The Indian Patent Office has denied a patent application by US pharmaceutical company AbbVie for its Hepatitis C combination therapy, glecaprevir/pibrentasvir, which is globally marketed as Mavyret. This therapy is recognized as a crucial treatment for Hepatitis C, making the availability of affordable generic alternatives vital for expanding patient access.
“This order highlights the importance of India’s patent safeguards, including pre-grant opposition, in averting unnecessary patent monopolies that could hinder access to medicines,” stated the public health advocacy group Third World Network (TWN).
The significance of this rejection is underscored by its prevention of AbbVie from obtaining a secondary patent on the composition of glecaprevir/pibrentasvir. If granted, this patent could have extended the company’s market exclusivity by an additional five years, according to a TWN lawyer.
The decision, made under Section 15 of the Patents Act, recorded that AbbVie failed to submit response statements or evidence addressing the pre-grant oppositions and subsequently informed the patent office of its intent to withdraw the application.
Additionally, the ruling’s impact is heightened by AbbVie’s licensing agreement with Medicines Patent Pool, which excluded India from the territories where the drug could be sold.
