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intellectual property

Parlamento Europeu envia carta em defesa da PI à Câmara e ao Senado

Brasília, BR – Foi protocolada hoje, quinta-feira, 23 de Setembro, uma carta enviada do Parlamento Europeu aos Presidentes da Câmara dos Deputados, Arthur Lira, e do Senado Federal, Rodrigo Pacheco. Na carta, 11 membros do Parlamento Europeu expressam suas preocupações com relação ao futuro da propriedade intelectual no Brasil após a Lei nº 14.200 de 2 de setembro de 2021, que prejudica o ambiente de propriedade intelectual (PI) no Brasil, ser aprovada. A carta questiona como as indústrias europeias, de muitos setores que dependem de proteção de PI, podem investir e comercializar no Brasil. A carta teve apoio do grupo internacional de defesa dos consumidores Consumer Choice Center e da Frente Parlamentar pelo Livre Mercado.

“Temos uma relação comercial muito próxima com o Brasil, e por isso estamos preocupados com o caminho que o Brasil vem seguindo no que diz respeito às leis de propriedade intelectual” disse em nota Gianna Gancia, MEP. “Países com fortes regimes de PI estimulam a inovação e a criatividade e são necessários para o crescimento econômico, a competitividade e a criação de empregos. Infelizmente, a PL nº 12/2021, e a consequente Lei nº 14.200, não ajudam o Brasil a cumprir os objetivos traçados na Estratégia Nacional de Propriedade Intelectual” concluiu Gancia.

“A exigência existente no PL nº 12/2021 que determinava que as empresas compartilhassem os seus segredos comerciais não tem precedentes e é inconsistente com as obrigações de proteção de segredos comerciais do acordo TRIPS. Forçar a transferência de tecnologia negaria aos inovadores a certeza e a previsibilidade necessárias para investir com confiança e acelerar o lançamento de novos produtos no Brasil” disse o Deputado Paulo Ganime, coordenador de Inovação da Frente Parlamentar pelo Livre Mercado. Para ele, “o governo acertou em vetar essa parte do texto, que poderia prejudicar a nossa credibilidade. O mais importante agora é garantirmos que o veto será mantido”, acrescentou.

Para Beatriz Nóbrega, Secretária Executiva da Frente Parlamentar do Livre Mercado, “existem alternativas melhores para criar no Brasil um ambiente que promova a inovação, o investimento estrangeiro direto e o acesso a novos produtos. Queremos ampliar as parcerias comerciais do Brasil no exterior e para isso precisamos honrar nossos acordos internacionais e buscar políticas que protejam a inovação e a criatividade, com o objetivo de deixar claro que no Brasil há estabilidade jurídica.”

Para Fábio Fernandes, Diretor de Comunicação da associação de consumidores Consumer Choice Center (Centro de Escolha do Consumidor), esta mudança na Lei preocupa muito os consumidores e pacientes brasileiros, pois decidirá o futuro da inovação nos campos da tecnologia, agropecuária e medicina.

“Os consumidores estão preocupados com a possibilidade de novos produtos, tecnologias e medicamentos não estarem disponíveis no Brasil por uma insegurança jurídica. A lei de propriedade intelectual no Brasil está de acordo com o padrão internacional porém essa nova lei, somada à recente decisão do STF sobre o Artigo 40 da Lei de PI, pode enfraquecer esse direito pondo em risco o futuro da inovação no Brasil” afirmou Fernandes. 

“Vacinas para o setor de agropecuária, remédios contra o câncer, componentes de informática como microchips para celulares, e até inteligência artificial são alguns exemplos de produtos e inovações que podem atrasar ou até mesmo nunca chegar ao mercado brasileiro” concluiu Fernandes.

Perlindungan Hak Kekayaan Intelektual dan Royalti untuk Pekerja Seni

Perlindungan Hak Kekayaan intelektual dan pekerja seni adalah dua hal yang sangat terkait dan tidak bisa dipisahkan. Melalui perlindungan hak kekayaan intelektual, maka para pekerja seni, seperti musisi dan sineas, bisa menikmati manfaat dari karya yang telah mereka buat.

Tanpa adanya perlindungan terhadap hak kekayaan intelektual, hal tersebut tentu akan sangat merugikan para pekerja seni. Para pekerja seni tersebut berpotensi akan semakin sulit untuk mendapatkan manfaat dari karya yang mereka buat untuk menafkahi kehidupan mereka, karena setiap orang dapat bebas membajak atau menampilkan karya-karya mereka tanpa harus membayar para pekerja seni yang membuat karya tersebut.

Di era digital, perlindungan hak kekayaan intelektual terhadap pekerja seni tentu memiliki tantangan baru. Seiring dengan perkembangan teknologi, setiap orang dapat dengan mudah membajak dan memasarkan produk-produk karya seni yang dibajak tersebut di dunia maya, untuk dinikmati dan disaksikan secara gratis oleh jutaan orang di seluruh dunia.

Namun, tantangan perlindungan hak kekayaan inteletual, khususnya di Indonesia, bukan hanya dari perkembangan dunia maya. Di sektor pelayanan, seperti rumah makan, kafe, karaoke, dan klub malam, kita bisa dengan mudah menemukan para pengelola tempat tersebut menampilkan musik atau lagu tertentu untuk menghibur para pengunjugnya, namun tanpa memberi bayaran kepada para musisi yang membuat berbagai lagu yang dimainkan.

Hal ini tentu merupakan sesuatu  yang perlu untuk diselesaikan. Terlebih lagi, karena yang menampilkan musik tersebut adalah tempat usaha yang bertujuan untuk mencari keuntungan.

Untuk mengatasi persoalan tersebut, pada tanggal 30 Maret 2021 lalu, Presiden Joko Widodo mengeluarkan Peraturan Pemerintah Nomor 56 Tahun 2021 tentang Pengelolaan Royalti Hak Cipta Lagu Dan/ Atau Musik. Dalam Pasal 3 ayat 1 peraturan tersebut, tertulis secara eksplisit bahwa “Setiap orang dapat melakukan penggunaan secara komersial lagu dan/atau musik dalam bentuk layanan publik yang bersifat komersial dengan membayar royalti kepada pencipta, pemegang hak cipta, dan/atau pemilik hak (cnnindonesia, 5/4/2021).

Dalam peraturan tersebut, dijelaskan secara eksplisit juga dituliskan berbagai penggunaan musik atau lagu yang diharuskan untuk membayar royalti kepada para musisi yang membuat lagu tersebut. Diantaranya adalah seminar, konser, transportasi umum, pameran, nada tunggu telepon, pertokoan, bank, dan kantor, pusat rekreasi, penyiaran televisi dan radio, serta fasilitas hotel (cnnindonesia, 5/4/2021).

Adanya peraturan tersebut tentu merupakan hal yang patut kita apresiasi. Diharapkan, dengan adanya peraturan pemerintah yang mewajibkan para pemilik usaha, seperti rumah makan, untuk membayar royalti kepada para musisi, maka kesejahteraan musisi dapat lebih terjamin, dan hak kekayaan intelektual yang mereka miliki terhadap karya yang mereka buat juga dapat semakin terjaga.

Hal ini semakin penting terutama pada saat pandemi COVID-19. Pandemi COVID-19 telah membuat industri musik di Indonesia menjerit, karena para musisi tidak bisa tampil di depan publik seperti tahun-tahun sebelumnya (voi.id, 16/7/2020).

Diharapkan, dengan adanya peraturan pemerintah tersebut, maka para musisi yang saat ini sedang mengalami kesulitan dapat terbantu,. Membuat musik, terlebih lagi yang sangat populer dan bisa dinikmati oleh banyak orang, bukanlah sesuatu yang mudah, dan dibutuhkan banyak usaha. Sudah selayaknya, para musisi tersebut bisa mendapatkan manfaat dari karya yang mereka buat.

Selain itu, argumen lain untuk membenarkan kebijakan pengelola usaha untuk memutar musik atau lagu tanpa royalti kepada para musisi adalah, tidak sedikit dari para pengelola yang memutar musik tersebut melalui media streaming yang berbayar, seperti Spotify misalnya. Karena sudah membayar layanan streaming tersebut, maka dianggap hal tersebut adalah sesuatu yang cukup sehingga pembayaran royalti adalah sesuatu yang kurang diperlukan.

Pandangan ini merupakan sesuatu yang sangat keliru. Berbagai layanan streaming tersebut secara eksplisit menyatakan bahwa layanan mereka hanya bisa digunakan untuk tujuan personal, dan bukan kegiatan usaha. Berdasarkan ketentuan dari layanan streaming Spotify misalnya, dijelaskan secara eksplisit bahwa layanan mereka hanya bisa digunakan untuk hiburan pribadi dan bukan untuk penggunaan komersial. Dengan demikian, layanan streaming ini tidak boleh digunakan secara publik di tempat usaha, seperti radio, toko, dan rumah makan (support.spotify.com, 15/4/2021).

Melalui ketentuan tersebut, maka sudah jelas bahwa ketentuan tersebut sejalan dengan peraturan pemerintah yang dikeluarkan oleh Presiden Joko Widodo pada bulan Maret lalu. Menggunakan layanan streaming untuk kepentingan komersil merupakan sesuatu yang tidak bisa dibenarkan.

Sebagai penutup, hak kekayaan intelektual, termasuk juga tentunya karya-karya seni seperti musik, merupakan hal yang patut dilindungi oleh negara. Oleh karena itu, adanya peraturan pemerintah yang bertujuan untuk menegakkan perlindungan hak kekayaan intelektual adalah sesuatu yang harus kita apresiasi, agar para pekerja seni bisa mendapat perlindungan atas karya yang mereka buat. DIharapkan, industri kreatif, termasuk juga industri musik, di Indonesia dapat semakin berkembang di masa yang akan datang.

Originally published here.

Propiedad intelectual, el derecho que se debate en el mundo por la liberación de patentes de las vacunas

Organizaciones internacionales rechazaron las medidas propuestas por la OMC. Si se aceptaran y aplicaran, sería contraproducente: profundizaría la crisis y debilitaría las bases de sustentación ante una futura pandemia.

El debate sobre el derecho de propiedad intelectual se puso al rojo vivo con la pretendida iniciativa de liberar las patentes de las vacunas.

Sin embargo, una acción de tal magnitud podría traer aparejado un efecto contrario al deseado ya que se vulneran los esfuerzos de empresas tras haber invertido cientos de millones de dólares en investigación y desarrollo.

Sobre este tópico, la Fundación Libertad y Progreso junto con otras 26 organizaciones internacionales rechazaron las medidas propuestas ante la Organización Mundial del Comercio (OMC), tendientes a anular los derechos de propiedad intelectual (DPI). El resultado de estas medidas, si se aceptaran y aplicaran, sería contraproducente: profundizaría la crisis en la que nos encontramos y debilitaría las bases de sustentación ante una futura pandemia.

Según el Global Health Innovation Center de Duke University, el mundo se encamina a producir 12.000 millones de dosis de distintas vacunas necesarias para brindar inmunidad de rebaño (70% de la población mundial). Una vejación masiva sobre los derechos de propiedad intelectual afectarán los incentivos para esta producción y futuras investigaciones para el bienestar de la humanidad.

El respeto por los derechos de propiedad intelectual es fundamental para acabar con la pandemia de la Covid-19 y reactivar la economía. La seguridad jurídica garantizará no sólo la producción, sino también el acceso a vacunas.

Libertad y Progreso suscribe a la declaración conjunta que establece los siguientes puntos:

*Los DPI son fundamentales para la producción a escala sostenible de vacunas;
*Los DPI son esenciales para la I&D para futuras pandemias;
*La competencia mundial, no la producción local forzada, será la que mantenga los precios bajos de las vacunas;
*Una suspensión de los DPI no tendrá efecto sobre la producción de vacunas sin una transferencia tecnológica forzada, la cual sería demasiado lenta, estaría llena de problemas legales y causaría mucho daño económico.

Al 20 de abril del 2021, había 217 vacunas anti-Covid (además de más de 600 tratamientos antivirales y terapéuticos) bajo desarrollo a nivel mundial. Este mercado competitivo e innovador se encuentra bajo riesgo con las iniciativas multilaterales anti-DPI. La escasez de vacunas en la Argentina y en otros países, no se hubiera producido o hubiera sido transitoria si los gobiernos respectivos hubieran actuado con diligencia.

Las organizaciones abajo firmantes, hacemos un llamado a los gobiernos para que protejan el sistema de innovación que ha suministrado múltiples vacunas y medicamentos anti-Covid en tiempo récord. De no ser así, la inversión futura para nuevos desarrollos para enfrentar las nuevas cepas de Covid-19 y futuras pandemias será menor y, por ende el costo humano será superior.

La declaración fue firmada por la   Asociación de Consumidores Libres de Costa Rica, Alternate Solutions Institute de Pakistán, Austrian Economic Centre de Austria, Bay Area Council Economic Institute de los Estados Unidos, Centro Mackenzie de Liberdade Econômica del Brasil, Center for Global Enterprise de los Estados Unidos,  Competere de Italia, Consumer Choice Centre de Bélgica, Free Market Foundation de Sudáfrica, Fundación Eléutera de Honduras, Fundación IDEA de México, Galen Centre for Health and Social Policy de Malasia, Geneva Network de Reino Unido, Imani Centre for Policy and Education de Ghana, Information Technology and Innovation Foundation de los Estados Unidos, Instituto de Ciencia Política de Colombia, Instituto de Libre Empresa del Perú, Istituto Bruno Leoni de Italia, Istituto per la Competitivà (I-Com) de Italia, KSI Strategic Institute for Asia Pacific de Malasia Libertad y Desarrollo de Chile, Libertad y Progreso de Argentina, McDonald-Laurier Institute de Canadá, Minimal Government Thinkers de Filipinas, Paramadina Public Policy Institute de Indonesia, Prime Institute de Pakistán y Property Rights Alliance de los Estados Unidos.

Originally published here.

The global organizations and populists who aim to seize COVID vaccine tech and IP

When Donald Trump claimed in September 2020 that every American would have access to vaccines by April 2021, his comments received scorn. The Washington Post said his claims were “without evidence,” CNN quoted health experts who said it was impossible, and The New York Times claimed it would take another decade.

Now, a year into this pandemic, nearly half of the eligible population has received at least one vaccine dose in the U.S., and distribution has been opened to every American adult.

Operation Warp Speed, which invested tax dollars and helped reduce bureaucracy across the board, has contributed to what has truly been a miraculous effort by vaccine firms.

While Trump’s proclamations eventually become true and the question of vaccine ability has been settled, there is now pressure on the Biden administration to turn over domestic vaccine supply to countries with skyrocketing cases.

On Sunday, the U.S. declared it will send additional medical supplies to India, currently experiencing the largest global spike in cases.

But at international bodies, countries and activist groups are petitioning for far more: they want to force biotech companies to waive intellectual property rights on vaccines and COVID-related medical technology.

Along with nearly 100 other countries, India and South Africa are the architects of a motion at the World Trade Organization called a TRIPS Waiver (Trade-Related Aspects of Intellectual Property Rights).

If the waiver is triggered, it would ostensibly nullify IP protections on COVID vaccines, allowing other countries to copy the formulas developed by private vaccine firms to inoculate their populations and play into the hands of future governments more hostile to private innovation.

This week, U.S. Trade Representative Katherine Tai met with the heads of the various vaccine makers to discuss the proposal, but it is uncertain if the Biden administration will support the measure at the WTO.

While many companies have voluntarily pledged to sell them at cost or even offered to share information with other firms, this measure would have more far-reaching implications.

This coalition seeking the TRIPS waiver includes Doctors Without Borders, Human Rights Watch, and World Health Organization Secretary-General Tedros Adhanom Ghebreyesus, who first backed this effort in 2020 before any coronavirus vaccine was approved.

They claim that because COVID represents such a global threat and because western governments have poured billions in securing and helping produce vaccines, low and middle-income countries should be relieved of the burden of purchasing them.

Considering the specialized knowledge needed to develop these vaccines and the cold storage infrastructure required to distribute them, it seems implausible that any of this could be achieved outside the traditional procurement contracts we’ve seen in the European Union and the U.S.

That said, rather than celebrating the momentous innovation that has led to nearly a dozen globally-approved vaccines to fight a deadly pandemic in record time, these groups are trumpeting a populist message that pits so-called “rich” countries against poor ones.

Intellectual property rights are protections that help foster innovation and provide legal certainty to innovators so that they can profit from and fund their efforts. A weakening of IP rules would actively hurt the most vulnerable who depend on innovative medicines and vaccines.

If the cost of researching and producing a COVID vaccine is truly $1 billion as is claimed, with no guarantee of success, there are relatively few biotechnology or pharmaceutical companies that can stomach that cost.

BioNTech, the German company headed by the husband-wife team of Uğur Şahin and Özlem Türeci that partnered with Pfizer for trials and distribution of their mRNA vaccine, was originally founded to use mRNA to cure cancer.

Before the pandemic, they took on massive debt and scrambled to fund their research. Once the pandemic began, they pivoted their operations and produced one of the first mRNA COVID vaccines, which hundreds of millions of people have received.

With billions in sales to governments and millions in direct private investment, we can expect the now-flourishing BioNTech to be at the forefront of mRNA cancer research, which could give us a cure. The same is true of the many orphan and rare diseases that do not otherwise receive major funding.

Would this have been possible without intellectual property protections?

Moderna, for its part, has stated it will not enforce the IP rights on its mRNA vaccine and will hand over any research to those who can scale up production. The developers of the Oxford-AstraZeneca vaccine have pledged to sell it at cost until the pandemic is over.

While this should smash the narrative presented by the populists and international organizations who wish to obliterate IP rights, instead they have doubled down, stating that these companies should hand over all research and development to countries that need them.

If we want to be able to confront and end this pandemic, we will continue to need innovation from both the vaccine makers and producers who make this possible. Granting a one-time waiver will create a precedent of nullifying IP rights for a host of other medicines, which would greatly endanger future innovation and millions of potential patients.

Especially in the face of morphing COVID variants, we need all incentives on the table to protect us against the next phase of the virus. 

Rather than seeking to tear them down those who have performed the miracle of quick, cheap, and effective vaccines, we should continue supporting their innovations by defending their intellectual property rights.

Yaël Ossowski (@YaelOss) is deputy director of the Consumer Choice Center, a global consumer advocacy group.

Think of the children! How to find cures for rare and children diseases.

The European Commission just published a working document assessing the EU’s orphan and pediatric drug strategies. Read here why incentives for research are key to extending patients’ lives:

A rare disease is a medical condition that meets the criteria defined in Article 3 of Regulation (EC) No 141/2000; a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 persons in the EU. Although so-called rare diseases affect a limited number of people per disease, collectively they affect one person in every 17 people within Europe. There are over 7,000 different rare diseases patients suffer from.

Regulators see an ‘imbalance of risk and reward’ for the industry to find cures and treatments for those diseases. Hence US, Japanese and EU regulators increased options for longer market exclusivity for drugs tackling diseases in children and rare diseases. In 2000, Regulation (EC) No 141/2000 and  2006 Regulation (EC) No 1901/2006 were adopted by the European Commission. The ‘standard’ incentives provided by the general legislative framework for pharmaceuticals in the EU are 10 years of market protection and 20 years of patent protection. For pediatric and orphan drugs manufacturers can apply for extended market exclusivity.

The purpose of this strategy is to improve and expedite patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. Adding prolonged exclusivity worked: A massive increase in orphan drugs could be seen in the last 20 years! Between 2012 and 2017 over three times as many orphan drugs entered the EU compared to 2000-2005. The EU Commission estimated that between 200,000 and 440,000 additional quality-adjusted life years were gained thanks to more incentives for these drugs.

Added IP Protection for Orphan Drugs correlates with more drugs entering the market

Voices who call now for less protection of orphan and pediatric drugs want to undo the successes of the last two decades. The 142 orphan medicines authorized between 2000 and 2017 have helped up to 6.3 million patients in the EU to either cure or cope with their health conditions.

But there are still millions of patients waiting for a breakthrough that can help to treat their rare or pediatric disease – For this, we need to have incentives and not populism. Intellectual property is key in allowing the inventor and her investors to reward them for their massive risk they undertook in trying to find a cure or treatment for a rare disease. The EU’s approach to orphan and pediatric drugs by increasing incentives for inventors and manufacturers has worked. The successes of the past 20 years should not be undermined by populist calls to nationalize research and IP. If we care about patients with rare diseases, we should not question the importance of protecting intellectual property but see it as a precondition for future innovations.

To sum it up: Think of the children and allow medical innovation to take place!

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