Newsletter ABPI – Special Edition Congress 2022 – Day 2


Generics on the trail of the innovative industry

On the second day of ABPI’s Congress, Panel 8 ⎯ Protection of confidential information in regulatory proceedings ⎯ speakers Ricardo Luiz Sichel, professor at UNIRIO and Robert DeBerardine, Chief Intellectual Property Counsel at Johnson & Johnson pointed out that the innovative drug and generic industries can coexist in the same market. Lawyer Roberto Ribeiro moderated the Panel. “The generic drug is a natural consequence of the game,” said Sichel. “Brazil can have both: the generics industry and the innovation industry”, added DeBerardine.

Brazil’s problem, said Sichel, is not the generics market. “The US and England are known as innovation hubs and both have a strong generic drugs industry,” he explained. For Sichel, the issue is legal uncertainty caused by the BPTO’s delay in granting a patent. “This delay creates a lot of uncertainty, both for the investor and for the generic manufacturer, and this generates an increase in costs”, he stated, adding that the insecurity explains why Brazil receives less than 30,000 patent applications per year while in India the applications almost reach 50 thousand.

For DeBerardine, in ten years, prescription drugs will be predominantly generic, which is already happening in the United States. He pointed out that this will not be a problem since these products will enter the market when the innovative drug industry has already made a profit. “When the system runs, it produces more and more innovation, and everyone benefits, governments, industries, people,” he explained.