The chief investigator for Brazil’s antitrust authority has recommended dropping an investigation into Lundbeck, due to insufficient evidence the drugmaker conducted sham litigation in an abuse of dominance on the national pharmaceuticals market.

On 19 April, Brazil’s Administrative Council for Economic Defence said Lundbeck did not make baseless claims and included all relevant information in its litigation. The authority said it did not find evidence of contradictory arguments in the potentially sham cases.

Brazil’s Association of Generic Drug Manufacturers, Pró Genericos, complained to CADE’s predecessor agency in June 2010 that Lundbeck was dominant in the national antidepressant market for drugs containing the active ingredient escitalopram, and was improperly challenging the health regulator’s procedure for granting generic drug registrations.

Lundbeck owned the dossier or data package of the submissions it had made in order to have Lexapro accepted as safe and efficacious. Generic drugmakers do not have to make such submissions, instead only having to prove  bioavailability and bioequivalence to the original drug, but Lundbeck claimed they needed to license the data in its submissions.

In December 2011, the Secretariat of Economic Law, initiated administrative proceedings to investigate whether Lundbeck’s conduct violated competition law. In January 2012, Lundbeck submitted a response to the authorities that framed its actions as enforcement of data protection rights.

Lundbeck also argued the association was choosing to use a narrow market definition, and that the broader national antidepressant market in which Lexapro falls aligns with the market definition by the Anatomical Therapeutic Chemical system, which CADE typically follows to define markets in its pharmaceutical cases. Following Lundbeck’s protest, the antitrust agency expanded the market definition to include all antidepressants containing selective serotonin reuptake inhibitors.

In a technical note, the General Superintendence concluded it had insufficient evidence under CADE’s jurisprudence to find that Lundbeck had engaged in sham litigation, which involves using objectively unfounded records, omitting relevant information or presenting contradictory positions that could lead to confusion of the judiciary.

"Any unfavourable effects on other competitors would come from the very decision on the merits of the matter, rather than from the alleged filing of a multiplicity of lawsuits with an evident low probability of filing. In other words, the evidence in the case-file does not allow the award of damages to competitors,” CADE’s investigative arm stated.

Though it recommended closing the administrative proceeding, it also suggested CADE’s tribunal should send its decision to other courts that are analysing the scope of protection for such pharmaceutical data packages.

Lundbeck’s counsel Ademir Pereira Jr, a partner at Advocacia Jose Del Chiaro in São Paulo, said the case “will be put before the tribunal” and would follow up with CADE’s commissioners “to persuade them to close the case”.

Joyce Honda, a partner at Cescon Barrieu in São Paulo, said the data packages required from drugmakers are costly and lengthy, requiring numerous studies and tests to determine the new medicine’s safety and efficacy. The authority said market definitions did not matter in this case, she said, given the observable decline in generic alternatives to Lexapro.

CADE did not respond to a request for comment. Lundbeck and Pró Genericos did not respond to requests for comment.

Counsel to Lundbeck

Advocacia Del Chiaro

Partners Jose Del Chiaro and Ademir Antonio Pereira in São Paulo are assisted by Mario Cabral and Yan Vieira

Counsel to Brazilian Association of Industries of Generic Medicines - Pró Genericos

Arystobulo Freitas Advogados

Partner Artorobulo de Oliveira Freitas in São Paulo is assisted by Fabio Andresa Bastos