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In a pioneering initiative, São Paulo State University (Unesp) will inaugurate on June 13th the first Contract Development and Manufacturing Organization (CDMO) with a Good Manufacturing Practices (GMP) environment in Latin America. Located in Botucatu, 230 km from São Paulo, the facility will be operated by the Center for the Study of Venoms and Venomous Animals (Cevap) and will focus on the development and production of biological medicines.

This new CDMO aims to provide specialized services to the pharmaceutical industry, producing pilot batches of biopharmaceuticals for clinical trials in a validated environment. Additionally, the facility will house a school for professional training and qualification in Good Manufacturing Practices (GMP) and offer space for biotechnology startups.

What is a CDMO?

A CDMO, or Contract Development and Manufacturing Organization, offers outsourced development and manufacturing services for pharmaceutical, biotechnological, or research companies. CDMOs are essential partners in assisting companies with the creation, development, and production of medicines, from initial research phases to commercial manufacturing and distribution, always adhering to regulatory guidelines.

Importance of CDMOs

CDMOs are valuable partners for pharmaceutical and biotechnological companies, offering a wide range of services that cover research and development, manufacturing, quality control, regulatory affairs, logistics, and distribution. They are particularly useful for companies that:
1.    Have promising medicines but lack manufacturing capacity.
2.    Need to quickly scale up production.
3.    Are developing complex medicines with stringent regulatory requirements.
4.    Seek flexibility and cost reduction.
5.    Aim to rapidly launch new medicines or expand into new markets.
6.    Prefer to focus on their core competencies and outsource manufacturing.

Services Offered

Key services provided by CDMOs include:
•     Research and Development: Formulation and development of medicines, stability studies and analytical testing, process development, and optimization.
•     Manufacturing: Small and large-scale production, manufacturing of various pharmaceutical forms, sterilization, and packaging.
•     Quality Control: Rigorous quality testing to ensure compliance with regulatory standards, process monitoring, and batch release.
•     Regulatory Affairs: Assistance in obtaining regulatory approvals and compliance with international standards (GMP).
•     Logistics and Distribution: Storage, transport, and distribution of medicines

A Growing Sector

The global market for biological medicines is experiencing significant and steady growth, with projections for 2024 estimating values up to US$ 300 billion. In Brazil, this sector moved approximately R$ 40 billion in 2023, with continuous growth expected.

The inauguration of the CDMO at Unesp marks a crucial moment for the research and production of biopharmaceuticals in Brazil. This innovative project offers essential infrastructure for the development of high-quality medicines. It will boost Brazilian biopharmaceutical production.

Source: G1

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Adopted by consensus by 176 member countries, the World Intellectual Property Organization agreement is the result of two decades of negotiations.

Brazil signed the Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge at the Diplomatic Conference of the World Intellectual Property Organization (WIPO), which closed in Geneva, Switzerland, last Friday, May 24.

The decision by WIPO, an international entity part of the United Nations (UN) System, is the body’s first agreement to interrelate intellectual property with respect for the genetic heritage and knowledge of indigenous peoples and traditional communities.

Presided over by Brazil’s permanent representative to the International Economic Organizations, the conference results from two decades of negotiations at WIPO. Brazil acted to incorporate respect for the genetic heritage and knowledge of indigenous peoples and traditional communities into the intellectual property system. With the treaty adopted by consensus by 176 WIPO member countries, patent applicants must disclose access to genetic resources and associated traditional knowledge necessary for their inventions.

Genetic resources include plants commonly linked to indigenous peoples and local communities for their use, conservation, and tradition, passed down through generations. Although genetic resources in their natural state cannot be directly protected as intellectual property (IP), inventions developed using these resources meet the requirements for obtaining protection, generally through patents. This is a historical issue for developing and megadiverse countries in the intellectual property regime, with expected impacts on multilateral environmental regimes and agreements such as CBD, Nagoya Protocol, TIRFAA, and BBNJ.

“Today is a historic day in many ways, not only because it is the new WIPO treaty in more than a decade, but also because it is the first to address the genetic resources and traditional knowledge held by Indigenous peoples and local communities. In this way, we demonstrate that the intellectual property system can continue to encourage innovation and, at the same time, evolve inclusively, responding to the needs of all countries and their communities”, said WIPO Director General Daren Tang.

PATENTS — Under the treaty, patent applicants whose inventions are based on genetic resources or associated traditional knowledge must disclose the country of origin, the original source of these resources, and which indigenous peoples or local communities provided the traditional knowledge used in research.

Since the resulting inventions occur in industrial sectors with a significant market share, such as pharmaceuticals, cosmetics, food, and others, the agreement strengthens efforts to conserve biodiversity by facilitating the benefits generated from these inventions are shared with the countries of origin of the genetic resources and with the people and communities that hold the associated traditional knowledge.

This is a historic and innovative step for Carolina Miranda, general coordinator of International Regulation at the Secretariat of Copyright and Intellectual Rights (SDAI) of the Ministry of Culture (MinC). “This treaty has a range of norms adapted to these traditional communities. It is a new way of looking at intellectual property, adapting its concepts to respect the needs of traditional communities and issues such as those of original peoples,” “he explained.

CONTRIBUTION TO SCIENCE – The agreement is a milestone in the international intellectual property regime that translates into concrete actions in the economic objectives of environmental protection and promotion of human rights. Brazil’s commitment to the negotiations reiterates Brazil’s determination to seek, also through multilateral means, opportunities to generate sustainable employment and income for traditional communities, supporting the conservation of forests and biodiversity.

The instrument could promote science and innovation in biodiverse countries. It should facilitate the inclusion of traditional communities in sharing economic benefits derived from patents that use their knowledge and customs. Judging by the Brazilian experience (patent applicants are already obliged to reveal this information in the country), the agreement’s benefits may also be felt by countries that host industries that use genetic resources and associated traditional knowledge. According to INPI, since 2015, when the Biodiversity Law came into force, the number of patent requests that use genetic resources and associated traditional knowledge has increased considerably, indicating an incentive for innovation.

In addition to the Ministry of Foreign Affairs, the Brazilian delegation included the Ministry of Environment and Climate Change, the Ministry of Indigenous Peoples, the Ministry of Justice, and the National Institute of Industrial Property, and had the participation of representatives of indigenous peoples from different biomes.

Brazil’s commitment to concluding the treaty was widely recognized in its choice to preside over the Diplomatic Conference, which signals the international perception of the country’s relevant role as a facilitator of consensual solutions for advances in the global agenda while keeping alive the space of economic multilateralism.

Source: Brazilian Government

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On May 3, 2024, Law No. 14,852 was sanctioned, establishing a new legal framework for the electronic games industry in Brazil. The legislation modifies the Intellectual Property Law (LPI) and regulates electronic games’ manufacture, import, commercialization, development, and commercial use. It is important to highlight that this regulation does not include betting, poker, and other games involving cash prizes.

Main Highlights of the New Law

• Tax Incentives: The electronic games industry will receive tax incentives similar to those provided in the Rouanet and Audiovisual Law.
• Customs Regulation: The government will regulate customs clearance and import fees for electronic games, promoting innovation in the sector.
• Support for Developers: Individual entrepreneurs and individual microentrepreneurs (MEIs) who develop electronic games will receive special treatment, which will be detailed in future regulations.

Protection for Children and Adolescents

The new legislation also establishes measures to protect children and teenagers who use electronic games:

• Design and Operation: The conception, design, management, and operation of games aimed at children and adolescents must meet the interests of this age group.
• Safeguards in Interactive Games: Interactive games must include systems for receiving complaints and reports.
• Safe Environment: Electronic game providers must ensure that their services do not promote negligence, discrimination, exploitation, violence, cruelty, or oppression against children and adolescents.

The State will be responsible for carrying out the indicative age classification of games, considering the risks associated with digital purchases, to avoid excessive consumption by children.

Source: ABPI

Meta, which manages Facebook, Instagram, and WhatsApp, won an appeal in court, allowing the company to continue using its trademark in Brazil. Judge Heraldo de Oliveira, from the São Paulo Court of Justice, suspended the effects of a previous decision that prevented the technology conglomerate from using the name “Meta” in the country.

At the end of February, the São Paulo Court had given Meta 30 days to stop using the name in Brazil. The daily fine for non-compliance had been set at R$100,000.

The decision was taken by the 1st Chamber of Business Law of the Court of Justice at the request of a Brazilian company, also in the technology segment, which has held the trademark registration granted by the Brazilian Patent and Trademark Office (BPTO) since 2008.

Risk of harm, according to the magistrate

When analyzing Meta’s appeal, Judge Heraldo de Oliveira, president of the private law section of the São Paulo Court of Justice, considered that there is a risk of damage that would be difficult to repair if the company was forced to comply with the previous decision and stop using the brand, since that there is the possibility of reversing the case in higher courts.

“The risk of irreparable damage or damage that is difficult to repair arises from the losses that would be caused by compliance, from the outset, with the determination that the appellant (Meta) cease the use of the trademarks containing the term ‘META’ and provide postings on its channels of communication and sending of letters to public bodies, within thirty calendar days, considering the possibility of reversing the R. (respectable) decision attacked, by the E. (Egrégia) Superior Court,” decided the judge, on Friday, 15.

Source: Exame

The Brazilian Patent and Trademark Office (BPTO) pressured parliamentarians to approve a draft legislative decree (PDL) related to the Budapest Treaty. The proposal introduces this pact into the Brazilian legal framework, which provides rules for depositing microorganisms for patent applications.

The text has already passed through several committees of the Chamber of Deputies. However, the rapporteur’s opinion in the House’s Constitution, Justice, and Citizenship Committee (CCJC) is still awaiting approval.

The BPTO, represented by its president, Júlio César Moreira, has been talking to federal deputies and senators to demand progress in the process, as it understands that Brazil’s adherence to the treaty is beneficial for research and development of biotechnology.

The main advantage of including the Budapest Treaty in Brazilian legislation is the reduced costs and time for sending and filling microorganisms for patents.

These microscopic beings are currently widely used in agricultural production but can also be used by the pharmaceutical industry.

Detailed Description

A complete description of the invention sought to be protected in a patent application is necessary. The guidelines must be clear enough so that a technician in the area can reproduce the product without unnecessary or exaggerated efforts.

When a patent is granted to an inventor, third parties cannot commercialize the product for 20 years. However, the system ensures that these third parties can appropriately know the invention, study it, and place something on the market after the exclusive protection period or even innovate immediately.

“Whoever appropriates that information can go to the laboratory, develop a new product based on that existing knowledge, edge, and file a new patent,” explains the president of BPTO. “That’s what the system exists for to encourage innovation and new products on the market.”

In cases where the invention involves biological material — microorganisms — the written description is insufficient to meet this objective. Therefore, besides the report, a strain of microorganisms used in the product must be deposited in a reference center.

These centers are called international depository authorities (IDAs). They are responsible for storing the microorganisms, conserving them, and making them available to the public upon request.

IDAs, for patent purposes, are regulated by the Budapest Treaty, signed in Hungary in 1977 and force since 1980. Currently, 89 countries are signatories to the pact.

Under the rules of the treaty, countries are required to recognize microorganisms deposited in IDAs as part of the patent-obtaining procedure. Thus, a deposit with one of these authorities is valid for all signatories.

Brazil

Although Brazil is not yet part of the Budapest Treaty, the BPTO accepts the file of biological material in ID; that is, it recognizes the capacity of these authorities to receive the microorganisms used in inventions.

But, without adhesion to the pact, Brazil cannot have centers of this type in its territory. Therefore, Brazilian inventors (individuals, companies, es, or institutions send microorganisms to IDAs in other countries.

Today, 49 foreign IDAs are certified by the treaty. The best known are the American Type Culture Collection (ATCC), located in Manassas, in the United States, and the German Collection of Microorganisms and Cell Cultures (DSMZ, its acronym in German), from the Leibniz Institute, located in the German city of Brunswick.

In Latin America, there is only one IDA, the Chilean Collection of Microbial Genetic Resources (CChRGM), in Chillán. However, according to Júlio César Moreira, this center in Chile “is minimal” and “is not diverse” as Brazil needs.

As a member of the international pact, Brazil could have a depository center recognized worldwide to store biological material in general. Part of the collection would be focused on patents.

But this would not be automatic. The country would need to suggest institutions capable of receiving biological material so the treaty council could evaluate them.

Source: Conjur

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BPTO ranked Brazil’s 50 most significant applicants for industrial property rights in 2023 and 2022.

Petrobras maintained its leadership in invention patents with 125 filings, 15 more than in 2022. In second place, the Federal University of Campina Grande made 101 applications, 60 more than in the previous year, when it occupied fourth place.

FCA Fiat Chrysler went from eighth place in 2022 to third last year, increasing from 31 applications to 58. The Federal University of Minas Gerais (48 filings) occupied the fourth position, which had been in second place in 2022 (54 ). The Hercílio Randon Institute appears in fifth, with 43 patent filings.

As with invention patent filings, educational institutions stand out among the 50 largest filers of computer programs in 2023, occupying 35 positions. The CPQD Foundation requests leadership (93 requests), followed by Autbank Projects and Consulting (88), Linx Systems and Consulting (55), Federal University from Sergipe (52) and Pedro Izecksohn (46).

The utility models with the highest highlights were Westrock, Pulp, Paper, and Packaging (with 17 filings), Fibracem Teleinformatics (12), Flávio Aparecido Peres (12), Edson Della Giustina (11), and Nely Cristina Braidotti (10).

In terms of trademarks, the National Confederation of Retail Managers took first place in 2023 (536 registration requests), followed by Top Defense (395), Localiza Rent a Car (230), Baptist Church from Lagoinha (186), and Baptist Convention Lagoinha (173).

In 2023, Jaderson de Almeida, with 139 registration requests, and Grendene (129) held the top two positions in industrial design. Tramontina, Franccino Móveis, and Savia Fotografia Intelectual Ltda were in third, fourth, and fifth place, respectively.

Ranking of non-resident applicants

The BPTO also released the ranking of non-resident applicants in 2023 and 2022. The companies that filed the most applications for invention patents last year at the BPTO were Qualcomm, with 1,134 filings, Huawei (460), Basf (257), Cilag ( 222), and Ericsson (208). Qualcomm and Huawei maintained their 2022 positions, while Basf rose from fourth to third place and Ericsson from sixth to fifth place.

Source: Brazilian Institute of Industrial Property

Undoubtedly, the intersection of intellectual property and artificial intelligence becomes increasingly relevant with the wide dissemination of technologies derived from it.

With 2024 beginning to take shape, the various areas of intellectual property are once again positioned as catalysts for transformation, with particular emphasis and attention being given to the intersection of intellectual property with artificial intelligence and the use of intellectual property as a tool for sustainable development.

Regarding the intersection of intellectual property with artificial intelligence, there is no doubt that this topic becomes increasingly relevant with the wide dissemination of technologies derived from it, such as ChatGPT, Jasper, and DALL-E2, creating a perspective for a society in which creativity and innovation, once characteristics unique to human beings, now involve collaboration between humans and machines.

In this sense, it is clear that this change of scenario raises crucial questions regarding how intellectual property can be applied to creations that result from joint efforts between humans and artificial intelligence, making it necessary to highlight issues involving ownership and authorship of creations and generated through these technologies, as well as the definition of legal responsibilities.

Regarding ownership and authorship, there is no consensus among jurists and different legislation on the subject, as some consider works created through collaboration between humans and artificial intelligence to be the property of the company that developed them. The technology algorithm, while another portion understands that the work would be owned and authored by the human interacting with the artificial intelligence.

Such discussions can and should be discussed this year and in the coming years in the National Congress, which regulates artificial intelligence in our country and defines a national fake intelligence policy through which parameters and guidelines for this technology will be described. , creating legal security for using, researching, and developing different types of artificial intelligence in the country.

About intellectual property as a driver of sustainable development, it is clear that this trend has already been observed by the Interministerial Group on Intellectual Property, which established, through its national strategy, a set of more than 200 actions to encourage an effective, balanced intellectual property system that encourages creativity, investments in innovation and access to knowledge.

Among these actions is the intention to conduct matchmaking in green technologies and training in the Amazon region, aiming to generate income from intellectual property assets, such as geographical indications and collective trademarks.

The trend of “green intellectual property” is not new. Still, it will undoubtedly expand in 2024, with the National Intellectual Property Institute announcing the establishment of the sustainability and biotechnology commission, which will focus on green patents, mentoring in geographical indications, a sustainable logistics program, and technological radars focusing on sustainable development.

Considering the relevance of environmentally responsible business for companies, another point of attention for this year will be the use of intellectual property as a vector for protecting products and services that incorporate ethical and sustainable principles, once again highlighting the convergence of intellectual property with governance environmental.

Thus, the prospects for intellectual property for this new year reveal a dynamic panorama, considering that it will be a tool to boost sustainable development and, at the same time, it will be essential to promote a balanced approach to the evolution of the intersection scenario with artificial intelligence.

Source: Correio Braziliense

If 2023 was the year that artificial intelligence changed everything, 2024 may be remembered as the year that US copyright law changed regarding AI.

The explosion of generative AI and the popularity of Microsoft-backed initiatives such as OpenAI, Meta, Midjourney, and others have resulted in several copyright cases brought by writers, artists, and other copyright holders who claim that AI has had success only thanks to their work.

Judges have so far been skeptical of plaintiffs’ claims of infringement based on AI-generated content. However, the courts have yet to address the more complicated and potentially billion-dollar question of whether AI companies are infringing on a massive scale by training their systems with vast amounts of images, writings, and other data obtained from the internet.

Tech companies warn that lawsuits could create significant obstacles for the growing AI industry. The plaintiffs claim the companies owe them for using their work without permission or compensation.

Several groups of authors filed class action lawsuits this year over the use of their texts in AI training. This includes writers like John Grisham and “Game of Thrones” author George R.R. Martin, comedian Sarah Silverman and former Arkansas governor Mike Huckabee.

Tech companies have hired legions of lawyers from some of the biggest law firms in the US to take on the cases. They defended AI training in comments to the US Copyright Office, comparing it to how humans learn new concepts and arguing that their use of the material qualifies as “fair use” under copyright law.

What comes next?

An ongoing lawsuit involving Thomson Reuters – the parent company of Reuters News – could be one of the first significant AI indicators copyright issues.

The company accused Ross Intelligence in 2020 of illegally copying thousands of “headnotes” from its Westlaw legal research platform. The portal summarizes court decisions and was used to train an AI-based legal search engine.

A federal judge ruled in September that the Delaware case must go to trial to determine whether Ross violated the law. The lawsuit could set an essential precedent for fair use and AI copyright litigation issues. A jury could begin hearing the case as early as August.

Source: Forbes

2024 started with something special for Disney’s iconic Mickey Mouse: the mouse became public domain (a transition that took place on January 1st). But detail: only the character’s first appearances in “Steamboat Willie” and “Plane Crazy” are in this new situation.

These animations date from 1928 and were Mickey’s debut to the public, together with his partner Minnie. The little mouse bears a lot of similarity to the current version. But, in addition to being black and white (and having other different details), the behavior is more mischievous and ruder (in fact, during most of the scenes in “Steamboat Willie”, Mickey has fun forcing animals to be musical instruments).

So, there are 95 years of animation history and, according to US law, the copyright on them has expired. And a lot of people were waiting for it.

Using Mickey sparingly

Despite Mickey Mouse’s entry into the public domain, copyright law in this regard remains complex. For example, newer design changes or depictions like Wizard Mickey from “Fantasia” are not included.

It is also not permitted to create works that falsely imply that they are from Disney, as Mickey is also a registered trademark of the company. To get a better idea of the differences between the “Mickeys”, check out the recent trailer for “Steamboat Silly”, the final episode of “The Wonderful World of Mickey Mouse” which is part of the 100th-anniversary celebration of The Walt Disney Company:

Challenges and possible legal battles

Experts point out that creators who dare to use more recent elements of the character may receive legal warnings. In other words, putting the mouse in red shorts or white gloves goes beyond what is permitted.

Mickey Mouse is also a registered trademark. Kembrew McLeod, professor of communication and intellectual property scholar at the University of Iowa (USA), recalls that trademark law in the country deals entirely with the protection of trademarks, logos, and names – such as Mickey Mouse in the logo or, simply, the name Mickey Mouse.

“And, of course, there is no end to trademark law,” adds Ruth Okediji, a professor at Harvard Law School. She says that Disney and other companies use trademarks to increase control over intellectual property. “As long as the trademark remains distinctive in the provision of goods and services, the registered trademark owner can protect it.”

Source: Olhar Digital