Non-profit group continues battle against Gilead patents
Non-profit group the Initiative for Medicines, Access & Knowledge (I-MAK) has brought another two patent challenges against Gilead over its hepatitis C medicine sofosbuvir.
In October, LSIPR reported that I-MAK had accused Gilead of obtaining “unmerited patents” for its medicine and filed the “first-ever” US challenges against six patents covering sofosbuvir at the Patent Trial and Appeal Board.
Gilead uses sofosbuvir for its drugs Sovaldi, Harvoni and Epclusa.
One of the patent challenges relates to the tablet form of Sovaldi.
I-MAK said in a press release that Gilead has obtained a patent by “simply claiming” that it has combined the active ingredient of Sovaldi with various “commonly used inert excipients in a particular weight percentage to make a tablet”.
The other patent covers a combination of two patented compounds.
“Combination patents are a part of the pharmaceutical industry’s toolbox for extending patent exclusivity in order to manage the lifecycle of existing products,” said I-MAK.
The non-profit claimed that if Gilead’s eight patents are overturned, US taxpayers will save more than $10 billion and generics will come to market 16 years earlier.
According to a white paper from I-MAK, “unmerited patents and over-patenting by the pharmaceutical industry will cause more than $55 billion in excess costs to Americans”.
There are 3.5 million people with hepatitis C in the US, said I-MAK, and more than 85% of Americans diagnosed with chronic hepatitis C will not receive treatment this year.
Separately, in February, non-profit Fundación Grupo Efecto Positivo (FGEP) filed a patent opposition against sofosbuvir in Argentina, with support from I-MAK.
On Monday, December 4, the FGEP reported that Argentina’s National Institute of Industrial Property rejected Gilead’s patent application.
I-MAK added that China’s IP office had rejected the same patent on sofosbuvir in response to legal challenges made by the non-profit in 2015.
Tahir Amin, co-founder and co-executive director at I-MAK, said: “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.”
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