New US trade deal fires huge blow for biologics patent exclusivity


The negotiations between the US, Canada and Mexico have reached an agreement to scrap patent exclusivity for biologics, meaning that each country can decide its own rules.

Previously the US had also negotiated favorable trade agreements regarding the pharmaceutical industry and have always pushed its exclusivity rules to its trade partners (previously 12-year patent exclusivity for biologics.) This change now means that pharma companies will not have the luxury of a 10-year period to keep data and other information related to their drugs confidential or have longer pricing monopolies on the market. 

According to Politco, this final agreement arose from the need to compromise to end the deadlock between the Republican and Democratic party.

Responding to these recent developments, industry organisation's BIO’s president and CEO stated that removing these IP protections for biologic medicines will not end foreign free riding on American innovation. And puts small pharma companies in jeopardy that depend on the government to protect them in the global markets.

This trade agreement might set a worrying precedent for pharma companies in future trade deals globally, meaning that global drugmakers could face sooner-than usual competition from biosimilars.

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