The United States and Australia have jointly developed a text proposal on the exclusivity term for biologics medicines and overnight began showing it to other Trans-Pacific Partnership (TPP) countries in an effort to build support, in a move that is raising optimism that negotiators can reach a broader agreement by the end of the day Sunday (Oct. 4), according to informed sources.
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The U.S.-Australia proposal would contain at least two options, one of which would be an obligation to provide eight years of exclusivity for biologics, sources said.
The other would be to provide five years of exclusivity, plus an obligation vague enough that it could be interpreted as requiring additional years of protection, or not. This appears to be an effort by both sides to craft language that would allow both of them to claim victory. (emphasis added)
If this proposal -- which I haven't seen -- becomes law, I really hope there is no complaining if and when a TPP panel has to interpret it and decide whether or not it requires those additional years of protection.
