Extension Of Patents Research Articles

Collaborative Network, Technological Progress and Potato Production in China

AbstractThe development of science and technology is one of the vital driving forces for the Chinese agricultural development. Based on 2,513 valid potato invention patents from 1986 to 2019 in China, a social network analysis is applied to investigate the effects of the network changes in potato patents on the innovation activities and potato production. The results show that China has formed a status quo of separation between potato-producing areas and patent-invention places. The collaborative relationships of potato patents are mainly distributed in non-main production areas. Most of the collaborations are intra-provincial rather than inter-provincial. The correlation relationship between potato innovation and potato yield is positive. But the density and cluster coefficients of collaborative networks in potato research affect the potato innovations differently. Considering the variation in collaborative networks and different technology progress in potato production across regions, a cross-regional exchange platform is needed to promote the dissemination and extension of potato patents in the main potato-producing areas.

SPC squatting

Abstract Supplementary protection certificates (SPCs) for pharmaceutical products are an important complement to patent protection which is often inadequate in commercial terms. SPCs are designed to ensure that originators can amortize their high investments in research and clinical trials. But unlike in the USA, for example, the European SPC is not simply a patent term extension. Rather, it is a unique form of intellectual property right whose subject matter is not the overall patented invention, but the active ingredient or combination of active ingredients of a patented and authorized pharmaceutical product. This link between the basic patent and market authorization has led to many questions of interpretation and Court of Justice of the European Union (CJEU) rulings since the SPC Regulation was adopted. An issue that has not yet been decided by the CJEU concerns the discrepancy between the ownership of the patent and the marketing authorisation under pharmaceutical law. This scenario, in which a patent proprietor relies on the marketing authorisation of a third party (possibly even a competitor) in said patent proprietor’s application for an SPC, is also referred to as “SPC squatting”. The following article discusses the admissibility of such a practice de lege lata, which also becomes relevant in light of current reform efforts by the legislator.

Use of patent term extensions to restore regulatory time for medical devices in the United States

ABSTRACT Background Medical devices can seek patent term extensions (PTEs), which extend market exclusivity to compensate for delays related to clinical trials and regulatory review. Pharmaceutical companies commonly use PTEs, but their use by medical device companies has not been clear. Research Design and Methods We examined the use of PTEs by medical device companies between 1984 and 2024 using a database published in the Federal Register and a list published by the Patent and Trademark Office. Results Only 178 medical device submissions were linked to a PTE application. They were mostly concentrated in 116 product codes associated with 15 medical specialties; nearly half were associated with cardiovascular devices. Numbers increased significantly in the past decade. Successful applications restored 987 days on average. Conclusions The patent restoration opportunity appears underutilized. It is unclear whether some companies do not recognize the opportunity it promises, or whether it does not meet their needs. Different business features and marketing strategies in device versus pharmaceutical industries may decrease the usefulness of the PTE program for these types of medical products. However, the finding that a small subset of manufacturers operating in competitive markets adopted patent extension strategies more commonly suggests a significant competitive advantage when competition increases.

Combatting Antibiotic Resistance: Regulatory Exclusivities for New Antibiotic Development in the United States and Europe

Abstract Antimicrobial resistance is a global concern that has led to millions of deaths worldwide. Genetic changes occur naturally in pathogens such as viruses, bacteria, parasites, and fungi. To overcome these concerns, there is a need to develop a new generation of antimicrobials. In an effort to encourage innovation, both the United States (US) and the European Union have introduced exclusivity programs. The US offered 5 years of additional nonpatent exclusivity for Qualified Infectious Disease Products under the Generating Antibiotic Incentives Now Act. In parallel, the European Commission offers a patent extension of 12 months across Europe (EU) countries or the option to sell the vouchers to other pharmaceutical companies through transferable exclusivity extension vouchers. This review focuses on the most important innovative strategies of antibiotic development the drug approvals, their mode of action, spectra of activity, and targeting of microorganisms, in past 5 years were mentioned, and discusses how to overcome the challenges of drug approval under antibiotic exclusivity in the US and EU, which will benefit the companies to develop novel drugs in several nations.

Recent Innovation in Manufacturing Bi-layer Tablet Technologies: An Emerging Trends Overview

Bi-layer tablet technologies is an upgraded advantageous technology that overcomes the disadvantages of the single - layer tablet. The development of pre-determined active ingredient sustained release and the inclusion of incompatible active pharmaceutical ingredients into a single unit dosage form have both been made possible through the availability of bi layer tablets to the pharmaceutical industry. One of the key design strategies for combining incompatible drugs with various indications and the same drug with a varying release rate is provided by bi layer tablets. A bi-layer tablet is appropriate for the combination of sequential release of two drugs as well as Sustained release of a tablet, wherein the first layer is for Immediate release as a loading dosage and the second layer is a maintenance dose. The best choice for drugs with low bioavailability and brief plasma half-lives is to formulate them as bi layer tablets for sustained release. Bi-layer tablets may be the best alternative to prevent physical separation from developing chemical incompatibilities across APIs and to allow for the development of many different profiles for drug release. Bi-layer tablets are currently being developed by several pharmaceutical companies for a variety of purposes, including patent extension, therapeutic use, and marketing, to name a few. As a result, the use of bi-layer tablet for analgesic, anti-inflammatory, and antihypertensive drugs is significantly different. To develop an innovative bi-layer tablet, a comprehensive mechanistic understanding must be developed through the use of dependable, analytical methods for risk management.

The end of patent extensions and the Productive Development Partnerships: effects on access to medicines in Brazil

Resumo A covid-19 jogou luz sobre o impacto negativo da propriedade intelectual na saúde e deu nova relevância à Ação Direta de Inconstitucionalidade 5529/DF, que, acatada pelo Supremo Tribunal Federal em 2021, culminou na extinção da extensão automática de patentes no Brasil. Este estudo busca analisar o efeito do julgamento histórico da ADI 5529/DF sobre pedidos de patente e as patentes de interesse das Parcerias para Desenvolvimento Produtivo (PDP). Trata-se de um estudo com base em uma pesquisa documental de análise do andamento, até 31 de dezembro de 2020, de 90 pedidos de patente relacionados a 15 medicamentos objetos de PDP. Nos sites do Instituto Nacional de Propriedade Industrial, do Ministério da Saúde, da Anvisa e da Câmara de Regulação do Mercado de Medicamentos, foram pesquisadas variáveis para comparar o cenário patentário dos medicamentos com o das PDP. De 88 pedidos válidos, 28 patentes foram concedidas, das quais dezessete foram estendidas para mais de vinte anos (média de 24 anos e nove meses). A decisão do STF resultou em mais de 68 anos de monopólio perdidos, potencialmente desanuviando alternativas para a produção de genéricos no país. Neste momento de retomada das PDP, estratégias para a superação de barreiras patentárias deveriam ser incorporadas à política.

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.

India's Decision to Deny an Extension of Patent for Bedaquiline: A Public Health Imperative.

Tuberculosis (TB) remains a major global public health concern, which has become worse in low- and middle-income nations due to the rise of drug-resistant strains of the disease. Bedaquiline, a groundbreaking anti-TB drug, shows great promise for addressing multidrug-resistant TB (MDR-TB). However, the recent decision by India to reject the application for a patent extension on bedaquiline raises crucial questions regarding access to essential medicines and public health requirements. This article examines the significance of India's rejection of the patent extension for bedaquiline, outlining the global implications of this decision and its impact on intellectual property rights, access to medicines, and the future of drug development. India's stance serves as a model for other countries to prioritize public health in their patent-related decisions, underlining the need for a balanced approach to intellectual property rights, innovation, and affordability in the pharmaceutical sector. In the context of the ongoing battle against drug-resistant TB, India's decision on bedaquiline signifies the evolving landscape of pharmaceutical patent practices in the service of global public health.

'Benevolent' patent extensions could raise billions for R&D in poorer countries.

'Benevolent' patent extensions could raise billions for R&D in poorer countries.

Patent term extension and test data protection obligations: identifying the gap in policy, research, and practice of implementing free trade agreements.

Much of the academic literature criticizes the inclusion of patent term extensions (PTE) and test data protection into the pharmaceutical provisions and/or intellectual property (IP) chapters of free trade agreements (FTAs), with many arguing that such provisions will increase the cost of pharmaceuticals for the implementing government. Such arguments are often backed by studies conducted prior to the conclusion of the relevant FTA. This is problematic for several reasons, most notably that the studies make assumptions that subsequently turn out not to be false and that the claims are not revisited and supported with empirical data following implementation. This article reviews the experience of two jurisdictions - Canada and Australia - in order to provide an analysis of legislative and judicial practices with a focus on implications and the cost of FTAs. The article examines how Canada and Australia have implemented their FTA obligations domestically and on the hereto ignored but important role of courts. One key finding is how courts in both countries are vigilant in narrowing the scope of obligations under FTAs to accommodate the need of the domestic market. The article ultimately concludes by calling on governments to conduct a detailed analysis of PTE and test data protection so as to better inform and prepare policymakers and, ultimately, improved FTA provisions and health outcomes.

Bilayer Tablets: A Promising Novel Drug Delivery System

The bilayer tablet heralds a new chapter in the development of controlled-release formulations with a wide range of properties that result in an effective drug delivery technique. Controlled release dosage forms have been commonly used to increase the treatment of a variety of important drugs. Uses of bilayer tablets for anti-inflammatory and analgesic purposes are a unique feature. Bilayer tablets are useful for releasing two medications in sequence, separating two incompatible chemicals, and creating a sustained-release tablet with the first layer of immediate-release as the initial dose and the second layer as the maintenance dose. The bilayer tablet is a more modern technology that corrects the flaws of single-layer tablets. The objective of this paper is to highlight the obstacles that arise during the preparation of bilayer tablets, as well as to suggest solutions to these issues. To better comprehend bilayer tablets, kinds such as single side press, double side press, and bilayer tablet displacement press are discussed, as well as uses, pros, and disadvantages. Its drug companies have become more interested in mixing two or more APIs (active pharmaceutical ingredients) in a single dosage form to improve patient convenience and compliance throughout the last decade. Many pharmaceutical industries are now working on bi-layer tablets for a variety of purposes, including patent extension, therapeutics, and advertising. This article provides an introduction of bilayer tablet technology, highlighting the key benefits of this type of oral dosage form while also describing current issues and developments in production techniques and the quality of products. The current report covers a variety of elements of bilayer tablets.

Patent term extensions and commercialization lags in the pharmaceutical industry: A growth-theoretic analysis

Due to the lags in commercialization, the effective life of a patent is generally less than its statutory term. We introduce commercialization lags into the Schumpeterian growth model and explore the effects of patent term extensions on pharmaceutical R&D and social welfare. Our results show that extending patent terms stimulates the consumption of homogeneous goods but generates an ambiguous effect on the consumption of pharmaceuticals. When patent extensions have an inverted-U effect on social welfare, the optimal patent extension increases with the length of commercialization lags but decreases with the input intensity of commercialization lags. Finally, we calibrate the model and find that increasing patent breadth reduces the optimal patent extension.

The Pediatric Pharmacy Association and Members Threaded Through a Career and the Impact on Pediatric Drug Development.

The Pediatric Pharmacy Association and Members Threaded Through a Career and the Impact on Pediatric Drug Development.

Lifecycle management of orphan drugs approved in Japan

BackgroundThe development of orphan drugs (ODs) is challenging from both development and business perspectives because of their small patient populations. To overcome such business challenges, lifecycle management (LCM), which maximizes profits by increasing sales and extending product lifetimes, is important to overcome the business challenges arising from their small patient populations. To clarify the activities of the LCM of ODs, we investigated additional indications that contribute to market expansion and marketing exclusivity using the patent extension and re-examination system of ODs approved in Japan between 2004 and 2019.ResultsThe 203 ODs consisting of 173 active ingredients were approved in Japan between 2004 and 2019. Sixty-eight (39%) of the 173 active ingredients have additional indications, of which 57 have at least one non-OD indication. Three-fourths of the 203 ODs had patent rights, and most of them included substance or use claims. Although the re-examination period for most ODs was 10 years after the approval, most patents had a longer duration than the re-examination period.ConclusionsPharmaceutical companies were actively adding non-OD indications and were emphasizing the use of patent rights by registering extensions of substance or use patents for exclusive marketing periods. These results indicate that LCM through the addition of indications and registration of patent extensions is carried out as a strategy for many ODs in Japan, similar to the LCM of general non-ODs.

Commercial Low Molecular Weight Heparins - Patent Ecosystem and Technology Paradigm for Quality Characterization.

Heparin is a subject of ever-growing interest for laboratory researchers and pharmaceutical industry. One of the driving factors is its critical life-saving drug status, which during the COVID-19 pandemic has assumed a central role in disease treatment and/or prevention. Apart, heparin is one amongst few drugs enjoying a “demand constant” status. In 2020, heparin market size was valued to US$6.5 bn., and given the ongoing stability in the COVID-19 health crisis, it is expected to reach US$11.43 bn. by 2027 with yearly growth rate momentum (CAGR) of 3.9% during the forecast period (Pepi et al., Mol Cell Proteomics 20:100,025, 2021). As patent is a limited monopoly, every year, many patents on low molecular weight heparin (LMWH; a chemically or enzymatically degraded product of unfractionated heparin) are losing market exclusivity worldwide, inviting the generic/biosimilar drug manufacturers to capture market share with cheaper drug products. By tracking patent expiration, drugs in patent litigation, regulatory setbacks for innovator companies (such as those seeking data exclusivity or patent term extension), or other unexpected events affecting market demand and competition, generics can make investment decisions in manufacturing off-patent LMWH drug products of commercial significance. However, given the US Food and Drug Administration (FDA), European Medicine Agency (EMA), Drug Regulatory Authority of Pakistan (DRAP), and other regulatory authorities scientifically rigorous standards for generic/biosimilar LMWH drug products marketing approval, the market is secured and momentous for drug makers that could demonstrate through scientific and clinical dataset that the generic/biosimilar LMWH drug product is of the same quality and purity as the innovator drug product. This study presents an overview of the patent landscape of commercially available LMWHs and advanced analytical techniques for their structural and biochemical characterization for quality control and quality assurance during manufacturing and post-marketing. The study also covers FDA, EMA, Health Canada, and DRAP’s current approaches to evaluating the generic/biosimilar LMWH drug products for quality, safety including immunogenicity, and efficacy.

Analysis of Patent and Regulatory Exclusivity for Novel Agents in China and the United States: A Cohort Study of Drugs Approved Between 2018 and 2021

Patent and regulatory exclusivity shall constitute incentives for pharmaceutical companies to develop new drugs. This study aims to investigate the differences in the patent term extension (PTE) and regulatory exclusivity between China and the United States, and to evaluate their potential impact on the market exclusivity period of novel drugs. Small-molecule novel drugs with their first indication approved in China and the United States between 2018 and 2021 were evaluated regarding their PTE and regulatory exclusivity. The PTE length of the China-approved drugs was calculated by simulation, whereas that of the US-approved drugs was extracted from the United States Patent and Trademark Office. Thirty-two and 107 novel drugs approved in China and the United States, respectively, were included in the study. The PTE length of the US-approved drugs calculated by the China-PTE method was significantly longer than that calculated by the US-PTE method. Patent extensions should be granted for 91% of new drugs in China and 82% in the United States. The simulated median PTE length of novel drugs approved in China was significantly higher than that of the United States (5.0 vs. 2.9years, P<0.05). It can be expected that the implementation of the PTE policy in China would significantly extend the period of market exclusivity for novel drugs similar to that of the United States. China should fully evaluate the potential impact of the PTE policy on the market exclusivity of novel drugs and provide better incentives to the development of novel drugs in addressing unmet clinical needs when developing its regulatory exclusivity policy.

What is behind the globalization of technology? Exploring the interplay of multi-level drivers of international patent extension in the solar photovoltaic industry

The increasing internationalization of economic activities highlights the necessity of expanding protections for technologies outside their home countries. Given the large scale and fast growth in international patent filings, understanding the motivations of international patenting behaviors has attracted much attention. This study extends prior literature by exploring additional important determinants of international patenting behaviors and the heterogeneity in international patenting across technology and assignee categories. This study focuses on the solar photovoltaic (PV) industry, which is a major sector in the renewable energy industry and plays a key role in achieving energy transition. As a critical application for semiconductors, PV technologies have grown into a substantial field of research and development through strong patents. In this study, we found that the quality and applicability scope of a patent, as well as the market size, manufacturing capacity, and imitation threats in a destination country, can impact international patent extensions in the solar PV industry. We also found that the strength of these motivators varies based on different types of technologies and assignees.

Patent Extensions Deemed Unconstitutional for Violating the Right to Health and the Social Function of Intellectual Property

Unconstitutionality of Patent Extensions

Pharmaceutical patent term extension and patent prosecution in Brazil (1997-2018).

In Brazil, if patent prosecution takes more than 10 years, this extra period is added to the regular 20-year term. This paper analyses all pharmaceutical patents granted by the Brazilian National Institute of Industrial Property (INPI) with term extension and later discusses some intellectual property and health policy implications. On average, pharmaceutical patent applications wait seven years after substantive examination is requested before being examined, which takes only three and a half years. Furthermore, the role of the Brazilian Health Regulatory Agency (Anvisa) in providing prior consent has a marginal effect in prolonging the prosecution. Therefore, the extension of pharmaceutical patents' term is caused by the number of pending applications per examiner, which halts the prosecution for double the time it takes to examine the applications. Thus, proper solutions should focus on reducing the backlog per examiner at the INPI, which has caused the extension of 92% of the pharmaceutical patents in three and a half years, on average. We concluded that the Brazilian pharmaceutical patenting policy is biased towards the patentee. This imbalance will only be effectively corrected when the INPI is financially and administratively autonomous to reduce the ratio between the pharmaceutical patent application backlog and the number of examiners.

"Unconstitutionality of Patent Extensions"

The sole paragraph of Art. 40 of the Brazilian Intellectual Property Act (Law No. 9279/1996) is unconstitutional.This decision has ex nunc effects.Exempted from the ex nunc effects – with only ex tunc effects – are (i) the judicial actions filed by or on 7 April 2021 (date of the partial upholding of the preliminary injunction in the present case), and (ii) the patents granted with an extension of the term related to pharmaceutical products and processes, as well as healthcare devices and/or materials.