Journal of Intellectual Property Rights

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Legal Pathways for Biosimilar: Comparison of Legal Rules in Different Countries


Affiliations
1 Department of Chemistry, Saranathan College of Engineering, Tiruchirappalli — 620 012, Tamil Nadu, India
2 Research and Development, Saranathan College of Engineering, Tiruchirappalli — 620 012, India

The generics of biologic drugs play a significant role in pharmaceutics and therapeutics owing to their affordability to a group of patients with fatal diseases. Even though the challenges in manufacturing of these drugs are overcome by biosimilar applicants, the disputes on patents hamper the market entry of biosimilar. The countries such as United States, European Union, Japan, Canada etc. follow divergent legal pathways to avoid these conflicts. In this article, the patent dancing in US and patent linkage systems in various countries are elaborated. As for India, few generic manufacturers attempted to resolve patent disputes through lawsuits, yet no patent linkage system is established by legislation.

Keywords

Biosimilar, Biologics, Reference Product Sponsor (RPS), Abbreviated Biologic Licence Application (aBLA), Patent Dance, Patent Linkage, United States Food and Drug Administration (USFDA)
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  • Legal Pathways for Biosimilar: Comparison of Legal Rules in Different Countries

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Authors

Sivakumar Priyarega
Department of Chemistry, Saranathan College of Engineering, Tiruchirappalli — 620 012, Tamil Nadu, India
Ramanathan Natarajan
Research and Development, Saranathan College of Engineering, Tiruchirappalli — 620 012, India

Abstract


The generics of biologic drugs play a significant role in pharmaceutics and therapeutics owing to their affordability to a group of patients with fatal diseases. Even though the challenges in manufacturing of these drugs are overcome by biosimilar applicants, the disputes on patents hamper the market entry of biosimilar. The countries such as United States, European Union, Japan, Canada etc. follow divergent legal pathways to avoid these conflicts. In this article, the patent dancing in US and patent linkage systems in various countries are elaborated. As for India, few generic manufacturers attempted to resolve patent disputes through lawsuits, yet no patent linkage system is established by legislation.

Keywords


Biosimilar, Biologics, Reference Product Sponsor (RPS), Abbreviated Biologic Licence Application (aBLA), Patent Dance, Patent Linkage, United States Food and Drug Administration (USFDA)