Abstract: In a judgment rendered on April 7, 2021, the Brazilian Supreme Courtroom determined to right away droop the validity of all patents of “pharmaceutical merchandise and processes, and gear and / or materials for use for well being functions” presently in power. , and had been filed over 20 (twenty) years in the past. Patents already granted in the long run in different technological fields aren’t affected.

On April 7, 2021, the Brazilian Supreme Courtroom launched the judgment within the lawsuit filed by the Public Prosecutor’s Workplace (PPO) relating to the period of patents in Brazil. The article of the dialogue is whether or not patents in Brazil are solely legitimate for a interval of 20 years from the submitting of the applying (as is customary world wide), or whether or not patents will proceed to profit for a minimal interval of 10 years. (ten) years from the issuance of the letter patent by the Brazilian Patent and Trademark Workplace (BPTO).

The truth is, to treatment the delay in examination by the BPTO, the Brazilian Patent Legislation (Legislation 9,279 of 1996) ensures this minimal interval of 10 years after grant. For a number of causes, the BPTO has constantly taken greater than 10 years to overview patent functions, triggering the adoption of this minimal time period by issued patents. This can be a frequent scenario in technological fields with the longest examination occasions, corresponding to prescribed drugs, chemical substances and telecommunications, the place 1000’s of patents are legitimate 25, 30 years after submitting, and typically even longer. that.

Nonetheless, such a provision has all the time been criticized, particularly due to the political sensitivity of the safety of pharmaceutical medication. Brazilian generics producers and sectors of the general public well being system argue that the longer safety afforded by patent legislation unduly will increase the value of medicines, thereby stopping the inhabitants from accessing well being remedies and demanding that authorities spending greater than it might in any other case be. case, if the patents had all expired 20 years after submitting.

The case presently being determined by the Supreme Courtroom is a particular sort of prosecution (the “Direct Plea of ​​unconstitutionality No. 5529”), filed by the PPO in 2016, requesting the declaration that the only paragraph of Article 40 of the Brazilian patent legislation violates the Brazilian Structure (promulgated in 1988) and, as such, it isn’t a legitimate provision and needs to be thought of struck out of the legislation:

Part 40. A utility patent can have a time period of 20 (twenty) years and a utility mannequin patent time period of 15 (fifteen) years, from the date of submitting.

Single paragraph – The time period shall not be lower than 10 (ten) years for utility patents and seven (seven) years for utility mannequin patents, from grant, besides when the BRPTO is prevented from continuing the substantive examination of the request, attributable to a confirmed court docket choice or to causes of “power majeure”

A number of amicus curiae intervene within the lawsuit, each in favor of the place of the OPP and towards it. Those that argue that the supply needs to be maintained argued that the Brazilian Structure doesn’t regulate what the time period of patents needs to be, that the actual downside is the shortage of sufficient funding for the BPTO to overview patents rapidly, as all patent holders of patents would like to have their patents examined and granted in just some years, fairly than benefiting from the additional time period of safety because the examination lasted greater than 10 years.

As well as, one of many causes for the size of the examination of patent functions within the pharmaceutical sector is the double examination of patents issued by each the BPTO and the Brazilian Sanitary Company “ANVISA” (equal to the FDA American), which doesn’t exist. in the remainder of the world, however is obligatory in Brazil attributable to a 1999 modification to the patent legislation.

Brazil didn’t permit pharmaceutical patents from 1945 till the approval of the Patent Legislation of 1996, which was a direct consequence of the 1994 TRIPS Settlement, a global treaty that’s a part of the agreements. who created the WTO – World Commerce Group. In accordance with TRIPS, a WTO member nation will not be allowed to refuse to grant patents in any technological subject. Consequently, the legislation has modified in Brazil, not with out protests from well-organized Brazilian generics producers. Since then, the controversy on pharmaceutical patents has had an essential weight in all discussions on patents in Brazil, though, these days, pharmaceutical patents signify solely 7.8% of the entire patents filed in Brazil.

After an unsuccessful try earlier than the Brazilian Congress to approve a invoice to revoke the only paragraph of Article 40, a Brazilian affiliation of generics producers (ABIFINA) filed the direct plea of ​​unconstitutionality (DPI) no. 5061 in 2013, which was rejected by the Supreme Courtroom on formal grounds (i.e. ABIFINA’s lack of standing to carry such a sort of lawsuit), which triggered the submitting of DPI 5529 by the PPO in 2016, primarily repeating the lawsuit beforehand introduced by ABIFINA. It’s subsequently DPI 5529 that started to be selected April 7, 2021.

These days in Brazil there are approx. 32,000 patents in power with a minimal time period of 10 years after grant, and approx. 39,000 patents in power which have been examined in lower than 10 years, and that are legitimate 20 years after submitting. In different phrases, the delay of the BPTO resulted in 45% of all issued patents benefiting from the extension of the time period of the one paragraph of Part 40 (for comparability, every year the BPTO receives about 27 000 new patent functions).

From the start, there have been a number of prospects for the end result of DPI 5529: for instance, if the impugned provision (the only paragraph of Article 40) was thought of legitimate, nothing would change. But when it had been discovered to be invalid, the Supreme Courtroom would nonetheless should determine whether or not all of the patents granted with an prolonged time period, and that are presently in power, could be canceled or not, and, furthermore, whether or not this cancellation could be retroactive. or not.

The case will finally be determined by the 11 Supreme Courtroom justices: such a public listening to was initially scheduled to happen on April 7, and can possible happen within the coming weeks. There was an adjournment as a result of want for the Courtroom to rule on one other matter, with extra urgency.

Nonetheless, the rapporteur decide, Mr. Toffoli within the mild of such a postponement and on the idea of his understanding that the problem of patent period is of the utmost significance, determined to grant a preliminary injunction instantly suspending the patent. results of all patents filed over 20 years in the past. within the following fields: “pharmaceutical merchandise and processes, and gear and / or materials for use for sanitary functions”. The choice will not be retroactive, that’s to say, it now solely produces results.

Mr. Toffoli gave his opinion on the deserves of the case, explaining in a protracted transient why he’s satisfied that the one paragraph of Article 40 violates the Brazilian Structure. Mr Toffoli’s choice will stay in impact till the complete court docket is ready to meet to make a closing choice on the matter.

In his opinion, Justice Toffoli can be of the opinion that patents already granted in the long run in different technological fields, corresponding to telecommunications, chemistry and others, ought to have their complete period preserved and never be affected by the choice. (That is the so-called “modulation of results” of the Supreme Courtroom.)

A number of closing remarks: It’s true that, at the least in Brazil, infringements of pending (ie not but granted) patents happen very hardly ever. Thus, regardless of the Supreme Courtroom ruling in favor of the PPO, we anticipate that the traditional 20-year timeframe from submitting will proceed to final with out violations by third events. And, if an infringement does happen, the patent applicant has sure treatments, though the possession proper (and unique rights) in truth solely arises after examination, when the patent is granted by the BPTO.

As soon as granted, patents are a really sturdy authorized title in Brazil, correctly utilized by the courts. Regardless of the setback for patent holders introduced up to now by this judgment, we’re satisfied that the elevated consciousness of the actions carried out by the BPTO, which is likely one of the penalties of this lawsuit, will encourage the federal government to take a position extra. sources within the examination of patent functions, finally serving to to cut back the examination time in Brazil.