In Between Breakthrough and Incremental Innovation : Rethinking pharmaceuticals’ Eligibility for IP Protection

Patents as an Incentive for Innovation / ed. Żaneta Pacud, Rafał Sikorski. Alphen aan den Rijn : Kluwer Law International B. V., 2021, s. 31-59.

Przesłanki zdolności ochronnej dalszych zastosowań medycznych z tytułu SPC : wyrok Trybunału Sprawiedliwości z dnia 9 lipca 2020 r. w sprawie C-673/18 Santen

Gdańskie Studia Prawnicze 2021, nr 1 (49), s. 154-166.

Wyrok TSUE w sprawie C-673/18 Santen przesądził kwestię udzielania dodatkowych świadectw ochronnych na dalsze zastosowania medyczne znanych substancji czynnych. Wcześniejsze orzeczenia trybunału w tym zakresie nie były jednolite i nie określały jasno, pod jakimi warunkami substancje opatentowane i autoryzowane do kolejnych zastosowań medycznych mogą być przedmiotem SPC. W glosowanym wyroku trybunał uznał, że jedynie nowe substancje czynne, niestosowane wcześniej jako produkty lecznicze, mogą być chronione SPC. Zgodnie z opinią trybunału, dodatkowe świadectwa ochronne zostały wprowadzone do porządku prawnego UE w celu stymulowania prac badawczo-rozwojowych nad nowymi lekami, stanowiącymi innowacje o charakterze pierwszorzędnym, przełomowym. Rozstrzygnięcie trybunału zostało w glosie pozytywnie skomentowane.

The CJEU judgment in case C-673/18 Santen resolved the problem of granting Supplementary Protection Certificates (SPCs) for further medical uses of known active substances. The earlier case-law of the Court was not uniform in this regard and did not specify enough under which conditions patented substances and substances authorized for further medical use could be subject to SPCs. In the discussed judgment, the Court found that only new active substances, not previously used as medicinal products, could be protected by SPCs. According to the Court’s opinion, SPCs were introduced into the EU legal order to stimulate research and development of new medicines, which are first-class breakthrough innovations. The author approves the Court’s decision in her commentary.

The CJEU abolishes Neurim and SPCs for new therapeutic indications

Journal of Intellectual Property Law & Practice 2021, t. 16, nr 2, s. 94-97.

Judgment of the Court of Justice of the European Union (Grand Chamber) in Case C-673/18 Santen SAS v. Directeur général de l’Institut national de la propriété industrielle, 9 July 2020. In Santen v INPI, the Grand Chamber of the Court of Justice of the European Union ruled that supplementary protection certificates must not be granted for further therapeutical indications of known medicines, adjudicating that the SPC system is aimed at promoting new active substances. Supplementary protection certificates (SPC), governed by Regulation 469/2009 (Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products OJ L 152, 16.6.2009; SPC Regulation), are legal instruments extending patent protection for innovative medicinal products. Any medicinal product in the EU needs a marketing authorization (MA), which is based on lengthy tests and trials carried out during the period of patent protection and thus consuming several years of it. The period of the so-called effective patent protection, starting at the moment of obtaining a MA for the final product, is deemed too short to cover the investment put into the research at hand and to incentivize further pharmaceutical innovation in the EU. Thus, the general function of an SPC is to enable the holder of a patent for a medicinal product to enjoy a maximum 15 years of overall basic and supplementary patent exclusivity, counting from the day of obtaining the relevant MA. Certificates are granted for a period not exceeding five years, and the protection granted is strictly confined to the product which obtained authorization.

Redakcja:

Patents as an Incentive for Innovation

Współredaktorstwo: Sikorski, Rafał

Alphen aan den Rijn : Kluwer Law International B. V., 2021