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

Pauline Londeix pauline.londeix at gmail.com
Tue May 19 19:40:36 PDT 2015

Congrats to all those involved !

On 20 May 2015 at 03:19, Priti Radhakrishnan <priti at i-mak.org> wrote:

> http://www.nytimes.com/2015/05/20/business/high-cost-of-hepatitis-c-drug-prompts-a-call-to-void-its-patents.html?_r=0
> High Cost of Hepatitis C Drug Prompts a Call to Void Its Patents
> <
> http://www.nytimes.com/2015/05/20/business/high-cost-of-hepatitis-c-drug-prompts-a-call-to-void-its-patents.html
> >
> 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
> interested.
> 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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