European Commission Opens Investigation into Teva over Suspected Abusive Patent Filings and Disparagement of Generic Competitors
On 4 March 2021, the European Commission (the Commission) announced having opened a formal investigation into Teva under Article 102 of the Treaty on the Functioning of the European Union over suspicion of abusive intellectual property strategies and unlawful denigration of generic products that compete with its multiple sclerosis medicine Copaxone®. Copaxone®, which contains the active substance glatiramer acetate, is Teva’s best selling medicinal product. Its basic patent expired in 2015.
The Commission will investigate whether, after the expiry of the Copaxone® patent, Teva abused a dominant market position by resorting to two practices aimed at artificially delaying generic entry. First, Teva is suspected of having repeatedly filed, and subsequently withdrawn, divisional patent applications covering matters from a previously filed patent application (the so-called parent application). In so doing, it allegedly hindered market entry by generic competitors as these competitors were forced to legally challenge each of Teva’s divisional patent applications.
Second, the Commission will examine allegations that Teva has run a communications campaign aimed at sowing doubt over the safety of generic glatiramer acetate products despite their approval by competent health authorities. According to the Commission’s press release, the disparaging communications were primarily meant to discourage healthcare professionals and hospitals from prescribing and using competing glatiramer acetate products.
While the Commission’s press release claims that “[t]his is the Commission's first formal investigation into potential abuses relating to the misuse of patent procedures […] in the pharmaceutical industry”, the Commission fined AstraZeneca as early as in 2005 for having misused the patent system with a view to delaying generic entry. At stake at the time was AstraZeneca’s strategy to obtain Supplementary Protection Certificates.
It will be interesting to see whether the Commission can establish that Teva holds a dominant position in the relevant market, particularly as its pay-for-delay decision against Servier was annulled on the question of dominance (see, Van Bael & Bellis Life Sciences News Alert of 27 December 2018). The commission clearly feels that it has a potential way forward in this case, perhaps due to the judgment of the Court of Justice of the European Union in Generics UK that some observers claim shifted the tide back in the Commission’s favour (see, Van Bael & Bellis Life Sciences News Alert of 3 February 2020).