Patent for Favipiravir rejected in Thailand

[snoop1130]

Image Credit: Government Pharmaceutical Organisation

 

A patent application for Japanese-made anti-viral drug Favipiravir has been rejected by Thailand’s Intellectual Property Department over its manufacturing quality.

 

The department’s director-general, Mr. Vuttikrai Leewiraphan, said yesterday (Wednesday) that the applicant for the patent failed to meet the legal requirements for registration.

 

Hence there is no private or legal entity in Thailand which has the monopolistic right to manufacture the drug here, paving the way for the Government Pharmaceutical Organization and private Thai pharmaceutical firms to produce the drug for domestic consumption.

 

Full Story: https://www.thaipbsworld.com/parent-for-favipiravir-rejected-in-thailand/

 

-- © Copyright Thai PBS 2021-05-06

 

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[Fromas]

5 minutes ago, snoop1130 said:

the applicant for the patent failed to meet the legal requirements for registration

 

Mind blowing. More to follow.

 

 

[worgeordie]

That's going to save them some money ,as they were

going to purchase the patent, Japanese will not be

happy.they did  check that the Japanese company

does not have World wide patent rights.....

regards Worgeordie

[internationalism]

so several thai companies will start producing generic version and thailand will have large stock for the next covid waves and has chance to export some.

Since the last week indian maker started to do 800mg pills, 4x stronger then the original ones. For covid a large dose is required.

This medicine is one, of only 4 medicines, approved  for treating covid

 

Edited May 6, 2021 by internationalism

[DLock]

2 hours ago, snoop1130 said:

A patent application for Japanese-made anti-viral drug Favipiravir has been rejected by Thailand’s Intellectual Property Department over its manufacturing quality.

 

This is going to take someone smarter than me on patent law to make sense of it.

 

The way I understand it, is Favipiravir is manufactured in Japan by Fujifilm, but it became a generic drug in 2019 and now manufactured in China...and India.

 

Was Thailand trying to patent a generic drug developed by someone else?

 

Then there is this from the Nation today "If Favipiravir is granted a patent, it will have a protection period of 20 years. However, a domestic formula can be developed without being hit by any lawsuit. Still, if it is produced for the market, it could be sued for patent infringement. Therefore, a voluntary licensing agreement must be negotiated with the patent owner so the GPO can produce and distribute its drug."

 

A paragraph of conflicting statements.

 

Anyone else figure this out yet.

 

https://www.nationthailand.com/in-focus/30387700 

Edited May 6, 2021 by DLock
dyslexic

[Elkski]

How convenient.   Steal From foreign companies and foreigners seems to be standard from top down.  

[Gulfsailor]

Favipiravir is not a new drug. The original patent for its formula dates back to 1999 in Japan and this priority filing date is used for the patents in other countries. Apart from Japan where the patent owner was granted a 5 year protection extension, it expired in all other countries in 2019, after the normal 20 years. Hence Chinese companies are already setting up generic manufacturing (although with restriction due to newer patents which are still active).

Between 1999 and 2016 the manufacturer was granted numerous follow up patents on how best to manufacture it and certain therapeutic uses. The latest patent granted for instance was for the use on Ebola in 2016. Many of these patents were priority filed through PCT which makes filing in most countries easier, but one still has to file in individual countries within normally 30 months. The manufacturer did this for the major markets like the EU, China and the US, but I can’t find any ‘world’ PCT filing for use against COVID-19, only several country specific applications. 
So, the situation right now appears to be that any non-Japanese manufacturer can make Favipiravir and market it, with certain restrictions in place on therapeutic use against COVID-19, influenza or Ebola. Also they cannot use the latest technological processes which are protected by newer patents.

 

As for the situation. In Thailand, any Thai manufacturer is free to make Favipiravir, market it and sell it on the Thai market, for use against Covid-19 or for any other reason.

 

[impulse]

41 minutes ago, Elkski said:

How convenient.   Steal From foreign companies and foreigners seems to be standard from top down.  

 

They're not stealing anything from anyone.  Patent protection begins and ends at every country's border.  It seems the Japanese company was trying to file for a Thai patent on a drug that's so old it's now a generic in several countries where the patent has expired. 

 

That's the money grab... 

 

Because patent law prevents the manufacture, sale or import of a patented item by anyone other than the patent holder.  Had Thailand issued the patent, that would have precluded importing the aged drug from a low cost country, or making it in Thailand, at least without paying a royalty.  And why would they want to pay a royalty on a drug that's off patent in many countries?

 

[impulse]

17 minutes ago, Gulfsailor said:

As for the situation. In Thailand, any Thai manufacturer is free to make Favipiravir, market it and sell it on the Thai market, for use against Covid-19 or for any other reason.

 

An idiosyncrasy in pharma patent law allows issuance of a patent to the company that does the clinical studies that result in national approval of a drug for a new use, even if it's an old drug.  There have been several recent controversial patents issued in the USA for old drugs under new uses. 

 

I suspect Thailand rejected the application because the quality of the study of Favipiravir against Covid 19 was inadequate, though it was reported that the quality of manufacture was the problem.  That makes more sense.

 

Of course, I'd love to hear from someone closer to the issue.  I'm guessing.

 

[Fromas]

The article doesn't have key details. Was it a process patent?

[WHansen]

Good work Gulfsailor and Impulse. Thanks for the infomation.

[RichardColeman]

9 hours ago, snoop1130 said:

rejected by Thailand’s Intellectual Property Department over its manufacturing quality.

I struggle to think of much made in Thailand that's quality is better than Japanese. 

[Captor]

On 5/6/2021 at 3:34 PM, Gulfsailor said:

Favipiravir is not a new drug. The original patent for its formula dates back to 1999 in Japan and this priority filing date is used for the patents in other countries. Apart from Japan where the patent owner was granted a 5 year protection extension, it expired in all other countries in 2019, after the normal 20 years. Hence Chinese companies are already setting up generic manufacturing (although with restriction due to newer patents which are still active).

Between 1999 and 2016 the manufacturer was granted numerous follow up patents on how best to manufacture it and certain therapeutic uses. The latest patent granted for instance was for the use on Ebola in 2016. Many of these patents were priority filed through PCT which makes filing in most countries easier, but one still has to file in individual countries within normally 30 months. The manufacturer did this for the major markets like the EU, China and the US, but I can’t find any ‘world’ PCT filing for use against COVID-19, only several country specific applications. 
So, the situation right now appears to be that any non-Japanese manufacturer can make Favipiravir and market it, with certain restrictions in place on therapeutic use against COVID-19, influenza or Ebola. Also they cannot use the latest technological processes which are protected by newer patents.

 

As for the situation. In Thailand, any Thai manufacturer is free to make Favipiravir, market it and sell it on the Thai market, for use against Covid-19 or for any other reason.

 

And also it will probably not help against Covid..... there is no scientist proof for that.

[Gulfsailor]

38 minutes ago, Captor said:

And also it will probably not help against Covid..... there is no scientist proof for that.

Well, actually the very limited research done on it (both in vitro and in small scale animal and human trials) indicates there is a probability it does help against Covid-19. Based on this the UK has just started a very large trial using Favipiravir against Covid-19 to get more significant results. 

[Captor]

6 minutes ago, Gulfsailor said:

Well, actually the very limited research done on it (both in vitro and in small scale animal and human trials) indicates there is a probability it does help against Covid-19. Based on this the UK has just started a very large trial using Favipiravir against Covid-19 to get more significant results. 

Right so no one don't know, but we can hope. IF that would be a game changer then I am sure it would already be on out in the open.

Besides that there is another medicine in the loop that might cure covid in early stages. Saw a scientist TV-show about that. I don´t know any name though.

We have to hope they will find something.

[Fromas]

The patent application was a formulation patent or a patent on the ingredients of the pill, so it didn't have much merit.