Initiative for Medicines, Access & Knowledge - a U.S.-based nonprofit also known as I-MAK - filed a set of patent challenges against sofosbuvir, according to a press release from the organization. According to I-MAK, the drug's six core patents do not meet the legal standards for novelty and non-obviousness.

Tahir Amin

"As an organization, we've been working on the issue of patents and medicines for over 10 years and we have identified that unmerited patents can be a driver of high drug prices, particularly where they're unnecessarily blocking drug competition," Tahir Amin, co-founder and co-executive director of I-MAK told Helio-com/Hepatology. "Through our research we have identified a number of examples where the over-patenting situation on drugs is getting in the way of more access and more competition in the marketplace, which naturally results in morefold prices."

The patent challenges include one against the base compound sofosbuvir. According to I-MAK, nucleo(t)sides like sofosbuvir existed in relation to antiviral and anticancer treatments years before Gilead filed its patents and that the core molecule in sofosbuvir has the same elements and arrangement as previous nucleos(t)ides except for one nonobvious change.

I-MAK also challenged three patents Gilead holds regarding the prodrug in Sovaldi. The organization stated that because sofosbuvir is a nucleos(t)ide, the prodrug used in Sovaldi was an obvious choice to activate the basic molecule.

Amin added that there was a publication that predates the application of this prodrug 17 days before Gilead acquired it and details how to deliver a nucleos(t)ide like the one Pharmasset developed for sofosbuvir. These three patents have been extended to 2029.

Finally, I-MAK challenged two patents Gilead holds for the crystalline structures in sofosbuvir.

"There's nothing inventive about it," Amin said. "It's just something that you screen for; it's common practice in the pharmaceutical industry to screen for different crystal forms which are naturally there."

According to Amin, 85% of the estimated 1.7 million people currently diagnosed with HCV will not receive treatment this year. Regarding Gilead's recent patent extensions, which Amin referred to as the common practice of lifecycle management to maintain a market as long as possible, I-MAK's concern is the overall affect that a lack of generic options for HCV will have.

"This is going to be a significant problem as we go along in the future years trying to treat patients," Amin concluded. "If you've got 85% who are not getting the drug today, it's going to be a significant problem going forward. We're trying to address it in a different way."

Gilead did not respond to requests for comment at the time of publication.

Reference:

Initiative for Medicines, Access & Knowledge. First-Ever U.S. Patent Challenges Dispute Gilead's Monopoly on Hepatitis C Drugs that Blocks Millions from Treatment. www.i-mak.org. Updated: Oct. 25, 2017. Accessed: Oct. 26, 2017.

Disclosure: Amin reports no relevant financial disclosures.

Editor's note: This article was updated with clarified information from Tahir Amin.