European Commission Sends Statement of Objections to Teva over Abusive Patent Filings and Disparagement of Generic Competitors
On 10 October 2022, the European Commission (the Commission) announced that it had sent a Statement of Objections to Teva, a pharmaceutical company marketing Copaxone®, a medicine indicated for the treatment of specific forms of multiple sclerosis. The Statement of Objections comes over a year and a half after the Commission opened a formal investigation into Teva’s practices (see, Van Bael & Bellis Life Sciences News Alert of 5 March 2021).
The Commission takes the preliminary view that Teva has been engaging in conduct contrary to Article 102 of the Treaty on the Functioning of the European Union (TFEU). First, Teva is accused of artificially extending the basic patent protection for the active substance in Copaxone®, glatiramer acetate, through the filing and subsequent withdrawal of divisional patent applications, which derive from an earlier patent application in that they claim similar subject matter. The practice of repeatedly filing and withdrawing divisional patent applications is referred to as “divisional games”. Second, Teva allegedly also implemented a systematic disparagement campaign casting doubts over the safety, efficacy, and therapeutic equivalence of generic glatiramer acetate medicine. In sum, the Commission is concerned that the two types of conduct had the overall objective of artificially prolonging the exclusivity of Copaxone®, hindering the market entry and uptake of competing products.
The case against Teva showcases the Commission’s interest in remedying perceived competitive deficiencies caused by otherwise lawful and legitimate uses of the patent system. Additionally, it ties into the growing trend (discernible at both EU and national levels) of pursuing parties in an allegedly dominant position over disparaging marketing tactics (see, Van Bael & Bellis Life Sciences News Alert of 20 June 2022). More fundamentally, the case serves as a reminder of the open-endedness of what can constitute abusive conduct within the meaning of Article 102 TFEU.