[Ip-health] High Cost of Hepatitis C Drug Prompts A Call to Void its Patents

Priti Radhakrishnan priti at i-mak.org
Tue May 19 18:19:27 PDT 2015


High Cost of Hepatitis C Drug Prompts a Call to Void Its Patents

A course of treatment with Sovaldi  costs $84,000 in the United States.
Credit Gilead Sciences, via Associated Press

Activists in several countries are seeking to void patents on the
blockbuster hepatitis C drug Sovaldi, saying that the price being sought by
the manufacturer, Gilead Sciences, was prohibitive.

The Initiative for Medicines, Access and Knowledge, a legal group in New
York, is expected to announce Wednesday that it has filed challenges in
Argentina, Brazil, China, Russia and Ukraine. In all those countries except
China, the organization is being joined by local patient advocacy groups.

The actions are a sign that the controversy over Sovaldi is spreading
beyond the United States, where the $84,000 charge for a course of
treatment has strained Medicaid budgets, to middle-income countries.

Sovaldi, when used with another drug, can cure most cases of hepatitis C in
12 weeks with few side effects. That has stoked huge demand for the
medicine around the world. Globally about 150 million people have hepatitis
C, which gradually destroys the liver.

Gilead is allowing 11 generic drug manufacturers in India to make
sofosbuvir, as Sovaldi is known generically, and sell it in 91 developing
countries. But those do not include some middle-income countries like
Argentina, Brazil, China and Ukraine, or Russia, which is considered a
high-income country by World Bank standards.

I-MAK, as the New York organization is known for short, estimates it would
cost $270 billion to treat the 40 million people with hepatitis C in those
five countries, assuming Gilead charges most of the other countries the
$7,500 a treatment it is proposing in Brazil.

“What that means in simple terms is that people who need the drug aren’t
getting it or are not going to get it in the near term,” said Priti
Radhakrishnan, a founder and director of I-MAK. If there were no patents,
the generic versions selling for about $1,000 in India could be sold in
those countries as well, she said.

Patent challenges are already underway elsewhere. In January, the patent
office in India denied a patent on sofosbuvir, the active ingredient in
Sovaldi, after challenges were filed by I-MAK and others. A patent
challenge was filed in Europe in February by Doctors of the World, a
humanitarian aid group.

I-MAK officials said it would be too expensive for them to try to nullify
Gilead’s patents in the United States. But they say they have received
inquiries from others, whom they would not identify, who might be

Gregg H. Alton, executive vice president for corporate and medical affairs
at Gilead, said the company was “working to facilitate broad patient access
to its hepatitis C treatments as quickly as possible in as many places as
possible.” He said at least 50,000 people in lower-income countries had
already been treated with sofosbuvir.

“We recognize that challenges to our intellectual property are an
inevitable consequence of implementing such a worldwide access effort with
such breakthrough products,” he said in an emailed statement. Gilead has
also faced challenges to its patents on H.I.V. drugs, some from the same
groups now trying to block its hepatitis patents.

Mr. Alton said Gilead would soon sign an agreement with the government in
Brazil that would allow for a significant increase in the number of
patients treated.

Marcela Vieira, a Brazilian lawyer involved in the patent challenge there,
said the government was proposing to treat only people whose livers already
show signs of damage. If the price were lower than the $7,500 Gilead is
proposing, the government might be able to treat less advanced cases,
preventing liver damage, she said.

Ms. Vieira, coordinator of a coalition called the Working Group on
Intellectual Property for the Brazilian Network for the Integration of
Peoples, said that with more than $16 billion in global hepatitis C sales
since Sovaldi reached the market in late 2013, Gilead had “already recouped
much, much more than was spent” on research and development for the drug.

Patents have not been granted yet in Argentina, Brazil and Ukraine, so in
those places the groups will seek to prevent them from being issued. The
challengers say that sofosbuvir is not novel compared with compounds
disclosed in other patent applications.

“Despite sofosbuvir’s medical benefits, it’s really based on old science,”
Ms. Radhakrishnan said.

That may be a hard case to make. Even the deputy patent controller in
India, a country in which it is notoriously difficult to patent drugs,
wrote in his decision in January that he had “no hesitation to acknowledge
the novelty and inventive step” of sofosbuvir.

Nevertheless, he denied that patent under a controversial clause in India’s
patent law that requires a patented drug to be more effective in treating
patients than an older, similar one. The clause was the reason the Supreme
Court of India denied a patent to Novartis for its highly effective
leukemia drug, Gleevec.

In the case of sofosbuvir, Gilead had failed to show that sofosbuvir was
more effective than a compound disclosed in a patent filing by another
company that Gilead says was never even developed as a drug. The case has
now been sent back to the patent office to be re-examined.

The activists face other hurdles as well. Sofosbuvir can be protected by
many patents, though I-MAK says there are two main ones. Also, sofosbuvir
cannot be used alone, and some of the drugs it can be paired with have
patents and high prices of their own.

Even if the challenges ultimately fail, however, the activists hope the
pressure could move Gilead to make some concessions.

*Priti Radhakrishnan*
Co-Founder and Director of Treatment Access, I-MAK
Echoing Green Fellow | Pop!Tech Fellow | Asia Society Associate Fellow

*"Where innovation meets access to affordable medicines"*

*Website: *www.i-mak.org
*Skype:* pritiwho
*Mobile:* +1 917 703 2876
*E-mail:* priti at i-mak.org

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