Two new patent challenges have been launched by the New York-based patient access and public health activist I-MAK – the Initiative for Medicines, Access & Knowledge.
The actions are being taken against sofosbuvir-based products. Sofosbuvir is the generic name for HCV drug Sovaldi.
These challenges, which build on previous legal bids that the group filed against six sofosbuvir patents in October, are based on patents which relate to particular mixtures of active and inactive ingredients, a practice I-MAK describes as a “classic case of how pharmaceutical companies try to extend their patent exclusivity.”
I-MAK says that if it is successful in overturning the eight patents held by California’s Gilead Sciences (Nasdaq: GILD), then US taxpayers would save more than $10 billion as a result of generics coming to market 16 years sooner.
The group notes that “China rejected a prodrug patent on sofosbuvir in response to legal challenges by I-MAK in 2015, and other patient advocacy groups have also filed challenges on sofosbuvir patents in Brazil, Russia, Thailand and Ukraine.”
In Europe, Gilead’s patent rights on the prodrug have been narrowed following a patent challenge by medical humanitarian groups, a decision which is being appealed.
I-MAK co-founder Tahir Amin said: “Americans with hepatitis C simply cannot wait decades to be able to afford and access life-saving treatment.”
“For too long, Gilead has abused our patent system to preserve its stranglehold on the hepatitis C market and keep prices astronomically high. It’s no surprise that more and more patent offices across the world are ruling that Gilead’s patents are unmerited.”
I-MAK says it is has been successful in 80% of its patent challenges, since 2006.