Brazil's medical device market is experiencing rapid growth, It attracts billions of dollars in imports each year, however, The boom is not just attracting legitimate businesses, It also attracts businesses that want to exploit loopholes.

Brazil's average annual import value exceeds67A billion dollar product, Annual roll-out1. 4Ten thousand new products. One example is, As the number of bariatric surgeries increases, Sales of endoscopic surgical equipment are also increasing, The number of operations per year has exceeded7Ten thousand cases.

Regulatory change

At the same time, Brazil's regulatory framework for medical devices is also evolving, To simplify and reduce cumbersome procedures. This attracts legitimate businesses at the same time, It also creates opportunities for those willing to exploit the loopholes. Foreign companies are increasingly taking advantage of Brazil's simplified regulatory framework to gain market access, At the same time, some companies began to infringe others' intellectual property rights.

Such as, Brazilian health regulatory agencyANVISAreleased2022Year control751Resolution Nos, The resolution is2023years3Effective January, Based on medical devices to consumers, patient, The degree of intensive risk to the health of the operator or associated third parties, Divide it intoI, II, IIIorIVclass.

All non-invasive medical devices fall under the NoIclass, Except for storing or transporting blood, Body fluid or tissue, For infusion, Devices that administer drugs or introduce fluids or gases into the body are part of the NoIIclass. In addition, The vast majority of surgical invasive medical devices used for short periods of time belong to the firstIIclass.

The categories in the risk category are correlated, Because it determines which regulatory procedures the device will be subject to. Belong toIStage sumIIMedical devices with grade A risk must be declared, Belong toIIIStage sumIVMedical devices with a level of risk must be registered.

The declaration process is much simpler, Just submit the declaration form, Declaration issued by the manufacturer of imported products, Certificate of conformity and proof of compliance with the legal provisions defined in the technical regulations. The most relevant point about the reporting system is this, There is no need to submit clinical study results, It is also not necessary to submit clinical evidence of safety and efficacy.

Only in the following circumstances, Results of clinical studies conducted specifically for products to be registered or for institutional notification are required, To demonstrate the safety and effectiveness of the product: (a) Innovative medical device, Whatever its risk level (design, Raw material, Innovations in the use of indicators) ; or (b) The risk level isIIIandIVMedical device, Due to its unique properties and properties, it is closely related to material design and manufacturing processes, Specific clinical data on the applied product is required to verify its safety and efficacy.

Although these regulatory developments have helped to increase the attractiveness and competitiveness of the Brazilian market, But it has also attracted companies that engage in unfair competitive practices, They use the ease of market access to exploit the intellectual property of others.

Development of design case law

therefore, With the rapid development of economy, Medical device intellectual property litigation has also increased. The size of the market has attracted the interest of innovative companies, Brazil is emerging as an important jurisdiction for enforcing intellectual property rights and a strong patent portfolio.

In addition, You can also see, When protecting critical innovative products, There is an interesting interplay between patents and designs. Companies dedicated to research in this field invest heavily in the development of innovative industrial designs, In addition to developing state-of-the-art technologies that improve the stability and accuracy of multiple medical procedures, These designs incorporate a variety of ergonomic and functional features. Take into account the sensitivity of each product developed and the consumer's trust in the devices used, Every company needs to establish a loud and reliable brand in the market, This makes protective measures such as commercial appearance extremely important for these manufacturers.

This forced the court into a different type of industrial property law——Invention patent, Industrial designs and commercial designs——Develop strong and clear case law. At present, Brazilian courts are facing this challenge.

Main case

2017years, A court in Sao Paulo state has upheld a trial verdict, determineGrandesc Materials HospitalaresviolatedBio Brasil Tecnologia ( "Bio Brasil" ) Holds industrial design registration rights for infectious and sharp waste disposal boxes used in medical and dental facilities. Bio BrasilFile a complaint with the High Court, The High Court quashed the decision of the Sao Paulo state court, It orders the State court to evaluate Appellant's defense that the industrial design registration is invalid. however, in2022When the appellant's defense arguments were reevaluated, The Sao Paulo state court stood by its position, On the basis of "Patent law" Regulation of, There is no record of annulment of industrial designs in independent action in federal court, And except that state courts have no jurisdiction to hear matters relating to the invalidity of the registration of industrial designs, The Appellant also failed to provide sufficient documentary evidence to convince the court that the registration was invalid, So the infringement judgment was again upheld. At present, The lawsuit went back to the High Court.

At present, The Sao Paulo State court is about to beEdward LifesciencesprosecuteEndolife ImportaçãoExpert evidence presented in a lawsuit violating the commercial appearance of a balloon dilated transcatheter heart valve is debated.

Brazilian case law on trade appearance is very new, There are even updates in medical device cases, Subsequent decisions will therefore provide information on the court's position, And add new content to the industry's exploration of Brazil's defense mechanisms. Late last year, The court also granted a preliminary injunction, prohibitPro-Tech Industria de Equipamentos de Proteção Ltda. Continued production and sale of suspected violations3M Innovative PropertiesThe company's patented maintenance-free respirator. [The case seeks an injunction, The defendant must immediately cease production and sale in any form or by any meansP1004V (S) andP1004 (S) respirator. ]

Another notable example is the Sao Paulo State Court in2024The trial verdict was handed down earlier this year.

The court approvedJohnson&Johnson do Brasil LTDA ( "Johnson&Johnson" ) Aim atScitech Medical Products Ltd. ( "Scitech" ) A request for a permanent injunction, The request relates to medical device patents and designs for surgical sutures. The background to this lawsuit is interesting.

2021years12month, Cilag Gmbh International, Ethicon Endo-Surgery INC. andJohnson&Johnson do Brasil LTDArightScitech Medical Products Ltd. Initiate infringement proceedings, Accused of copying the design and patented technology of their surgical sutures. They demandScitechStop selling infringing products and pay damages. ScitechIs a local medical device manufacturer with a large presence in the Brazilian market.

A Sao Paulo state court judge initially granted a temporary injunction (preliminary injunction) , But an appeals court overturned the decision, Considering that the plaintiff was aware of the alleged infringement a year ago, So there is no direct harm to justify injunctive relief.

After the evidence stage, A court-appointed expert came to a conclusion, ScitechThe weight loss suture machine violatedJohnson&JohnsonPatents and industrial designs. Experts believe thatScitechThe suturing apparatus has all the technical and functional features of the Plaintiff's invention. The expert concluded that the plaintiff's industrial design had been infringed, Because the decorative features of the product are closer to the object of industrial design registration protection than the prior art.

As a defense, ScitechAttempted to argue to the State Court of Sao Paulo that the plaintiff's patents and industrial designs were invalid. At the same time, At the beginning of infringement proceedings18Months Later, ScitechTwo separate lawsuits were filed in the federal court of Rio de Janeiro. The lawsuits seek to invalidate patents and industrial designs. ScitechAsk the court for a temporary injunction, Suspend the implementation of patents and industrial designs, Thus effectively preventing the final ruling of the infringement case. however, The federal court in Rio de Janeiro rejected itScitechRequest of, As a result ofScitechThere is no proven likelihood of success.

2023years7month, The expert report is released4Months Later, The judge presiding over the infringement case approved the expert's report, And dismissedScitechAdditional clarification of the issue, Pushing the lawsuit to trial.

2024years1month16day, Johnson&JohnsonReceived the first trial verdict of the year in favor of its medical device company in Brazil. The Sao Paulo court issued a ruling againstScitechPermanent injunction, Confirm the infringement of patents and industrial designs, And ordered the recall of all infringing products currently in circulation on the market. The court also awardedJohnson&JohnsonObtain compensation for material losses, The exact amount will be assessed later in the trial. The court said: "Considering that the report in the case file indicates that the plaintiff's rights are likely to exist, And given the urgency of the case, To prevent the defendant's wrongful conduct from continuing, I consider it appropriate to grant the plaintiff's request for emergency relief. "

In addition, The presiding judge also granted a warrant for violationJohnson&JohnsonCompensation for moral damage caused by patents and industrial designs. In a patent case in Brazil, The award of emotional damages is a relatively rare practice, It is not often used by trial judges. This means that patent holders can assert their intellectual property rights, And ensure that violations themselves are punished, It has a strong deterrent effect on future infringement.

The ruling is an excellent signal for the medical device industry. The judgment protects patent owners, The effectiveness of law enforcement system in intellectual property infringement cases is verified. (Be compiled fromipwatchdog. com)

TRANSLATORS: Wu Xian　proofread: Liu Peng



　　disclaimer: This network reprint or compile the original articles are from the network, Does not represent the views of this website or confirm the authenticity of its content. If the source is mislabeled or the copyright of the article is involved, Please contact us, This website will be corrected in due course, delete, thank you.