Supreme Court Suspends the Rule that Determines Minimum Expiry Date for Patents on Medicines and Pharmaceutical Products
Minister Dias Toffoli, of the Federal Supreme Court (STF), suspended today (7) the validity of a rule that extends patents on medicines and pharmaceutical products. In a preliminary decision, he suspended Article 40, sole paragraph, of the Industrial Property Law (Law 9.279 / 1996).
With the health crisis caused by the pandemic, the Attorney General filed a preliminary injunction requesting that the rule has a direct impact on the fundamental right to health, since, while the patents of large laboratories have not expired, the pharmaceutical industry will be prevented from producing generic drugs against the new coronavirus and its current and future variants. He pointed out that there were drugs whose patent would have expired, had the rule not been questioned.
On January 5th, Brazilian PTO published the first edition of the Manual of Geographical Indications, which contains guidance and recommendations to users and examiners of the INPI, details on the procedures and examination guidelines, as well as technical definitions relevant to the matter.
The Manual aims to increase the quality, transparency, and uniformity of Geographical Indication examination practices and provides instructions for ordering, serving as a reference for examiners, prosecutors, and users in general.
The first edition of the Geographical Indications Manual enters into force on February 1st, 2021, and was made official by Administrative Rule INPI / PR nº 415, of December 24, 2020, published in the bulletin, Section I.
The publication of the Geographical Indications Manual takes place after a public consultation carried out between February 27 and May 27, 2020. INPI received 153 contributions from 11 participants, which were discussed and answered by the Standing Committee for Improvement of Examination Procedures and Guidelines (CPAPD).Read More
Since 2016, the Brazilian PTO (INPI) has been implementing several bilateral Patent Prosecution Highway (PPH) programs with different PTOs in order to accelerate substantive examination of patent applications while reducing the large still existing backlog.
The first round of bilateral agreements consisted of a phase I pilot program and among the partnering PTOs were those of the United States of America, Austria, the European Patent Office, Japan, China, Denmark, the United Kingdom, South Korea, Sweden, and Singapore.
On December 21st, 2020 INPI issued Ordinance #404/2020 to bring Phase II of those PPH pilot projects forward from December 1, 2022, to January 1, 2021, which signals the success of the system and its expected growing use.
According to this regulation, Phase II is going to last until December 31st, 2024, will have a limit of 600 applications per year (instead of the 400 of Phase I) and each applicant may request up to 1 (one) case per week (instead of one per month of Phase I).
One very important difference between Phase I and Phase II is that under Phase II the Office of Earlier Examination (OEE) and the Office of First Filing (OFF) must not be the same.
So now a patent application filed with any OFF having a bilateral PPH can be expedited based on the examination performed by any other OEE partner on a PPH where there is a patent of the same family examined with positive result.
The claimed subject matter of the application object of the request must not be broader than that of the patent examined by the OEE nor should it include prohibited or not patentable subject matter according to Brazilian Law and regulations.
As under Phase I, a chart comparing both sets of claims must be filed with the request but under Phase II it is also possible to just file a declaration confirming that the new set of claims in the Brazilian application are a translation of the claims as accepted by the OEE
In order to speed up the examination, the corresponding official fees must be paid, and, unlike under Phase I, decisions issued by INPI refusing to include an application can not be appealed.Read More
1. Introduction: MERCOSUR-EU Agreement and the legislation on Data Protection
As is well known, last year, after several rounds of negotiations, the agreement between Mercosur and the European Union on economic matters emerged. Said agreement included matters related to customs duties, exchange of goods and services, sanitary measures, intellectual and industrial property rights, SMEs, dispute resolution, among other issues of relevance to both blocks.
Among these issues, although not as an integral part of the text of the agreement, discussions related to the Protection of Personal Data were also included. Currently, the States of the European Union are governed by the General Data Protection Regulation, or by its acronym, the GDPR, which is mandatory since May 25, 2018. During her visit to Argentina, in July of last year, the European Commissioner for Justice, Consumers and Gender Equality Vera Jourova, spoke about the benefits that the regulation and harmonization of data protection legislation would bring to both blocs.
For sure the EU is at the forefront in this matter, and in order to enable the advancement of this agreement for both blocs and above all, for the MERCOSUR countries, it is necessary that their laws harmonize with the provisions and principles of the GDPR, as which would bring about a quantitative and qualitative leap towards respect for the individual rights of people, the self-determination of the person regarding the processing of their data on the internet and in files, the final recognition of data protection as a fundamental human right, among other conquests.
Nowadays, in the current global situation of the coronavirus pandemic that hits the whole world, the negotiations have stalled, since there are urgent issues to address regarding the countries that make up each block. However, it is noteworthy that the will to move forward is intact.
That is why is necessary to carry out a review of the situation in which the laws of the MERCOSUR countries are in relation to the Protection of Personal Data, and why it is almost mandatory to use this time to be able to adapt them to the required standards by the EU in order to finally reach the conclusion of the negotiations carried out at the time of carrying out the revision of the Agreement between the two trade blocs.
2. Country by Country: MERCOSUR-EU Agreement and the legislation on Data Protection
The law that regulates the protection of personal data in Argentina is Law 25326, enacted on October 4, 2000, and is currently in force.
This law regulates what pertains to the treatment of personal data, its classification, the principles that should govern its treatment, international transfer of data, the rights of its owners, and the resources and actions that they have both administrative as well as judicially to obtain the deletion, rectification, modification, addition and correction of the data found in files or databases, both public and private, and the obligations of the owners of said files or databases when collecting and processing personal data.
In Argentina, the enforcement authority regarding Personal Data and Access to Public Information is the National Agency of Access to Public Information, which has a secretariat that is in charge of regulating and supervising everything related to personal data and the compliance of the Personal Data Protection law, which is the National Office of Protection of Personal Data.
In 2018 a Bill was presented to amend the Data Protection law and bring it as closely as possible to the GDPR standards, but unfortunately, the bill lost parliamentary status this year.
In 2018 it was sanctioned the new Law on Personal Data Protection – No. 13,709 LGPD-. On August 26 the Brazilian Parliament decided that the suspension of its enforceability would not be extended, so it is the law that is currently in force in Brazil to regulate everything related to the protection of the personal data of natural persons, processed both within the borders of the country, and by foreign companies that process data of persons located in Brazil.
This law has many points in common with the European General Data Protection Regulation, establishing an adequate legal framework regarding the collection, processing, and storage of personal data in general and sensitive data in particular, as well as the obligations and responsibilities of those –processors and controllers- who collect, process, select and store personal data, and may be liable –in case of non-compliance with the provisions of the law-, to be sanctioned administratively, civilly and criminally.
Likewise, it establishes the rights of the holders of personal data to grant informed consent for the collection and processing of their data and to control access, correction, rectification, updating, anonymization, and deletion of their data that are contained in databases both public and private.
For this law, it is mandatory -in certain cases- the need to have a Data Protection Delegate, and the enforcement authority is the National Data Protection Agency of Brazil.
In Paraguay, the Protection of Personal Data is regulated not only in the country’s Constitution but is also based on Laws No. 1682/2001, 1969/2002, which amends the first one and Law 5542 / 2015.
This set of laws regulate, among other issues: the processing and treatment of personal data contained in files, records, and public and private databases. The collection, processing, and treatment of personal data is only allowed for scientific, economic, statistical, or marketing purposes.
However, the current legislation establishes nothing regarding the figures of the database administrator; but it does regulate obligations pertaining to those responsible for said bases. Nor does it make a distinction between processors and controllers. Nor does it establish any obligation to report data breaches or incidents that occur with personal data.
The international transfer of data and its regulatory framework is not established in the legislation of Paraguay.
Likewise, there is no authority in Paraguay that regulates matters relating to the Protection of Personal Data and compliance with the law.
Finally, although the law does not establish anything regarding the possibility of making claims before administrative or judicial entities for violation of Personal Data, the penalties are established by other regulations, which allow those whose data have suffered any violation the right to claim before civil or criminal justice the pursue of a compensation.
There is a bill presented to the Paraguayan Parliament in 2019.
In Uruguay, personal data is ruled by Law No. 18,331, amended by Law No. 19,670, whose regulatory decree 64/020 modified certain articles of the first-mentioned law.
The law regulates the following aspects: a) it establishes a sort of glossary with definitions pertaining to personal data and the principles applicable; b) it also regulates the registration of the databases of the entities that collect and process personal data, whether they are located in Uruguay or process personal data of persons residing in Uruguay -under certain circumstances-; c) Establishes for public and private entities the need to have a Data Protection Officer and its obligations and responsibilities thereof; d) the need to have the informed consent of the owner of the data to collect, process and treat said data; e) the international transfer of data, the cases in which it proceeds and the requirements to transfer data to third parties; f) the obligations of the person in charge and the administrator of the databases; g) In the event of personal data breached or incidents that occur with them, the collectors, processors and responsible of the databases has to give notice and take the necessary measures to minimize risks; h) administrative sanctions concerning non-compliance with the rules contained in the law, ranging from warning to imposition of fines.
The application authority in the field of Data Protection in Uruguay is the Regulatory and Control Unit of Personal Data.
In February 2020, Law 19,670 was regulated, which among other issues complements Law 18,331 in terms of: 1) the adoption by the person responsible for the treatment of technical and/or organizational security measures to avoid and/or minimize incidents and breaches that may occur with personal data; 2) the promotion of national and international standards on cybersecurity; 3) the documentation of such measures and the planning and impact assessment regarding Personal Data.
3. Conclusion: MERCOSUR-EU Agreement and the legislation on Data Protection
After having made a brief reference to the Agreement between the European Union and Mercosur and the current state of the negotiations, reviewing the legislative situation of some of the countries that make up this last regional bloc, the truth is that it is essential to have an adequate level of protection of personal data, especially due to the extraterritoriality principle generated by compliance with the provisions of the GDPR and the cross-border flow of data.
Today we are witnessing a new era in human rights, where digital self-determination is no stranger. Where the right to digital existence of people cannot be overwhelmed over other issues such as those of an economic nature. That existence must be protected against any kind of violation.
Likewise, it is necessary to harmonize the laws of both economic blocs, which pushes MERCOSUR to take all the necessary steps to adapt its laws and regulate this new human right as an imperative, in order to achieve safer agreements in pursuit of a conciliatory and protective globalization of this new right that appears today.
Finally, it is worth highlighting the position that countries such as Argentina and Uruguay have in terms of recognition by the European Union regarding the adequate level of protection that these countries ensure to Personal Data, which places them at the forefront in the region.
However, it is mandatory for Argentina to update its law in order to continue maintaining that position in the face of the constant requirements of a globalized world both materially and digitally.
The Brazilian PTO has postponed the entry into force of the resolution that regulates the division of trademark applications/registrations (Resolution 244, of August 27, 2019) to July 1, 2021. Until this new date, it will not be possible to divide applications or registrations of brands. As a consequence, before the mentioned date, international multiclass deposits, which entered Brazil through the Madrid Protocol, cannot be divided either.
Brazilian PTO informs that, as of September 15, 2020, co-ownership will become an option in trademark applications, through the following services:
– Code 389 (Trademark registration request with pre-approved specification) – value per class; and
– Code 394 (Trademark registration request with free entry specification) – value per class.
In addition, using service code 349 (Holder transfer note), an order or registration with a single holder may be transformed into an order or registration with more than one holder, also allowing for any future transfers involving any issue in co-ownership.
If you are looking to designate Brazil or Germany in your international trademark application, this article is perfect for you. Here, we shall cover the procedure relating to notification of provisional refusal by a pre-registered Brazilian or German TM holder who believes that your international trademark application would infringe on their pre-existing IP rights.
Here, we will go over the procedures to go against such a notification and fight to protect your IP in Brazil and Germany.
Provisional Refusals Brazil
Brazil recently joined the Madrid Protocol in 2019, making it one of the newest members of the Madrid Union. In the Brazilian legal framework, the key law to be aware of is the Law on Industrial Property (9,279/1996), and the national TM office is the Brazilian Patent and Trademark Office (BPTO).
It should be noted that due to the nature of Brazil’s accession to the Madrid Protocol, if you already have an international trademark then you will not be able to simply designate Brazil as a new territory in which their brand is protected, but instead you will have to file a separate international registration from the beginning through the WIPO or choose to file a national application through the BPTO.
Therefore, if you have manoeuvred this system and have submitted your international trademark application, then that’s the first obstacle over and done with.
Brazilian IP Gazette
Once the BPTO has received the application, it will be published in their national bulletin, the Brazilian IP Gazette. From this date, any third party may file an opposition against the application within 60 days. The notice of opposition will then be published in the Brazilian IP Gazette around 60-90 days after the filing of the opposition.
At this point, all applicants should be aware that, unlike other members of the Madrid Union, Brazil does not publish any notice of opposition through WIPO channels – they will only be published on the Brazilian IP Gazette. Therefore, all applicants should be aware of the need to monitor the updates on the Gazette throughout the duration of the application procedure – we offer this service free of charge with any international trademark application.
The trademark applicant then has 60 days from the date of the publication of the notice of opposition to reply and reinforce their claim. Once submitted, the BPTO will examine the entire application, including any oppositions and counter statements to oppositions, and will publish a decision within 12-18 months. This is unlike many signatories to the Madrid Protocol, given that the BPTO does not make independent decisions specifically regarding oppositions. They take the application as a whole, including oppositions, and carry out a full analysis of the trademark application.
If the final outcome is unfavourable, it is good to know that all BPTO decisions are subject to appeal. Any party to the proceedings may make an appeal to the President of the BPTO within 60 days of publication of the decision in the Gazette. The President will then look over the application once more and within 6-8 months will give a decision on the appeal. This is a final decision and puts an end to the administrative proceedings.
If you need help with a trademark application or any other IP matter in Brazil, we’d love to help you out.
Provisional Refusals Germany
Germany is one of the most popular countries in Europe for trademark applications and has a similar procedure for provisional refusals under the Madrid Protocol as many of its European neighbors. The relevant national law is the Trade Mark Act, and the national TM office is the German Patent and Trade Mark Office (DPMO).
German Trade Mark Journal
Once the application has been received by the DPMO, it will be published in the German Trade Mark Journal, from which date any preregistered TM holder will have 3 months to file an opposition (Form W 7202) and pay the corresponding fees – €250 plus €50 per extra opposing sign.
Once initiated, trademark opposition proceedings in Germany tend to be documentary proceedings consisting of one or two rounds of submissions from both parties, during which the opponent and applicant will make their claims, which if they are to have a strong chance of succeeding, must be well-structured and based on coherent legal arguments – these submissions ought to be redacted and revised by an experienced IP lawyer. Usually, there are no oral hearings at any stage of the opposition proceedings.
At the request of both parties, the DPMO will grant a cooling-off period, similar to the EUIPO in their provisional refusal proceedings, with a duration of 2 months in which the parties may attempt to come to an amicable settlement regarding their trademark dispute. If unsuccessful, the documentary rounds shall continue and the DPMO will give a decision within 12-18 months.
If the final decision of the DPMO ends up being unfavourable, it is still possible to make an appeal to the Federal Patent Court. Such an appeal must be filed in writing with the DPMO within 1 month of the publication of the decision. In this appeals process, a Board of Appeal shall be established that will dictate the proceedings.
The decision from this Board shall be final, unless in said final decision the Board allows for appeal on points of law. If you are able to make an appeal based on points of law, then you may have the chance to appeal to the Federal Court of Justice, however, this is under very limited circumstances – see Section 83 of the Trade Mark Act. Any decision from the Federal Court will be final and no further appeals would be permitted.
Due to the documentary nature of the German provisional refusal proceedings, it would be highly recommended to make good use of an experienced IP lawyer to assist you in the drafting of your submissions to the DPMO. If you have any doubts or would like assistance in any IP-related matter, let us know, and we can get the ball rolling right away.Read More
Free live Webinar on Computer Implemented Inventions (CII) in Latin America on Wednesday July 8th at 12;00 EDT.
Join Jose Santacroce, Head of Moeller’s Patent Department, and Mariano Municoy, Head of our Legal Department in this live webinar where they will analyze the most important issues when filing, prosecuting and enforcing patents protecting CII in Latin America, particularly in Argentina, Brazil and Mexico
Mr. Santacroce retired as Director at the European Patent Office in the field of Computers (Human-Computer Interaction) after working there for 30 years and since early 2018 has led Moeller Patent Department.
Mr. Municoy has 20 years of legal experience and teaches regularly IP courses both in the US at Chicago-Kent as well as in Argentina at Austral and San Andres Universities.
Even though in absolute terms the number of CII patent applications in Latin America is still very low when compared to those of developed countries/regions, relatively speaking they have been growing faster than applications in other fields of technology, which very likely will accelerate in the near future as we all adapt to the new ways of living and working in an-after-COVID 19-world
During the webinar, they will present both a general picture and some particular insights about the best ways to achieve the optimal legal patent protection for CII inventions in Latin America.
At the end, there will be some time available for live Q&ARead More
As from July 18, 2020, the amounts of the individual fee payable in respect of Brazil will change. Those amounts will be:
- 75 Swiss francs (first part) and 135 Swiss francs (second part) for each class of goods or services, when designating Brazil in an international application or subsequently;
- 193 Swiss francs for each class of goods or services, when renewing an international registration in which Brazil has been designated. Where the payment is received within the period of grace, the fee will be 292 Swiss francs for each class of goods or services.
For further information, please refer to Information Notice No. 47/2020.
Moeller IP will monitor your international TMs in the Brazilian TM Gazette for free. Please do not hesitate to contact us at any time with any doubt or questions you may have at firstname.lastname@example.orgRead More
Brazilian PTO and CAS Establish Technical Cooperation Agreement to Strengthen the Fight Against Patent Backlog
BRPTO and CAS, a non-profit division of the American Chemical Society, signed a technical cooperation agreement (ACT) to expedite the examination of patents. ACT was published in the Federal Official Gazette this Wednesday (06/10). The agreement establishes INPI’s participation in a CAS Search Report pilot, with the objective of improving the patent workflow at the Institute.
The technology, which will be tested and optimized, is able to assess similarities with the state of the art from parameters of a patent application important for the examiner’s analysis. In addition, the system combines machine learning and data selected by humans, which improves the results offered.Read More