Infringement

An action for infringement may be filed before a state court by any party with a legitimate interest in the subject matter of the lawsuit, according to Article 17 of the Brazilian Code of Civil Procedure (CPC). In life sciences infringement suits, the interested parties who take part in an infringement action are the patentee (or other parties authorised to act on the patentee’s behalf – eg, a licensee) and the entity accused of infringement.

Unlike other jurisdictions (eg, the United States), the Brazilian Patent Statute (BPS) does not provide specific guidance on the joint ownership of patents. Therefore, the Civil Code’s general rules of joint ownership apply to intellectual property, including patents. In this sense, unless otherwise specified by contract, co-owners are cleared to act in defence of the patent independently of each other.

In turn, Article 61 of the BPS allows patentees to grant authorisation towards licensees to act independently in defence of the patent, even without the participation of the actual patent owner. However, Article 62 of the BPS requires such licence contract to be recorded with the Brazilian Patent and Trademark Office (BRPTO) in order to produce effects against third parties.

Nullity

Unlike infringement lawsuits, nullity actions may be initiated before a federal court by a wide array of parties. According to Article 56 of the BPS, any person with a legitimate interest may file for a patent’s nullity. Historically, case law construes this “legitimate interest” quite broadly to encompass any person potentially affected by a patent’s existence. Statute also provides that the BRPTO itself is a legitimate party to request a patent’s nullity before a federal court.

That said, patent nullity may also be argued as a means of defence within a patent infringement lawsuit (per Article 56, Section 1 of the BPS and the Superior Court of Justice’s ruling in Motion for Clarification on Appeal #1,332,417/SP). When used as a defence, a finding of patent nullity will produce effects strictly between the parties engaged in litigation (inter partes effects), whereas a verdict issued in an independent nullity lawsuit will remove the existence of the patent for any party (erga omnes effects).

Moreover, when an independent nullity lawsuit is filed, the BPS requires the participation of the BRPTO in that lawsuit, as it is the federal agency in charge of analysing patent applications. In these proceedings, the BRPTO is not necessarily compelled to act in defence of the patent. Rather, the BRPTO will assess the nullity allegations and provide an opinion on whether the patent should be declared valid, invalid or partially invalid (ie, undergo amendments to restrict claim scope and satisfy patentability requirements).

A further pathway is open to potential plaintiffs in nullity proceedings. According to Article 51 of the BPS, any party with a legitimate interest may initiate an administrative nullity proceeding (PAN) before the BRPTO within six months after a patent is granted. After this six-month period, parties may only seek the patent’s nullity before the courts. Filing a PAN does not stay the effect of the patent but provides an additional means to seek a patent’s nullity before going to the courts. If a PAN is unsuccessful, the parties may further question the patent’s validity by filing a nullity lawsuit before a federal court.

The BPS designates a wide array of acts as infringing (see 2.1 Infringing Acts for more detail). Due to this, patentees may direct lawsuits at many parties that take place in infringing activity (eg, manufacturers, distributors, importers). In Brazil, the most common target for lawsuits is manufacturers, as these parties have the largest potential for market impact by competing directly with patentees. In life sciences cases, another common target is importers of active ingredients covered by Brazilian patents.

Another potential target for lawsuits is any party engaging in contributory acts for patent infringement (eg, supplying specialised components for use in patented processes). Under Brazilian law, patent infringers (including contributory infringers) may be prosecuted through both criminal and civil proceedings.

In infringement proceedings, the parties to a lawsuit are usually limited to the patent holder and the accused infringer. Article 57 of the BPS provides that the BRPTO must take part in all nullity proceedings, as it is the authority responsible for granting or rejecting the patent application. However, as stated in 1.1 Claimants/Plaintiffs to an Action, the BRPTO is not bound to defend or attack the patent; it may agree with the arguments of the plaintiff or the defendant.

Under Article 300 of the CPC, litigants may request preliminary injunctions (PI) in patent-related litigation. Such PIs may be granted ex parte or after hearing preliminary arguments from the adverse party.

To attain a PI, a litigant must demonstrate that three conditions are simultaneously met:

• the requesting party is likely to succeed in its claims;
• there is urgency in the relief (ie, the injunction) being sought, as, without it, the requesting party may suffer harm or the lawsuit may lose its purpose; and
• the party that will be targeted by the injunction will not run the risk of suffering irreversible harm.

Considering that urgency is one of the requirements for a PI to be granted, it is important for the party requesting the PI to act consistently with the alleged urgency. Therefore, if a potential plaintiff is known to have learned of a potentially infringing activity, it would be inconsistent for this party to request urgent relief while also taking too long to file suit, although Brazilian Civil Procedural Law does not provide a specific timeframe for requesting it, since the assessment of the urgency depends on the elements of the case. See 5.6 Relevance of Claimant/Plaintiff Conduct to Relief for more detail.

Although there is no specific timeframe for requesting a PI, the earliest a party can file for relief is after the patent has already been granted, as Article 17 of the CPC requires the existence of a legitimate interest. In nullity lawsuits, if relief is requested to declare the nullity of a patent, the patent must have already been granted by the BRPTO. Conversely, if a lawsuit is brought to declare the nullity of an act by the BRPTO to reject or withdraw a patent, the act must have already been performed before a lawsuit may be initiated.

In life sciences infringement cases, PIs are usually awarded if the plaintiff can offer convincing prima facie evidence of the infringing acts. Conversely, in nullity cases, the assessment for granting a PI tends to be more restrictive. Brazilian courts have a narrow understanding of the possibility of granting PIs aimed to stay patent effects in nullity actions, since the BRPTO’s act is presumed to be valid until it is overruled by a court. Judges usually prefer to hear all the parties and produce expert evidence before ruling on the preliminary injunction request. In other words, infringement (state) judges are more open to granting PI requests than nullity (federal) judges.

Although Brazil offers a wide array of interim relief for litigants, it is important to say that the life sciences industry has a few peculiarities. One example is the availability of the Bolar exemption for parties looking to attain regulatory approval in Brazil or abroad. Therefore, although the filing of a Market Authorisation Application (MAA) may be an early indication of infringement acts, it is not the definitive factor when relating to infringement.

In regard to the procedural aspects of the PI request, the court may summon the defendant to reply to such request, or may decide on the PI request before hearing the defendant. When the PI is requested upon filing the lawsuit, defendants should be personally summoned by a service letter, which may be delivered within a few days through the Brazilian postal system or through a bailiff; alternatively, the service letter may be personally delivered by the plaintiff, when authorised by the judge, which is usually faster than the court service. As the timeframe for the effectiveness of the defendant’s summoning may vary depending on the method of delivery of the service letter, the deadline for response will only count from the date the receipt of acknowledgement of the service letter is attached to the case dockets.

When served to respond to a PI request, the defendant may present whatever evidence is available to allege that no infringement has occurred. Considering that the plaintiff must prove their “likelihood” of success, defendants generally do not have to prove conclusively that they are not infringing; it should be enough to demonstrate that it would be reasonable to believe that no infringement is taking place.

Under Brazilian law, protective letters are not allowed as an attempt to circumvent PI requests. Nevertheless, the CPC provides that, if a final decision on the merits reverses the decision that granted the preliminary injunction, the party who benefitted from the PI must compensate the defendant for any damages caused. See 5.4 Damages for more information.

Prospective infringement defendants may also take other action to mitigate the possibility of being targeted by a PI, such as:

• filing a pre-emptive non-infringement lawsuit to obtain interim relief ensuring the continuation of commercial activities while the matter of infringement is litigated; or
• initiating a nullity lawsuit with a request for preliminary injunction staying the effects of the patent – either before the whole market (erga omnes effects) or strictly between the litigating parties (inter partes effects).

Brazil adopts a bifurcated system of patent lawsuits. Infringement claims are brought before state courts and nullity claims are brought before federal courts. Article 57 of the BPS requires the BRPTO to be a party to lawsuits with independent nullity claims.

Conversely, the participation of the BRPTO is not necessary if the issue of patent nullity is raised as a matter of defence (see 1.1 Claimants/Plaintiffs to an Action). If a nullity claim is brought through an independent lawsuit before a federal court, a finding of nullity will produce widespread effects removing the patent retroactively – as if it had never existed in the first place. If the issue of patent nullity is raised by means of defence, patent nullity may only produce effects limited to the parties in litigation; other parties are still subjected to the patent’s effects.

According to Article 56 of the BPS, patent nullity may be claimed in federal court at any time after grant (within the patent term). If patent nullity proceedings are ongoing before the BRPTO, the nullity lawsuit may take precedence and stay the administrative proceedings before the BRPTO if there is a judicial decision ordering such stay or if the BRPTO itself finds it appropriate to stay the administrative proceedings while the lawsuit is decided.

For infringement lawsuits, plaintiffs are subject to a five-year statute of limitations, as provided under Article 225 of the BPS.

On the other hand, a claim for patent nullity may be brought at any time during the term of the patent, according to Article 56 of the BPS.

Concerning the procedural means for the service of alleged infringers to a lawsuit, the same provisions indicated in 1.3 Preliminary Injunction Proceedings also apply here. Usually, service occurs through postal services with a notice of receipt. If the postal service is not able to reach the infringer, the plaintiff may request other means to effect service – eg, by conducting service through a bailiff or through public notice.

In nullity lawsuits, service tends to be easier. Pursuant to Article 217 of the BPS, patentees established abroad must keep an attorney in Brazil with sufficient powers to be served in the patentee’s stead. This allows prospective nullity plaintiffs to direct their service to the attorney residing in Brazil instead of relying on the postal service or other means (eg, letters rogatory).

When evidence of service (eg, notice of receipt) is attached to the dockets of the lawsuit, the clock starts ticking for the defendant to present their statement of defence. In infringement lawsuits, the deadline is 15 business days. In nullity lawsuits, the deadline is longer – 60 calendar days (or 45 business days at Federal Courts for the 2nd Circuit). In nullity lawsuits, after the patentee presents their statement of defence, the BRPTO is summoned to evaluate the submissions of the nullity claimant and the defendant (ie, the patentee) and to present a statement, within 30 business days, on whether the patent should be upheld or revoked.

Hearings are not common in Brazilian patent litigation. Infringement and nullity cases mainly involve the production and assessment of documents submitted by the parties and technical evaluations conducted by a court expert. From the start of litigation to the start of expert examination, timelines may vary widely depending on the disposition of the court and the attitude of the parties. Usually, it takes ten to 12 months (for infringement cases) or 14–18 months (for nullity cases) from filing to the beginning of the technical examination. Conversely, if the parties are combative and the court is not as diligent, it may take longer than two years before expert examination is started.

Regarding evidence, the Brazilian CPC authorises parties to submit evidence at any time during the lawsuit, as long as they are able to prove that the evidence is new or that it could not be submitted at a prior stage.

On average, the State Court of São Paulo (which handles nearly 70% of all patent infringement cases in Brazil) takes nearly four years from the filing of the lawsuit to reach a final decision. The Federal Court of Rio de Janeiro, which handles nearly 90% of all nullity actions filed in Brazil, takes nearly five years to issue a decision on the merits.

A patent infringement lawsuit may only be filed once a patent has been granted by the BRPTO. If the patent is not yet granted, the applicant does not have a legally enforceable right, only the “expectation of a right”. As such, applicants must wait until the letters patent is granted before enforcement may occur.

Nevertheless, when an application is eventually granted, Article 44 of the BPS allows the patentee to claim retroactive damages for infringement that took place during the patent’s pendency (ie, when it was still an application), limited by the five-year statute of limitations.

In infringement lawsuits involving process patents, there may be a reversal of the burden of proof. In such cases, the infringer must prove that their process does not infringe the subject matter of the patent.

Alternatively, the judge may choose to reverse the burden of proof pursuant to Article 373, paragraph 1, of the CPC. This may occur when the judge is convinced that the burden of proving infringement would place undue hardship on the patentee and the defendant would be more easily able to prove non-infringement.

There is no procedure such as discovery/disclosure in Brazil, but Brazilian law admits the filing of an action for early production of evidence to ensure the integrity of the evidence to be used in the main action. In this case, Article 381 of the CPC enables the anticipated production of evidence when:

• there is a well-founded fear that it will become impossible or very difficult to verify certain facts pending the action;
• the evidence to be produced is likely to enable self-composition or other appropriate means of conflict resolution; or
• prior knowledge of the facts may justify or prevent the filing of an action.

Discovery proceedings are not available under Brazilian law. However, a patentee may request a search and seizure order from a court to preliminarily halt infringing activity, and to gather evidence for evaluating infringement.

Search and seizure requests are usually formulated as preliminary injunction requests; the same requirements for granting explained in 1.3 Preliminary Injunction Proceedings also apply here. It should also be noted that such request may be presented within the main action or as an independent early production of evidence.

Considering that patent infringement is a crime under Brazilian law, patentees may also seek search and seizure orders from criminal courts. Criminal judges may be more willing to allow the seizure of infringing products, as the Criminal Procedure Code requires the prior investigation of the infringing product to allow the later filing of criminal charges.

Search and seizure orders are usually assessed and granted ex parte. After the court issues the order, a bailiff is designated to carry it out, and the parties must work alongside the bailiff to secure and arrange transportation of the seized materials. Although rare, a judge may also designate a court expert to accompany the plaintiff and bailiff on the search and conduct an on-site examination of the infringing materials.

The evidence produced from a lawfully granted search and seizure is usable in national and foreign proceedings. So long as the applicant proves that the evidence has been legally obtained in Brazil and the foreign procedure allows the use of such evidence, there should be no problem in using it in judicial or arbitral proceedings abroad.

Declaratory relief is allowed under Brazilian law. Pursuant to Article 5 (XXXV) of the Brazilian Constitution, no statute may remove the violation (or threat of violation) of a right from the examination of the Judiciary. In other words, if the rights of a person are under threat of violation, this person may access the court system. Furthermore, according to Article 19 of the CPC, a plaintiff’s legitimate interest may be limited to a declaration of the (in)existence of a legal relationship or the way in which the relationship must be carried out. This would include a declaration of non-infringement or an “arrow” declaration, for example.

To justify standing, it is important for the party seeking declaratory relief to demonstrate that they are legitimately interested in attaining the declaration sought. For example, a party is seeking a declaration of non-infringement should demonstrate that they were targeted with a cease-and-desist letter or a notice of infringement, or even that their clients were contacted by the patentee regarding possible infringement.

Article 186 of the BPS specifically states that a patent is infringed “even if the violation does not affect all the claims of the patent or if it is restricted to the use of means equivalent to the subject matter of the patent”. This provision incorporates the Doctrine of Equivalents into Brazilian law. Although there are no statutorily set criteria for a finding of infringement under the “equivalence” doctrine, courts often use tests found in foreign case law to reach their conclusions; common examples are the US’s three-part test (the Graver Tank standard) or Germany’s “obvious equivalence” tests (the Schneidmesser standard).

Although there is no legal requirement to clear the way ahead of a product’s launch, doing so is certainly advisable. One of the best ways to ensure that the path is clear before product launch is to conduct a Freedom to Operate (FTO) assessment. Through the FTO, a company may find and examine patents (and applications) that are potentially capable of posing problems to the product’s launch. Entering the market without conducting this precaution may expose the company to an avoidable risk of infringement enforcement, including hefty damages and injunctions (both preliminary and final).

Expert evidence is crucial for the determination of infringement/validity issues. It is exceedingly rare for judges to go against the findings of experts.

Considering the highly technical nature of patent disputes in life sciences, judges appoint a court expert to act as an independent technical aid. This court expert may be contested by the parties if their expertise is not ideal for the technical discussion (eg, if a chemist is designated to perform an analysis that is best suited for a biologist) or if there is reason to believe that the expert would not be impartial (eg, previous ties to the parties-in-dispute).

The parties may also engage their own experts to convey their technical arguments to the court expert. There are two main ways to make effective use of technical experts:

• engaging experts to produce their own written reports in support of a party’s claims; or
• retaining experts to act as “technical assistants”, to accompany the court expert’s examination, submit technical questions and comment on the court expert’s conclusions.

The conducting of expert assessments may vary according to the particulars of the dispute. Usually, infringement discussions involve a detailed in-person examination of the accused product. Conversely, disputes regarding validity seldom require in-person examination, relying instead on the review of technical documents.

Expert evidence usually takes the form of a written report containing the expert’s assessment of the subject matter in dispute and a response to the questions posed by the parties. After the expert report is presented, the parties may request clarification and/or present additional questions. It is exceedingly rare for oral depositions and cross-examinations to occur.

On the other hand, when PIs are requested, the production of expert evidence is the exception, not the rule. When assessing requests for PI, judges tend to rely on documents provided by the parties (eg, technical reports, affidavits from technical experts) concerning the technical subject matter. From this cursory examination of the pleadings, the judge decides whether to grant or deny the injunction. In recent years, some judges have started to conduct expedited expert assessments to rule on preliminary injunction requests, but this is still rare.

The presentation of experiments is admissible as evidence under Brazilian Law. This evidence may be presented as a document when produced unilaterally by a party (eg, a patentee conducts their own experiments on the infringing product). Experiments may also be carried out during the court expert examination with the participation of all parties.

When experiments are conducted unilaterally, it is common for the other party to contest the methodology and/or the results attained from the experimentation. When the test is to be carried out by the court expert, litigants often engage in lengthy discussions about the correct methodology for the expert examination. It is also common for the parties’ technical assistants to be present to inspect and intervene during the experimentation by the court expert.

There is no specific procedure to ensure the admissibility of expert results. Nevertheless, parties may use best practices to ensure that their experiments are hard to discredit (eg, ensuring that the acquisition/storage/transportation of tested samples is proper and documented, or providing evidence that the methodology employed is the best available).

Discovery proceedings are not allowed under Brazilian law. Under the general rule, the plaintiff bears the burden of proving their claims, and the defendant bears the burden of proving their defences.

Nevertheless, under certain conditions, judges may shift the burden of proof onto the defendant. For example, when a patent covers a process, the BPS (Article 42, Section 2) dictates that it is the burden of the defendant to prove that their process differs from the one protected by the patent. Moreover, under the CPC (Article 373, Section 1), the burden of proof may be shifted onto the defendant if the judge finds that it would be impossible or unduly difficult for the claimant to produce this evidence. A judge may also shift the burden of proof if he or she deems that it would be easier for the evidence to be produced by the defendant than the plaintiff.

Article 43 of the BPS provides a set of seven exceptions that serve as affirmative defences to patent infringement. These exceptions cover:

• private and non-commercial uses that are not harmful to the legitimate interests of the patentee;
• experimental uses for technological/scientific research;
• preparing medication according to medical prescriptions for individual cases;
• products placed in the internal market directly by the patentee or with their authorisation (ie, exhaustion);
• third parties that, in the case of patents related to living matter, use the patented product as the initial source of variation or propagation for obtaining other products, without economic ends;
• third parties that, in the case of patents related to living matter, use, place in circulation or commercialise a patented product that has been introduced lawfully onto the market by the patentee or authorised parties, provided that the patented product is not used for commercial multiplication or propagation of the living matter; and
• acts practised by unauthorised third parties relating to the patented invention carried out exclusively to produce information, data and test results to seek market approval in Brazil or abroad, in order to exploit or commercialise the patented product after expiry of the patent term (ie, Bolar exception).

The law also provides a few other exceptions to patent protection, such as the prior use exception (Article 45 of the BPS) and the opportunity to claim patent invalidity as a means of defence (Article 56, Section 1º of the BPS).

Compulsory licences are also available (per Article 68 et seq of the BPS) if statutorily set criteria are met (eg, if the patentee engages in patent misuse, or if the commercialisation is not sufficient to meet market needs) and after a specific process is started at the discretionary authority of the chief of the Executive Branch. Nevertheless, the award of compulsory licences is exceedingly rare and may be dismissed if the patentee provides one of the following three justifications:

• lack of use occurs for legitimate reasons;
• there are serious and effective efforts in place to prepare for commercialisation; or
• lack of manufacture/commercialisation is due to a legal impediment.

State court judges have discretion on whether to stay infringement proceedings when parallel patent nullity proceedings are initiated before federal courts. Recent rulings by the Superior Court of Justice seem to favour the stay of infringement discussions while nullity proceedings are underway (unless the finding for infringement has already been issued when the stay is requested – per Motion for Clarification on Appeal #1,558,149/SP), but this guidance is not binding on lower courts. Therefore, state judges’ discretion on the issue is still wide.

Nevertheless, there is no stay if the invalidity proceedings are underway in foreign courts referring to foreign counterparts of national patents. According to Article 24 of the CPC, foreign lawsuits do not constitute lis pendens unless a treaty demands local cases to be halted while foreign proceedings are ongoing.

After being granted, patents may not be voluntarily amended, but they may undergo amendments as a result of administrative or judicial nullity proceedings. When a court or a reviewing body of the BRPTO finds that a patent is partially valid, the decision will propose amendments restricting the scope of the patent in order to meet patentability requirements.

While forum shopping is not allowed under Brazilian law, patent litigants have some leeway to direct their cases to specialised judges.

In infringement proceedings, lawsuits must be directed to the place of the defendant’s domicile (per Article 46 of the CPC) or to the place where infringement occurred (per Article 53 of the CPC). If infringement is widespread throughout Brazil, some courts welcome plaintiffs’ choice in where to hold lawsuits.

Regarding nullity disputes, lawsuits may be filed in the place of the plaintiff’s headquarters, but it is far more common to direct lawsuits to the federal courts of Rio de Janeiro or Brasília, where the BRPTO has standing offices and the courts are used to hearing complex IP cases.

Sophisticated patent litigants tend to prefer the specialised state courts found in São Paulo or Rio de Janeiro for infringement litigation. Both jurisdictions have trial courts specialised in business law, with judges who are veterans in intellectual property matters. São Paulo also boasts two specialised appellate panels for business law that hear appeals in IP infringement cases.

For nullity proceedings, patent litigants mostly choose Rio de Janeiro or Brasília’s federal courts. Both jurisdictions have trial courts specialising in IP issues, with Brasília being a more recent venue in specialising. Rio de Janeiro also has two specialised appellate panels for IP nullity cases.

Articles 42, 183 and 184 of the BPS award patentees the right to enjoin unauthorised third parties from engaging in many infringing acts, such as:

• making;
• using;
• offering for sale;
• selling;
• importing;
• exporting;
• maintaining stock; or
• receiving for commercial purposes.

Some acts of infringement (eg, preparatory acts for attaining market authorisation) are exempt under Article 43 of the BPS (see 1.15 Defences and Exceptions to Patent Infringement).

Nevertheless, market authorisations attained well before patent expiry may be targeted for enforcement, as the renewal of market authorisation requires actual commercialisation of the product. Other commercial acts – such as offers for tender/supplying patented products – constitute acts of infringement that may be enjoined by a patentee.

The possibility of skinny labelling in Brazil is still uncertain. While the Brazilian Food and Drug Authority (ANVISA) has authorised the practice, some court decisions have noted that skinny labelling does not excuse the practice of infringing acts. This discussion is ongoing in the Judiciary.

Regulatory Data Protection (RDP) is applicable in Brazil under Article 39.3 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Moreover, Statute #10,603/02 institutes specific rules governing RDP under Brazilian law, albeit expressly excluding pharmaceutical products for human use (which means the enforcement and implementation thereof currently lack regulation in Brazil).

Under Statute #10,603/02, RDP may be awarded to pharmaceutical products for veterinary use, agrochemicals and its components, fertilisers and bioinputs, for different periods depending on the product to which they refer (all of which are counted from the award of market authorisation):

• ten years for products using new chemical/biological entities; or
• five years for products not using new chemical/biological entities.

These terms may be shortened if the test data is released anywhere, in which case the applicant is entitled to enjoin a minimum one-year term of RDP.

New data required by regulatory agencies after registration of products using or not using new chemical/biological entities will also be protected for the same term awarded to the product. If the term has already expired, the new test data will be protected for the one-year minimum term.

Although Statute #10,603/02 institutes RDP for a wide range of life sciences products (eg, agrochemicals, fertilisers), the statutory text carves out an exception for pharmaceutical products destined for human use.

Article 43 of the BPS establishes exemptions for infringing acts that are exclusively aimed at producing information, data and test results to attain market authorisation (ie, Bolar exemption) and non-commercial acts directed at experiments, studies and scientific research. For more information on the exemptions allowed under Brazilian law, see 1.15 Defences and Exceptions to Patent Infringement.

Brazil does not have an Orange Book equivalent. ANVISA publishes information concerning new market authorisations (MA) and market authorisation applications (MAA) on its official website and on the National Official Gazette. However, MA holders are not notified of other MA or MAA for similar/generic products, so interested parties should be ever vigilant and set up monitoring practices in Brazil to obtain a comprehensive outlook on the market scenario.

Brazil does not have a patent linkage system. MA decisions and decisions on pricing and reimbursement are made irrespective of patent status.

Pricing regulation for drugs is conducted by the Drug Market Regulation Chamber (CMED), which is responsible for setting maximum drug prices for retail markets, government purchases and consumers. Regulation for prices relies on a six-tier classification established by CMED’s Resolution No 2/2004, based on which the CMED establishes rules for pricing (eg, prices for generic medicines may not surpass 65% of the reference medicine’s price).

The same considerations as discussed in 2.1 Infringing Acts apply also to biologics or biosimilar patents.

The same considerations discussed in 2.2 Data and Regulatory Exclusivity also apply here.

The same considerations discussed in 2.3 Acceptable Pre-Launch Preparations also apply here.

The same considerations discussed in 2.4 Publicly Available Drug and Patent Information also apply here.

The same considerations discussed in 2.5 Reimbursement and Pricing/Linkage Markets also apply here.

Supplementary Protection Certificates (SPCs) are currently not available under Brazilian law. However, there is active ongoing debate and litigation involving the possibility of awarding Patent Term Adjustment (PTA) due to delays by the BRPTO in examining patent applications.

Until 2021, patent applicants in Brazil enjoyed a minimum ten-year patent term (counted from date of grant). This mechanism acted as a safeguard for applicants against the BRPTO’s notable backlog and delay in examination – a reality that has been mitigated in the last few years.

In May 2021, the Federal Supreme Court (STF) declared this safeguard to be incompatible with the Brazilian Constitution and the respective section of the BPS was later revoked by the Congress. The STF’s decision had prospective effects for most patents (ie, the minimum ten-year term would still apply for patents already granted) but made a notable exception for patents relating to technologies used in healthcare. Thus, many patents related to pharmaceuticals and medical devices had their terms shortened significantly. This led to a wave of litigation requesting compensation for the patent term unduly lost due to the BRPTO’s inactivity in means of term of protection equivalent to the loss in protection time.

These lawsuits were – and still are – the target of broad legal discussion and media attention. Plenty of rulings were handed down to award or deny preliminary injunction requests. After initial negative results for PTA plaintiffs, 2025 saw the first trial court decisions affirming plaintiffs’ requests for term compensation.

Brazil does not allow paediatric extensions for intellectual property rights.

Brazil does not provide specific rules for market authorisations in case of paediatric medicines.

Brazil does not allow orphan medicine extensions for intellectual property rights.

Preliminary injunctions are available in Brazil and may be requested in the same proceedings in which final relief is sought. If awarded, a PI may remain in force throughout the pendency of the legal proceedings or until a new decision by the trial or appellate court revokes it.

To attain a PI, a litigant must demonstrate that three conditions are simultaneously met:

• the claimant is likely to succeed in its claims;
• there is urgency in the relief (ie, the injunction) being sought, as, without it, the claimant may suffer harm or the lawsuit may lose its purpose; and
• the party that will be targeted by the injunction may not run the risk of suffering irreversible harm.

Although rare, a judge may demand the party seeking the PI to post a bond to ensure that the harm suffered by the other party may be compensated if the injunctive relief is later found to have been improper.

After a PI is awarded, the relief is enforceable upon publication of the decision granting the injunction. Parties are expected to comply immediately with the injunctive order and may be subject to daily fines for non-compliance.

Although very rare, there have been cases in which a PI was substituted in favour of a bond or a periodic court deposit based on the sales of the infringing activity.

Parties targeted with a PI may file an interlocutory appeal with a specific request to stay the effects of the injunctive relief. To demonstrate that a stay is warranted, an accused infringer must show that:

• the PI request did not meet one or more of its requirements; and
• the party targeted by the preliminary injunction is exposed to urgent and potentially irreparable harm if the stay is not granted.

Final injunctions are enforceable from the publication of the decision that issues the relief. The date of publication also marks the start of the 15-day deadline for filing an appeal (counted in business days).

Generally, final injunctions are immediately enforceable after the publication of the decision. If the court recognises that compliance with the injunction will involve significant effort, the decision may stipulate an additional timeframe for compliance with the injunctive order.

An infringer that was targeted by an injunction is expected to comply with the court’s order immediately. If the infringer fails to comply with the injunctive order, courts may impose daily fines to encourage compliance. Should the party fail to comply with the court order, other harsher measures may be imposed (eg, seizure of assets).

It is possible to attain a stay of the final injunction by filing an appeal. In most cases, the act of filing an appeal will automatically stay the final injunction. Nevertheless, if certain conditions are met (eg, if the trial court’s verdict confirms a PI that was awarded beforehand), the final injunction is immediately enforceable even if an appeal is filed.

If the final injunction is immediately enforceable, the infringer may file a request for the appellate court to lift the injunction throughout the pendency of the appeal. In this scenario, the infringer must demonstrate that:

• their appeal is likely to succeed; and
• the injunction’s effects are potentially irreversible or pose risk of grievous harm.

Unlike other jurisdictions, if a patent is found valid and infringed in Brazil, an injunction is the appropriate remedy provided by statute. Unless the patent has expired by the time infringement is found, a Brazilian court is expected to award injunctive relief.

In very rare cases, PIs have been substituted in favour of the payment of hefty court bonds or periodic court deposits based on sales of the accused product. Nevertheless, if a court issues a final ruling for infringement, a final injunction is expected.

Two forms of damages are allowed under Brazilian law:

• actual damages; and
• moral/reputational damages.

Both forms of damages are often requested and awarded in intellectual property life sciences cases. Punitive/enhanced damages (eg, wilful infringement) are not allowed.

Article 210 of the BPS designates that actual damages must be calculated according to whichever of the following three criteria is most beneficial to the patentee:

• the amount the patentee would have accrued if infringement had not occurred;
• the amount won by the infringer through the infringing activity; or
• the amount the infringer would have paid to the patentee as a reasonable licence.

There are no treble damages or wilful infringement in Brazil, nor punitive damages; therefore, indemnifications are usually in low amounts that are not sufficient to tackle the actual damages supported by the patentee due to the infringement acts.

On the other hand, moral/reputational damages are not based on strict parameters. Judges have broad discretion to set these awards based on the financial situation of each party and the extension of harm caused by the infringing acts.

After there is a finding of infringement, the prevailing party may initiate a new proceeding to calculate the appropriate damages award. The court then appoints an accounting expert to calculate the relevant amount owed. The parties are expected to intervene in this quantification phase and may designate their own accounting assistants and submit questions to the court expert. This calculation will also account for monetary adjustment as appropriate considering the date on which infringement took place.

If an accused infringer that has been targeted by enforcement action (eg, through preliminary injunctive relief) prevails in their defence, they may request damages from the patentee. This claim for damages is specifically allowed under Article 302 of the CPC.

If third parties (ie, parties that were not directly targeted by infringement lawsuits) are affected by wrongful enforcement, they may seek damages through separate proceedings, although this is very rare. In this scenario, the parties claiming damages must demonstrate:

• the harm they suffered;
• the existence of an unlawful act by the patentee; and
• the causal link between the unlawful act and the harm.

Under Brazilian law, some legal costs are recoverable, while others are not. The relevant provisions are found in Article 82 et seq of the CPC.

Specifically, a successful litigant (plaintiff or defendant) may recover the following costs upon prevailing in the lawsuit:

• court costs (eg, filing fees, court expert fees);
• travel costs (eg, travelling for in-person hearings);
• technical assistance costs (eg, fees owed to a party’s technical assistant); and
• daily stipends for witnesses (eg, expenses incurred to ensure the participation of witnesses in the proceedings).

Legal costs associated with hiring and retaining lawyers are not recoverable by the prevailing party, but the defeated party (plaintiff or defendant) must pay 10% to 20% of the claim’s value to the prevailing party’s attorneys. This amount is not paid to the successful party: it is owed directly to the attorneys of the prevailing party as a form of “award” for succeeding in the lawsuit

Although Brazil does not establish pre-litigation conditions for the plaintiff (eg, a requirement to engage in pre-action correspondence), prospective claimants may benefit from being mindful of the following issues:

• plaintiffs who take a long time to file claims against infringement are less likely to attain PIs and other forms of interim relief, considering that “urgency” is an important requirement when assessing these requests;
• the Administrative Council for Economic Defence (CADE) is the Brazilian antitrust authority and may take action against plaintiffs engaging in patent misuse and sham litigation (eg, levying fines and other sanctions); and
• courts may levy fines against bad-faith litigants who engage in conduct detrimental to the lawsuit (eg, making false representations, unjustifiably delaying proceedings, producing baseless filings).

Trade mark disputes are common in the life sciences. Courts are often called upon to decide on infringement disputes, which are not limited to controversies over product naming, but also encompass presentation and trade dress concerns. Moreover, given the public interest issues inherent to the life sciences industry, judges tend to be stricter when assessing the risk of consumer error in a trade mark case.

The governing law for trade marks is found in the BPS. However, life science trade marks are subject to additional regulatory scrutiny by ANVISA, as established in Statute #6,360/76. According to Article 5 of said statute, products regulated under health vigilance rules may not be marked with names, labels or packages that may induce consumer error.

To ensure compliance, ANVISA has established an examination procedure to approve commercial names for regulated products. This procedure is regulated by a few internal rules, the most important of these being Collegiate Directorate Ordinance (RDC) #59/14, further clarified by Service Ordinance (OS) #43/17. The steps carried out by ANVISA in this examination involve checking many criteria, with the overall goal of preventing consumer error.

Copyright disputes are rare in the life sciences industry in Brazil, and they are often presented in conjunction with unfair competition claims.

Usually, trade secrets in the life sciences industry are handled by Brazilian law through one of two pathways: (i) rules against unfair competition or (ii) RDP rules.

In the first case, the violation of a trade secret must fall within one of the 14 hypotheses established in Article 195 of the BPS. The most common grounds raised in such cases are:

• using fraudulent means to garner another’s clientele (Article 195, III); or
• disclosing, exploiting or using, without authorisation, any knowledge that was attained through employment or a contractual relationship (Article 195, XI) or through fraud or other illegal means (Article XII).

See 2.2 Regulatory Data and Market Exclusivity for a more thorough analysis of the role of RDP in protecting trade secrets.

A final decision on the merits issued by a trial court is always appealable. However, further appeals to the superior courts are not automatically admitted and are subject to strict criteria for evaluating appealability. Appeals in infringement lawsuits are assessed by a state court of appeals (one for each state and the Federal District), while invalidity lawsuits are directed to a federal court of appeals (which is divided into six circuits).

A final decision on the merits may be appealed within 15 business days from publication. Timelines for judging this appeal may vary by case and court. A very quick decision may be rendered in three months from appeal; but slower cases may take as long as 11 months or more.

Generally, appeals are heard by a panel of three judges. If the court is split, an expanded judgment is called for. In this scenario, new appellate judges are called on to hear the appeal and aid in reaching a definitive result. Furthermore, no new issues of law or fact may be presented on appeal if they were not presented in the earlier trial (except if the issue is new or could not have been previously known).

Interlocutory Appeals

Interlocutory appeals are also allowed against decisions rendered during trial (eg, when a preliminary injunction is granted or rejected). These interlocutory appeals may be lodged within the same 15-day timeframe. Timelines for interlocutory appeals also vary widely. A quick decision may come within three months, while a slower ruling can take six months or more. If there is urgency, an appellant may request a stay of the appealed decision while the parties await the decision of the appellate court.

If an interlocutory appeal is filed against a decision granting/rejecting a preliminary injunction, an appellant must demonstrate that the statutory criteria are met (see 1.3 Preliminary Injunction Proceedings). If a patent is revoked by a decision that is effective immediately, the grounds for injunction are removed. Nevertheless, it is good practice to inform the court of the revocation and arrange a meeting with the judge to confirm that the injunction is no longer in place.

As discussed in 7.1 Timeframe to Appeal Decision, the panel of appellate judges that will hear a given case may vary according to the nature of the dispute (ie, infringement or invalidity) and the territorial jurisdiction.

Moreover, while some appellate courts have specialised judges, most Brazilian courts do not. For a more thorough discussion of this issue, see 1.18 Court Arbiter.

Claims related to IP follow the specific procedures set out in the BPS, for industrial property claims, or Statute #9,610/98 (the Copyright Statute) if the claim relates to copyright. If there are no special provisions in these statutes, intellectual property claims are processed under the general rules of the CPC, if it is a civil claim, or the CPP, if it is a criminal claim.

The most common venue for infringement disputes is the court system. However, parties may also take action before customs authorities, as authorised by Section 4 of the TRIPS Agreement (border measures). Under certain conditions, parties may also take action before the national health authority (ANVISA) to gather information on parties possibly engaging in infringing activity.

While ADR is available under Brazilian Law (see Statute #9,307/96), and there are arbitration chambers specialised in IP (eg, Carb-ABPI, of the Brazilian Intellectual Property Association), it is uncommon for IP disputes to go to arbitration or mediation. Moreover, courts may not mandate parties to engage in arbitration but may designate a mediation/conciliation hearing.

In Brazil, pharmaceutical and biopharmaceutical settlements and co-operation agreements are subject to heightened antitrust scrutiny by CADE due to the sector’s economic, regulatory and technological specificities. CADE may assess such agreements as potentially anticompetitive conduct, particularly where they involve exclusivity, non-compete clauses, sensitive co-operation between competitors, or information exchanges. Or, when they entail the transfer of strategic assets, such as patents, commercialisation rights, or R&D pipelines, it may view them as merger control matters. CADE also aligns with international practice by closely examining the impacts on future competition and innovation, including pipeline markets, and frequently imposes behavioural or structural remedies in complex cases.

Collective redress is available in Brazil if a claim is one that may be made by multiple people who can be joined together to advance that claim in court. Such collective redress is often found in cases related to environmental harm, consumer complaints, and – in some cases – life sciences litigation. Common claimants in these cases are public entities (eg, environmental protection agencies), consumer welfare organisations and other associations.

The most common means to advance a claim of collective redress is through a Public Civil Action (ACP), as established by Statute #7,347/85. In an ACP, public entities and private associations are able to file claims for moral and actual damages related to collective rights. In the life sciences sector, such harm may include defective or mislabelled products as well as other forms of collective harm that may arise in the life sciences industry, such as environmental harm due to a faulty chemical processing plant.

Specifically in the consumer context, collective redress is also authorised by Statute #8,078/90 (Consumer Defence Code – CDC). The CDC authorises individual or collective action in defence of consumers and victims of faulty products for a number of collective claims. In the life sciences industry, these claims may involve, for example, discriminatory practices in the healthcare sector.