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CADE’s General Superintendence concludes investigation in the antidepressants market

Sham litigation

The case was submited to the Administrative Court, responsible for the final decision.
by Assessoria de comunicação published: Apr 27, 2018 01:23 PM last modified: Apr 27, 2018 01:23 PM

CADE’s General Superintendence recommended the filing of an Administrative Proceeding that investigates alleged anticompetitive conducts perpetrated by the Lundbeck group companies in the antidepressants market, that has escitalopram as active ingredient (PA 08012.006377/2010-25).

The investigation was initiated from a complaint filed by the Brazilian Association of Generic Medicine Industry (Pró-Genéricos). According to the association, Lundbeck would be the leader in the national antidepressant market because of the sales of the drug Lexapro (which has escitalopram as the acting ingredient) and would be applying efforts to maintain, artificially, its market exclusivity.

According to Pró-Genéricos, Lundbeck would be moving a series of abusive judicial and extrajudicial actions against sanitary and regulatory authorities, and against competing companies, distorting facts and misleading judges – a practice known as sham litigation. The main point of the complaint is Lundbeck’s judicial questioning about the procedures adopted by Anvisa (Brazilian Health Regulatory Agency) to the concession of generic drugs licenses.

The opinion of the General Superintendence states that the registry of a reference medicinal product (such as Lexapro) requires the presentation of onerous and lengthy tests to prove its safety and efficiency, which compose the data package that belongs to the manufacturing company. The registry of generic and similar drugs, though, dispenses testing, sticking to proof of bioavailability and bioequivalence in relation to the reference medicine. Thus, the register of generic and similar drugs is supported, even if indirectly, in the data package presented when the reference medicine is registered.

According to Lundbeck, the unfair competition was being practiced by the laboratories that obtained sanitary registration from Anvisa, relying on the company’s data package, even if indirectly, without a prior license. The defendant sustains that the generic/similar drugs should make their own data package or to license Lundbeck’s while it was protected, and then obtain the sanitary registration of the drug. This is the thesis that supports the judicial and administrative actions intended by Lundbeck and considered abusive by Pró Genéricos.

Analysis

After the analysis of the judicial and extrajudicial actions taken by Lundbeck, the General Superintendence concluded that the elements verified were not sufficient to validate the violation, according to parameters considered in the agency’s jurisprudence. The opinion points out, though, that the debate surrounding the proper protection of the data package cover divergent positions, which were broadly shown in the proceedings, and it’s not CADE’s role to decide which thesis should prevail.

According to the General Superintendence, even the eventual disagreement on the thesis defended by Lundbeck (due to possible anticompetitive effects if the thesis prevails) is not enough to categorize the sham litigation conduct. As stated by the Technical Note 16/2018, it is not possible to claim that the defendant made use of documents purposely unfounded, hid relevant information or showed contradictory positions that could mislead the Judiciary Power. Neither it can be surely said that Lundbeck planned a series of anticompetitive actions, with a low probability of favorable outcome and causing collateral damages.

Given this scenario, the General Superintendence submitted the process to CADE’s Administrative Tribunal, responsible for issuing the final decision about the case, recommending the case filing.

Debate

The General Superintendence understood that the lack of antitrust violation does not prevent the debate about the deadline for the data package protection, which has important competitive implications. However, it is the role of the Judiciary System, and not Cade’s role, to deliberate upon the merits of the issue related to the thesis defended by Lundbeck.

According to the company, the fact that manufacturers of generic/similar drugs use the data package related to the reference medicinal product manufactured by Lundbeck to obtain the sanitary registration, without a previous license, can be seen as unfair competition. In their point of view, either the laboratories create their own data package or they should license Lundbeck’s for a period.

On the other hand, the position taken by Anvisa, in accordance with the Law 10.603/2002, does not foresee the establishment of a deadline to the protection of data related to human health medicine, but only to other kinds of products. According to the General Superintendence, this understanding favors the entrance of generic drugs in the market, resulting in greater competition and users’ faster access to low-cost medication.

In this sense, the General Superintendence recommends that, when deliberating upon the matter, the Judiciary take into account that a broader protection to the data package can be harmful to both the competition and to the policies of generic drugs in the country.