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.

Today, the hepatitis C infection rate sits at an all-time high with the opioid epidemic accelerating transmission. There are 3.5 million people with hepatitis C in the USA, and more than 85% of Americans diagnosed with chronic hepatitis C will not receive treatment this year, according to I-MAK.

“These Gilead patents simply don’t meet the legal standard of being novel and non-obvious. Unmerited patents are a root cause of high drug prices and deserve much closer scrutiny. Removing these unmerited patents will allow more affordable generic drugs to be introduced much sooner, saving lives and saving taxpayers billions of dollars,” argues Tahir Amin, co-founder and co-executive director of I-MAK.


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