Compulsory Licenses As a Defense in Pharmaceutical and Biotech Patent Litigation

Falck, Andreas von

doi:10.4155/ppa-2016-0035

Cited by 3 publications

(4 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…LMICs argued for the right to issue compulsory licensing for patented pharmaceuticals that were expensive for their citizens, while high-income countries, usually influenced by the pharmaceutical industry, argued for the limited use of compulsory licensing [37]. High-income countries feared that massive issuance of compulsory licensing would adversely impact the profits of the industry and would harm the ability of these companies to research and develop in the long term [36, 38]. Therefore, the use of compulsory licensing of pharmaceuticals was restricted to highly infectious diseases such as HIV/AIDS in LMICs [39], and compulsory licensing other than this restricted area was deemed unjustifiable [38].…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Importance of the intellectual property system in attempting compulsory licensing of pharmaceuticals: a cross-sectional analysis

Son

2019

Global Health

View full text Add to dashboard Cite

Background Recently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a country’s income- level. We aim to investigate the use of compulsory licensing as a legitimate part of the patent system and tool for the government to utilize by demonstrating that countries with a mature patent system were more likely to utilize compulsory licensing of pharmaceuticals. Methods We used a multivariate logistic model to regress attempts to issue compulsory licensing on the characteristics of the intellectual property system, controlling for macro context variables and other explanatory variables at a country level. Results A total 139 countries, selected from members of the World Trade Organization, were divided into a CL-attempted group ( N = 24) and a non-CL-attempted group ( N = 115). An attempt to issue compulsory licensing was associated with population (+) and a dummy variable for other regions, including Europe and North America (−). After controlling for macro context variables, mature intellectual property system was positively associated with attempting compulsory licensing. Conclusions Our study provided evidence of an association between attempting compulsory licensing and matured patent systems. This finding contradicts our current understanding of compulsory licensing, such as compulsory licensing as a measure to usurp traditional patent systems and sometimes diametrically opposed to the patent system. The findings also suggest a new role of compulsory licensing in current patent systems: compulsory licensing could be a potential alternative or complement to achieve access to medicines in health systems through manufacturing and exporting patented pharmaceuticals.

show abstract

Section: Discussionmentioning

confidence: 99%

“…The license seeker then responded by requesting a compulsory license under the Patent Act [42]. Specifically, the Court concluded that the license seeker was entitled to emergency relief and granted provisional compulsory licensing based on the need of patients to have the drug available continuously during the course of treatment [38].…”

Section: Discussionmentioning

confidence: 99%

Importance of the intellectual property system in attempting compulsory licensing of pharmaceuticals: a cross-sectional analysis

Son

2019

Global Health

View full text Add to dashboard Cite

show abstract

“…First, in 2016, the German Federal Patent Court ordered a CL for HIV/AIDS drugs under Section 24 of the Patent Act for the first time. 24 Second, China recently released the "Measures for Compulsory Licensing of Patent Implementation" that updated intellectual property laws to allow for CL. Under the new measures, China's State Intellectual Property Office (SIPO) may issue and terminate compulsory licensing for patents considering 3 factors: non-use of the patented invention or misuse of patent; public welfare, including public interest and national emergency; and cross licensing for exploitation of an improvement invention.…”

Section: Current Understandings Of CL and Possible Factors Influencinmentioning

confidence: 99%

How Much Time Before Attempting Compulsory Licensing of Pharmaceuticals? A Non-parametric Event History Model With P-splines

Son

2018

Int J Health Serv

View full text Add to dashboard Cite

Compulsory licensing (CL), provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights, enables countries, including high-income countries, to ensure the protection of public health in the context of stringent intellectual property regimes. This study investigated associations between the time to attempted CL and a series of factors at the drug and country level. We used a dataset of all attempted CL that occurred from 1995 to 2014, calculated the duration as the difference in years between the year of global marketing of a certain drug and the year of attempted CL in a certain country, and applied a nonparametric event history model. We found that the Doha Declaration was quite effective in shortening the time to attempted CL. Additionally, even though global justice movements have encouraged some countries to attempt CL for various medicines since 2012, the time to CL attempts in this period became significantly longer compared to those that occurred immediately after the Doha Declaration. Our findings show that the subject of CL has not successfully expanded to oncology medicines from HIV/AIDS medicines and that recently approved medicines are not yet subjects of CL. Furthermore, our duration model suggests a learning-by-doing effect in attempting CL: previous experience of CL not only triggers CL for the same drugs in other countries but also accelerates CL for other drugs within the country.

show abstract

“…In order to increase the availability of sofosbuvir for patients with hepatitis C is necessary the use of the "flexible" mechanisms of the TRIPS Agreement (Agreement on trade-related aspects of intellectual property rights), namely involving the grant of compulsory licenses, the implementation of parallel imports, the tightening of the criteria for patentability etc. [71][72][73][74][75][76][77][78][79][80].…”

mentioning

confidence: 99%

Sofosbuvir: Treatment of Chronic Hepatitis C and the Main Trends in Patent Protection

Литвинова

Olga

Nataliia³

2019

Int J App Pharm

View full text Add to dashboard Cite

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).

show abstract

Compulsory Licenses As a Defense in Pharmaceutical and Biotech Patent Litigation

Cited by 3 publications

References 0 publications

Importance of the intellectual property system in attempting compulsory licensing of pharmaceuticals: a cross-sectional analysis

Importance of the intellectual property system in attempting compulsory licensing of pharmaceuticals: a cross-sectional analysis

How Much Time Before Attempting Compulsory Licensing of Pharmaceuticals? A Non-parametric Event History Model With P-splines

Sofosbuvir: Treatment of Chronic Hepatitis C and the Main Trends in Patent Protection

Contact Info

Product

Resources

About