The Kellis IP Weekly: Issue 8.3
BRAZIL
Patents
UFRJ Study: Judicial Orders Extending Patent Term of Pharmaceuticals Would Have R$1-9 Billion Price Tag: Shortly after Brazil’s Supreme Court invalidated the 10-year minimum patent term guarantee previously found in Art. 40, sole paragraph of Brazil’s industrial property law, approximately 40 lawsuits were filed seeking judicial orders to extend the terms of affected patents due to undue administrative delay. Now, the Innovation Economy Group of the Economy Institute at the Federal University of Rio de Janeiro has released a study concluding that denying the relief requested in those lawsuits will save Brazil’s universal health system between R$365.6 million and R$1.1 billion, and will save private purchasers of the medicines in question between R$694.94 million and R$7.6 billion. The study also lists several unquantified consequences that the authors allege would occur if the lawsuits were successful. According to UFRJ, the study has been submitted to the court in each action in which Grupo FarmaBrasil has been admitted as an amicus curiae. See https://drive.google.com/file/d/ 1sNFJbcjfujX_qYpr6jEFUEY9pgrKd_fR/view (Portuguese); https://abifina.org.br/facto/74/artigos/medidas-juridicas-para-extensao-do-prazo-das-patentes-apos-a-adi-5529/ (Portuguese). #patents #patenttermadjustment #PTA
The Federal University of Rio de Janeiro is a persuasive authority within Brazil on policy issues involving health and intellectual property policy. Brazil’s Supreme Court cited a UFRJ study in its ADI 5529 decision striking down the Art. 40, sole paragraph minimum patent term guarantee, see https://www.ie.ufrj.br/index.php?option= com_content&view=article&id=274 (Portuguese), and a UFRJ study on alleged negative effects of adopting regulatory data protection is widely credited with having stymied long-standing efforts to persuade Brazil to adopt such a system, see https://www.gov.br/propriedade-intelectual/pt-br/publicacoes/arquivos/estudo-impactos-da-exclusividade-sobre-dados-de-testes.pdf (Portuguese)—despite at least one subsequent study refuting the UFRJ report, see https://copenhageneconomics.com/ wp-content/uploads/2023/03/Regulatory-Data-Protection-for-Pharmaceuticals-in-Brazil_092023.pdf (English). #patents #RDP
On the topic of regulatory data protection, in May and June 2024, at the request of Senator Izalci Lucas (PSDB/DF), the Senate Commission on Science, Technology, Innovation, and Information held hearings on regulatory data protection, in which a significant majority of participating witnesses strongly opposed adoption of regulatory data protection in Brazil—with one witness asserting that to do so would dishonor the memory of those who died, unvaccinated, during the COVID-19 pandemic. See https://www.youtube.com/ watch?v=qfPcvbdQ2Vs (Portuguese); https://www.youtube.com/ live/fxa0rcG8B30 (Portuguese). Even after those hearings, opponents have continued to speak out against the adoption of RDP. See https://grupofarmabrasil.com.br/2024/06/20/ferres-fala-ao-gfb-sobre-as-consequencias-da-introducao-da-prdt-no-brasil/ (Portuguese); https://abifina.org.br/abifina-na-midia/especialista-em-propriedade-intelectual-da-abifina-discute-impacto-da-protecao-de-dados-de-testes-clinicos-no-panorama-talks/ (Portuguese); https://www.southcentre.int/research-paper-204-24-july-2024/ (English). Despite Brazil’s lack of regulatory data protection being highlighted in the United States Trade Representative’s Special 301 Report every year since 2006 in response to complaints from the innovative pharmaceutical industry, see https://ustr.gov/issue-areas/intellectual-property/special-301 (English), little if any progress on the issue has been made during that time. Moreover, the apparently unified opposition of Brazil’s powerful generic pharmaceutical industry, Brazilian academia, and the Executive Branch suggests that the innovative pharmaceutical industry must develop new strategies for persuading Brazil to adopt regulatory data protection, as current strategies are having little effect—other than driving increased negative dialogue around the topic. #RDP
SEPs: Appeals Court Upholds Preliminary Injunction in Ericsson – Lenovo Dispute: The 11th Civil Chamber of the State Court of Rio de Janeiro upheld a preliminary injunction granted at Ericsson’s request in an SEP dispute following an August 7th hearing. The win gives Ericsson leverage in the U.S., where the Federal Circuit recently heard arguments regarding Lenovo’s request for an anti-suit injunction against Ericsson, presumably sought by Lenovo to blunt the effects of the Brazilian preliminary injunction. See https://ipfray.com/ericsson-wins-brazilian-sep-appeal-against-lenovo-preliminary-injunction-upheld/ (English). #patents #SEPs
Government Divided on Patentability of Microorganisms: The Lula Administration’s “New Industry Brazil” program includes among its goals to develop sustainable agro-industrial chains, meet 70% of national needs in the production of medicines and vaccines, increase the share of biofuels used for transportation, and increase the technological and sustainable use of biodiversity by 1% per year. In light of those goals, and also given existing levels of Brazilian investment in research and development focused on the country’s immense biodiversity, INPI—with backing from Embrapa (the Brazilian Agricultural Research Corporation, linked to the Ministry of Agriculture and Livestock) and entities such as the Brazilian IP Association—strongly believes that Brazil’s patentability criteria need to be loosened to allow for the patenting of microorganisms. However, others within the government—including MDIC, INPI’s parent agency, and the Ministry of the Environment—disagree. The opponents’ concerns include that microorganisms are discovered, not invented; that the change would result in the privatization of a common good; and that well-financed foreign companies would benefit from the change, at the expense of local businesses. See https://agenciabrasil.ebc.com.br/economia/noticia/2024-01/entenda-o-programa-nova-industria-brasil (Portuguese); https://valor.globo.com/brasil/noticia/2024/08/12/patente-de-organismos-vivos-aumenta-debate-sobre-biodiversidade-do-brasil.ghtml (Portuguese). #patents #biotechnology #patentability
INPI’s New Patent Appeal Rules Require New Strategies: As previously reported, INPI in April adjusted the rules applicable to administrative appeals of first-instance patent examination decisions. The new rules significantly narrow the scope of permissible amendments at the appeal stage, such that applicants can no longer, for example, introduce completely new claim sets that have been allowed in other jurisdictions during that stage. Additionally, the rules apply retroactively, although at least one court order (which may still be appealed) has been issued mandating that INPI apply the previous rules to an appealed case. See https://www.daniel-ip.com/en/articles/brazils-new-appellate-stage-guidelines-strategies-for-efficient-patent-prosecution/ (Portuguese). #patents #administrativeappeals
INPI Publishes Latest Numbers: According to the agency, average patent pendency in July 2024 was 4.5 years counted from the filing date, and 3.3 years counted from the date of request for examination. Accelerated examination programs achieved an average time to resolution (from the date of the accelerated examination request) of 11.2 months. On the trademark side, applications without opposition received a final decision in 16.2 months on average, with opposed applications receiving a final decision within 23.8 months on average. INPI’s authorized 2024 budget grew from R$53 to R$58 million, with all but R$600,000 already spent. See https://www.gov.br/inpi/pt-br/governanca/planejamento-estrategico/central-de-monitoramento (Portuguese). #patents #patentpendency #trademarks #trademarkpendency #IPoffice
Trademarks
Santos FC Wins Counterfeiting Suit: The soccer club sued a small online vendor for unauthorized sales of shirts using the team’s logo. Judge Rogério Sartori Astolphi of the 6th Civil Court of Piracicaba ruled in favor of the club, ordering micro entity Ricart Camisetas to stop the manufacture and sale of products bearing Santos FC’s trademarks and to pay damages of R$2,000. Santos FC appealed the damages award, seeking at least R$10,000 to discourage future counterfeiting, but that request was denied on the basis of the defendant’s total capital of R$5,000. See https://g1.globo.com/sp/santos-regiao/noticia/2024/08/14/justica-condena-microempresa-a-indenizar-santos-fc-por-uso-de-simbolo-em-produtos-sem-autorizacao-entenda.ghtml (Portuguese). #trademarks #counterfeits
Copyright
New Ibero-American Program on Cultural and Creative Industries to Focus on the Creative Economy and Copyright: The program, launched at the Forum of Ibero-American Vice-Ministers and High Authorities of Culture for the Creative Economy, will seek to boost the cultural potential of the regional economy. One focus of the program will be the guarantee of just and adequate remuneration to creators in the digital economy. Participating countries currently include Colombia, El Salvador, Spain, Ecuador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, Portugal, the Dominican Republic, Argentina, and Brazil, although countries outside the Ibero-American region are invited to join as well. See https://www.gov.br/cultura/pt-br/assuntos/noticias/minc-assume-presidencia-pro-tempore-do-forum-de-vice-ministros-e-altas-autoridades-da-cultura-de-paises-ibero-americanos-para-a-economia-criativa (Portuguese). #copyright #remuneration
Meta’s Brazilian Subsidiary Ordered to Pay Damages for Disactivating Instagram Account Following Takedown Notice: Facebook Serviços Online do Brasil Ltda. received a takedown notice alleging that a micro-entity’s Instagram account infringed the submitter’s copyright, and subsequently disactivated the account. The micro-entity account owner sued Facebook, claiming that the disactivation occurred arbitrarily, with no warning and no opportunity to be heard, and further that the allegedly infringing post was old and referenced a product no longer offered for sale. When Facebook failed to present concrete evidence of the allegedly violated copyright or any other supporting documentation, Judge Altamiro Rodrigues Torres of the 11th Branch of the Special Court of Campo Grande ordered the company to restore the account and pay R$5,000 in moral damages. The judge also noted that Brazil’s Marco Civil da Internet (Law 12,965/2014) requires a court order for accounts to be deactivated. See https://fronteiranews.com/facebook-e-condenado-em-ms-por-desativar-perfil-de-loja-no-insta-apos-propaganda-de-bolsa-chique/ (Portuguese). #copyright #noticeandtakedown
Enforcement
Audiovisual Industry Demands More Action from ANCINE on Piracy: Participants of the PayTV Forum in São Paulo roundly criticized the National Film Agency, ANCINE, for having abandoned the fight against piracy when the Lula administration took office. Globo’s CEO, Paulo Marinho, noted that the industry lost R$50 billion due to piracy from 2017-2021, and contrasted the National Telecommunications Agency’s (ANATEL) action with ANCINE’s inaction. Claro’s vice president of strategy and operations also called out ANCINE, while representatives of Sky/Direct TV and Warner Brothers Discovery emphasized the economic harm caused by piracy. Notably, Law 14,185/2024, passed in January, specifically assigns responsibility to ANCINE for “determining the suspension and cessation of unauthorized use of protected Brazilian or foreign works.” See https://teletime.com.br/13/08/2024/ancine-volta-a-ser-cobrada-por-operadores-e-programadores-a-atuar-no-combate-a-pirataria/ (Portuguese); https://www2.camara.leg.br/legin/fed/ lei/2024/lei-14815-15-janeiro-2024-795251-republicacao-170858-pl.html (Portuguese). #IPenforcement #piracy
Soccer Fans Are Largest Audience of Pirated TV: According to ANATEL, sporting events and soccer in particular drive the largest amount of pirated TV consumption, in both the broadcast and cable markets. The agency estimates that piracy in just the paid TV market causes average annual losses of R$12.5 billion. See https://www1.folha.uol.com.br/colunas/painelsa/2024/08/futebol-e-o-que-motiva-maior-pirataria-na-tv-diz-anatel.shtml (Portuguese). #IPenforcement #piracy
ANATEL Continues Initiative Against ISDs, Awaits ANCINE and Receita Federal for Further Action: ANATEL has already seized 8 million pieces of equipment in its effort to combat illicit streaming devices, including 40,000 seized last month at a port in the state of Pará. The agency has also blocked approximately 9,200 IP addresses used by pirated TV boxes, leading to a surge in complaints against pirated TV brands on consumer complaint websites such as Reclame Aqui. Future plans include automating IP-blocking activities, expanding inspections nationwide through integration in Receita Federal’s Integrated Foreign Trade System (a step approved by MDIC but awaiting RF approval), and working together with ANCINE to block websites and applications. ANCINE and ANATEL signed an agreement to collaborate on site-blocking months ago, but ANCINE is preparing regulations for a public consultation before commencing activities under the agreement. See https://teletime.com.br/13/08/ 2024/anatel-aguarda-ancine-e-receita-para-novos-passos-contra-pirataria/ (Portuguese). #IPenforcement #siteblocking #piracy #IPTV
Seized IPTV Boxes Donated for Educational Use: The Ponta Porã campus of the Instituto Federal de Mato Grosso do Sul (IFMS) runs Project Educabox based on donations of the seized devices from Receita Federal. Students in the program learn how to modify the boxes by disassembling them, reconstructing them as computers, and replacing the software. The resulting computers are then donated to schools and other institutions in the region. Project Educabox has also published the procedure for transforming the IPTV boxes into computers, allowing anyone who wishes to do so. See https://www.gov.br/ receitafederal/pt-br/assuntos/noticias/2024/agosto/ifms-ponta-pora-apresenta-educabox-projeto-que-transforma-tv-box-em-computadores-educacionais (Portuguese). #IPenforcement #IPTV
Other
Ministry of Culture, WIPO Host Seminar on IP for Quilombolo Communities: The one-day event, attended by Minister of Culture Margareth Menezes and WIPO’s Director of the Latin America & Caribbean Division Beatriz Amorim, represented WIPO’s first foray into IP capacity building for women in Quilombolo communities. Ms. Amorim spoke to the importance of breaking the traditional concept of IP, creating a more inclusive and accessible system, and stated that this is WIPO’s objective. See https://www.gov.br/cultura/pt-br/assuntos/noticias/ministra-celebra-sucesso-da-formacao-em-propriedade-intelectual-para-comunidades-quilombolas (Portuguese). #IPgenerally #IPinclusivity
Non-IP Topics of Interest
Brazil Announces Major Additional Investment in Pharmaceutical Industry Strategy: President Lula and Vice-President Geraldo Alckmin participated in the announcement of R$42.7 billion in additional investment toward developing a more independent domestic pharmaceutical industry. The funds will be used to advance the More Production Plan, part of New Industry Brazil, which ultimately aims to enable Brazil to meet 70% of its universal healthcare system’s needs by 2033. A portion of the money will be used to develop and produce diabetes, cancer, anti-inflammatory, and anti-allergen medicines, with additional funds earmarked for development of biotechnological drugs, monoclonal antibodies, phytocosmetics, generic drugs, and various medical devices. The announcement brings Brazil’s total announced investment in the Health Economic-Industrial Complex to R$342.7 billion. See https://www.gov.br/planalto/pt-br/acompanhe-o-planalto/noticias/2024/08/201co-governo-cuida-do-povo-e-da-soberania-desse-pais201d-diz-lula-em-anuncio-de-estrategia-para-industria-farmaceutica (Portuguese). #pharmaceuticals #NIB
Amicus Curiae Without Headquarters in Brazil Received with Skepticism: During a plenary session of the Supreme Court on August 8, Minister (Justice) Luis Fux raised concerns about the admission of a U.S.-based amicus curiae that wanted to provide an “international perspective” regarding the subject of the case, which ultimately turned on a question of Brazilian constitutional law. While the amicus curiae, which had already been admitted, was ultimately heard, Minister Edson Fachin, the court’s Acting President, emphasized that the instance would not establish a Court precedent. See https://www.migalhas.com.br/quentes/412950/stf-fux-questiona-admissao-de-amicus-curiae-sem-sede-no-brasil (Portuguese). #STF
Lula Administration Meets with Congress to Discuss Legislative Priorities: In remarks shared following the meeting, the Minister of Institutional Relations, Alexandre Padilha, stated that the administration is focused on legislation that will bring economic growth, reduction of unemployment, and lower inflation. More specifically, the administration’s priorities include legislation regarding tax reform, credit for small- and medium-sized enterprises, new fuels, the green energy transition, and a carbon market. See https://www.gov.br/planalto/pt-br/acompanhe-o-planalto/noticias/2024/08/ governo-prioriza-no-congresso-pautas-que-impactam-no-crescimento-economico (Portuguese). #legislation #economicgrowth #taxreform
Chamber Headed toward Approval of Second Reform Bill: The Chamber of Deputies has begun voting on PLP 108/24, the bill that creates a steering committee to manage a new Tax on Goods and Services (IBS) that will replace existing state- and municipal-level taxes, and indications are that the bill will be approved. The steering committee, which will have technical and financial independence, will include representatives from across the federal government to coordinate the collection, inspection, collection, and distribution of the tax, as well as to set the tax rate. Opponents of the bill warned that the unelected steering committee will only gain power over time as it oversees more than R$4 trillion in tax revenue. See https://agenciabrasil.ebc.com.br/politica/noticia/2024-08/camara-aprova-segundo-projeto-de-regulamentacao-da-reforma-tributaria (Portuguese); https://www.camara.leg.br/noticias/1088458-deputados-divergem-sobre-regulamentacao-do-imposto-sobre-bens-e-servicos/ (Portuguese). #taxreform
ARGENTINA
Aapresid Congress 2024: Intellectual Property Key to Agricultural Production: The Argentine No-Till Farmer’s Association (Aapresid) held its 2024 Congress from August 7-9 in Buenos Aires. During the Congress, President Martín Biscaisaque noted the weak growth of Argentina’s wheat production (22% since 2010) compared to wheat production in Brazil (120%) and Russia (70%), and highlighted an urgent need for Argentina to resolve the issue of respect for intellectual property. Separately, the companies participating in the Sembrá Evolución certified seed program underlined the growth of that program within the country, thus expanding adoption of the latest innovations in genetics and technology. Even so, Don Mario’s Patricio Munilla observed that intellectual property recognition of seeds shows a downward trend in Argentina, reaching 32% in 2023, in contrast to 90% recognition in Uruguay and 70-80% in Brazil. Also at the Aapresid Congress, the Argentina Cooperatives Association and GDM’s Neogen signed an agreement to boost marketing of their best seed varieties and agricultural inputs. GDM Global Business Director Santiago De Stéfano noted that GDM and ACA have a shared commitment to reverse Argentina’s downward trend in the recognition of seed IP. See https://www.lanacion.com.ar/economia/ campo/un-mensaje-de-alerta-en-el-medio-de-una-verdadera-usina-de-ideas-nid10082024/ (Spanish); https://www.lanacion.com.ar/economia/campo/propiedad-intelectual-un-programa-privado-por-la-soja-no-para-de-crecer-y-este-ano-alcanzara-4-nid08082024/ (Spanish); https://www.lanacion.com.ar/ economia/campo/acuerdo-dos-empresas-se-unieron-con-foco-en-la-ultima-genetica-de-soja-nid08082024/ (Spanish). #patents #seeds #agriculturalIP
CHILE
INAPI Launches 6th Edition of Educational Series on IP: The series, which begins on August 13, is open to the general public and will be held online to reach as many interested persons as possible. Topics that will be addressed over the course of the series generally relate to patent and trademark applications and searches. See https://www.inapi.cl/sala-de-prensa/detalle-noticia/inapi-inicia-segundo-ciclo-formativo-sobre-propiedad-industrial-denominado-martes-de-pi (Spanish). #IPoffice #IPeducation
PERU
INDECOPI Denies Allegations Regarding Trademark Registration: An August 13 press release by INDECOPI “strongly reject[ed]” allegations made by unidentified party that the agency accepted an improper payment in exchange for registering a trademark. The release further notes that INPI will investigate any appropriate legal action and encouraged the complaining party to provide any available evidence supporting the claim of wrongdoing. See https://www.gob.pe/institucion/indecopi/ noticias/1003199-comunicado (Spanish). #trademarks #IPoffice
PARAGUAY
DINAPI Launches Mediation Service: The service, which is supported by WIPO’s Arbitration and Mediation Center, follows approved regulations with registered mediators, and can conduct proceedings virtually. Access to the service, which is available for trademark oppositions as well as civil IP infringement disputes, will be free during a pilot period currently set to end on January 31, 2025. See https://www.dinapi.gov.py/portal/v3/noticias/detalle-noticia?idNoticia=449 (Spanish). #IPoffice #ADR
U.S. PUBLIC CONSULTATIONS
USPTO – Experimental Use Exception Request for Comments: Published June 28, 2024; closes September 26, 2024. See https://www.federalregister.gov/documents/2024/06/28/2024-14164/experimental-use-exception-request-for-comments (English). #patents #publicconsultations
QUESTIONS OR CONCERNS
Kellis IP is available to provide consulting services to help you understand and respond to any of the developments highlighted in this newsletter, or any other IP issues in Brazil and the surrounding region.
