European Commission issues statement of objections in abusive patent filing case

 

European Commission issues statement of objections in abusive patent filing case

The European Commission has sent a statement of objections to Teva alleging that it has abused its dominant position contrary to Article 102 TFEU through conduct that is intended to block or delay competition with its multiple sclerosis drug, Copaxone.

The Commission has made a provisional finding that Teva engaged in abusive practices in the markets for glatiramer acetate which is the active ingredient in Copaxone, in Belgium, Czechia, Germany, Italy, the Netherlands, Poland and Spain.

Teva's basic patent for glatiramer acetate expired in 2015.  The Commission contends that Teva has artificially extended patent protection for Copaxone by strategically filing and withdrawing secondary patent applications (for divisional patents).  According to the Commission this caused competitors to have to bring new legal challenges which delayed their market entry with an alternative.

The exclusionary effect of (patent) filing strategies on competition between incumbents and new entrants was examined in detail by the Commission as early as 2008 in its Pharmaceutical Sector Inquiry.  It is not surprising that owners of patents develop commercial strategies that are aimed at and have the effect of extending the breadth and duration of their IPR protection which affects the ability of new entrants to enter and expand on the market. The question is whether this is abusive.

A dominant company may not use regulatory procedures in such a way as to prevent or make more difficult entry of competition in a market, unless it can as an undertaking engaged in competition on the merits, rely on grounds relating to the defence of legitimate interests or objective justification.

The case has some parallels with the Commission’s finding that AstraZeneca infringed Article 102 TFEU through two practices: (1) making misleading representations before the national patent offices and before the national courts in order to obtain supplementary protection certificates for its Losec drug (which extend patent protection); and (2) filing requests for deregistration of marketing authorisations combined with the withdrawal from the market of Losec capsules with the intent of blocking the entry of generic products or preventing parallel trading. C-457/10 P AstraZeneca v Commission, ECLI:EU:C:2012:770

The Teva case represents an uptick in the Commission’s enforcement strategy against abusive conduct in the context regulatory procedures in the pharma sector.

https://ec.europa.eu/commission/presscorner/detail/en/ip_22_6062