On March 4, 2021, the Commission launched a formal in-depth investigation into Teva’s patent filings conduct related to its blockbuster multiple sclerosis medicine, Copaxone.[1] This is reportedly the first time that the Commission investigates potential abuses relating to divisional patents filing strategies.[2] This announcement, together with the recent formation, on March 16, 2021, of a multilateral working group on pharmaceutical mergers with leading competition authorities, confirms the Commission’s continued interest in the pharmaceutical sector.[3]


The Commission’s investigation aims to determine whether Teva’s conduct relating to its best-selling Copaxone amounts to an abuse of a dominant position under Article 102 TFEU. In 2015, Teva’s patent covering glatiramer acetate—the active ingredient used in Copaxone—expired, allowing generic versions of the medicine to enter the market. Many market players then accused Teva of misuses of patent procedures and exclusionary denigration to illegally block or delay the market entry of competitors’ generic products. This led to several dawn raids at the premises of Teva’s subsidiaries in the EEA in October 2019.

Abusive use of divisional patents

The Commission is investigating whether Teva may have artificially extended Copaxone’s dominance by filing and withdrawing divisional patent applications, thereby forcing its competitors to file a new legal challenge each time. While divisional patents are commonly accepted by patent offices, the Commission noted that a repetitive filing of divisional patents could be a way for a patentee “to multiply the patent barriers that a generic competitor needs to overcome to enter the market.”[4]

A 2009 report on European pharmaceutical practices already warned that divisional applications “may in certain cases only be aimed at excluding competition.”[5] But the Commission has so far not sanctioned these practices as abusive.

In June 2005, the Commission fined AstraZeneca €60 million for misusing the patent system to block market entry for generic competitors,[6] by providing misleading information to several national patent offices to obtain supplementary protection certificates, and selectively deregistering market authorizations. Teva’s probe seems to go further than the AstraZeneca case, as it does not involve any allegations of misleading representations and thus focuses on conduct which is prima facie legitimate under intellectual property rules.

The Commission investigation follows similar cases in Italy and the United States. On January 11, 2012, the Italian Competition Authority fined Pfizer for exploiting the patent system by using divisional patents as part of a strategy to delay the launch of generic drugs competing with its Xalatan medicine (the decision was upheld in 2014 by the Consiglio di Stato). In the United States, the U.S. Court of Appeals for the Federal Circuit rejected Ritz Camera & Image’s claim that SanDisk had violated antitrust law by filing divisional patent applications, due to lack of sufficient evidence.[7]


The Commission is also examining whether Teva conducted a disparaging communication campaign to hinder the use of rival generic medicines. While national authorities have already tackled similar conduct,[8] this is the Commission’s first formal investigation into exclusionary disparagement. In F. Hoffmann-La Roche, the Court of Justice held that the coordinated dissemination of misleading safety claims about a medicine’s off-label use, in a context of scientific uncertainty, qualifies as a by-object restriction of competition.[9]

Although this probe relates to an alleged abuse of dominance, and not an anticompetitive agreement, the Commission can be expected to rely on the Court of Justice’s reasoning in F. Hoffmann-La Roche, especially because the disparagement was carried out “even following the approval of these medicines by competent public health authorities.”[10]

Creation of cross-Atlantic pharmaceutical mergers working group

On March 16, 2021, the FTC initiated a multilateral working group for several agencies to update and align their approach to pharmaceutical mergers.[11] This working group will also include the European Commission, the Canadian Competition Bureau, the U.K. CMA, the U.S. DOJ, and three U.S. Offices of Attorneys General. It will notably consider theories of harm, effects on innovation, and appropriate remedies. The FTC acting chairwoman, Rebecca Kelly Slaughter, has already announced that the new approach will be “aggressive.”[12]

[1]      Commission Press Release IP/21/1022, “Commission opens formal investigation into possible anticompetitive conduct of Teva in relation to a blockbuster multiple sclerosis medicine,” March 4, 2021.

[2]      Under the IP law principle of unity of invention, a patent application may only concern one invention or several inventions linked together in such a way that they form a single general inventive concept. Divisional patents enable the applicant to overcome the lack of unity of invention of an original or “parent” application, splitting the parent application into narrower patent applications, each covering a specific invention.

[3]      Commission Press Release IP/21/1203, “The European Commission forms a Multilateral Working Group with leading competition authorities to exchange best practices on pharmaceutical mergers,” March 16, 2021.

[4]      Commission Press Release IP/21/1022.

[5]      See, European Commission, “Pharmaceutical Sector Inquiry – Final Report,” July 8, 2009, para. 523.

[6]      AstraZeneca (Case COMP/A.37.507/F3), Commission decision of June 15, 2005.

[7]      U.S. Court of Appeals for the Federal Circuit, Giuliano v. SanDisk LCC, July 27, 2017, available at: http://www.cafc.uscourts.gov/sites/default/files/opinions- orders/16-2166.Opinion.7-25-2017.1.PDF.

[8]      In 2013, following a complaint from Teva Santé, the French Competition Authority fined Sanofi-Aventis €40.6 million for implementing a disparaging campaign targeting pharmacists and doctors regarding the quality and safety of generic products competing with its own Plavix drug. In 2014, the Italian Competition Authority fined F. Hoffmann-La Roche and Novartis over €180 million for a cartel that aimed to disseminate misleading safety claims against the cheaper ophthalmic drug Avastin, a competitor of the more expensive drug Lucentis. The Italian Council of State upheld the decision in 2019, but it also referred several questions to the Court of Justice. In 2020, the French Competition Authority also fined Genentech, Novartis, and Roche €444 million for having misled public authorities regarding the risks related to the use of Avastin. The decision is currently under appeal.

[9]      F. Hoffmann-La Roche and Others (Case C-179/16) EU:C:2018:25, para. 95. Preliminary ruling requested by the Consiglio di Stato on December 3, 2015.

[10]    Commission Press Release IP/21/1022.

[11]    Commission Press Release IP/21/1203.

[12]    Federal Trade Commission Press Release, “FTC Announces Multilateral Working Group to Build a New Approach to Pharmaceutical Mergers,” March 21, 2021.