US to block generic drugs in India.

[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.