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TOPIC: India Patent Office approves Gilead's hepatitis C drug patent

India Patent Office approves Gilead's hepatitis C drug patent 1 year 2 months ago #15839

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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.
Gt 1a, F0, VL 6.5 million, AST 59, ALT 62
Started Twinvir 1/15/16
6 wk. labs, VL UND, AST 27, ALT 20
EOT labs, VL UND, AST 23, ALT 19
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Last Edit: 1 year 2 months ago by Greedfighter.
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India Patent Office approves Gilead's hepatitis C drug patent 1 year 2 months ago #15859

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Use twinvir.

Make Gilead mad
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India Patent Office approves Gilead's hepatitis C drug patent 1 year 2 months ago #15862

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This is I guess what I expect, but dreadful
www.caravanmagazine.in/vantage/indian-of...ad-patent-forced-out
Genotype 3 30 years, 2x treatment interferon/ribavirin non responder. Cirrhosis 17 years. Fibroscan 40 down to 22 by 29/3/16- 10/16 dropped to 9.5, no cirrhosis. Started Buyers Club Sof/Dac 14 Nov 15. SVR 12 29/0716
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India Patent Office approves Gilead's hepatitis C drug patent 1 year 2 months ago #15864

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so what does this mean for someone who goes to India to buy the drug ? or for the Indians
Treatment naive
F 3/4
Genotype 1 a
V/L 17 MILLION
Started Harvoni 11th Dec 2015 for 12 weeks
4 weeks VL UND
6 WEEKS ALT 32, AST 34
EOT 03/03 2016 ! UND
ALT 34, AST 26
04.04.2016 SVR 4
26.05.2016 SVR 12
16.08.2016 SVR 24
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India Patent Office approves Gilead's hepatitis C drug patent 1 year 2 months ago #15867

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I guess it's a "wait and see" situation at this point. Hoping it doesn't effect availability, cost, or distribution of generics. :dry: That article you posted hazelriannon makes me feel :sick:
GT1a; Got it some time in the 70's; Diagnosed @1976
Tx naive
METAVIR: A2-F2
SOT May 18, 2016: CMP: AST 162 ALT 241 VL 13000000
3 weeks after SOT: AST 27 ALT 31 VL 138
Reached EOT Aug. 10, 2016 / Received svr4 results Sept. 20, 2016: AST 22 ALT 24
Hep C RNA "NOT DETECTED"
AS OF 3/20/2017 ,Hep C RNA PCR "NOT DETECTED" THAT'S SVR24!
Last Edit: 1 year 2 months ago by Matt-Kenney-google. Reason: Additions
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India Patent Office approves Gilead's hepatitis C drug patent 1 year 2 months ago #15877

  • Ariel
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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
Gen 1a
Peg/inf/riba 2012(!?!) stopped at Week 43 due to potassium level ext. low plus other issues (relapse at week 4 post tx, VL120,000) many secondary niggles eg. adenomas.
pre sof/led VL 240,000 Fibrosc F0
Day 25 VL <30
Day 32 UND
Week 10 UND
EOT UND ALT 11 AST 17 GGT 19
SVR4 UND ALT 10 AST 16 GGT 13
SVR8 UND ALT <9 AST 16 GGT 15
SVR12 UND ALT 14 AST 19 GGT 12 Bili 5
EOT +18 ALT13 AST 20 GGT 9 Bili 5
EOT +21 ALT 11 AST 15
Cured at SVR12
Dysplasia Adenoma removed Aug '16
SVR24 UND ALT 11 AST16
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India Patent Office approves Gilead's hepatitis C drug patent 1 year 2 months ago #15880

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Always good to stay positive, nothing wrong with being optimistic Areil B)
Still appreciate all the effort of FHC and both James n' Greg. Their efforts continue to inspire don't they sis.
:+1: :+1:
GT1a; Got it some time in the 70's; Diagnosed @1976
Tx naive
METAVIR: A2-F2
SOT May 18, 2016: CMP: AST 162 ALT 241 VL 13000000
3 weeks after SOT: AST 27 ALT 31 VL 138
Reached EOT Aug. 10, 2016 / Received svr4 results Sept. 20, 2016: AST 22 ALT 24
Hep C RNA "NOT DETECTED"
AS OF 3/20/2017 ,Hep C RNA PCR "NOT DETECTED" THAT'S SVR24!
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India Patent Office approves Gilead's hepatitis C drug patent 1 year 2 months ago #15889

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I agree, stay positive! :cheer:

But in the mean time, advocate like hell!!

Gilead did not push so hard for this patent for no reason.
Gt 1a, F0, VL 6.5 million, AST 59, ALT 62
Started Twinvir 1/15/16
6 wk. labs, VL UND, AST 27, ALT 20
EOT labs, VL UND, AST 23, ALT 19
SVR 16, VL UND, AST 28, ALT 17
SVR 24, VL UND, 10/8/16
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India Patent Office approves Gilead's hepatitis C drug patent 1 year 2 months ago #15948

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Thank u incepta, beximco and beacon pharma!
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India Patent Office approves Gilead's hepatitis C drug patent 1 year 2 months ago #15975

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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
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17

And I couldn't wait to get on the road again
On the road again, on the road again!
- with apologies to Willie ;)
Last Edit: 1 year 2 months ago by Gaj.
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India Patent Office approves Gilead's hepatitis C drug patent 1 year 2 months ago #16013

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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...
Diagnosed Jan 2015: GT-3, A0+F0/F1. Fatigue + Brain-Fog.
Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
Week4: AST 47, ALT 58. VL < 15 (unquantifiable).
Week12 (EOT): AST 30, ALT 26, VL UND
Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND
Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND
Ever grateful to Dr James.
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India Patent Office approves Gilead's hepatitis C drug patent 10 months 3 days ago #21574

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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
In fiecare an HCV ucide peste 500000 oameni.Medicamentele generice pentru hepatita C functioneaza. Nu deveni statistica! Cauta pe Google “medicamente generice pentru hepatita C”.
HCV kills more than 500000 people every year. HCV generic drugs work. Don't become a statistic.
By sharing this Youtube video you might save someone’s life!
My TX: HEPCVIR-L[generic Harvoni]-India
SVR12 achieved = cured!!!
Last Edit: 10 months 3 days ago by rohcvfighter.
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India Patent Office approves Gilead's hepatitis C drug patent 7 months 4 weeks ago #22821

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I've been trying to find whether there are any news about this topic today, no luck so far ..... :angry:
In fiecare an HCV ucide peste 500000 oameni.Medicamentele generice pentru hepatita C functioneaza. Nu deveni statistica! Cauta pe Google “medicamente generice pentru hepatita C”.
HCV kills more than 500000 people every year. HCV generic drugs work. Don't become a statistic.
By sharing this Youtube video you might save someone’s life!
My TX: HEPCVIR-L[generic Harvoni]-India
SVR12 achieved = cured!!!
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India Patent Office approves Gilead's hepatitis C drug patent 7 months 4 weeks ago #22832

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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.
Gt 1a, F0, VL 6.5 million, AST 59, ALT 62
Started Twinvir 1/15/16
6 wk. labs, VL UND, AST 27, ALT 20
EOT labs, VL UND, AST 23, ALT 19
SVR 16, VL UND, AST 28, ALT 17
SVR 24, VL UND, 10/8/16
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India Patent Office approves Gilead's hepatitis C drug patent 7 months 4 weeks ago #22836

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.
YMMV
Last Edit: 7 months 4 weeks ago by James-Freeman-facebook.
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