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2019, Number 3

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Rev Cubana Farm 2019; 52 (3)

Freedom to operate to produce antiviral drugs of antihepatitis C direct action in Cuba

González HR, Cruz GMY

Language: Spanish
References: 15
Page: 1-18
PDF size: 607.71 Kb.


ABSTRACT

Introduction: Recommended anti-hepatitis C drugs are combinations of at least two active pharmaceutical ingredients called antivirals of direct action.
Objective: To determine if there is freedom to operate in Cuba to produce antiviral drugs of anti-hepatitis C direct action.
Methods: For this informative study, there were collected keywords and the codes from the International Classification of Patents corresponding to the pharmaceutically active ingredients of interest, as well as the pharmaceutical products that they form. Strategies were developed for the search in the public databases and those of restricted access that contain documents of Cuban patents. There were analysed the claims of the patents found as notable, there were identified the legal states and compared the technical characteristics of products to produce with the features of the patented ones. A study was made on the overall patents` family for each pharmaceutically active ingredient, in order to investigate the possibility of exporting to other countries.
Results: It was found a notable Cuban patent application in which the applicant (Gilead) tries to protect two new crystalline forms of sofosbuvir. The comparative analysis of the technical characteristics (crystalline forms) of sofosbuvir patent´s found and those of the one intended to be used in the production showed that they are not equal. In addition, this patent was declared as abandoned. It was found that the patents related to the active pharmaceutical ingredients of interest (sofosbuvir, ledipasvir, and velpatasvir), as well as that of the products (Harvoni® and Epclusa®) are currently in force in many countries.
Conclusions: There is freedom to operate for the production in Cuba of antiviral drugs against the hepatitis C virus (Harvoni® and Epclusa®) with the active pharmaceutical ingredients: sofosbuvir and ledipasvir, or sofosbuvir and velpatasvir, respectively, as they are not protected by patents in the national territory. However, exportation of the production is not possible, since there were found patent rights currently in force in other countries.


REFERENCES

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