How India's Patent Office Destroyed Gilead's Global Game Plan

[Avik274]

Photographer: Manish Swarup/AP Photo

In 2006, members of the Indian Network for People Living with HIV/AIDS demonstrated in New Dehli against a patent applied for by Gilead Sciences.

Gilead Sciences charges a lot for the hepatitis treatment Sovaldi, which sells for as much as $84,000 to U.S. patients. The innovative medication has become one of theworld's best-selling drugs despite its price tag, fueling huge growth at Gilead. The company had revenue of $24.2 billion in 2014, according to analysts' estimates, more than double its sales in 2013. Earnings for last year are projected to reached $12.8 billion, more than four times higher.

But the high price of Sovaldi threatens to make the drug too expensive for many patients with hepatitis C in developing countries such as India, where protesters last year lobbed accusations of gouging and carried signs renaming the company "Killead." In September the U.S. pharmaceutical company announced a licensing deal with seven Indian drugmakers to produce generic versions of Sovaldi that could be sold in 91 countries. That, according to Gilead, would help take care of the problem. "Our view is that the competition and the capabilities of these partnerswill bring down the price," Gregg Alton, executive vice president, told reporters in New Delhi at the time of the announcement.

Unfortunately for Gilead, this week government officials stepped in the way: India's patent office on Tuesday sided with critics who had challenged the company's patent. By rejecting the claim, the Controller General of Patents, Designs and Trademarks has opened the door for more Indian pharmaceutical companies to produce sofosbuvir, the generic version of Sovaldi. And unlike the seven companies that agreed to the deal with Gilead in September, the newcomers won't have any restrictions on where they can sell their generics.

"Getting sofosbuvir out of the stronghold of Gilead's monopoly will be crucial to expanding treatment for people with hepatitis C globally," Dr. Manica Balasegaram, executive director of the Action Campaign of Doctors Without Borders/Médecins Sans Frontières, one of the groups behind the Indian patent office challenge, said in a statement.

The news is a victory for MSF partner Tahir Amin, the New York-based lawyer in charge of intellectual property at the Initiative for Medicines, Access & Knowledge.Amin is an English-trained solicitor who once worked as a corporate lawyer for Levi Strauss and now oversees a small team of attorneys challenging big pharma patents in India and other countries. While Gilead had pointed out to the Indian patent office that 17 countries, including China, Indonesia, and Israel, had already granted patents for similar claims, India makes challenges easier thanks to its policy of requiring would-be patent holders to demonstrate that their compounds are new and not obvious—and also better than existing compounds.

"India believes that the patent standards are so low that companies can get patents for inventions very easily," Amin said in an interview. The patent office's examiner ruled Gilead's patent claim "lacks novelty and inventive step," as Bloomberg News noted, and also doesn't demonstrate it's significantly more effective than already known compounds. Amin explains that the controller general's decision holds that "there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for."

But Sovaldi is a breakthrough drug. Shouldn't that be worth something? "It's important to recognize that what the patent office deals with is whether something is new in science," Amin said. "The decision says there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for. It's a scientific decision and has nothing to do with the utility of the drug." Gilead didn't offer comment on Wednesday.

The company can appeal, a process that could take years. For now, Amin is hopeful the patent office decision will allow 49 million people—or 74 percent of the total number of hepatitis C patients globally—access to the drug in countries that had been off-limits to generics under the September agreement between Gilead and the seven Indian drugmakers. "Gilead's licensing deal is what we call managed competition," he says. "What this case can achieve is open competition, a real free market."
How India's Patent Office Destroyed Gilead's Global Game Plan - Businessweek

 

[Echo_419]

Photographer: Manish Swarup/AP Photo

In 2006, members of the Indian Network for People Living with HIV/AIDS demonstrated in New Dehli against a patent applied for by Gilead Sciences.

Gilead Sciences charges a lot for the hepatitis treatment Sovaldi, which sells for as much as $84,000 to U.S. patients. The innovative medication has become one of theworld's best-selling drugs despite its price tag, fueling huge growth at Gilead. The company had revenue of $24.2 billion in 2014, according to analysts' estimates, more than double its sales in 2013. Earnings for last year are projected to reached $12.8 billion, more than four times higher.

But the high price of Sovaldi threatens to make the drug too expensive for many patients with hepatitis C in developing countries such as India, where protesters last year lobbed accusations of gouging and carried signs renaming the company "Killead." In September the U.S. pharmaceutical company announced a licensing deal with seven Indian drugmakers to produce generic versions of Sovaldi that could be sold in 91 countries. That, according to Gilead, would help take care of the problem. "Our view is that the competition and the capabilities of these partnerswill bring down the price," Gregg Alton, executive vice president, told reporters in New Delhi at the time of the announcement.

Unfortunately for Gilead, this week government officials stepped in the way: India's patent office on Tuesday sided with critics who had challenged the company's patent. By rejecting the claim, the Controller General of Patents, Designs and Trademarks has opened the door for more Indian pharmaceutical companies to produce sofosbuvir, the generic version of Sovaldi. And unlike the seven companies that agreed to the deal with Gilead in September, the newcomers won't have any restrictions on where they can sell their generics.

"Getting sofosbuvir out of the stronghold of Gilead's monopoly will be crucial to expanding treatment for people with hepatitis C globally," Dr. Manica Balasegaram, executive director of the Action Campaign of Doctors Without Borders/Médecins Sans Frontières, one of the groups behind the Indian patent office challenge, said in a statement.

The news is a victory for MSF partner Tahir Amin, the New York-based lawyer in charge of intellectual property at the Initiative for Medicines, Access & Knowledge.Amin is an English-trained solicitor who once worked as a corporate lawyer for Levi Strauss and now oversees a small team of attorneys challenging big pharma patents in India and other countries. While Gilead had pointed out to the Indian patent office that 17 countries, including China, Indonesia, and Israel, had already granted patents for similar claims, India makes challenges easier thanks to its policy of requiring would-be patent holders to demonstrate that their compounds are new and not obvious—and also better than existing compounds.

"India believes that the patent standards are so low that companies can get patents for inventions very easily," Amin said in an interview. The patent office's examiner ruled Gilead's patent claim "lacks novelty and inventive step," as Bloomberg News noted, and also doesn't demonstrate it's significantly more effective than already known compounds. Amin explains that the controller general's decision holds that "there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for."

But Sovaldi is a breakthrough drug. Shouldn't that be worth something? "It's important to recognize that what the patent office deals with is whether something is new in science," Amin said. "The decision says there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for. It's a scientific decision and has nothing to do with the utility of the drug." Gilead didn't offer comment on Wednesday.

The company can appeal, a process that could take years. For now, Amin is hopeful the patent office decision will allow 49 million people—or 74 percent of the total number of hepatitis C patients globally—access to the drug in countries that had been off-limits to generics under the September agreement between Gilead and the seven Indian drugmakers. "Gilead's licensing deal is what we call managed competition," he says. "What this case can achieve is open competition, a real free market."
How India's Patent Office Destroyed Gilead's Global Game Plan - Businessweek

People's life matter more than Profit of Western MNCs

 

[Bagha]

These medical MNCs forms one the most powerful lobby group in west.

 

[Steakhouse]

Even the drug price out for majority poor patient dying need of the medication, up to the drug company to cut down the price and make it affordable for the poor people, not for India drug company to steal the drug then produce the generic drug to sell at lower price. A thief is a thief even it meant for a noble cause but reality India drug company earn 100 of millions selling generic drug without spend 100 millions in advance science research for the effective drug.

 

[arbit]

Even the drug price out for majority poor patient dying need of the medication, up to the drug company to cut down the price and make it affordable for the poor people, not for India drug company to steal the drug then produce the generic drug to sell at lower price. A thief is a thief even it meant for a noble cause but reality India drug company earn 100 of millions selling generic drug without spend 100 millions in advance science research for the effective drug.

I curse you to contract the worst strain of hepatitis C and then be forced to shell out 84000 $.

 

[samv]

India needs to break the stranglehold of these western companies that make medicines only for the rich ie westerners; it has the expertise and the means to do so unlike many other developing countries. It is abominable that people do not have access to life saving drugs and medicines simply because the cost is too high.

 

[SarthakGanguly]

Even the drug price out for majority poor patient dying need of the medication, up to the drug company to cut down the price and make it affordable for the poor people, not for India drug company to steal the drug then produce the generic drug to sell at lower price. A thief is a thief even it meant for a noble cause but reality India drug company earn 100 of millions selling generic drug without spend 100 millions in advance science research for the effective drug.

Thanks, you made me proud. We should continue doing this. In fact I say, we should emulate the Chinese and strive to make copies of everything. Our priorities are different at the moment.

 

[Echo_419]

Even the drug price out for majority poor patient dying need of the medication, up to the drug company to cut down the price and make it affordable for the poor people, not for India drug company to steal the drug then produce the generic drug to sell at lower price. A thief is a thief even it meant for a noble cause but reality India drug company earn 100 of millions selling generic drug without spend 100 millions in advance science research for the effective drug.

We are still far behind Chinese man

 

[wolfschanzze]

Even the drug price out for majority poor patient dying need of the medication, up to the drug company to cut down the price and make it affordable for the poor people, not for India drug company to steal the drug then produce the generic drug to sell at lower price. A thief is a thief even it meant for a noble cause but reality India drug company earn 100 of millions selling generic drug without spend 100 millions in advance science research for the effective drug.

FYI,Indian generic drugs are in huge demand all over the world and even China.Many Patients import Indian generic drugs through people as they are unable to afford the huge costs of drugs in china which are priced at the same range as its sold in USA.

 

[Bagha]

Even the drug price out for majority poor patient dying need of the medication, up to the drug company to cut down the price and make it affordable for the poor people, not for India drug company to steal the drug then produce the generic drug to sell at lower price. A thief is a thief even it meant for a noble cause but reality India drug company earn 100 of millions selling generic drug without spend 100 millions in advance science research for the effective drug.

At Least we do it for a noble cost. What do you think a poor man earning less than 2$ a day would do otherwise. Die ? Your argument is a dangerous one.

 

[sree45]

But Sovaldi is a breakthrough drug. Shouldn't that be worth something? "It's important to recognize that what the patent office deals with is whether something is new in science," Amin said. "The decision says there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for. It's a scientific decision and has nothing to do with the utility of the drug." Gilead didn't offer comment on Wednesday.

The crux of the whole problem: India doesn't allow patents for compounds which were a result of making "small" modifications to previously known compounds.

This makes sure that companies don't evergreen their existing patents.

 

[wolfschanzze]

Thanks, you made me proud. We should continue doing this. In fact I say, we should emulate the Chinese and strive to make copies of everything. Our priorities are different at the moment.

The Chinese, gave up their right to make cheap generic drugs to western companies in order to attract more investment from west. The drugs which are sold there are made and priced as the same in West, i know many patients and Doctors who import drugs from India as the cost is cheaper from India,while its price in China is unaffordable to them.

 

[Steakhouse]

I curse you to contract the worst strain of hepatitis C and then be forced to shell out 84000 $.

Curse me or not still you could not deny India drug company stole the patent from the US company then proceed to make a profit on the knock off generic drug. Great that generic drug lower the cost of the drug so the sick poor people can afford the treatment instead of India stole from the US to treat the Indian at the lower cost. Nothing noble about what India drug company did with the backing of the India government.

 

[The enlightened]

not for India drug company to steal the drug then produce the generic drug

Look who's talking LOL
As if we need a lecture from Chinese on how to treat IP rights.
Indian patent law is well within the TRIPS agreement in WTO. We don't bar companies from filing for patents and selling expensive druggggsssss, we only stop them from 'ever-greening'.
Just post ''I hate India'' instead of posting factually incorrect rants to say the same and looking foolish in the process! Atleast ''I hate India'' will be factually correct!

 

[SarthakGanguly]

Curse me or not still you could not deny India drug company stole the patent from the US company then proceed to make a profit on the knock off generic drug. Great that generic drug lower the cost of the drug so the sick poor people can afford the treatment instead of India stole from the US to treat the Indian at the lower cost. Nothing noble about what India drug company did with the backing of the India government.

I will say this - Kudos to the theifs do did this. I hope all other life saving drugs formulae are stolen and generic alternatives made out of them. We should get the Chinese and Brazilian even to make a joint venture.