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- No. 45-1, March 2020
Letter from the Editor-in-chief
Publication year | 2020 |
Author | Thomas A. Ward |
Thomas A. Ward
CommScope
Welcome to the spring edition of New Matter for 2020. The cover art for this issue illustrates the intellectual property (IP) issues arising due to coronavirus. Gilead Sciences' experimental patented drug remdesivir developed to combat ebola has emerged as a promising candidate against coronavirus. But its patent in China has raised some IP issues.
As a first issue, the Chinese pharma company BrightGene has successfully copied remdesivir and has already mass-produced remdesivir's active ingredient and is in the process of turning it into finished doses. BrightGene made clear the generic version is still in an R&D phase, and that its final marketing requires permission from the patent holder, Gilead. BrightGene's board secretary explained that there isn't any patent infringement issue at this point in China because it's not selling the product. But manufacturing a copycat to a patented drug at scale without any license is unusual and could create concerns about protection of IP in China.
Gilead has kicked off two phase 3 trials in Wuhan to test remdesivir in adult patients with the respiratory disease caused by coronavirus. Investigators aim to enroll over seven hundred patients with test results expected as early as April. Gilead is providing the drug for free for the studies. BrightGene said it will also provide its version mainly through donations during the epidemic if it's granted the marketing go-ahead.
Chinese IP law does provide for compulsory licenses for eligible companies to produce generic versions of patented drugs during a state of emergency or other unusual circumstances. However, it is uncertain whether authorities will issue a compulsory license, especially since Gilead offers it free and as drug IP remains a sensitive topic on the international community's radar.
In a further IP development, researchers at the Chinese Academy of Sciences' Wuhan Institute of Virology said they...
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