scholarly journals Development Time and Patent Extension for Prescription Drugs in Canada: A Cohort Study

Author(s):  
Joel Lexchin

The Comprehensive Economic and Trade Agreement between Canada and the European Union provides for an extension of Canadian patents for prescription drugs by up to 2 years. One of the arguments advanced for longer patent time is to compensate companies for the length of the overall drug development time (the time between patent application and market approval). This study investigates overall development time in Canada for different groups of drugs approved between January 1, 2009 and December 31, 2018 and how many of these drugs are eligible for up to 2 years of patent term extension. Based on a list of patents and dates of market approval, the change in overall development time for all drugs was calculated along with whether there were differences in development time between different groups of drugs. Using Canadian patent filing dates, overall development time for all drugs went from a mean of 2240 days (95% CI: 1832, 2648) in 2009 to 4197 days (95% CI: 3728, 4665) in 2018 (analysis of variance [ANOVA], P<.0001). Using first global patent filing dates, overall development time went from a mean of 4481 days (95% CI: 3053, 5908) in 2009 to 6298 days (95% CI: 4839, 7756) in 2018 (ANOVA, P=.0118). There was a statistically significant difference in the overall development mean time between small molecule drugs (3553, 95% CI: 3361, 3746) and biologics (3903, 95% CI: 3595, 4212), (t test, P=.0487) when using Canadian patent filing dates but not when first global patent filing dates were used. There was no statistically significant change in overall development time among drugs that were substantial, moderate or little to none additional therapeutic value compared to existing drugs. Out of 238 drugs, 218 (91.6%) would have been eligible for patent term extension with 195 (80.7%) eligible for the full 2 years. Patent term extension does not appear to be justified based on changes in overall development time, except possibly in the case of biologics. There are also trade offs in terms of increased expenditures that need to be considered if patent terms are lengthened.

2000 ◽  
Vol 42 (2) ◽  
pp. 35-62 ◽  
Author(s):  
José Antonio Sanahuja

Mexico and the European Union signed a new Political and Economic Association Agreement in December 1997 and ultimately a free-trade agreement in March 2000, aiming to establish a new model of relations with a more dynamic trade and investment component. This article analyzes the 1997 agreement as background to the final accord. Economic and political changes in the 1990s modified both parties’ participation in the international political economy, helping to overcome some of the structural obstacles to the relationship. The policy toward Latin America adopted by the EU in 1994 was influential. The negotiation process revealed divergences over the scope of the liberalization process and the so-called democracy clause.


Author(s):  
Y T B Bambaradeniya ◽  
W A I P Karunaratne ◽  
J K Tomberlin ◽  
P A Magni

Abstract Chrysomya rufifacies (Macquart), the hairy maggot blow fly, is of great importance for the field of forensic entomology due to its habit as an early colonizer of decomposing vertebrate remains and myiasis producer. Development studies on this species have been conducted in scattered regions of the world, using types of tissue from several species of animals as a rearing medium. Despite the commonality of C. rufifacies in Sri Lanka, developmental studies have never been performed in this region. As well, the effects of diet on development have not been tested. In the current study, C. rufifacies immatures were reared on skeletal muscle, liver, and heart from domestic swine, with flies from colonies maintained at 25 and 28°C. The minimum time needed to complete each stage at 25°C on liver (224.14 h) was fastest followed by skeletal muscle (249.33 h) and heart (251.64 h) respectively, whereas at 28°C, fly development was quickest on heart muscle (178.27 h) followed by liver (178.50 h) and skeletal muscle (186.17 h) respectively. A significant difference in total development time was determined for temperature, while the rearing medium was not significant. Temperature also showed a significant effect on the length and the width of the larvae, while the type of tissue statistically impacted only the width.


2022 ◽  
pp. 001573252110579
Author(s):  
Phan Thanh Hoan ◽  
Duong Thi Dieu My

Vietnam is one of the top information and communication technologies (ICT) exporters globally, and the ICT products constitute nearly one-fifth of Vietnam’s total exports to the European Union (EU). This study empirically investigates the determinants of Vietnam’s ICT exports to the EU by applying the gravity model for trade with panel data from 2000 to 2019. Besides the traditional variables of the gravity model, we added gross capital formation, patent application and exchange rates as explanatory variables. The results show that among factors affecting Vietnam’s ICT export to the EU, market size, patent applications, and exchange rate are the most significant determinants. The article also suggests some policy implications for the development of ICT exports between the two parties. JEL Codes: F14, C2


2015 ◽  
Vol 5 (2) ◽  
pp. 19-36
Author(s):  
Anis Kacem

Tunisia has signed a free trade agreement with the European Union in 1996, which provides for the reduction of tariff barriers between Tunisia and the EU. In this article, we aim to know and test whether the similarity of the institutional framework has to stimulate international trade between Tunisia and the European Union. In this context, we built a variable called “Institutional distance” to valid the institutional dimension of international trade, near borders effects reported in the literature. To this end, a gravity model was used initially (Tunisia and 21 European countries). Secondly, the estimate shows the existence of spatial autocorrelation. The latter has been corrected using spatial econometrics. The results show that the geographical distance remains more important than the institutions in this type of agreement between north and south shores of the Mediterranean.


2021 ◽  
Vol 23 (Fall 2021) ◽  
pp. 193-211
Author(s):  
Kaan Yiğenoğlu

This article scrutinizes relations between economic diplomacy and free trade agreements by focusing on the Turkey-UK free trade agreements which came into force in 2021. Accordingly, the article first introduces the concept of economic diplomacy, an important issue as it has been shown that bilateral trade agreements, nowadays preferred by many countries, can be used as a tool of economic diplomacy. The article then discusses the history and development of free trade agreements signed by Turkey, including its long-running experience of economic integration with the European Union. Although Turkey began establishing free trade agreements in the 1990s, it has been concentrating on and accelerating its use since 2000. Based on economic and political reasons underlying the free economic agreements, the reasons why Turkey and the UK have reached such an agreement are summarized. Economic relations between the two countries are then analyzed and the details of the agreement are investigated in the context of the changes that it provides.


IG ◽  
2021 ◽  
Vol 44 (4) ◽  
pp. 301-317
Author(s):  
Mariano Barbato

The talks that have been resumed for reaching a free trade agreement between the European Union and India have a good chance for success. Both partners, especially India, have to achieve new economic dynamics in order to be able to face the challenge posed by China. This decisive reason is supported by Brexit, the pandemic and the climate crisis, which also spark an exogenous, geostrategic dynamic that gives new impetus to the paralyzed liberal paradigm of free trade. Taken together, it is likely that exogenous geostrategic factors realign the endogenous economic factors and thus promote a positive outcome despite the ongoing weakness of liberal free trade ideas.


2017 ◽  
Vol 3 (3) ◽  
pp. 167-175 ◽  
Author(s):  
Suchita Markan ◽  
Yogmaya Verma

In this study, patent application filing trends in India for the last decade (2005–2014) were analysed to understand the medical device patent filing profile. As India is the key emerging market with huge market potential, this study was also undertaken to identify the top medical device companies filing patents in India, the niche technology domains with maximum filings, key gaps in medical device innovation profile and scope for business opportunities. It was observed that patent application filings in the medical device sector during the last 5 years (2009–2013) contributed only to 2% of the total patent applications filed, which may be attributed to nascent medical device sector and lack of Intellectual Property (IP) awareness or funding support for IP filings. The analysis shows increasing trends in medical device patent applications in India, with major share of patent applications being filed from the USA. The Indian applications in this sector contributed only to 17% of the total patent application filings in the last decade. Although foreign players dominate the medical device sector, this study indicates that though at a small scale, Indian applicants are actively filing patents in all key domains of the medical device sector. With the enabling environment being provided by the Government of India with recent policy initiatives such as Startup India, Make in India, 100% Foreign Direct Investment (FDI)and so on and support to start-ups for IP filings, the Indian medical device industry is expected to witness aggressive IP filing and innovation trends and is poised to grow exponentially targeting US$50 billion industry by 2025.


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