PTAB rejects IPR challenges to Gilead patents
The Patent Trial and Appeal Board (PTAB) has now rejected challenges to six patents owned by Gilead covering the company’s hepatitis C medicines.
Yesterday, June 13, the board refused to institute the last two of eight inter partes reviews (IPRs) against the six patents filed by non-profit group the Initiative for Medicines, Access & Knowledge (I-MAK).
Since May, the board has rejected eight petitions for IPRs of Gilead’s patents, which include 7,964,580; 8,334,270; 8,633,309; and 9284342.
Yesterday, the PTAB refused to institute an IPR of US patent number 7,429,572 B2 because I-MAK had failed to demonstrate a reasonable likelihood that it would prevail in showing unpatentability.
The patent, called “Modified fluorinated nucleoside analogues”, discloses compositions and methods of treating hepatitis C.
The PTAB also rejected I-MAK’s petition for an IPR of patent 8,735,372 B2, which covers a “method of treating a human infected by hepatitis C virus comprising administering both an NS5a inhibitor and a prodrug of a nucleoside derivative”.
I-MAK announced that it had filed the “first-ever” US challenges against six patents covering sofosbuvir at the PTAB in October last year.
The non-profit had accused Gilead of obtaining “unmerited patents” for its hepatitis C medicine, which Gilead uses for its drugs Sovaldi, Harvoni and Epclusa.
Two months later, in December, I-MAK brought another two challenges against two Gilead patents, one of which relates to the tablet form of Sovaldi and the other which covers a combination of two patented compounds.
At the time, I-MAK claimed that if Gilead’s eight patents were overturned, US taxpayers would save more than $10 billion and generics would come to market 16 years earlier.
There are 3.5 million people with hepatitis C in the US, I-MAK said, and more than 85% of Americans diagnosed with chronic hepatitis C will not receive treatment this year.
I-MAK’s December petitions for IPRs of patents 9,393,256 and 8,889,159 are still pending.
The non-profit has requested a rehearing on one of the IPRs and is reviewing the other decisions.
Tahir Amin, co-founder and co-executive director at I-MAK, said: “Rampant abuse by pharmaceutical companies of the drug patent system is harming millions of American families. The PTAB is an important agency, but it can only enforce the laws and standards provided.”
Amin added that the PTAB’s decision raises questions about “where the balance of power lies in the American patent system and its ability to get life-saving drugs into the hands of people who need them”.
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