The Pharmaceutical Intellectual Property and Competition Law Review: Brazil
The Brazilian Federal Constitution (Article 6) establishes access to healthcare as a right of every Brazilian citizen. Following this constitutional principle, the Brazilian government created the Unified Health System (SUS) through enactment of Law No. 8,080 of 1990. Under the SUS, the government has the duty to provide all Brazilian citizens with access to healthcare, including related products and services. The Brazilian Ministry of Health (MOH) was entrusted by the Brazilian Federal Constitution with the duty to provide public healthcare and to coordinate SUS activities. The MOH is also responsible for public healthcare policies and clinical protocols, as well as for regulation of non-traditional medical treatments.
The Brazilian Heath Regulatory Agency (ANVISA), a regulatory agency subject to the MOH, has a mandate to monitor, control and regulate public health issues, and has powers to regulate and supervise the registration, manufacturing, distribution and dispensation of drugs (and, thus, ensure the health and safety of consumers). Together with the state and municipal health offices, ANVISA's role is to oversee production of pharmaceutical products and to ensure their quality and safety, to protect community and consumers' health and welfare.
Considering that Brazil is among the most relevant markets within the pharmaceutical industry worldwide, from an intellectual property perspective, patent protection, provided by the National Industrial Property Institute (INPI) and ANVISA play an important role to guarantee the necessary incentives for innovation, research and development.
The Administrative Council for Economic Defence (CADE), in turn, is responsible for analysing merger cases, as well as scrutinising alleged anticompetitive practices in all economic areas, including the pharmaceutical industry, which has been always under close analysis of antitrust authorities worldwide. Within its activities, CADE is entitled to investigate concentrations or anticompetitive conducts that could actually or potentially harm competition.
Legislative and regulatory framework
i Heath regulation by ANVISA
Pharmaceutical regulations are under the jurisdiction of ANVISA, a regulatory agency created by Law No. 9,782 of 1999, vested with the institutional purpose of promoting and protecting people's health through public health control over the production and marketing of relevant products and services.
Among its activities, ANVISA is in charge of the approval process required as a condition for pharmaceuticals to be commercialised in Brazil (either through local manufacturing or imports), pursuant to general rules provided under Law No. 5,991 of 1973 and Law No. 6,360 of 1976, and specific requirements provided under ANVISA's regulation for each category of pharmaceutical, notably Resolution RDC No. 200 of 2017. All pharmaceutical products require registration, except those posing fewer risks to health, such as acids, and calcium carbohydrate, among others, which are subject to notification only as per ANVISA's Resolution RDC No. 199 of 2006.
In addition, ANVISA is also responsible for the certification and inspection of manufacturing plants in Brazil and abroad, as per ANVISA's Resolution RDC No. 39 of 2013 and for post-marketing surveillance of pharmaceuticals (e.g., recall), as per ANVISA's Resolution RDC No. 4 of 2009. ANVISA and the state and municipal health authorities are responsible for issuing federal, and state and municipal healthcare licences, respectively, for companies to operate, according to ANVISA's Resolution RDC No. 16 of 2014 and regulations issued by state or municipal authorities.
ii Price control
Most pharmaceuticals are subject to price control, pursuant to mechanisms defined by ANVISA's Drug Market Regulation Chamber (CMED), created under Law No. 10,742 of 2003. In the case of pharmaceutical products that were not clearly exempted from CMED's control, a registration holder must obtain the CMED's approval for the respective price after approval and registration before ANVISA and before launch. The CMED-approved price is the maximum selling price in the private market. Besides this, for pharmaceuticals under CMED's control, the Chamber also defines the final price for consumers and mandatory discounts for the public market.
iii Public purchases
Because the Brazilian healthcare system is to be offered to all Brazilian citizen, the Brazilian government is one of the main purchasers of pharmaceuticals in the country. As a general rule, only pharmaceuticals incorporated in the MOH's formulary can be purchased by the Brazilian government. The incorporation process is an attribution of the National Commission for Technology Incorporation and is mainly regulated under Law No. 9,784 of 1999, Law No. 12,401 of 2011 and Decree No. 7,646 of 2011.
Public purchases of pharmaceuticals must follow the Brazilian public procurement laws and principles, mainly provided under Law No. 8,666 of 1993, Law No. 10,520 of 2002 and Decree No. 5,450 of 2005, which set forth public tenders and public contract requirements at the federal level. Given the decentralised structure of Brazilian healthcare system, states and municipalities, as purchasers of pharmaceutical products, are subject to specific local laws and regulations. Generally, public purchases are subject to strict transparency and publicity rules, and must be guided by a balanced analysis involving quality and price criteria.
iv Intellectual property
Pharmaceutical patent application requires not only the review of the INPI, but also the prior consent of ANVISA, as provided in Law No. 10,196 of 2001.
v The Brazilian Competition Law
The main competition legal source in Brazil is Law No. 12,529/11 (the Brazilian Competition Law), which came into effect on 28 May 2012, replacing Law No. 8,884/94, and introducing several important changes to the Brazilian competition system. The Brazilian Competition Law structured the Brazilian system for protection of competition and empowered CADE with relevant investigative and decision-making attributions, as well as the necessary independency to comply with its legal obligations. In this context, the Brazilian Competition Law also sets forth the general rules for the mandatory merger control system, and clarifies important definitions on anticompetitive conducts and applicable fines. To guide its decisions, CADE also takes into account several resolutions and guidelines issued in past years.
Brazil is among the most relevant pharmaceutical markets worldwide and, similarly to other emerging countries in the health sector, there is a lot of debate around public policies and legislation to spur innovation. Some recent governmental and legislative initiatives in force and in the pipeline include increasing investments in research and development activities in Brazil, developing a legal landscape for clinical trials (which are currently regulated solely on regulatory and ethical basis), creating alternative risk-sharing mechanisms for public purchase of highly innovative pharmaceutical products and improving regulatory framework on gene therapy.
Under Law No. 9,279 of 1996, any patent application remains confidential for 18 months from the filing. After this period, any interested party may present documents and information to assist INPI with the patent examination. If the patent is ultimately granted, any interested party may file an administrative appeal or file a nullity action either to limit the scope of the patent or declare its nullity. It is not usual to have patent application discussions in pre-litigious mediation proceedings. Although such dispute resolution method is perfectly valid in Brazil and its use is increasing in recent years, it is not often used for patent disputes.
In addition to the above, Law No. 9,279 of 1996 provides for the mechanism of a compulsory licence, by which a patent licence is granted to third parties without the consent of the holder. Compulsory licences can be applied against a patent granted in Brazil in the following events:
- abusive exercise of the patent rights or abusive exercise of economic power duly evidenced and declared by an administrative or judicial decision;
- lack of exploitation of the patent in Brazil (except in the case of economical infeasibility to do so, a situation in which the importation of the product will be authorised);
- insufficient commercialisation to meet market demand;
- a situation involving dependent patents; and
- national emergency or public interest events declared by the Brazilian federal government.
To date, there has been only one case of compulsory licence in Brazil related to an HIV drug. The matter recently came up again due to the covid-19 pandemic, with many bills of law being discussed in Congress, but there are no updates so far.
CADE is the primary competition authority in Brazil. CADE's structure is composed of two main entities: the CADE's General Superintendence; and the CADE's Administrative Tribunal, composed of a president and six commissioners.
The General Superintendence is the first authority to analyse merger cases in Brazil and may either issue a definitive decision to approve the transaction, or issue a non-binding decision referring more complex transactions to the Administrative Tribunal, for a final decision. In relation to anticompetitive conducts, the General Superintendence is responsible for instructing and investigating the case.
The Administrative Tribunal is responsible for the analysis of merger cases referred by the General Superintendence and cases in which third parties appeal from the General Superintendence's approval decisions. The Administrative Tribunal may also request to review transactions approved by the General Superintendence. In relation to anticompetitive conducts, the Administrative Tribunal is responsible for deciding on the existence of anticompetitive conduct, and adopting the applicable penalties.
Sensitive markets such as the pharmaceutical one have historically occupied an important position in CADE's agenda. On merger control, CADE has developed cautious analyses on transactions submitted for review, requiring merger remedies in more complex cases, to avoid concentrations that could reduce competition. More recently, CADE has also indicated its concerns as regards acquisitions of small entrants by incumbents, to identify and prevent possible 'killer acquisitions'.
On anticompetitive behaviour, CADE has a number of investigations on the pharmaceutical industry, especially related to sham litigation, collusive practices and commercialisation of inputs – in both the private and in the public sector. CADE has also demonstrated concerns about disclosing tables on drug prices and possible price abuses in the context of the covid-19 pandemic.
The Brazilian Competition Law adopts a pre-merger control, pursuant to which competition approval is a condition precedent for the closing of a transaction whose filing is mandatory. Any acts of consummation carried out prior to CADE's approval are subject to fines and other penalties.
According to the Brazilian Competition Law, certain types of transactions (mergers, acquisitions, joint ventures, associative agreements,2 among others) are subject to mandatory notification to CADE when: at least one of the involved 'economic groups'3 registered gross revenues or volume of businesses equal to or exceeding 750 million reais in the year preceding the transaction in Brazil; and at least one other involved 'economic group' registered gross revenues or volume of businesses equal to or exceeding 75 million reais in the year preceding the transaction in Brazil. There are no specific rules for transactions in the pharmaceutical industry.
i The definition of relevant markets
Relevant product market
The relevant product markets related to the pharmaceutical industry, more specifically in relation to drugs for human health, take into consideration the Anatomical Therapeutic Chemical (ATC) classification system – usually levels 3 and 4 and – and the therapeutic indication of each drug.4
The ATC system, developed by the European Pharmaceutical Marketing Research Association and by the Intercontinental Medical Statistics, classifies drugs in four levels, indicating the level of substitutability between products, based on the similarities in each of these categories.
CADE recognises, however, that, in certain cases, the ATC classification can be too broad, encompassing non-substitute products designed for distinct uses or, in other cases, too strict, when it sets aside important substitutes for the drug under scrutiny. Considering these difficulties when adopting a market definition solely based on the ATC, CADE may also rely on the therapeutic prescriptions of the drug (identifying treatment protocols used in Brazil or abroad). Under this approach, the authority may find actual substitutes for the drug under scrutiny, based on the market perception and practice.5
A third criteria already discussed in precedents issued by CADE is the distinction between over-the-counter drugs and drugs that demand medical prescription. Accordingly, this differentiation would be relevant to distinguish consumers' level of choice, considering that prescript drugs usually have limited advertising and have the prescription as a choice-limiting factor.6
Geographic relevant market
CADE's settled precedents confirm that the scope of the geographic market is national, to the extent that drugs registration with ANVISA is only granted to firms set up in Brazil.7 CADE has also considered that drugs distributors are capable of reaching the entire national territory.8
Barriers to entry
It has already been recognised by CADE that the pharmaceutical market has relevant regulatory barriers to entry to the extent that the process for development of a drug and the issuance of requisite registrations by the competent bodies take time and involve considerable costs. CADE has described factors that constitute market entry barriers, including: high investment costs, time required for registration at ANVISA, minimum time required for an entrant to initiate its activities and existence of patent requirements.
ii Relevant cases
The first transaction conditioned to merger remedies in the pharmaceutical market after Law 12,529/2011 was the creation of a joint venture between GlaxoSmithKline PLC (GSK) and Novartis AG (focused on over-the-counter healthcare products), submitted to CADE as Merger No. 08700.008607/2014-66.
CADE understood that the merger could raise high concentrations in the antismoking drugs market. To mitigate this concern, the companies committed to a structural remedy, translated into the divestment of a package of assets related to its main antismoking product, including tangible and intangible assets, such as intellectual property rights, licences and contracts. The parties also committed to a behavioural remedy, agreeing to adopt measures to avoid undue information exchanges between the joint venture partners.
In March 2019, CADE's Administrative Tribunal ruled on Merger No. 08700.005972/2018-42, related to SM Empreendimentos Farmacêuticos Ltd's (SM) acquisition of All Chemistry do Brasil Ltd.
The main discussion in the case was related to the fact that SM's expansion strategy would include the acquisition of companies whose economic groups did not meet the revenues notification thresholds. In this context, after a complaint presented by a third party, CADE became aware of the transaction and determined its notification, even though the turnover filing thresholds were not met. CADE understood that SM's dominance would cause a bottleneck effect in the pharmaceutical compounding market, raising barriers to access of final consumers to medicines to fit the unique need of a patient. Thus, approval of the transaction was conditioned to a set of behavioural remedies.9
More recently, in July 2019, Merger No. 08700.001206/2019-90, a joint venture between GSK and Pfizer Inc (Pfeizer) (combining the companies healthcare divisions) was approved by CADE's Administrative Tribunal after the parties committed to structural remedies.
CADE understood that there were concerns related to the simple antacids (A2A1) market. GSK would be the market leader and there would be few other relevant players in the market (only GSK, Hypermarcas and Pfizer held market shares higher than 5 per cent). To address those concerns, the transaction's approval was conditioned to a structural remedy, the divestiture of Pfizer's Magnesia Bisurada business. The divestiture was combined to behavioural remedies to guarantee its effectiveness (i.e., related to the divestiture independency, transitional agreements and personnel availability).
In relation to CADE's role related to punitive measures, the authorities are responsible for investigating and curbing alleged anticompetitive behaviour across all range of markets, including the pharmaceutical sector.
According to the Brazilian Competition Law, anticompetitive practices encompass any acts whatsoever intended or otherwise purporting to produce the following effects, even if any such effects are not achieved, and irrespective of fault:
- to limit, distort or otherwise injure free competition or freedom of enterprise;
- to dominate a relevant market for goods or services;
- to arbitrarily increase profits; and
- to engage in abuse of a dominant position.
Within this context, the Brazilian Competition Law provides for a non-exhaustive list of practices that may be considered anticompetitive, including collusion and abuse of dominance.
i Sham litigation
The Brazilian Competition Law innovated by adding the following example to the list of anticompetitive practices: 'the exercise or exploitation of industrial or intellectual property rights, technology or brands in an abusive manner'. Even though this conduct was already subject to punishment under the original legislation, listing it as a specific example signals that this type of conduct was significantly under CADE's radar at the time the Law was enacted. This movement reflects upon recent claims of sham litigation involving intellectual property rights in the pharmaceutical sector.
A paradigmatic case involving sham litigation in Brazil commenced after a complaint was offered to CADE by the Brazilian Association of Generic Drug Manufacturers against Eli Lilly do Brasil Ltd and Eli Lilly and Company (the defendants). The investigation refers to Administrative Proceeding No. 08012.011508/2007-91, in which the defendants filed contradictory and misleading claims to obtain patent protection and exclusivity rights to commercialise the medicine 'Gemzar'.
The patent requests were submitted both to the judiciary and to INPI. The improper acquisition of exclusivity by the defendants made it impossible for patients with severe health problems to acquire more affordable treatment using a similar or generic drug, and prevented competitors from entering the market. Thus, population lacked alternatives to access potentially different treatments that could have been promoted by other pharmaceutical companies if innovation had not been hindered by the defendants. As a result, the companies were convicted for sham litigation under the new regime (Law 12,529/11), even though the conduct occurred under the original regime (Law 8,884/94), as CADE concluded that its terms were more beneficial to the defendants.
On the sham litigation topic, after years of investigation, CADE decided to dismiss a case in which the practice was being assessed. According to the case files, Genzyme would have filed a series of judicial and administrative abusive measures with the objective of delaying the entrance of competitors in the market. The investigation was dismissed, as CADE concluded that the evidence related to the abusive practice was insufficient to lead to conviction. CADE also stated that sanctioning Genzyme would imply hindering the search for technological innovation, which could reduce the incentives for companies within the pharmaceutical sector to invest in R&D.10
The investigation relating to a collusive scheme to prevent the sales of generic drugs in which Merck SA was convicted in 2014 is also a noteworthy case11 within the pharmaceutical sector. CADE found that Merck SA colluded with the biggest pharmaceutical labs in Brazil to hinder the entrance of generic drugs in the country. CADE concluded that Merck SA's participation in a meeting with other competitors was enough to serve as evidence for the scheme and demonstrate the company's attempt to boycott the generics market.
According to the case files, Merck SA did not actively agree to the strategy being discussed in the meeting where the anticompetitive conduct allegedly took place. Supposedly, the meeting allowed the companies to discuss paying generic drug makers to keep their competing products off pharmacy shelves.12 However, CADE concluded that the acceptance was implicit, and – even though the decision was not unanimous – ultimately decided to convict the company.
The precedent above signals that CADE is concerned about the generics market in Brazil. Generics present a more affordable option for consumers, so it assists a significant portion of the population that does not have access to the originators' drugs. The entrance of generics in the market constitutes a pro-competitive measure, and probably sensing the urgency of combatting conducts that pose risk to this market, the authorities have decided to convict Merck SA with the support of little evidence.
CADE has also convicted companies in the pharmaceutical sector for colluding in the context of public bids. In 2016, during the investigation of Administrative Proceeding No. 08012.008821/2008-22, CADE held two companies and four individuals responsible for cartel formation on the market of inputs for the development of antiretroviral medicines.
According to the case files, the investigated companies previously agreed on the outcome of the bidding process, by using mechanisms such as price fixing, cover proposals and the suppression of proposals. As a result, the medicine produced by the public laboratories – targeted by the cartel – was overpriced, as the inputs acquired at the bids were overpriced.
iii Other relevant investigations
More recently, CADE decided to initiate an administrative procedure13 – which is still ongoing – to investigate whether disclosing tables on the price of hospitality materials and drugs to companies in the market (i.e., electronic publications by Brasíndice and Simpro) could constitute anticompetitive conduct. These tables were published in electronic magazines, and, supposedly, could enable hospitals to impose these prices on health plans, and entities that represent the companies in the healthcare sector to influence their associates to adopt the prices displayed on these tables.
In the context of the covid-19 pandemic, CADE has initiated an investigation14 against companies related to the hospitality and pharmaceutical sectors to evaluate whether there was an arbitrary and abusive increase in prices due to the high demand for medical and pharmaceutical products. CADE has issued requests for companies that produce masks, alcohol-based hand rub products and medicines that treat covid-19 symptoms, etc., to instruct the analysis. The investigation is still ongoing, and demonstrates CADE's efforts to tackle abusive practices during this period.
Notwithstanding CADE's intention to restrain competitive conducts during the pandemic, the authorities have also indicated that they will be working towards facilitating – on an exceptional basis – cooperation between competitors to minimise the harmful effects caused by the pandemic, which could contemplate agreements between companies in the pharmaceutical sector in the near future.
Outlook and conclusions
Cases involving the pharmaceutical industry may attract great exposure due to the essential nature of the market affected. If mergers and anticompetitive conducts concerning drugs and other medical equipment pass unnoticed, harm to consumers could be immeasurable. For this reason, cases within this segment usually receive an in-depth analysis by CADE.
On merger control, apart from conducting a cautious analysis on transactions submitted to its approval, and imposing merger remedies in more complex cases, CADE has also been monitoring transactions that are not notifiable but that may pose risks to consumers. Notwithstanding, an excess of regulation can also hinder innovation incentives, in a market that heavily relies on these incentives to grow and provide access to more efficient health treatments.
CADE's approach to anticompetitive conducts in the pharmaceutical sector is also cautious, as it recognises the urgent need to combat anticompetitive practices that affect the industry.
Finally, as the pharmaceutical industry is one of the most regulated sectors in Brazil, it may be viewed as a challenging market. However, we have seen some movement by the government to increase access to pharmaceutical products through public policies. For example, it has incorporated risk-sharing agreements as a possibility for the development of highly innovative pharmaceutical products and public purchase. It has also established specific regulations concerning pharmaceuticals for rare, negligent and emerging diseases, and the relaxation of ANVISA's regulations in extraordinary situations, such as the covid-19 pandemic.
1 Júlia de Castro Kesselring, Marina Souza e Silva Chakmati and Carolina Destailleur Bueno are associates, and Cristianne Saccab Zarzur is a partner at Pinheiro Neto Advogados. The authors wish to thank Angela Fan Chi Kung, partner at Pinheiro Neto Advogados.
2 Resolution CADE No. 17/2016 determines that 'associative agreement' stands for any agreement with a duration equal to or above two years that that sets out a joint enterprise to pursue an economic activity, provided that, cumulatively: the agreement provides for sharing of the corresponding risks and results of the economic activity that formed its object; and the parties by way of a contract be competitors in the relevant market object of the agreement.
3 To calculate the groups' revenues, the general definition of 'economic group' takes into consideration companies under common control and companies in which any member of the group holds at least 20 per cent interest. Specific rules are applied to investment funds.
4 Merger No. 08700.001206/2019-90 (GSK/Pfeizer); Merger No. 08700.001339/2020-08 (GSK/Stada).
5 Mergers No. 08700.001206/2019-90 (GSK/Pfeizer); No. 08700.001339/2020-08 (GSK/Stada).
6 Mergers No. 08700.001206/2019-90 (GSK/Pfeizer); No. 08700.001339/2020-08 (GSK/Stada).
7 Mergers No. 08700.001206/2019-90 (GSK/Pfeizer); No. 08700.001339/2020-08 (GSK/Stada); No. 08700.005093/2016-59 (Sanofi and Boehringer), No. 08700.006159/2016-28 (Pfizer and Astrazeneca), No. 08700.003725/2015-69 (Pfizer, Perkins and Hospira) and No. 08700.009834/2014-09 (União Química and Novartis).
8 Mergers No. 08700.001206/2019-90 (GSK/Pfeizer); No. 08700.001339/2020-08 (GSK/Stada).
9 Behavioural remedies included: the prohibition of participating in mergers and acquisitions of competitors for the next two years; the submission of any transaction of the same nature to CADE's prior approval in the following two years; and the submission of any transactions in the markets horizontally or vertically related to the analysed market to CADE's approval for the next four years.
10 Administrative Proceeding No. 08012.007147/2009-40.
11 Administrative Proceeding No. 08012.005928/2003-12.
13 Administrative Procedure No. 08700.001180/2015-56.
14 Preparatory Procedure No. 08700.001354/2020-48.