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Gilead’s Patents on Hepatitis C Drug Challenged by Consumer Group

  • Group says patents have blocked access to life-saving medicine
  • Pricey hepatitis C treatment has been a top seller for Gilead

Gilead Sciences Inc.’s U.S. patents on the blockbuster $84,000 hepatitis C treatment Sovaldi were challenged by a consumer group that’s battled the drugmaker around the world over the pricing.

The Initiative for Medicines, Access & Knowledge, a nonprofit focused on how patents affect access to medicine, said that it’s filed petitions with the U.S. Patent Trial and Appeal Board seeking to challenge intellectual-property rights that would keep generic versions of Sovaldi from entering the market. 

The drug generated $4 billion in revenue for Gilead last year. Nearly half of that amount came from the U.S. 

I-Mak, the nonprofit group, has challenged Sovaldi patents in India, China, Ukraine, Argentina, Brazil and Europe, accusing Gilead of making insignificant changes to a known compound, called sofosbuvir, so it could block competition for its high-priced medicines.

I-Mak says the main patents on the active ingredient and the crystalline structure of Sovaldi aren’t new. It says that the patents have been used to prop up high prices and have curbed access to a drug that could save lives.

“It’s not new science,” said Tahir Amin, director of I-Mak.

Legal Challenges

This isn’t the first time Gilead’s patents on Sovaldi, first approved in 2013, have come under attack. Gilead is trying to fend off a $2.54 billion verdict -- the largest patent-infringement judgment in U.S. history -- won by Merck & Co. over who was first to develop the class of compounds that includes sofosbuvir. It’s also battling a suit in which the University of Minnesota is demanding royalties on a school-owned patent for antiviral compounds.

As many as 4 million people in the U.S. have chronic hepatitis C virus infection, according to the Centers for Disease Control. The disease, transmitted through needles, infected blood, or unprotected sex with an infected person, attacks the liver and can lead to cirrhosis and liver cancer.

There are nine patents covering the drug, according to the U.S. Food and Drug Administration’s registry of information on approved drugs. I-Mak is challenging those that would prevent a generic-drug company from entering the market once Gilead’s data exclusivity period ends in December 2018, Amin said.

Gilead often sells Sovaldi at a substantial discount to its list price due to competition and discounts given to insurers and other payers. For Medicaid, Gilead has reduced the price of Sovaldi by more than half.

Review Process

The patent review board, typically made up of three administrative patent judges, will review the group’s petitions and any response by Gilead. In about six months, it will announce whether I-Mak has established a “reasonably likelihood of success” in its bid. If so, it will institute a review, conducting a hearing and issue a final decision in a year.

When patent reviews have gone all the way to final written decision, more than half of all challenged drug patent claims were invalidated, according to a study of PTAB data by lawyers at Fitzpatrick Cella Harper & Scinto.

— With assistance by Caroline Chen

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