US to block generic drugs in India.

[Samm]

We can't have poor people with cancer actually able to afford to get better at the expense of our big corp bosses.
http://thebricspost.com/india-to-tak.../#.Uw3VN7mYbIU

"Even as trade lobbies are putting pressure on the US government to castigate India by putting it in the ‘Priority Foreign Country’ list for intellectual property rights, sources in New Delhi said India will retaliate by dragging the US to WTO.

India insists its intellectual property rights are compliant with global laws, including the World Trade Organisation (WTO).

The US imposes trade sanctions after a country is included into the “Priority Foreign Country”.

The US Trade Act defines a Priority Foreign Country is the worst classification given to those which deny adequate and effective protection of intellectual property rights (IPR) or fair and equitable market access to the US persons relying on IPR protection.

Officials in New Delhi have said the demands of the US industry are “completely wrong”.

“If the US does that, then India probably will have no option but drag them to the WTO’s dispute settlement mechanism,” an official said.

A low-level trade war between the two largest democracies has been long simmering.

US pharma companies had objected to India’s move to issue a compulsory license in 2012 to India-based Natco Pharma to manufacture and sell cancer-treatment drug ‘Nexavar’ at a price over 30 times lower than charged by patent-holder Bayer Corporation.

The German drugmaker Bayer had sought to block the entry of Natco’s generic version of Nexavar, which the Indian firm has been told to sell at 8,800 rupees ($160) for a monthly dose.

The USITC has raised this issue besides the rejection of patent to Bristol-Myers Squibb’s Sprycel and Novartis’ Gleevec. It has stated that Indian IPR laws are not Trade Related Aspects of Intellectual Property Rights (TRIPS) compliant under the WTO.

In India, generic medicines account for more than 90 per cent of sales.

Swiss pharma major Novartis AG had lost a legal battle for getting its blood cancer drug Gleevec patented in India and to restrain Indian companies from manufacturing generic drugs. India’s top court had rejected the multinational company’s plea last year.

The US International Trade Commission (USITC), a quasi-judicial federal American agency, has already initiated an investigation against India’s trade and investment policies.

It has alleged that New Delhi’s laws discriminate against the American companies.

“The country’s IPR (intellectual property rights) laws are fully compliant with WTO. If America has any issue with our laws, they can raise that in the WTO,” an Indian official was quoted by Press Trust of India."

[finnbow]

If the drugs are still under patent, we are right in fighting India for manufacturing them as generics. Once the patent runs out, however, all bets are off.

[Oerets]

Me thinks there is more to this then meets the eye.

I think the manufacturers want the ability to outsource but have created a monster in their search for lower costs.


""Offshoring companies "are paying Chinese wages and selling at U.S. prices," said Alan Tonelson, of the U.S. Business and Industrial Council, a trade group for small business. "They're not creating better living standards for America.""

http://www.commondreams.org/headlines03/1224-07.htm

[Samm]

Originally Posted by finnbow

If the drugs are still under patent, we are right in fighting India for manufacturing them as generics. Once the patent runs out, however, all bets are off.

India has already won at the WTO in a past case and is in full compliance with the international trade agreement. The US through TPP Agreement wants to raise the patent protection from 7 years to 20 years. Most drug company research is done with government grants. (our tax money)
Do you want you Mother, brother, daughter having to wait 20 years to be able to afford a drug that will save their lives?
The generic version of the HIV drugs are now affordable through out the world and saving many lives and have helped to drop the orphan rate drastically in Africa. Screw Big Pharma.
http://www.worldipreview.com/news/us...pp-drug-policy

[finnbow]

Originally Posted by Samm

India has already won at the WTO in a past case and is in full compliance with the international trade agreement. The US through TPP Agreement wants to raise the patent protection from 7 years to 20 years. Most drug company research is done with government grants. (our tax money)
Do you want you Mother, brother, daughter having to wait 20 years to be able to afford a drug that will save their lives?
The generic version of the HIV drugs are now affordable through out the world and saving many lives and have helped to drop the orphan rate drastically in Africa. Screw Big Pharma.
http://www.worldipreview.com/news/us...pp-drug-policy

Patents on pharmaceuticals last 20 years, for better or worse. Though I certainly have my complaints with Big Pharma, I also understand their concern about imports of generics from places like India.

http://www.reuters.com/article/2013/...98B17C20130912

[Samm]

Originally Posted by finnbow

Patents on pharmaceuticals last 20 years, for better or worse. Though I certainly have my complaints with Big Pharma, I also understand their concern about imports of generics from places like India.

http://www.reuters.com/article/2013/...98B17C20130912

"For a period of seven years after the Food and Drug Administration (FDA) approves a new drug application for an officially approve the same drug for the same use for another sponsor only if the Agency finds that the holder of the first approved new drug application cannot assure the availability of sufficient quantities of the drug to meet the needs of the patients or if the holder consents to the approval of other new drug applications."

"On January 4, 1983, Public Law 97-414, The Orphan Drug Act (the Act), became law. 21 U.S.C. ss525 et seq."

Straight from the FDA website.
http://www.fda.gov/aboutfda/partners.../ucm116364.htm

[finnbow]

Originally Posted by Samm

"For a period of seven years after the Food and Drug Administration (FDA) approves a new drug application for an officially approve the same drug for the same use for another sponsor only if the Agency finds that the holder of the first approved new drug application cannot assure the availability of sufficient quantities of the drug to meet the needs of the patients or if the holder consents to the approval of other new drug applications."

"On January 4, 1983, Public Law 97-414, The Orphan Drug Act (the Act), became law. 21 U.S.C. ss525 et seq."

Straight from the FDA website.
http://www.fda.gov/aboutfda/partners.../ucm116364.htm

This applies only to "orphan" drugs. I understand why Big Pharma is interested in having its US patents honored elsewhere for 20 years to correspond to our laws and I also understand why other countries are interested in manufacturing generics prior to expiration of these patents. As with many such issues, there are two sides to it and how you feel depends on where you sit.

[Samm]

Originally Posted by finnbow

This applies only to "orphan" drugs. I understand why Big Pharma is interested in having its US patents honored elsewhere for 20 years to correspond to our laws and I also understand why other countries are interested in manufacturing generics prior to expiration of these patents. As with many such issues, there are two sides to it and how you feel depends on where you sit.

"3. How long is exclusivity granted for?

It depends on what type of exclusivity is granted.
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)

See 21 C.F.R. 314.1083 New Drug Product Exclusivity."

[noonereal]

Big Pharma is a worse than any other drug cartel on the planet.

[Dondilion]

Big Pharm is just greedy.