System (Law No. 62/2011, from 12/2012); Directive 2001/29/EC, Art. 4. “Unipessoal”. IIC 50, 1144–1153 (2019). https://doi.org/10.1007/s40319-019-00878-x
- Arbitral tribunal
- Generic drugs
- Marketing authorisation
- Patent nullity exception
- Incidental competence