Patent Barriers Research Articles

Economic and non-economic determinants of renewable energy consumption (REC): evidence from BRICS nations

Purpose This study aims to identify the various economic and non-economic determinants of renewable energy consumption (REC) in Brazil, Russia, India, China and South Africa (BRICS). Due to the adverse effect of carbon emission on the environment, every country is trying for a transition from fossil fuel towards renewable energy. Renewable energy plays a crucial role in reducing carbon emission and combating climate change. Understanding the determinants that influence REC helps to promote this transition. Design/methodology/approach The study is based on an unbalanced panel data over the period 2002–2019 for all five BRICS nations. The panel corrected standard error (PCSE) method has been adopted to examine the determinants of REC. Findings Industrialization, population growth and foreign direct investment (FDI) are found to be significant economic determinants of REC while patent on environmental technologies, political instability and industrial design are significant non-economic determinants of REC in the BRICS nations. Research limitations/implications The findings imply that to increase REC in BRICS nations, policymakers should incentivize industries for investments in renewable energy, attract FDI aligned with environmental regulations, raise population awareness through training, enforce industrial design standards, establish fair technology transfer frameworks to overcome patent barriers and create stable, long-term renewable energy policies with risk mitigation instruments to address political instability. Originality/value The study captures the effect of patents on environmental technologies and industrial design on the consumption of renewable energy. Thus, the novelty lies in investigating unexplored variables in the previous literature likely to affect REC.

O fim da extensão das patentes e as Parcerias para Desenvolvimento Produtivo: reflexos no acesso a medicamentos no Brasil

Abstract The COVID-19 pandemic has shed light on the negative impact of intellectual property on health and has given new relevance to the Direct Action of Unconstitutionality 5529/DF, which was ruled by the Supreme Court in 2021, resulting in the extinction of automatic patent extensions in Brazil. This documentary case study analyzes the effects of the judicial decision on patent applications and patents of interest for Productive Development Partnerships (PDP), investigating the progress of 90 patent applications related to 15 PDPs drugs of interest until Decembre 31, 2020. Variables for comparing the drug patent scenario with that of the PDPs were researched on the websites of the National Institute of Industrial Property, the Ministry of Health, ANVISA, and the Brazilian Medicines Market Regulation Chamber. Of 88 valid applications, 28 patents were granted, 17 of which had been extended to more than 20 years (24 years and 09 months average). The court decision resulted in a loss of over 68 years of monopoly, potentially opening alternatives for generic production. This resumption of the PDP policy should incorporate strategies to overcome patent barriers.

Trade-Related Aspects of Intellectual Property Rights Flexibilities and Public Health: Implementation of Compulsory Licensing Provisions into National Patent Legislation.

The protection of intellectual property (IP) rights, given international legal effect through the World Trade Organization (WTO) Trade-Related Aspects of IP Rights (TRIPS) Agreement, has long been a contentious issue. In recent years, the long-standing debate on IP rights as a barrier to the access of affordable medicines has been heightened by the global vaccine inequity evidenced during the COVID-19 pandemic. The TRIPS Agreement contains a number of flexibilities that WTO members can exploit in order to accommodate their policy needs. Among these is the mechanism of compulsory licensing, whereby patent licenses may be granted without consent of the patent holder in certain circumstances. TRIPS Article 31bis created a special mechanism for compulsory licenses specifically for the export of pharmaceutical products to countries with insufficient manufacturing capacity. We analyzed domestic patent legislation for 195 countries (193 UN members and two observers) and three customs territories. We analyzed patent legislation for provisions on compulsory licenses, including those defined in Article 31bis of the TRIPS Agreement. We identified 11 countries with no patent legislation. Of the 187 countries with domestic or regional patent laws, 176 (94.1%) had provisions on compulsory licensing and 72 (38.5%) had provisions implementing TRIPS Article 31bis. The results of this study have highlighted the gap in the implementation of TRIPS flexibilities in countries' national patent legislation, especially in least-developed countries. Although it will not fully solve patent barriers to the access of medicines, implementation of compulsory licensing (and specifically those for the import and export of pharmaceutical products) will provide governments with another tool to safeguard their population's public health. Further discussions are needed to determine whether the WTO can provide effective responses to future pandemics or global crises.

Why patent waiver for Covid‐19 vaccines and pharmaceuticals?

AbstractPatent protection emerged as one of the most challenging barriers to the access to medicines, medical equipment, and vaccines as well for the treatment and containment of Covid‐19 when it became a pandemic. The severe scarcity of vaccines and pharmaceutical products were weakening the fight against Covid‐19, and endeavor to contain the recurrence of pandemic waves while mutation of the SARS‐CoV‐2 was also on the full swing. Therefore, India and South Africa jointly proposed for patent waiver at WTO in October 2020 to effectively deal with the short‐supply of medicines, medical equipment, vaccines and high price concern related to these products. After 20 months of consultation and negotiations with major stakeholders, the WTO came up with decision on patent waiver in 12th Ministerial Conference (12th MC). The time taken to reach to the decision in the pandemic situation and the narrow scope of the decision is a serious concern for the entire world to deal effectively with Covid‐19 and its variants. This paper attempts to analyse the patent waiver in the context of the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). It discusses patent barriers, alternative measures and needs for equitable access to vaccines and pharmaceuticals amidst the pandemic. Paper applies the qualitative methodology of research mainly content analysis method in the framework of contextualisation, decontextualisation, and recontextualisation. Results show that suspending certain provisions of the TRIPS required for the production of vaccines and medicines would prove a crucial tool for economies to return to its pre‐Covid‐19 era. Paper concludes that, patent waiver can be one of the most important tool to fight the Covid‐19 (as WHO has not yet declared the end of pandemic) and will pave the way to deal with any such unknown future pandemic effectively.

Decision-Making Models and Coordination in a Closed-Loop Supply Chain Considering Patent Protection for DfR

With improvement in consumers’ environmental awareness and the level of design for remanufacturing (DfR), the traditional supply chain is gradually changing into a closed-loop supply chain (CLSC). However, a high level of remanufacturing design will increase design costs for manufacturers, while also reducing the cost for remanufacturers. Moreover, manufacturers usually use patent barriers to restrict the development of remanufacturers. The main aims of this study were to explore how manufacturers and remanufacturers can benefit each other, taking into account patent protection and carbon emissions. Firstly, we adopted game theory to establish four decision-making models of the manufacturer and remanufacturer regarding DfR. Secondly, we designed a cost-sharing contract for DfR based on the decentralized decision-making model to coordinate a CLSC. The results of this study showed that under the patent-protected market environment, DfR increased the manufacturer’s profit but did not necessarily promote the remanufacturer’s profit growth. A cost-sharing contract can effectively achieve improvements in the presence of DfR, increase profits for both parties, and improve the economic and environmental benefits of the CLSC.

Intellectual property barriers to access to COVID-19 health products in South Africa

The COVID-19 pandemic has exposed the fragility of local, regional and global health systems and their inability to meet their populations’ health needs. South Africa also experienced severe shortages of health technologies, attributable to a lack of institutional capacity, corruption in supply chain management and procurement, inadequacy of local manufacturing capacity, and intellectual property barriers. This chapter analyses the extent to which intellectual property barriers have impeded the availability, affordability and accessibility of health products, especially vaccines, needed to avert COVID-19 infection. Global initiatives to improve access, such as the COVID-19 Vaccines Global Access facility, the COVID-19 Technology Access Pool, and the waiver of intellectual property rights proposed at the World Trade Organization by South Africa and India, are appraised. A situational analysis of the relevant health product landscape, is also provided. The two-year delay in tabling a Bill to amend the Patents Act, and the limited use of legal flexibilities to circumvent patent and other barriers, are examined. South Africa experienced significant shortages of diagnostics, personal protective equipment and other products; the country’s vaccine acquisition programme lacked urgency; intellectual property rights holders were unable to meet demand for vaccines and their failure to implement technology transfer prevented any prospect of scale-up or local production; and government has stalled on its commitment to patent law reform. It is recommended that the government urgently give attention to, among others: accelerating its vaccine acquisition and administration; addressing the severely strained health infrastructure; eliminating corruption in procurement contracts and the distribution of supplies; and tabling of a Bill to reform patent legislation.

COVID-19 Vaccines, Patent Barriers and Local Production in Developing Countries

COVID-19 Vaccines, Patent Barriers and Local Production in Developing Countries

The Joint United Nations Programme on HIV/AIDS 95-95-95 targets: worldwide clinical and cost benefits of generic manufacture.

The Joint United Nations Programme on HIV/AIDS aims for HIV testing, treatment and viral suppression rates to be 95%--95%--95% by 2025. Patented drug prices remain a barrier to HIV treatment. Generic alternatives are being produced and exported from countries without patent barriers at a fraction of the cost. We collated export records of active pharmaceutical ingredient for HIV drugs to estimate the minimum costs of production. Using epidemiological data describing national HIV epidemics, we calculated the cost to treat 164 countries at 95%--95%-95%. Using weighted log-linear regression models, we estimated the mother-to-child transmissions (MTCTs), HIV-related deaths and new HIV infections preventable every year by increased treatment. We estimated that TDF/3TC/DTG could be produced for $59 per person per year. At this price, the 164 countries in our analysis could be treated at 95%--95%--95% for $2 billion a year, preventing 66 308 MTCTs, 241 811 HIV-related deaths and 631 398 new HIV infections every year. In comparison, global expenditure on HIV pharmaceuticals in 2019 was $28 billion. At $2 billion/year, the 164 countries in our analysis could be treated for the price of 4 weeks of current global sales. Global access to generic alternatives could reduce expenditure and improve clinical outcomes.

Patent Protection and Access to COVID-19 Medical Products in Developing Countries

Several new vaccines that have been developed for COVID-19 are patent protected. The patentees control the production, supply and pricing of these vaccines. Most people in low-income countries have been unable to access the vaccines. India and South Africa supported by a large number of developing countries have submitted a proposal to the TRIPS Council of the WTO requesting a temporary waiver to eliminate patent and other intellectual property barriers for the development, production and supply of all COVID-19 medical products. Nine months have passed since the proposal was first made in October 2020 but still no decision could be taken because of the opposition from developed countries. The disagreements essentially revolve around four issues: whether suspension of patent rights will act as a disincentive for the development of new medical products; whether patented products can be manufactured in the absence of manufacturing capacities; whether voluntary initiatives are better than a patent waiver; and whether a waiver is necessary in view of compulsory licensing and other measures which TRIPS permits. The paper briefly reviews these issues and also provides some suggestions about what developing countries can do to make COVID-19 medical products affordable and accessible.

The COVID-19 Pandemic: R&D and Intellectual Property Management for Access to Diagnostics, Medicines and Vaccines

The ongoing rapid spread of COVID-19 is challenging the capacity of governments and of the World Health Organization (WHO) to timely put in place a global coordinated response to the pandemic. Developing countries and Least Developed Countries (LDCs) in particular in Africa are especially vulnerable to the unfolding effects of the public health crisis. A priority area for global collaboration is to advance research and development (R&D) for vaccines and medicines that are made available, affordable and accessible worldwide.There is currently no vaccine and no proven safe and effective direct therapy for COVID-19. There is also the need to accelerate testing capacity and tools in developing countries and LDCs with increased access to low-cost diagnostics. The approach to the management of intellectual property rights by research institutions, pharmaceutical and biotech companies and R&D funders will decisively affect availability and access, as well as the transfer of technology and know-how. Governments must ensure that they have legislative and procedural frameworks in place to enable them to over-come any patent, data exclusivity and trade secret barriers to procure and produce COVID-19 diagnostics, vaccines, medicines and other therapeutics.

Reaching UNAIDS 95-95-95 Targets Worldwide: Predicted Benefits and Treatment Costs with Generic Manufacture

Background: UNAIDS aims for HIV testing, treatment and viral suppression rates to be 95%-95%-95% by 2025. Patented drug prices remain a barrier to HIV treatment. Generic alternatives are being produced and exported from countries without patent barriers at a fraction of the cost. Methods: We collated export records of active pharmaceutical ingredient for HIV drugs to estimate the minimum costs of production. Using epidemiological data describing national HIV epidemics, we calculated the cost to treat 164 countries at 95%-95%-95%. Using weighted log-linear regression models we estimated the mother-to-child transmissions (MTCTs), HIV-related deaths and new HIV infections preventable every year by increased treatment. Findings: We estimated that TDF/3TC/DTG could be produced for $59 per person per year. At this price, the 164 countries in our analysis could be treated at 95%-95%-95% for $2 billion a year, preventing 66,308 MTCTs, 241,811 HIV-related deaths and 631,398 new HIV infections every year. Global expenditure on HIV pharmaceuticals in 2019 was $28 billion. Interpretation: At $2 billion/year, the 164 countries in our analysis could be treated for the price of four weeks of current global sales. Global access to generic alternatives could reduce expenditure and improve clinical outcomes. Funding Statement: This study was funded by the International Treatment Preparedness Coalition (ITPC), grant number ITPC_MV_001. Declaration of Interests: The authors report no conflicts of interest

SOFOSBUVIR: TREATMENT OF CHRONIC HEPATITIS C AND THE MAIN TRENDS IN PATENT PROTECTION

The purpose of the study was to analyze and systematize the literature data on the benefit/risk ratio of sofosbuvir administration in the treatment of patients with chronic hepatitis C and the main trends in its patent protection. Studies were conducted using databases on the Internet: Ukrainian patent office, the European patent office, the US patent office, the Food and drug administration, European Medicines Agency (EMEA), State enterprise “The State Expert Center” of the Ministry of Health of Ukraine. It has used retrospective, logical, systematic and analytical methods. Data from clinical studies abroad and meta-analyses indicate that sofosbuvir is one of the most promising drugs for the treatment of chronic HCV infection. Its indisputable advantages are that this drug can be used with different genotypes of the virus, decompensated liver function, it is well tolerated. Sofosbuvir has an improved safety profile and a low probability of viral resistance. The high cost of sofosbuvir is due to the powerful patent protection. As mechanisms for working with patent barriers, it is recommended to use the flexible mechanisms of the TRIPS Agreement: the grant of compulsory licenses, the implementation of parallel imports, the tightening of the criteria for patentability (prohibition of patenting new forms that do not improve therapeutic efficacy).

Writing successful patents and overcoming patent barriers

Inventions related to pre-harvest and post-harvest technologies have revolutionized agriculture. There is a significant growth of intellectual property rights (IPR) in agriculture across the globe. The predominant forms of IP relevant to agriculture sector are patents and designs. Patents are given to inventions that qualify patent eligibility, patentability criteria and disclosure norms. In the area of agriculture, patents provide a great opportunity for improving agricultural processes and products. Understanding the requirements of an invention under the Indian Patents Act, 1970 is necessary to know what can be patentable in India. The criteria of novelty, non-obviousness and industrial application and disclosure norms are applicable to all inventions irrespective of the technology areas. Examination guidelines for each technology area indicate to the elaborateness of the practice in relation to patents. While preparing patent specifications for agriculture inventions, it is important to ensure that the subject matter claimed should not be a method of agriculture (under Section 3h) or plants or plant parts (under Section 3j of the Act). Identification of relevant prior art and its anticipatory value is very important for the assessment of novelty of inventions. Agriculture inventions which can lower the cost, be obtained by reduced number of steps and are environment friendly can be considered under ‘economic significance’ by the Indian patent office (under the purview of Section 2(1) ja). Adhering to the disclosure norms (as mandated under Section 10 of the Act) are also important. Inventors/applicants need to also consider the deposit requirements. The present work examines the relevance of IPR and expansion of the patentability criteria, disclosure norms and additional requirements in relation to agriculture. It will highlight the need for patent search as an integral requirement for research, the process of preparation of invention disclosures to enhance the innovative ability of academic institutions as well as researchers.

Addressing IP barriers to the elimination of HCV as a public health problem in Latin America

Treatment of HCV has evolved from injection-based regimens with severe side effects to DAAs with cure rates of 95%. However, due to patent monopolies high prices are charged and pose a major barrier to access, especially in Latin America, which precludes countries to access more affordable generic DAAs. While DAA patent holders have developed voluntary licensing schemes, with a view to offer more affordable prices to developing countries, too many middle income countries and most Latin America are excluded from it. As a result, countries are facing prices, that range from $12,000 to $6,212 for DAA treatment, which are unsustainable to reach HCV elimination targets. To face this challenge, DNDi has developed a HCV public health approach that, besides developing a new affordable and pangenotypic treatment, aims to seize the opportunity of the new DAAs available to advocate for its expansion of treatment widely. This strategy will require governments to take active steps to increase access and affordability, including by making use of IP flexibilities, allowed under international trade law, to overcome high prices and patent barriers. To enable this environment, DNDi seeks to work with governments, civil society, patients and other stakeholders to overcome IP and regulatory barriers to an affordable pan-genotypic treatment, particularly to countries in Latin America that are facing high prices and that are excluded from voluntary schemes. Recently, DNDi has welcomed Malaysiás leadership and example to developing countries facing high prices of DAAs to issue a government-use license to source generic sofosbuvir, in order to accelerate access to affordable sofosbuvir in its public hospitals. Seizing the public health potential of DAAs to ensure the elimination of HCV as a public health problem in Latin America will require strong leadership from Ministries of Health, governments, active involvement of treatment providers and patient's groups to advocate for the implementation and strengthening of pro-access policies, overcoming IP and regulatory barriers, to allow for scale up of diagnostic and treatment of HCV in Latin America.

Access to hepatitis C virus treatment: Lessons from implementation of strategies for increasing access to antiretroviral treatment

At September’s 2017 United Nations General Assembly, a state-of-the-art HIV medicine was announced to be made available at just $75 per person per year. There have been a number of strategies that the global AIDS community and countries have utilized to reduce prices and make antiretrovirals (ARVs) accessible for people living with HIV/AIDS. There appears to be an opportunity for the treatment of hepatitis C virus infection using direct-acting antivirals (DAAs) to benefit from the often painful and laboured history of driving down the prices of ARVs. In general, the success of lowering prices for ARVs has stemmed from the politics needed to initially support generic entry into the on-patent market. The use of flexibilities present in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have been used to overcome patent barriers, with the use of compulsory licenses and/or the threat of their use as instruments for strengthening the bargaining power in price negotiations.These strategies have been combined with new financing mechanisms that have promoted more effective procurement and price negotiations. Partnership among the different stakeholders has also been critical in this regard. Countries have also invested in their health systems and implemented several strategies to reduce stigma and discrimination to increase access to and improve utilization of ARVs. This article suggests that any future international initiatives to increase access to DAAs can learn from these lessons surrounding price reduction, improved financing, advocacy, as well as health systems strengthening and stigma reduction. Adopting and reconfiguring these strategies will also incur substantial savings in time, money and lives.

Initiatives to challenge patent barriers and their relationship with the price of medicines procured by the Brazilian Unified National Health System.

Since 1996, when antiretroviral (ARV) treatments started being guaranteed to people living with HIV in Brazil, the government has faced the challenge of ensuring sustainability of this policy within a context of incorporating patented medicines. This article sought to analyze the historical series of the price of lopinavir/ritonavir (LPV/r) in Brazil and in the international market also considering the initiatives to challenge patent barriers between 2001 and 2012. The methods used were mapping initiatives to challenge LPV/r patent barriers and the analysis of historical series of its price in Brazil and in the international market. Results show that, between 2001 and 2003, there were efforts to use compulsory licensing as a threat. From 2005 to 2007, initiatives by different satkeholders were identified: declaration of public interest, pre-grant opposition ("support to examination") and civil action. From 2006 to 2008, compulsory licensing initiatives in other countries resulted in a price reduction in Brazil. Between 2009 and 2012, there was a 30% reduction in the Brazilian purchasing price.

Are patent trade wars impeding innovation and development?

When patents support anti-competitive conduct, innovation can be damaged not only by lack of market access but by the prohibitive costs of litigation. The creation of patent barriers is inconsistent with IP protection and enforcement agreed upon under the World Trade Organization and trade-related aspects of intellectual property rights (‘TRIPS’). The study uses the US Apple v HTC IP legal case to investigate anti-competitive market behavior and trade barriers. The research provides a formal patent analytic methodology and the case analysis result. The research method tests whether patent conflicts and technical trade barriers are significantly encouraged by existing IP laws.

A Study of Patent Acquisition and Resolution Strategies on Patent Disputes

As globalization is accelerating, companies are making great efforts to grow. Thus, many companies are trying to make innovations, and their interest in patent, the result of innovations, is also increasing. Thus, this study tried to examine cases that companies registered study results from innovations as patents, and activities that they are doing with obtained patents. And because when patent disputes occur, companies come to devise various measures, this study tried to examine those measures through an empirical analysis. As a result of the analysis, activities performed with obtained patents turned out to be patent barrier establishment, manufacturing, cross licensing, technology transfer, and royalties through licenses, in order. Coping measures in case of patent litigation turned out to be a counter-suit, patent invalidation suit, cross licensing, suit through solidarity with other firms, and patent right fee payment, in order.

Method and Application of Patented Design Around by Combination of IPC Cluster Analysis and TRIZ

Patent barriers have become a major obstacle to China's enterprises in the market competition. With the technical information provided by the patents, the combination of patent's IPC cluster analysis and technical maturity is used to determine the circumvented patents and patent avoidance goals. Components weights analysis is applied to extract the technical characteristics of patent clusters, according to the patent circumvention target technology research and development direction is identified to design around existing patented technology range. Technology research and development direction guides the designer to construct TRIZ standardized model of invention problem which is solved to realize innovation, the designer applies knowledge tools of TRIZ to solve the invention problem and gets the original understanding of the patent design around. Combining the advantages of existing patented technology the designer can develop new products with innovative technology, enabling innovative design around to the existing patent group. Taking the packer as an example, the application patent group design around process of IPC cluster analysis and TRIZ is to design around packer patents, develop secondary seat packer and the apply for related patents.

Method about Innovation Design Based on the Function Clipping and Principle of Patent around

The world has entered the time of the knowledge economy, the patent technology, which is irreplaceable, can improve the enterprise market competitiveness and sustainable development. However, because of patent barriers, the room of technology development is decreasing. Therefore, how to make full use of patent technology to innovate is becoming more and more important. The process of innovation design was based on the patent infringement principle and clipping method of TRIZ. Eventually this process which based on TRIZ was formed rationally and effectively which was applied to analysis the robot inspecting the pipeline.