Inside U.S. Trade reports that Trade Ministers have scheduled Trans Pacific Partnership Ministerial for the end of July in Hawaii. Chief negotiators will meet prior to the Ministerial to try to iron out remaining areas of disagreement.
Jiji press reports that there are six unresolved areas where “negotiations are not proceeding smoothly.” Data exclusivity for biologics is one such area. The story quotes a Japanese negotiator saying “Unless Washington shortens the requested protection period, there is little chance of an agreement.”
Politico also highlights the IP and pharmaceuticals as one of the toughest set of issues remaining, with a specific reference to the application of linkage rules to biologics:
“Critics say this ‘hard linkage’ system would slow down the introduction of cheaper generic medicines, adding it should be up to the patent holder, not the government, to defend drugs from generic competition. They also say the U.S. could be going beyond its domestic law by applying hard linkage rules to a new class of biologically derived medicines, known as ‘biologics,’ which include pioneering treatments for cancer and other deadly diseases.
In another story last week, Politico reported on a newly leaked draft IP chapter “as it stood on May 11, at the start of the latest negotiating round in Guam.” It reported that the text “would give U.S. pharmaceutical firms unprecedented protections against competition from cheaper generic drugs, possibly transcending the patent protections in U.S. law.”