Knowledge Ecology International's leaked document is dated May 11 2015, so it would not reflect any changes from last week's negotiations in Hawaii, though it is likely close to the working version entering those discussions.
US negotiators have consistently been arguing for stronger IP protections to be built into the TPP, but the newest leak seems to show that it has backed down on at least one demand. That demand was a provision that signatory countries may not deny a patent "solely on the basis that the product did not result in an enhanced efficacy of the known product" if the invention otherwise met all the other requirements of patentability.
This provision was a response to the India Supreme Court's ruling in 2013 invalidating Novartis's Glivec patent on the grounds that it violated Section 3(d) of the Patent Act, which states that a new form of a known substance is not patentable unless it shows enhanced efficacy.
The provision in the TPP, proposed by the US and Japan but opposed by the other TPP countries, was in Article QQ.E.1 in both the leaks released in November 2013 and October 2014, but not in the most recent version.
Going into last week's negotiations, reports pointed to IP protection as one of the main issues to be hammered out. Debates over data exclusivity provisions, particularly for biologics is one of several issues believed to be a sticking point.
US law provides data exclusivity for biologics for 12 years and it is believed that its negotiators were seeking an identical term in the TPP. However, countries such as Australia would only go up to five years. For countries like Australia, the logic was simple- the government through its national healthcare system would have to bear the additional costs due to lower-cost biosimilars entering the market at a later date.
Interestingly, in the debates that ultimately resulted in the 12-year data exclusivity period in the US, the Obama administration initially argued for a shorter seven-year term, saying that Medicare would have to bear the additional costs.
Knowledge Ecology International director James Love is one of Managing IP's 50 most influential people this year.
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