More on the 5 year marketing exclusivity and Nevirapine in Thailand

[James Love <love@cptech.org>]

I was asked to give a bit more detail regarding the TRIPS transition
rules and the requirements for exclusive marketing rights. This is not an
area I have spent a lot of time, and I welcome corrections or comments.

It is my understanding that the rule is as follows.  If there is a pending
patent application, including an application in the mailbox (Article
70.8), the exclusive rights must be 5 years from the date first marketed
in that country, or until a patent is granted or rejected, which ever
comes first. 

According to Tido in Bangkok, Nevirapine was granted a patent in the USA
in 1994, but has only been on the market for 2 years in Thailand.   As I
read the TRIPS, so long as Thailand has not acted on the Nevirapine
patent, it is required to provide 5 years of market exclusivity, beginning
with the date marketed in Thailand --  meaning  another 3 years.  (This is
an example of why the existance of a patent isn't the only consideration
in determining entry barriers).

If Thailand granted the Nevirapine patent, it could then eliminate the
regulatory marketing exclusivity, but then it would have to deal with the
patent.  But, at least then it could issue a compulsory license, say to an
Indian firm that would import the drug, or to a domestic generic producer.

Some countries won't even consider a compulsory license in the first year
of a patent.  I haven't read the Thailand law.  If Tito still has a copy
in English, maybe he could resend it. I had a copy earlier, but I'm not
sure where it is right now, following some earlier computer problems.

Tido says this is an issue in Thailand for several AIDS drugs.  

It would also be possible for Thailand to eliminate the marketing
exclusivity, even if it was a violation of the TRIPS, and hope that the
USA and the EC would not bring a WTO action.  With Nevirapine, one might
also worry about Canada, because the patent owner is a Canadian firm.  
There was consideration in Seattle to give developing countries 2
years without filing complaints, and although nothing was decided, things
have changed politically in both the US and the EC.

   Jamie Love <love@cptech.org>



      Article 70.9 9.  Where a product is the subject of a patent
      application in a Member in accordance with paragraph 8(a), exclusive
      marketing rights shall be granted, notwithstanding the provisions of
      Part VI, for a period of five years after obtaining marketing
      approval in that Member or until a product patent is granted or
      rejected in that Member, whichever period is shorter, provided that,
      subsequent to the entry into force of the WTO Agreement, a patent
      application has been filed and a patent granted for that product in
      another Member and marketing approval obtained in such other Member.