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In 2024, several events occurred that set the stage for major developments in life sciences and pharma IP litigation in Brazil in the coming years. Some of the key events are detailed below.

Restrictive Amendments to Patent Application Claim Charts Allowed

The 1ª Specialized Panel of the Federal Court of Appeals for the Second Circuit (TRF-2) in Brazil issued a relevant precedent regarding the interpretation of Article 32 of the Brazilian Patent Statute (BPS – Law # 9.279/96), especially for the life sciences and pharmaceutical research and development industries. For the first time in an invalidity lawsuit, the court confirmed the legality of making restrictive amendments to a patent application claim chart, whether voluntarily or in response to a BPTO (Brazilian Patent and Trademark Office) order, even after a request for examination has been submitted to the BPTO – provided these amendments are included in the patent application as filed. The court has also confirmed that BPTO Ordinance # 93/2003, which regulates this matter, is legal and does not violate any prior legal precedent (namely, Case # 0513584-06.2003.4.02.5101). This precedent is still subject to appeals to the superior courts, but it is relevant, since generic industry often mentions the judgment of Case # 0513584-06.2003.4.02.5101 to argue against the possibility of restrictive amendments after the request for examination. This decision provides greater legal certainty, aligns with what the BPTO has already established on the matter, confirms the provisions of the TRIPS Agreement, and sets the standard for how such cases will be analysed going forward.

Invalidity As a Defence in Infringement Lawsuits

Brazil has a bifurcated judicial system, where patent infringement lawsuits are judged by the state court, while invalidity cases are handled separately by the federal court, with the BPTO as a party. Although this structure is expressly provided by the BPS and remains in force, the Superior Court of Justice (STJ) confirmed in 2024 that defendants in infringement lawsuits have the right to present patent invalidity arguments in their answer to a complaint. This decision was rendered in the judgment of Appeal # 1,332,417/RS, where the STJ gathered two panels with divergent interpretations of this legal matter, and established this unified understanding that must be followed hereafter.

In recent years, there has been considerable debate on whether the accused in a patent infringement could bring an invalidity defence in cases before the state court, especially considering that patent invalidity cases are to be tried before the federal courts as a matter of jurisdiction. Until this STJ decision, state courts had been ruling on a case-by-case basis, leading to different approaches, depending on the jurisdiction or judge handling the infringement case. The STJ precedent clarifies this scenario, providing patent owners and stakeholders with legal certainty, and allowing them to be prepared with accurate procedural, legal and technical strategies.

Developments After ADI # 5,529 and the Patent Term Adjustment-Like Lawsuits

After the trial by the Brazilian Supreme Federal Court (STF) of ADI # 5,529, owners with patents facing substantial reduction in terms of protection, sought compensation for the BPTO’s delay in examination through patent term adjustment-like (PTA-like) lawsuits.

In May 2021, the STF declared that the sole paragraph of Article 40 of the BPS was unconstitutional (ADI # 5,529). Previously, the law assured patent protection of up to 20 years from the filing date, with at least ten years of protection after the granting, due to a possible backlog at the BPTO. From 12 May 2021 onwards, all patents granted, no matter the BPTO delay, are valid for 20 years from the date of the deposit. In addition, the decision immediately determined that certain granted patents would lose the ten-year period of protection after the granting, namely: (i) patents under discussion in invalidity lawsuits filed up to 7 April 2021; and (ii) patents related to pharmaceutical treatments and products.

Until the end of 2024, it was possible to identify 64 PTA-like lawsuits:

• Among these cases, 26 had requests for preliminary injunctions (PIs) – four PIs were granted and three are still in force (in one, the PI was granted at trial court level but was revoked in an appeal filed by the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, or Anvisa) after the original term of protection reinstated by the PI expired) and 22 PIs were denied.
• So far, 21 cases have been decided on the merits at trial level, all of which received unfavourable decisions rejecting the PTA-like claims. The plaintiffs filed appeals against 18 of these decisions. The Federal Court of Appeals for the First Circuit (TRF-1) has decided two appeals on the merits and upheld the trial-level decisions. Both appellate decisions were challenged, and the appeals are pending before the superior courts.
• Several constitutional complaints on the ADI # 5,529, filed by the BPTO and/or life sciences and pharma companies, pending before the STF, discussed the PIs granted by the federal courts, all of them deciding against granting compensation in patent terms due to delays in the BPTO’s examinations.
• On this same matter, with Bill # 2,056/22, Congress proposes to amend Law # 5,648/1970 (which established the BPTO) to foster better management and governance practices at the BPTO, and to amend the BPS to:
  • allow divisional applications after the decision that granted the patent application and, in case of rejection, until the final decision (including the appeal phase);
  • allow claim modifications until the end of the examination phase;
  • declare that the end of the examination phase includes the appeal phase; and
  • establish a PTA mechanism for BPTO delays.

São Paulo Court of Appeals Sets Precedent for Technical Examination in Pharma Patent Case

In an infringement lawsuit (Case # 1002787-10.2022.8.26.0100) a decision on the merits in 2023 focused on certain invalidity aspects of the patent raised by the defendant (with no court ratification in the appropriate proceeding) and ignored infringement issues, without any technical examination. In June 2024, the First Reserved Chamber of Business Law of the São Paulo State Court of Appeals voided the trial decision, reasoning that the synthesis of a chemical component within the human body involves significant complexity, which requires technical examination, with a knowledge of biochemistry or organic chemistry, to determine whether there is illicit activity.

The decision established a significant precedent for pharma patent owners, ensuring the broad collection of evidence to prove infringement. It also confirmed that the appellate court can determine the technical examination to be performed, even if this was previously deemed unnecessary at the trial level. The panel decision can still be challenged before the superior courts.

Drug Advertising Rules Set by Anvisa Considered Illegal by the STJ

In deciding Appeal # 2,035,645/DF, the STJ recognised that Rule # 96/2008, issued by Anvisa, which regulated drug advertising, was illegal as it restricted dispositions set forth by the law. The STJ stated that Anvisa’s authority is limited to controlling, supervising and monitoring the advertising and publicity of products subject to health surveillance, in accordance with the existing health legislation (Law # 9,294 of 1996), but the agency does not have the legislative authority to issue new limitations rules on companies’ advertising for pharmaceuticals, against what is provided by law.

The case was filed against Anvisa by a pharmaceutical company, which argued that it could not be subject to sanctions from the agency based on the mentioned rule, as it created prohibitions that exceeded Anvisa’s regulatory authority. For instance, Rule # 96/2008 prohibited:

• indirect advertising in scenic contexts, performances, movies, radio programmes, or other types of electronic or printed media, as well as the broadcasting of images of people using drugs;
• required the inclusion of warning clauses, indicating the substances contained in the medication, especially those causing sedation or drowsiness; and
• prohibited the use of certain expressions, like “scientifically proven” or “demonstrated in clinical trials”, in the advertising of over-the-counter drugs.

The STJ decision highlighted a legislative gap on the subject and officially notified the Ministry of Health and the National Congress about it, to initiate discussions on the matter within the legislative sphere. This topic may therefore come up for discussion in the coming years.

Productive Development Partnerships (PDPs) Are Back

In 2012, the federal government established Productive Development Partnerships (PDPs), bringing together public institutions (PIs) and private entities (PEs), with the latter transferring their expertise in producing active pharmaceutical ingredients (APIs) to the former. In summary, these are technology transfer agreements, including the supply of the product by the PEs. The aim is to reduce the importation of APIs and boost the country’s economic-industrial complex, to ensure Brazilians have access to essential drugs and health products through the Brazilian public health system (Sistema Único de Saúde, or SUS), supplied at a lower price to the Ministry of Health (MoH), and thereby protect the treasury’s coffers.

Over the last few years, PDPs have sparked intense debates about APIs under their scope that were still under patent protection, and the infringement acts involved in this. This discussion will possibly arise once more in 2025, as:

• between June and October 2024, several PIs, such as Fiocruz, Bahiafarma and the Butantan Institute, conducted public calls to start new PDPs;
• the MoH received 147 PDP proposals; and
• in December 2024, the MoH published SECTICS/MoH’s Rule # 1/2024, which approved the new internal regulations for this project, including the creation of a scoring system for PDP proposals, to serve as the criteria for analysing and classifying them (although it is still not clear what parameters will be applied to score each of the criteria).

Agrichemical Company Wins Unfair Competition Case, Halts Sale of Professional Solutions Products for Agricultural Use and Obtains Damages

Following an extensive investigation, an agrichemical company obtained evidence that another party was selling professional solution products containing a compound duly registered with Anvisa to farmers as agricultural pesticides. Not only is this regulatory fraud (misuse of a product), but the agrichemical company and its licensees were the only companies in Brazil authorised by the Ministry of Agriculture and Livestock (Ministério da Agricultura e Pecuária, or MAPA) to produce and sell pesticides containing this compound. In addition, the seller of the professional solution products engaged in comparative advertising, claiming that their products were identical to the original pesticides, also making use of the registered trade marks of the original product.

A lawsuit was filed, grounded on the trade mark violation and unfair competition before the State Court of São Paulo (Case # 1004858-48.2023.8.26.0100). At the trial, the final decision on the merits recognised the unfair competition act and ordered the defendant to refrain from making any statement that encouraged and/or taught third parties to use their professional solution products as agricultural pesticides and/or compare them to the originals. It also ordered the defendant to pay damages. In April 2024, the Second Reserved Chamber of Business Law confirmed the reasoning of the trial court decision.

This case shows that chemical product misuse in the agricultural market – unfortunately an issue in Brazil – can be associated with intellectual property violations beyond patents and regulatory subjects. This shows that IP title-holders must remain watchful.

Leading Cases in Agrichemical Data Protection Litigation: Preventing Unfair Competition

In 2021, in a preliminary injunction decision, the Fifth Chamber of TRF-1 recognised that merely receiving and processing – not only examining or granting – applications for the registration of equivalent technical products or formulated products based on equivalent technical products (generic agrichemicals) submitted by unauthorised third parties during the term of regulatory data protection of the reference molecule, constitutes misuse of the regulatory dossier (regulatory data) by the authorities in charge of agrichemical registration in Brazil (MAPA, Anvisa and IBAMA – the latter being the Brazilian Environmental Protection Agency or Instituto Brasiliero do Meio Ambiente e dos Recursos Naturais Renovaveis) and violation of Article 4, I of Law # 10.603 of 2002 (the Regulatory Data Protection Law or RDPL). As a result, the queue of cases waiting to be analysed by the Administration is to be reorganised, as applications submitted after the expiration of their term have to be placed in the position of applications filed after the expiration of protection.

According to the TRF-1, the document check performed when the application for registration of an equivalent technical product is submitted already represents misuse of the reference molecule’s regulatory dossier (regulatory data), which corresponds to the act of processing the application prohibited by the RDPL, leading to unfair advantage on the part of the applicant and violating the principle of equality. In a fair competitive environment, third parties would not be in a privileged position compared to others who wait for the expiration of the regulatory data protection period before submitting their applications. Accepting the early submission of applications gives those applicants an advantage, which is unfair competition practice.

In a similar case, in 2024, the Seventh Federal Court of the Federal District rendered a preliminary injunction on the same grounds and with reference to the above TRF-1 decision. The trial court decision ordered MAPA, Anvisa and IBAMA to refrain from processing, analysing and/or approving any formulated and/or equivalent technical product applications that referred to the regulatory data of the reference molecule under regulatory data protection. The order applies to registration requests pending in the analysis queues, as well as those submitted before the expiration of the regulatory data protection. The final decisions on the merits of these cases are expected in 2025.

Superior Court of Justice Validates Medicinal Cultivation of Cannabis by Companies

In November 2024, the First Section of the STJ ruled it legally possible to grant sanitary authorisation for the planting, cultivation and commercialisation of industrial hemp – a type of Cannabis sativa with a tetrahydrocannabinol (THC) content of less than 0.3% – by legal entities, for exclusively medicinal and pharmaceutical purposes (Case REsp # 2024250/PR).

The STJ highlighted that the cultivation must follow regulations – to be written in six months, by Anvisa and the federal government. With this ruling, the court issued a precedent that must be observed by all Brazilian trial courts and appellate courts.

As industrial hemp has a low THC content, there are no psychoactive effects, making it different from marijuana and other variations of cannabis used for drug production. As a result, industrial hemp is not subject to the prohibitions in the Law # 11.343/2006 and can be cultivated in Brazil, as ruled by the STJ.

The rapporteur also explained that this ruling does not encompass the possibility of importation or cultivation of industrial hemp by individuals, nor does it discuss uses of the product other than medicinal and pharmaceutical applications. Although Brazil currently authorises the use and commercialisation of cannabis-based medicines, the national production of the elements necessary for their preparation is prohibited.  

Decisions Regarding the Supply of High-Cost Medicines by the Government

In 2024, the STF ruled on new guidelines for the judicial provision of drugs by the government, editing Topic # 6 and Topic # 1,234.

Topic # 6 (RE # 566,471)

This has been under discussion since 2020. The STF decided that the government is not obliged to provide high-cost medicines requested in court, when they are not provided for in the list of the SUS Exceptional Drug Dispensation Programme, nor registered with Anvisa.

Currently, the criteria for exceptions are under discussion before the STF, for circumstances in which the state may be required to provide high-cost medicines not available in the system, provided that the following are verified:

• the scarcity of resources and efficiency of public policies;
• the equal access to health and respect for technical and technical expertise; and
• the evidence-based medicine.

Topic # 1,234 (RE # 1,366,243)

The STF decided that claims related to drugs not incorporated into SUS public policy are within the jurisdiction of the federal courts, when the value of the specific annual treatment of the drug or active ingredient is equal to or greater than the value of 210 minimum wages (currently approximately BRL300,000 or USD50,000).

Non-incorporated drugs are those that are:

• not included in SUS lists;
• provided for in official clinical protocols for other purposes;
• not registered with Anvisa; and
• used off-label without a clinical protocol, or not part of lists of the basic component.

A special commission was created for debates with representatives of federative entities and civil society, culminating in the ratification by the STF of agreements signed between the federal government, the states, the federal district and the municipalities. These agreements include the competence of the federal courts to judge cases that deal with the supply of medicines not incorporated by the SUS, as well as the reimbursement to be made by the federal government to satisfy such demands.

The STF also determined the need to create a national platform to gather data on every lawsuit in which plaintiffs seek the supply of drugs, and to facilitate the management and monitoring of responsibilities between the federal government, states and municipalities, in addition to improving the performance of the judiciary in this matter.

This topic is relevant to the life sciences and pharma industry in relation to market dynamics, strategic planning of pharmaceutical companies, pricing strategies, reimbursement policies and potential alterations to the regulatory landscape.

Battling Counterfeit Seeds in Brazil: an Ongoing Struggle in the Agricultural Sector

As Brazilian agribusiness exports break records every year, the country faces a serious problem regarding seed counterfeiting. The agribusiness sector estimates that 30% of the seeds on the market are of unknown and illegal origin, putting the economy at significant risk. This is particularly concerning for those investing in cultivars and genetic improvement of seeds, protected by patents. As there are no criminal provisions in the Plant Varieties Law (Law # 9,456/1997), all actions against counterfeiters related to cultivars have only civil implications.

As an example of actions in this area, CropLife Brazil, a non-profit civil association that represents R&D companies in the sectors of germplasm, biotechnology, agrichemical and bio inputs, has been leading an investigation and litigation project against soybean seed counterfeiters, which has resulted in significant outcomes. For example, in 2024, CropLife was able to seize over 1.488 million kilograms of illegal seeds, thereby preventing the return of what is estimated to be more than BRL8 million’s worth of illegal seeds to the Brazilian market.

Class Action Filed by ABPI Regarding the BPTO’s Funds and Efficiency

The Class Action filed by the Brazilian Association of Intellectual Property (Associação Brasileira da Propriedade Intelectual, or ABPI) that questions the allocation of 10% of the revenue earned by the BPTO to the BPTO itself, in view of understaffing and backlog issues, is pending analysis before the Appellate Court for the Federal Second Circuit (TRF-2), with the trial session expected to happen in 2025 (Case # 5095710-55.2021.4.02.5101).

In 2022, the trial court rendered a decision on the merits determining that the federal government should structure a report on the inefficiency of and need for the BPTO, and allocate financial resources to the IP authority to enable the development of activities and reduce the backlog.

Given the sensitive issues raised by life sciences and pharma IP cases, the sector would benefit from the success of this public civil action, as the incomings would allow the BPTO to improve the quality and delivery time of its services to applicants. Accurate and expedited analysis by BPTO examiners could prevent the need for lawsuits challenging BPTO actions.

The BPTO Joins the Global Patent Prosecution Highway

In July 2024, the BPTO joined the Global Patent Prosecution Highway (Global PPH or GPPH) programme, aiming to speed up the prosecution of patent applications by sharing examination results from any of the 35 participating offices, including those obtained under the Patent Cooperation Treaty (PCT), that indicate patentable subject matter.

For 2025, the BPTO issued Ordinance # 48 on 29 November 2024, which:

• establishes Phase V of the PPH Pilot Project, regulating the Global PPH;
• expands the participation limit to 3,200 PPH requests per year, with a maximum of 1,000 requests for the same section of International Patent Classification (IPC); and
• accepts substantive examination results indicating patentable subject matter from all Global PPH participating authorities, including those examined under the PCT.

This initiative may enhance Brazil’s contribution to global protection for the pharmaceutical and life sciences industries in 2025, as it encompasses faster patent prosecution by leveraging examination results, while being cost effective.

Also aiming to reduce the BPTO’s backlog, Bill # 2210/2022 proposes amendments to the BPS, to:

• create a provisional patent application;
• devise mechanisms for the BPTO to benefit from searches of technical examinations published by other patent offices and international organisations; and
• eliminate the automatic 36-month term required for applicants to request the examination of the patent application, and restrict the capability of amending the application only until the beginning of the technical examination.

This proposal of restriction limits the possibility of amending the patent application and favours the conclusion of the analyses of applications in Brazil before other jurisdictions, aiming to address backlog issues at the BPTO. A new proposal, including a PTA mechanism, was presented to the Senate in July 2024. The ongoing discussion in Congress must be closely monitored, particularly regarding the term to request examination and the possibility for the BPTO to consider searches from other patent offices.

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