[Ip-health] IUST: U.S., Australia Move Toward Biologics Compromise With Options

Thiru Balasubramaniam thiru at keionline.org
Sat Oct 3 10:43:05 PDT 2015

Saturday, October 03, 2015

Daily News

U.S., Australia Move Toward Biologics Compromise With Options

Posted: October 03, 2015

ATLANTA – The United States and Australia are inching toward a compromise
on the exclusivity period for biologic drugs that would give Trans Pacific
Partnership (TPP) countries more than one option for providing an
appropriate level of intellectual property (IP) protection, according to
informed sources.

They said this progress is increasing the chances of reaching an overall
TPP deal here, although such a broader agreement is not likely to come
together until Sunday at the earliest.

This is in part because, even if the U.S. and Australia reach a bilateral
deal, they need to share it with other countries who will have to vet any
compromise with their capitals, sources said.


The likelihood that the talks here will be extended through Sunday means
some ministers may have to travel directly from Atlanta to the G20 trade
ministerial, which kicks off on Monday (Oct. 5) in Istanbul. The TPP
countries who are also part of the G20 are Australia, Canada, Japan,
Mexico, and the United States.

U.S. Trade Representative Michael Froman held a bilateral meeting late this
morning with Japanese TPP minister Akira Amari, where they were expected to
discuss the general status and dynamics of the negotiations.

In a related development, sources said Japan has expressed reservations
about the U.S. proposal on tobacco, which would make it optional for
countries prevent tobacco control measures from being challenged under the
investor-state dispute settlement (ISDS) mechanism.

The Japanese government owns a minority stake in the Japan Tobacco company,
but at an earlier stage in the TPP negotiations indicated that its stake in
the company would have no bearing on its position on this issue. U.S.
officials appear optimistic that Japan just needs time to evaluate the U.S.
proposal and will eventually come around to the idea.

Despite making progress overnight on the biologics issue, the U.S. and
Australia have not yet moved from their formal positions. The U.S. is
seeking eight years of market exclusivity for biologics, while Australia is
saying it cannot go beyond the level of protection in its current domestic

Australian law currently provides for five years of data exclusivity for
biologics, but Australian officials argue that biosimilars do not typically
enter the market until at least one to two years later due to additional
regulatory requirements.

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