First US patent challenges dispute Gilead's monopoly on hepatitis C drugs

As US voters demand action to lower prescription drug prices, USA-based nonprofit Initiative for Medicines, Access & Knowledge (I-MAK) is taking its own action against the maker of some of the leading hepatitis C treatments.

It alleges that biotech major Gilead Sciences (Nasdaq: GILD) has obtained unmerited patents for hepatitis C medicine sofosbuvir (brand name Sovaldi), blocking millions in the USA from affordable treatment s.

I-MAK yesterday filed the first-ever U.S. patent challenges against sofosbuvir, the backbone of Gilead’s Sovaldi, Harvoni(ledipasvir and sofosbuvir) and Epclusa (sofosbuvir and velpatasvir), arguing that the drug’s six core patents do not meet the legal standards for novelty and non-obviousness. I-MAK is also putting a spotlight on the pharmaceutical industry’s widespread patent use in a new white paper that finds unmerited patents and other strategies to delay competition used by the industry on three major cancer and hepatitis C drugs will cause more than $55 billion in excess costs to payers and taxpayers.