How patent rules could keep new hepatitis C drug from saving ‘millions of lives’

Doctors are calling Gilead Sciences’ new hepatitis C drug a “game changer.” The pill, called sofosbuvir, is more effective than comparable drugs, works more quickly and makes treatment less painful.

“Suddenly, it’s realistic to think we can cure most patients with hepatitis C,” said Dr. Greg Fitz, president of the American Association for the Study of Liver Diseases, in a news conference where Gilead presented research on sofosbuvir. 

But patient rights advocates argue that the drug’s price tag — an estimated $84,000 per treatment — puts sofosbuvir out of reach for many.

The Food and Drug Administration gave the go-ahead on Dec. 6. Gilead will own the market in the United States for at least 20 years before generic drug producers can get in the game and bring prices down.

But in India, advocates for affordable medicine are fighting to block the pharmaceutical company’s patent. If they win, the country will be able to crank out low-cost copies of the drug for millions in India and other developing countries.

In the meantime, in Singapore last week, dignitaries from 12 countries met to hammer out a trade agreement that threatens to ban such lawsuits. 

As part of the pact, called the Trans-Pacific Partnership, US negotiators are attempting to strengthen pharmaceutical patents, lengthen monopoly protection beyond the typical 20-year limit and dismantle international laws that enable poor countries, where high costs may bar sick people from getting medicine, to develop cheaper alternatives. 

India was not represented at the negotiating table and isn’t slated to sign the deal, but experts say the outcomes of the talks could still have significant consequences for the country and the future of generic drugs. 

Hepatitis treatment for all

Hepatitis C, an infectious disease that attacks the liver and often leads to cancer, is spread primarily by blood-to-blood contact. Most often associated with intravenous drug use, infection can also be traced back to poorly sterilized medical equipment or inadequately screened blood transfusions.

“You can pick it up at the dentist or during surgery,” said Leena Menghaney, the coordinator for Doctor’s Without Borders’ access to affordable medicine campaign in India. “The symptoms move slowly, so you may not know you are sick for a decade.”

Ninety percent of hepatitis C patients live in low- and middle-income countries. In India, the World Health Organization estimates as many as 12 million people may be chronically infected with hepatitis C. Nearly 96,000 Indians die from the infection each year. 

Until now, doctors primarily have been treating the infection with two drugs: interferon alfa, which is given in weekly injections for 24 or 48 weeks, and daily tablets of ribavirin. The combination can cause debilitating side effects, including flulike symptoms, anemia and depression, and it only cures about half of patients. 

Gilead’s new drug, a daily pill, boasts a 90 percent cure rate and much fewer side effects, Menghaney said. Because the treatment is administered orally and not intravenously, it wouldn’t require a trained doctor to administer — a perk that’s especially important in poor countries where healthcare workers are in short supply.

“This drug could save millions of lives in developing countries,” Menghaney said. “It’s a complete game changer in public health.”

Even before sofosbuvir came along, treatment for hepatitis C was out of reach for many in India, which the World Bank reports had a per capita GDP of $1,489 in 2012. One vial of the injectable drug interferon costs $350.

“Patients sell their homes, their gold, everything they have to get treatment,” said Menghaney. “Some people even take out bank loans.”

The cost is prohibitive even for NGOs. Doctors Without Borders runs India’s only free-of-cost hepatitis C program. Menghaney said drug companies would not negotiate a deal with the NGO, so it has only been able to enroll three patients.

“The treatment just isn’t scalable,” she said. “We need generic competition to bring down the prices.”

The Initiative for Medicines, Access and Knowledge, a legal group based in New York, is challenging Gilead’s patent on the grounds that sofosbuvir is based on an “old science.” India’s patent laws don’t consider new forms of a known substance to be innovative unless it improves efficacy.

“India’s patent law doesn’t give monopolies for old science or for compounds that are already in the public domain,” said I-MAK director Tahir Amin in a press release. “We believe this patent on sofosbuvir does not deserve to be granted in India and have the legal grounds to prove it.”

A recent study from Britain’s Liverpool University suggests a 12-week course of the drug could be produced for as little as $62 to $134. 

“It only takes a few grams of these drugs to cure hepatitis C,” study author Andrew Hill told Forbes. “Companies have a choice: continue treating a very small number of people with hepatitis C at a very high cost, or expanding access to these treatments, lowering treatment costs significantly, and working towards eradication of this disease.”

In response to the patent opposition, Gilead told PharmaTimes that it is committed to making sure hepatitis C treatments reach as many patients as possible.  

“As we did with our current HIV access program, we are working very closely with advocates in the communities that are affected by HCV to develop an appropriate access and pricing strategy,” Gilead stated.

A regional trade deal with global impacts

The Trans-Pacific Partnership, a free trade deal between the US, Canada and 10 countries in the Asia-Pacific region, is one of several regional and sub-regional trade negotiations that have sprung up in recent years as World Trade Organization talks have hit an impasse. 

US leaders have called the TPP the first step in an attempt to import stricter rules into the World Trade Organization.

“Our goal is for high standards for the Trans-Pacific Partnership to enter the bloodstream of the global system and improve the rules and norms,” said Vice President Joe Biden in a speech in April. “What we’re talking about is shaping a new standard that then becomes the metric by which all future trade agreements are measured.” 

As part of the deal, US negotiators have attempted to crack down on pre-patent oppositions, like the one that has been filed against Gilead. In a draft of the trade agreement published by Wikileaks in November, the TPP forbade challenges to patents until after they were granted. 

Drug companies say stronger patent protection is necessary to allow them to recover investments and continue research. But activist groups like Doctors Without Borders argue that stricter intellectual property rules will delay the development of generic drugs and keep healthcare prices high.

Unless India joins the TPP (which isn’t an unheard-of proposal), advocates for affordable medicine will still be able to file pre-grant oppositions, said Amitendu Palit, a senior research fellow at the Institute of South Asian Studies at the National University of Singapore. India’s scientists can continue to develop generics and distribute them to Indians.

But, member or not, because India is the world’s biggest producer of generic medicine, the country’s economy would likely sustain a hefty hit if the trade agreement is passed as written, Palit said. TPP countries represent 40 percent of the world’s gross domestic product and a number of them import generic drugs from India. When the pact goes into effect, those countries will have to close their accounts.

“When the TPP kicks in with much stronger intellectual property rules, Indian producers will be feeling the heat,” he said.

The TPP also includes an anti-counterfeit provision, which empowers customs officials to seize shipments of drugs they suspect to be counterfeit without a formal complaint. Because generic drugs are more susceptible to counterfeit, Palit said, even valid shipments from India are likely to run into roadblocks.

“Say there’s a TPP country located between India and another country where generic shipments from India are travelling,” Palit said, “India’s trucks are going to become targets.”

The tension between India and US pharmaceutical companies is longstanding. India’s patent system is notorious for tripping up US patent holders. Each year, generic medicines companies based in India chip away a larger share of the US market.

In a landmark decision in April, India’s Supreme Court denied the pharmaceutical company Novartis AG patent protection for its cancer drug Glivec. A slue of hits to the pharmaceutical industry followed. Roche lost its patent for the hepatitis C drug Pagasys. Merck was denied a patent for asthma treatment Singlulair. Gilead’s HIV drug Viread and Pfizer’s cancer drug Sutent both failed to win patents.

Members of the Senate finance committee and a group of 170 House legislators this summer prevailed upon Secretary of State John Kerry to address the issue, saying Indian patent policies were undermining US business innovation. 

"Since early 2012, India's policies and actions have undermined patent rights for at least nine innovative medicines,” said Pfizer’s chief intellectual property officer, Roy Waldron, testifying before a subcommittee of the House Energy and Commerce Committee in July. “This is not only creating significant uncertainty in the market but it also undermines our ability to compete fairly in India, and our willingness to invest there." 

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