StemCell Therapy

What are the criteria for patentability in your jurisdiction?

A creation must first be considered an invention or utility model. There is no statutory definition of invention, although the Brazilian Patent Statute does provide a list of what is not an invention. A utility model, on the other hand, is defined as an object of practical use or a part thereof.

To be patentable, an invention must meet the requirements of novelty, inventiveness and industrial applicability. Utility models share the same requirements of novelty and industrial applicability, but the level of inventiveness required for utility models is lower than that required for inventions.

What are the limits on patentability?

The Patent Statute stipulates that the following are not considered to be inventions or utility models and are therefore unpatentable:

To what extent can inventions covering software be patented?

Only the softwareper se that is, the source code is excluded from patentability. Any technical result obtained from a given software can be patented (eg, a method carried out by software instructions and systems or devices affected by software instructions). The Brazilian Patent and Trademark Office (BPTO) Examination Guidelines state:

An industrial creation process or product associated with the process implemented by a computer program, which solves a problem found in the technique not solely concerning the way in which this computer program is written, can be considered an invention.

To what extent can inventions covering business methods be patented?

Business methodsper seare not patentable. However, the simple fact that a method has a commercial nature does not necessarily render it ineligible for patent protection. The claimed matter must be analysed as a whole, particularly if it solves a technical problem. For example, a method for authenticating a user for a financial transaction and a method for increasing the security of bank accounts both constitute patentable subject matter.

To what extent can inventions relating to stem cells be patented?

Stem cells are not eligible for patent protection a claim directed to a stem cell in its preamble will be rejected. Natural living beings (eg, animals), in whole or in part (eg, cells), are excluded from patentability even if they are in modified or recombinant form. Therefore, cells derived from animals are not considered to be inventions in Brazil.

However, compositions containing stem cells, the processes of obtaining stem cells and applications (ie, uses) thereof may be patentable if they do not imply or include a therapeutic or surgical method.

Are there restrictions on any other kinds of invention?

Yes, the Patent Statue sets out additional limitations on patentable subject matter. The following are not patentable:

Grace period

Does your jurisdiction have a grace period? If so, how does it work?

Yes. Any disclosure of the invention or the utility model made within one year before filing the application in Brazil or the priority date claimed will not be considered as a prior art reference, provided that such disclosure is made by:

Oppositions

What types of patent opposition procedure are available in your jurisdiction?

Pre-grant and post-grant oppositions are available. Pre-grant oppositions essentially entail submitting observations up to the end of the patent application examination period. It is not a formal opposition procedure, inasmuch as the applicant is not obliged to submit a response. The BPTO examiner will take into account any submitted observations during the substantive examination phase. Post-grant oppositions, on the other hand, must be formally commenced by a party with a legitimate interest within six months from grant. The patentee will be notified to respond within 60 days, after which a first opinion from the BPTO concerning the nullity request will be issued. Both parties will then have 60 days to submit their final considerations.

Apart from oppositions, are there any other ways to challenge a patent outside the courts?

Yes. If a patent application is rejected after substantive examination and the applicant decides to appeal, it is possible for a third party to submit counterarguments to the appeal within 60 days of its publication.

How can patent office decisions be appealed in your jurisdiction?

Before the BPTO or the courts.

Timescale and costs

How long should an applicant expect to wait before being granted a patent and what level of cost should it budget for?

The average backlog at the BPTO is around 11 years. This timeframe may increase, depending on the technical nature of the application (eg, backlogs for telecoms and pharmaceutical applications can extend up to 15 years). In view of this, applicants should consider using some of the fast-track options available. Costs will depend on the complexity of each matter, but applicants should budget $10,000 on average.

Enforcement through the courts

Strategy

What are the most effective ways for a patent owner to enforce its rights in your jurisdiction?

Filing an infringement suit before a state trial court is the best way to enforce patent rights in Brazil. The patent owner can request the court to grant preliminary injunctive relief against the infringer. In practice, the legal standards for obtaining injunctions are relatively low when compared to other jurisdictions, since there is no need to give notice to the defendant or to post a bond or give security, and typically there are no discussions regarding the balance of hardships or public interest. This makes Brazil an attractive jurisdiction for patent owners seeking to enforce their rights.

What scope is there for forum selection?

As a general rule, the plaintiff must file the suit before the state trial court of the venue where the infringer is headquartered. Nevertheless, patent infringement suits in which damages are claimed alongside restraining orders may be filed wherever the infringement is taking place or even where the plaintiff resides.

Pre-trial

What are the stages in the litigation process leading up to a full trial?

First, there is a mandatory conciliation hearing as an attempt at alternative dispute resolution, unless both parties indicate that they have no interest in doing so. Thereafter, if no agreement is reached, the parties are entitled to file briefs with their arguments and to present documents in support of their case. At this stage, it is common to file technical and legal opinions prepared by renowned scholars or experts in their respective fields. Next, the judge decides on the controversies that need to be resolved and an unbiased court-appointed expert prepares a technical report regarding the case. Courts typically rely on the technical report prepared by the court-appointed expert. After this, the parties can file briefs in response to the technical report prepared by the court-appointed expert and can present final arguments. Finally, the judge in charge of the case issues a decision on the merits (bench trial).

How easy is it for defendants to delay proceedings and how can plaintiffs prevent them from doing so?

Most of the delay depends on the judges schedule and willingness to rule on the case. Another factor is the time that it takes the court-appointed expert to deliver the technical report. Defendants often try to delay the proceedings by filing pointless motions, unnecessary questions for the courts expert or unnecessary interlocutory appeals. However, the new Federal Rules of Civil Procedure (adopted in 2015) provide parties fewer appeal opportunities, which makes delaying attempts less effective. Also, it is now harder to delay the proceedings because such attempts may be punished by a court-issued fine. Nevertheless, if the plaintiff can obtain preliminary injunctive relief, the defendant will have no interest in delaying the procedure.

How might a party challenge the validity of a patent through the courts in anticipation of a potential suit for infringement being issued against it?

Brazil has a bifurcated system (similar to the German and Japanese systems) whereby invalidity suits must be filed in separate court proceedings before federal district courts (while infringement actions are filed before state trial courts).

At trial

What level of expertise can a patent owner expect from the courts?

Most patent-related cases are filed before the courts sitting in Rio de Janeiro, Sao Paulo and Brasilia. Except for certain judges in these jurisdictions, most Brazilian courts have no expertise in patent law.

Are cases decided by one judge, a panel of judges or a jury?

Cases are decided by a single judge at the first-instance trial level and by a panel of appellate court judges at the appellate level. Juries do not decide IP-related disputes in Brazil.

If jury trials do exist, what is the process for deciding whether a case should be put to a jury?

Not applicable.

What role can and do expert witnesses play in proceedings?

Expert witnesses play a key role in convincing the judge to grant or reject a request for preliminary injunctive relief. Moreover, they work with the unbiased court-appointed expert during the expert examination, addressing questions to him or her and delivering opinions on his or her technical report.

Does your jurisdiction apply a doctrine of equivalents and, if so, how?

Yes, the Patent Statute provides for patent infringement on an equivalence of means basis. However, it does not set out the criteria for applying the doctrine of equivalents and there is no binding precedent establishing a test or standard for applying the doctrine.

Is it possible to obtain preliminary injunctions? If so, under what circumstances?

Yes. The legal requirements for obtaining injunctions arefumus boni juris(ie, there is a likelihood of the complaint being decided in favour of the plaintiff) andpericuluminmora(ie, immediate measures are needed to cease the infringement and thus prevent the plaintiff from bearing further damages).

How are issues around infringement and validity treated in your jurisdiction?

Infringement suits must be brought before state courts, while invalidity suits must be brought before federal courts against both the patent owner and the Brazilian Patent and Trademark Office.

Will courts consider decisions in cases involving similar issues from other jurisdictions?

Attorneys typically quote foreign precedents in support of their arguments, particularly when there is no Brazilian precedent or rule dealing with the issue. However, judges rarely cite foreign cases or rely on them to ground their own decisions.

Damages and remedies

Can the successful party obtain costs from the losing party?

The prevailing party may recover a small part of the attorneys fees, in addition to court costs and the fees charged by the court-appointed expert.

What are the typical remedies granted to a successful plaintiff?

A permanent injunction preventing the defendant from using the claimed technology and damages.

How are damages awards calculated? Are punitive damages available?

Damages are calculated based on:

The basis chosen for damages calculation depends on what works best for the plaintiff. There are no statutory punitive damages and such requests are usually rejected pursuant to case law.

How common is it for courts to grant permanent injunctions to successful plaintiffs and under what circumstances will they do this?

Courts often grant permanent injunctions whenever the final ruling favours the rights holder.

Timescale and costs

How long does it take to obtain a decision at first instance and is it possible to expedite this process?

Most courts take approximately three years to issue a first-instance decision on the merits. The timescale depends on the judges schedule and willingness to rule on the case, as well as on how long the court-appointed expert takes to prepare and present his or her technical report.

How much should a litigant plan to pay to take a case through to a first-instance decision?

Costs vary significantly according to the case, but a litigant should expect to spend at least $200,000 from the beginning of the case until a first-instance decision on the merits, including legal fees, court costs and fees charged by the court-appointed expert.

Appeal

Under what circumstances will the losing party in a first-instance case be granted the right to appeal? How long does an appeal typically take?

The defeated party is always entitled to appeal the decision. A ruling by the court of appeals usually takes up to three years.

Options away from court

Are there other dispute resolution options open to parties that believe their patents to be infringed outside the courts?

Alternative dispute resolution methods are available, but they are not relevant to most patent infringement cases.

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Patents in Brazil - Lexology (registration)

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