At the third round of TPP negotiations in Malaysia last week, representatives from a number of industries accompanied their country’s delegations to provide support and feedback to the discussions. Representatives from the pharmaceutical industry travelled with Mexico’s delegation to provide input about what they seek in the agreement. Three issues of particular interest are data exclusivity, secondary use patentability and patent linkage.
“One of the big issues we would like to see is clear provisions on data protection. There is language in the draft providing for data protection, but it does not say how long the periods are,” explained Carlos Flores Ruiz of Novartis. “Innovator pharmaceutical companies would like to see a longer period of protection for biologic drugs than the five years for chemicals”.
Article 1711 of the North American Free Trade Agreement (NAFTA) provides for a minimum of five years, though there is some concern that vagueness in the language allows for compliance without providing for true data protection.
By comparison, the United States, considered one of the driving forces behind the TPP, provides for 12 years of data protection for biologic drugs and five years for chemicals.
Last year, Mexico’s Seventh Auxiliary Circuit Court upheld a decision in support of data exclusivity, though Alejandro Luna of Olivares & Cia, who also accompanied the Mexican TPP negotiators as an industry representative, said patent holders would like to see more explicit provisions on the issue. The TPP, he noted, would be a good opportunity to clarify these issues for all signatory countries.
The pharmaceutical industry is also concerned about the patentability of second use claims as well as patent linkage. While both are available in Mexico, much like the data exclusivity issue, Luna says that the TPP can be an opportunity to not only ensure that all signatory countries afford a similar level of protection, but also to help bring clarity as to the scope of these provisions in Mexico.
In many ways, innovator pharmaceutical companies see the TPP as a way to formalise and solidify existing protections.
“NAFTA’s references to IP protections tended to provide for a minimal level of protection,” Luna explained. “The TPP is a chance to go more into the details.”
The spectre of ACTA
Luna dismissed concerns that the TPP is vulnerable to the same criticisms levelled at ACTA, that the negotiations lacked transparency and represented only certain interests. These complaints led to vigorous protests in 250 cities worldwide, ultimately leading to ACTA’s failure.
“The difference between the TPP and ACTA is that with the TPP, a wide variety of private sector interests have the opportunity to meet with government officials and negotiators to express their views,” he argued. “We received the same treatment as the representatives for the generic manufacturers, who were also there.”
Many other delegations also have private sector representatives accompanying. For example, Flores Ruiz noted that a Novartis colleague from Chile was also in attendance.
NGOs such AIDS patient groups were also present at the negotiations, though some noted that these groups don’t necessarily have the same level of access to their governments as industry representatives.
Intra-governmental transparency was also an issue for ACTA in Mexico. Though Mexico was one of the negotiators of ACTA, the Senate ultimately advised against signing the treaty. Luna said that the government’s response is different this time.
“When ACTA was negotiated, it was done through executive power and the Senate was not really involved,” he explained. “This time, the Senate is much more involved in the process to keep track of developments.”
Another private sector representative also suggested that there may be a wider range of interests represented among the TPP negotiating countries. He said that some delegations, including those from Vietnam, Chile and Peru, are pushing for considerably weaker IP protection provisions than the ones advocated by countries such as the United States and Mexico.
Closing time?
Luna said that one concern is the timing of the negotiations and the likelihood of completing on schedule. He said that though the goal is to finish negotiations by October, Japan’s recent entry may delay that.
“The Japanese delegation was quite large; it looked like it had a hundred people,” he joked, though he noted that given Japan’s strong IP-focused industries, it will likely be an ally on IP issues.
When asked about the possibility of further delay given China’s increasing interest in joining the talks, Luna was sceptical, saying that the TPP is intended to act as a balance to China’s growing economic clout.
Despite uncertainties and challenges, rights holders see the TPP as a chance to shore up IP protections.
“I am glad that Mexico is taking a position that is in favour of stronger IP rights,” sand Daniela Vaca Leyva, the director of industrial property for the Asociación Mexicana de Industrias de Investigación Farmacéutica. “I think the TPP can bring about improvements on some of the IP issues that relate to innovator pharmaceutical companies.”
