E-drug: Linkage of Patents and drug registration (cont)
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Toby Kasper had asked earlier why it is important if a country links
drug registration to patent status. The short answer is, this gives the
patent owner a new mechanism to enforce the patent that goes beyond
what they are entitled to from a judge. This is a big problem in the
USA, for example, where companies file, with the US FDA, lots of weak
or bad patents, triggering a 30 month period of protection under the
US FDA rules. Many of these patents are eventually busted in court,
or are so bad that the patent owner could have never convinced a
judge to issue an injunction. In the case of Taxol, for example, the
FDA blocking patents
were on the dose of Taxol given to a patient, and the courts eventually
ruled against BMS, but meanwhile, BMS had an extra 30 months of
exclusivity. Then BMS started the whole thing again with a new bogus
patent, which was also busted in court.
As far as I know, no other industry has a similar deal, with respect to
enforcement. Imagine, for example, if the owners of various
e-commerce patents could get the FCC or the banking industry to
enforce their software or business method patents. Unlike the drug
companies, other patent owners have to actually get a judge to
enforce the patent, which for weak or bad patents, isn't easy.
I would be interested in learning which other countries have something
like the US system. Several persons are asking about this, given the
PhRMA/USTR emphasis on this in various bilateral and regional trade
agreements (Jordan FTA, Chila FTA, FTAA).
Jamie
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James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
http://www.cptech.org
love@cptech.org
1.202.387.8030 fax 1.202.234.5176
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