 |
 |
|
   |
       |
|
| ||||
 |
|
[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index] E-DRUG: Bolar Roche exemption (cont'd)
E-drug: Bolar Roche exemption (cont'd) ----------------------------------------------------- This comment from Prof Davis is very helpful. I think that I was confusing Roche/Bolar with the Waxman/Hatch bill in the U.S. which was the one that granted the originator companies patent life restoration and at the same time made it easier for generics to come onto the U.S. market. Given what Prof. Davis says there is a significant difference between what is allowed in the U.S. versus what is allowed in Canada. If he is correct then before patent expiration generic companies in the U.S. can only engage in activities designed to obtain FDA approval, whereas in Canada generic companies can not only engage in activities to obtain regulatory approval but can also stockpile the drug in anticipation of marketing it once the patent has expired. Of course, as I said in an earlier message, here in Canada the originator company can delay the marketing of a generic for up to 30 months simply by claiming that there is still an existing patent on a drug. So it's not clear that allowing stockpiling has much benefit for the generic industry in these cases. Joel Lexchin MD 121 Walmer Rd. Toronto, Ontario CANADA M5R 2X8 Phone: (416)-964-7186 Fax: (416)-923-9515 e mail: [email protected] -- Send mail for the `E-Drug' conference to `[email protected]'. Mail administrative requests to `[email protected]'. For additional assistance, send mail to: `[email protected]'.
| |||
