[CTC] U.S., Australia Move Toward Biologics Compromise With Options

[Arthur Stamoulis]

Inside US Trade

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. 

One informed source said that, given the progress between the U.S. and Australia, the chances of reaching a broader TPP agreement here had increased to 50 percent from 20 percent on Friday. Another informed source expressed confidence that a TPP deal would be reached here.

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 <http://insidetrade.com/node/136910> 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 system.   

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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