DrugBuyers.Com: Need Advice...Letter From U.S.Customs at P.O.

"It is illegal for anyone, including a foreign pharmacy, to ship prescription drugs that are not approved by FDA into the U.S. ..."

Yes, it says "to ship, not "to receive." It makes a difference.

You're certainly on the right track, but it's even more complicated. You are correct that the FDA can (if they want) seize the Indian generic Paxil under authority of the FFD&C Act because it was not manufactured in an FDA-approved facility, has the required markings and product insert, etc. ... but the FDA will often let unscheduled drugs through. But not always, as you say. Pfizer is probably not too happy that an Indian generic of a Viagra pill they sell for $12 here has several companies in India that sell it there for a few pennies.

All Indian patent law cares about is whether the generic manufacturer illegally used a patented "recipe" to make the drug; they don't care that Pfizer has exclusive marketing rights for Viagra in the rest of the world. There are at least five versions of sildenafil sold in India ... all legal (at least there in India).

India and South Africa are the only two industrial countries who have not joined the rest of the world in respecting "use patents" for drugs. The major reason South Africa hasn't joined has to do with HIV and AIDS. So they copy-cat the very expensive HIV drugs because they say they have no choice.

The unique patent status of Indian and South African drugs can set off red flags at Customs because they know that "the purple pill" is protected by U.S. patent law. This is almost the same reason that Customs will seize conterfeit Gucci handbags and Rolex watches; the difference is that the Indian drugs violate patent law, not the trademark law that protects the Gucci and Rolex names. To make it even stranger, some Indian companies have FDA-approved factories in India and legitimately sell the generics made there in U.S. pharmacies. A company named Dr. Reddys is one example: http://www.drreddys.com . But most of their factories in India are not FDA approved. I think Dr. Reddys even has factories in the U.S.

And Viagra is made in a Pfizer factory located in Ireland. Yup. Pfizer pays the FDA to fly inspectors and QA auditors to Ireland to in order to approve the production of Viagra.

Since you mention paroxetine, Customs can also theoretically seize it for patent violation. Another obvious example would be that Viagra. The Indian drug companies call their drugs Silagra, Kamagra ... anything but Viagra (because India respects the registered trademark Viagra).

India does not have "use patents" in their drug laws ... only "process patents." They don't give exclusive market rights (or respect the market rights of other companies) for drugs. A drug manufacturer will either patent a synthesis procedure or protect it as a trade secret. If they patent the synthesis, then nobody (not even in India) can use legally the same method to create the drug. But the problem with patents is that they expire. Trade secrets can stay secret as long as they keep the secret. Someone who breaches an employment or other type of contract by publicizing something they agreed to keep secret can be sued for monetary damages and given restraining orders or injunctions. Others who steal a recipe to sell to a competitor can be sued for the same kind of civil damages, as well as be convicted of grand larceny or other criminal charges relating to theft of intellectual property. Industrial espionage is a crime in itself, even if it is unsuccessful.

Trade secrets can last for a long time. The classic example is Coca Cola. How many people know the exact recipe and all the ingredients after a hundred years? It's probably a better-kept secret than how an H bomb works.

Trampy