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24 July 2018Americas

PTAB shoots down tenth I-MAK Gilead challenge

The Patent Trial and Appeal Board (PTAB) has rejected another challenge to a Gilead-owned patent covering the company’s hepatitis C medicines.

On Thursday, July 19, the board refused to institute an inter partes review (IPR) against US patent 8,889,159, which covers “compositions and methods for treating hepatitis C virus” and relates to the tablet form of Sovaldi (sofosbuvir).

Non-profit group the Initiative for Medicines, Access & Knowledge (I-MAK) filed for the IPR in December last year.

In rejecting the petition, the board found that the I-MAK hadn’t proven that it was “reasonably likely to prevail” with respect to at least one challenged patent claim.

This is the latest refusal in a line of rejections—since May, the board has dismissed ten petitions for IPRs of Gilead’s patents.

I-MAK accused Gilead of obtaining “unmerited patents” for sofosbuvir back in October last year, and filed eight IPR petitions against six patents covering sofosbuvir.

Then, in December, I-MAK brought another two patent challenges, on that occasion for patents ‘159 and 9,393,256.

In June, LSIPR reported that the PTAB had rejected I-MAK’s eight challenges against six Gilead-owned patents. Later that month, the board dismissed a further challenge.

Even before the latest dismissal, I-MAK had begun the appeals process, asking the board to rehear some of its petitions. Some of the requests have been denied, while others are still pending.

Tahir Amin, co-founder and co-executive director at I-MAK, said these decisions have “exposed the imbalance of power between the interests of pharma and the interests of American families in the US patent system”.

He claimed this demonstrates the need for long-term patent reform and that the only way to address the crisis of high drug prices is to solve the patent problem.

“Through legal work, investigations and research, and public education we will continue to expose how the patent system is a root cause of our drug pricing crisis and creates barriers to medicines for people who need them,” added Amin.

According to I-MAK, there are 3.5 million people with hepatitis C in the US, and more than 85% of Americans diagnosed with chronic hepatitis C will not receive treatment this year.

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More on this story

Americas
14 June 2018   The Patent Trial and Appeal Board has now rejected challenges to six patents owned by Gilead covering the company’s hepatitis C medicines.
Asia
26 July 2018   In India, a non-profit organisation and an advocacy group have united to take on a patent covering pibrentasvir, part of the drug combination that forms AbbVie’s hepatitis C product Mavyret.
Americas
2 August 2018   Aggressive and exploitative patenting strategies are enabling drug makers to regularly increase prices in the US and extend monopolies, according to a new report from non-profit group the Initiative for Medicines, Access and Knowledge.

More on this story

Americas
14 June 2018   The Patent Trial and Appeal Board has now rejected challenges to six patents owned by Gilead covering the company’s hepatitis C medicines.
Asia
26 July 2018   In India, a non-profit organisation and an advocacy group have united to take on a patent covering pibrentasvir, part of the drug combination that forms AbbVie’s hepatitis C product Mavyret.
Americas
2 August 2018   Aggressive and exploitative patenting strategies are enabling drug makers to regularly increase prices in the US and extend monopolies, according to a new report from non-profit group the Initiative for Medicines, Access and Knowledge.