[e-drug] Patented new uses for old drugs (7)

e-drug
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E-DRUG: Patented new uses for old drugs (7)
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Dear all,

This practice is known as ever-greening, and is a favourite twist taken
by pharmaceutical companies to unfairly prolong patents on their
products. I have still to confirm this-and would appreciate more
insights- but another possible product whose patent was extended might
have been pentamidine- initially patented for treatment of other
infections- but increase in its use for PCP is reported to have made the
manufacturer apply for a patent for the new indication.

My personal opinion is that this practice of extending patents is not
only anti-competitive, but ends up denying patients access to cheaper
treatments.

John, Kenya
"Wasonga, John \(KENYA/OPH\)" <JWasonga@usaid.gov>

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E-DRUG: Patented new uses for old drugs (8)
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Thank you. I am glad for all the answers, but I also want to know what does this mean in practice.

Is a regulatory authority limited by the patent when approving a new indication?

Is the doctor prohibited or hindered in prescribing the old or generic medicine for the
new indication?

Is a pharmacy forced to not dispense generic product on patented indications/uses?

Are there any examples of trials or other power demonstrations due to this sort of
patent violatons?

Examples of real life consequences, please.

Stein Lyftingsmo
Hospital Pharmacy of Elverum, Norway
stein@lyftingsmo.no
www.lyftingsmo.no (the world best webpage on labelling of medicines)

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E-DRUG: Patented new uses for old drugs (10)
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Here is my understanding of what has happened in the U.S. with respect to
Prozac/Serafem but I'm happy to be corrected by anyone with more intimate
knowledge of the situation.. Lilly got a patent on the use of fluoxetine for
the treatment of premenstrual dysphoric disorder and did clinical trials to
show that the drug is more efficacious than placebo for this disorder. These
trials were used to get FDA approval for this indication. Now physicians can
write a prescription for any form of fluoxetine (generic, Prozac or Serafem)
but if they write a prescription for it for PMDD then the pharmacist is only
suppose to fill the prescription with Serafem since none of the generic
versions have this indication. (Don't ask me how the pharmacist is suppose
to know what indication the prescription is written for.)

Joel Lexchin
--
Joel Lexchin MD
121 Walmer Rd.
Toronto ON
Canada M5R 2X8
Tel: 416-964-7186
Fax: 416-736-5227
E mail: joel.lexchin@utoronto.ca