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May 10 (Reuters) - India has reversed course and granted approval to Gilead Sciences Inc's patent for its hepatitis C drug Sovaldi, marking a setback for patient groups who said the move could stop affordable copies of the drug.

The drug, which has a list price of $1,000 a pill in the United States, was rejected for a patent by the Indian patent authority in January 2015 on the basis it represented only minor changes to a previous formulation, and the company already had licensing deals with manufacturers in India.

After an appeal by Gilead, the Indian Patent Office of New Delhi on Monday approved its application for the drug saying it found its compounds to be "novel" and "inventive."

Gilead, in a statement, welcomed the move, but said it will have no impact on availability of the compound, which is already licensed to 11 generic manufacturers in India for distribution in 101 developing countries.

Patents guarantee drugmakers exclusive sales for a decade or more, before generic competition is allowed, so the companies can recoup their investment and use profits to then develop new medicines. Gilead said the goal of its voluntary licensing program, and "partnership" with Indian manufacturers, is to enable access to medicines for as many people as possible, as quickly as possible.

But patient groups said Gilead's licensing deals do not serve patients and the patent approval could prevent exports of raw materials to other countries seeking to make the drug, hailed by some as a breakthrough in the global fight against hepatitis.

"Like unmerited patents, these schemes manipulate the market, violate patients' rights and block millions of people from getting the medicines they need," the Initiative for Medicines, Access & Knowledge said in a statement.

Gilead said eight of its licensees have launched sales in India and other licensed territories under the company's program for supplying its hepatitis C, hepatitis B and HIV drugs to "resource-challenged countries." Licenses have also been granted to two manufacturers in Egypt and one in Pakistan.

Sovaldi was first launched in the United States in 2013 at a list price of $28,000 for a 28-tablet bottle, or $1,000 a pill.

The list price in India as of April 26, according to the Asia Pacific Network of People Living with HIV, was $384 per bottle, or about $14 per pill.

Use twinvir.

Make Gilead mad

This is I guess what I expect, but dreadful
www.caravanmagazine.in/vantage/indian-of...ad-patent-forced-out

so what does this mean for someone who goes to India to buy the drug ? or for the Indians

I guess it's a "wait and see" situation at this point. Hoping it doesn't effect availability, cost, or distribution of generics. That article you posted hazelriannon makes me feel

Hi all, the way I try to look at it, and yes I'm an optimist, there have been setbacks before and always will be
The buyers club keeps coming through despite any odds.
Some meds are held by customs, modes of carrying have had to be changed etc
I'm not working at FHC so I have no real concept of the magnitude of the challenges but I have seen time and again both James and Greg overcome hiccups big and small
Fingers and flippers crossed for continued access
Ariel

Always good to stay positive, nothing wrong with being optimistic Areil
Still appreciate all the effort of FHC and both James n' Greg. Their efforts continue to inspire don't they sis.

I agree, stay positive!

But in the mean time, advocate like hell!!

Gilead did not push so hard for this patent for no reason.

Thank u incepta, beximco and beacon pharma!

darbara wrote: so what does this mean for someone who goes to India to buy the drug ? or for the Indians

I think within India there probably won't be a great deal of change in availability short term. Indians will continue to be able to access the meds if they can afford them. Gilead will probably continue to collect licence fees rather than impose their patent rights as far as manufacturing goes. However, they may well seek to prevent the current heavy discounting that we see from the various manufacturers seeking greater market share. So the cost will become the label price less the traditional local market discount of probably up to 20%. In other words the best available minimum price for Harvoni may settle at around the $300-330 per bottle level with Sovaldi at an equivalent lower price. If this does occur then it has implications for many Indians who are at the lower end of the income scale and not able to afford the higher prices. Similarly, individual tourists are always good for the local economy and will find ways to get what they need but I think any attempts to set up group medical tours will be very quickly thwarted.

Longer term, there will be greater impact as one of the main drivers of lower prices is market size and competition. If Gilead succeeds in its main aim of preventing export (while also controlling domestic prices) then the manufacturers will have less incentive and opportunity to attempt to compete for customers. Probably the current rapid expansion of manufacturing will cease and contract. This will drive up costs and result in further price increases for the Indian domestic market which in turn limits that market even more. The end result of this process is that India falls in line with the rest of the world and Gilead ensures maximum profit for their shareholders and a self sustaining income stream into the future from the new infections that will occur due to only a small percentage of those with HCV being able to access/afford excessively expensive treatment.

While the non Indian generic pill manufacturers are doing a great job, all of them are currently situated in countries that don't have high levels of international trade so there are very real risks to continued supply from them either through Gilead actions or just the political climate. We have already seen this occur in Australia at the end of last year when our government restricted imports from Bangladesh due to alleged terrorist risk.....whatever the reason the simple fact is they are not a significant trade partner so it's easy to achieve with little public interest or concern.
Chinese APIs are less likely to be impacted because of their stance on patents and the huge volumes of international trade they participate in but that sets us back to last year's situation which isn't really sustainable for a mass market and many patients don't/won't have the inclination, confidence or skills to follow that path.

So the patent situation in India has a very real potential to severely impact worldwide supply of generics unless international opinion can be focussed on the situation. The best way to achieve this is advocacy at both a public and personal level. We need to make the public, medical staff and politicians worldwide aware of the availability of generics and the greed and inhumanity being perpetrated by Gilead in their quest for obscene profits.

There are some excellent thoughts and suggestions about how everyone concerned by this can start to help that process in some small way in the link below:

fixhepc.com/forum/experts-corner/998-you...ifference.html#15940

Thank you for this analysis Gaj,

I agree, for the people of India, probably not much difference. For the rest of the world, I fear a lot depends on how Gilead might now play it with their (no doubt new) licences with India manufacturers. They can write potentially anything they like, and probably it will not be doing the world any favours...

For those who are interested, here is a link to the text of the latest patent decision:

freepdfhosting.com/a03fe3f626.pdf

No doubt there will be appeals by MSF and I-MAK...

The hearing on the Sofosbuvir patent challenge was adjourned from 13.sep.2016 to 22.Nov.2016 as the Patent Controller and Union of India asked for more time:
www.pharmabiz.com/NewsDetails.aspx?aid=97524&sid=1


I hope it is not a trick to just gain time for inventing arguments....

Cheers,
RHF

I've been trying to find whether there are any news about this topic today, no luck so far .....

Trump is talking about killing the TPP, which is great for HCV patients.

Anyone who wants treatment and is reading this can purchase their own medication for under $1100 USD.

You need to utilize this site, spend your own money. What a deal to be UNDETECTED. I would have paid much more than the $1600 it cost me in January. Remember, if you spend your own money here, no one will deny you treatment. What is your dignity worth? If you need direction, PM me.

Trump is talking about killing the TPP, which is great for HCV patients.

Yes, that would not have helped however when you have articles with titles like Drugmakers help Trump shape health care agenda

www.bendbulletin.com/nation/4835280-151/...e-health-care-agenda

That notes stuff like:

But the president-elect appears to have downgraded plans to act aggressively to control rising drug prices — an early victory for the pharmaceutical industry and another illustration of the influence of lobbyists on the new Trump administration, despite Trump’s promise to “drain the swamp” of special interests.

....

Vice President-elect Mike Pence’s political career, for example, has long been supported by pharmaceutical giant Eli Lilly, which is based in his home state of Indiana. The drugmaker, through its political action committee and employees, is Pence’s third-largest all-time political contributor, according to the independent Center for Responsive Politics.


It looks like generics may remain the cornerstone of access for the foreseeable future.