Intellectual Property, Data Exclusivity, Innovation and Market Access

2012 ◽  
pp. 111-146
Keyword(s):  
Intellectual Property ◽  
Market Access ◽  
Data Exclusivity ◽  
Property Data

From Market Access to Cumulative Innovation

2017 ◽  
Author(s):  
Adrian Kuenzler
Keyword(s):  
Intellectual Property ◽  
Market Access ◽  
Step Test ◽  
Property Law ◽  
Intellectual Property Law ◽  
Rights Protection ◽  
Intellectual Property Rights Protection ◽  
Property Rights Protection ◽  
Production Output

This chapter argues for a reinvigorated role of the market access doctrine and references a number of important antitrust and intellectual property law decisions in which courts have given priority to market access. It finds a novel function for market access to play within antitrust and intellectual property law liability: courts that grant plaintiffs access to a defendant’s production output should refer to a three-step test under which they inquire (1) whether the inventor, through first-mover advantages, has reaped a sufficient reward such that contractual or intellectual property rights protection would no longer be required to facilitate innovation, (2) whether competitors were able to challenge the proprietary platform’s position in the market without the possibility of granting access, and (3) whether competitors seeking to benefit from market access will make use of it to facilitate the introduction of new goods rather than merely to copy the initial invention.

The European framework for intellectual property rights for biological medicines

2021 ◽  
Vol 10 (4) ◽  
pp. 172-183
Author(s):  
Josette Sciberras ◽  
Raymond Zammit ◽  
Patricia Vella Bonanno
Keyword(s):  
Intellectual Property ◽  
Market Access ◽  
Access To Medicines ◽  
Marketing Authorization ◽  
Joint Procurement ◽  
Europe 2020 ◽  
Increasing Trend ◽  
Biological Market ◽  
The Impact ◽  
The Eu

Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and its impact on accessibility of biological medicines and makes some recommendations. Methods: A non-systematic literature review on IP for biological medicines was conducted. Data on authorizations and patent and exclusivity expiry dates of biological medicines obtained from the European Medicines Agency’s (EMA) website and literature was analysed quantitatively and qualitatively. Results: The analysis showed that as at end July 2021, 1,238 medicines were authorized in Europe, of which 332 (26.8%) were biological medicines. There were only 55 biosimilars for 17 unique biologicals. There is an increasing trend in biological authorizations but signifi cant delays in submission of applications for marketing authorization of biosimilars, with no signifi cant diff erences in the time for assessment for marketing authorization between originator biologicals and biosimilars. For some of the more recent biosimilars, applications for authorization were submitted prior to patent and exclusivity expiry. COVID vaccines confi rmed the impact of knowledge transfer on accessibility, especially when linked to joint procurement. Discussion: IP protects originator products and impacts the development of biosimilars. Strategies to improve competition in the EU biological market are discussed. Pricing policies alone do not increase biosimilar uptake since patients are switched to second generation products. Evergreening strategies might be abusing the IP framework, and together with trade secrets and disproportionate prices compared to R & D and manufacturing costs lead to an imbalance between market access and innovation. Conclusion: The European Pharmaceutical Strategy should focus on IP initiatives that support earlier authorization of biosimilars of new biologicals. Recommendations include knowledge sharing, simplifi cation of the regulatory framework and transparency of prices and R & D costs.

scholarly journals Intellectual property and agricultural trade: Producer perceptions of tea and coffee as potential geographical indications

2018 ◽  
Vol 3 (1) ◽  
pp. 586-595
Author(s):  
Fredah Wangui Maina ◽  
John Mburu ◽  
Chris Ackello-Ogutu ◽  
Henrik Egelyng
Keyword(s):  
Intellectual Property ◽  
Value Chain ◽  
Market Access ◽  
International Market ◽  
Developed Countries ◽  
Agricultural Trade ◽  
County Government ◽  
Geographical Indications ◽  
Production Area

Abstract Kenya tea and coffee are major foreign exchange earners and have high reputation among consumers in the international market. Faced by declining prices and competition from other sub-sectors, production area under these commodities has been declining. Use of intellectual property (IP) rights to protect and market agricultural commodities has been on the increase. Geographical indications as IP have been successfully implemented in developed countries and increasingly in developing countries. The study assesses producers’ awareness and perceptions of territorial-based qualities and the influence on product profits from the two export beverage crops, tea and coffee. Factor analysis was conducted on Likert scale perception questions administered to producers of coffee and tea from Muranga and Kirinyaga, respectively, in the Central region of Kenya. Producers of the two products were aware of the uniqueness of their products and their geographical source. Only perceptions related to market access in coffee and tea, and policies and rules as well as role of county government in coffee positively influenced income. Rather than have GI as a certification trademark, a prescriptive sui generis law would provide the required streamlining needed for collective participation of various actors along the value chain of potential GI products.

Intellectual Property Protection for Biologics: Why the Trans-Pacific Partnership (TPP) Trade Agreement Fails to Deliver

2016 ◽  
Vol 22 (1) ◽  
Author(s):  
Kristina M Lybecker
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
Research And Development ◽  
Intellectual Property Rights ◽  
Trade Agreement ◽  
The United States ◽  
Rights Protection ◽  
Intellectual Property Rights Protection ◽  
Data Exclusivity ◽  
Property Rights Protection

Biopharmaceutical research and development is overwhelmingly focused in the U.S. becasue here it is incentivized and encouraged through a robust intellectual property rights protection environment.  Across the board, the United States provides the most comprehensive, effective intellectual property rights protections for biopharmaceuticals.  As a result, the industry locates here, researches here, and thrives here.  With an acknowledgement of the importance of intellectual property rights as well as the wider benefits of biopharmaceutical research and development, it's tremendously disappointing that the recently negotiated Trans-Pacific Partnership (TPP) Trade Agreement fails to deliver sufficient IP protections for biologics.  This article explores the importance of a rigorous intellectual property environemtn for the biopharmaceutical industry through an examination of the importance of data exclusivity provisions.  Such protection is critical as the number, complexity and cost of clinical trials increases.  Technology inevitably evolves faster than the legal architecture that surrounds it.  As technology evolves, making the development of new biologic vaccines and therapies possible, society's commitment to incentivize innovation and protect it must be enshrined in the intellectual property protections of agreements such as the TPP.

scholarly journals DEVELOPING STRATEGY TO IMPROVE MARKET ACCESS: INDONESIA-US FTA

2018 ◽  
Vol 1 (1) ◽  
pp. 48-67
Author(s):  
Imbang Listiyadi
Keyword(s):  
Intellectual Property ◽  
Free Trade ◽  
Fair Trade ◽  
Free Trade Agreement ◽  
Market Access ◽  
Trade Agreement ◽  
Property Right ◽  
Intellectual Property Right ◽  
Developing Strategy ◽  
Joint Study

Prinsip-prinsip dasar kepentingan didalam merangkai hubungan perdagangan bilateral antara dua negara yaitu Indonesia dan Amerika Serikat adalah lebih ditujukan kepada landasan kerja sama perdagangan yang saling menguntungkan. Tawaran serta permintaan yang dapat diintegrasikan bersama secara spesifik dan dapat menunjang pertumbuhan ekonomi masing-masing.Free Trade Agreement (FTA) Indonesia-Amerika Serikat diharapkan dapat menciptakan susasana kesepakatan yang disebut sebagai kebebasan dalam perdagangan atau Free Trade, keadilan didalam perdagangan atau Fair Trade. Landasan Filosofi “Free Trade” dan “Fair Trade” perlu dicarikan formulasi/rumusan jbersama terlebih dahulu guna mencari jawaban bahwa perdagangan bilateral yang dituangkan di dalam agreement nantinya tidak menjadi hambatan baru bahkan sengketa perdagangan didalam kerangka perdagangan bebas, sehingga perlu adanya pembicaraan bersama atau kajian bersama (Joint Study).FTA Indonesia Amerika Serikat akan memberikan fungsi penting sebagai alat penjamin manakala secara tiba-tiba terjadi perubahan kebijakan perdagangan kedua belah pihak FTA Indonesia Amerika Serikat juga berfungsi sebagai kepastian “Market Access” masing masing sebagai mitra dagang, serta bagi dunia usaha yang akan membangun komitmen untuk berbagai investasi baru.FTA Indonesia AS diharapkan akan memperkecil ketimpangan yang selama ini dirasakan oleh pihak Indonesia sebagai negara berkembang. Anggapan adanya ketimpangan antara negara maju dan negara berkembang yang secara tradisi ditandai dengan tingkat ekonomi maupun teknologi yang berbeda menyolok. Tingkat ketergantungan (dependence) Indonesia terhadap AS akan sangat mempengaruhi posisi tawar.Perdebatan di forum Kongress Amerika Serikat yang menganggendakan Free Trade Agreement seri9ng dikaitkan dengan permasalahan lain seperti: lingkungan hidup, pelanggaran hak asasi manusia, pelanggaran hak cipta, patent, ppolitik dan lain-lain dan sering bersifat sepihak atau unilateral. Tak urung masalah ini akan menjadi beban berat bagi negara-negara mitra dagang yang sebenarnya tidak terkait langsung dengan masalah bisnis. Di wilayah yang lebih bersifat teknis banyak hal yang sulit dpenuhi oleh negara-negara berkembang untuk mengimbangi perilaku negara-negara maju. Amerika Serikat telah banyak menguasai masalah-masalah Ïntellectual Property Right” yang mana hal paradox tergambar atau mewakili ketertinggalan negara-negara berkembang/miskin.

scholarly journals MAIN PROBLEMS OF COMMERCIALIZATION OF INTELLECTUAL PROPERTY FACILITIES IN KAZAKHSTAN

2021 ◽  
Vol 9 (2) ◽  
pp. 11-15
Author(s):  
Anargul' Kulembaeva ◽  
Al'mira Ksembaeva ◽  
Rysty Sartova ◽  
Mayra Kushenova ◽  
Gul'mira Nurbaeva
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
High Efficiency ◽  
Developed Countries ◽  
Trade Secrets ◽  
Know How ◽  
Improve Efficiency ◽  
Property Data ◽  
Commercial Organization

Commercialization allows customers to have a wider range of products and allows companies to generate more revenue, improve efficiency, and reduce costs. In the article, the authors characterize the main problems of commercialization of intellectual property objects, as well as the conditions that ensure the effectiveness of this process. The rights to commercialize intellectual property objects come from a commercial organization, and the owner retains the rights throughout his life as a legal leverage over competitors. Intellectual property rights broadly include patents, trade secrets, know-how, property data, registered designs, copyrights and trademarks, among others. The study revealed the experience of developed countries, which showed the importance and high efficiency of the commercialization of intellectual property objects. The authors identified the main directions of improving the process of commercialization of intellectual property objects.

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