Leaked TPP Chapter on IP Sets Terms of Biologics Data Exclusivity

Posted 09 October 2015 By Zachary Brennan

placeholder+image

Information on biologics data exclusivity provisions in the Trans-Pacific Partnership remains murky, despite a leaked copy of the final version of the TPP Chapter on Intellectual Property rights from WikiLeaks on Friday.

The section of the chapter on biologics data exclusivity seems to offer two options with respect to the "first marketing approval" of a new biologic: that countries involved shall provide "effective market protection…for a period of at least 8 years from the date of first marketing approval," or " for a period of at least 5 years from the date of first marketing approval."

But for the five-year period, the text seems to leave the door open for other provisions that might extend that time, with the ambiguous statement "through other measures," which comes just above the statement that the countries recognize "that market circumstances also contribute to effective market protection."

The chapter also adds that biologic company applicants "may request approval of a pharmaceutical product that is a biologic…within 5 years of entry into force of this Agreement, provided that other pharmaceutical products in the same class of products have been approved by the Party."

In addition, a number of TPP governments, including Australia and New Zealand, have said that deal does not require them to shift from five years of exclusivity.

Some countries will have transition periods, and the leaked text shows those periods would last three to ten years.The deal also says the TPP commission will review the period of exclusivity after 10 years.The TPP negotiating countries include the US, Mexico, Canada, Japan, Australia, Malaysia, Chile, Singapore, Peru, Vietnam, New Zealand and Brunei. The US Congress has 90 days to sign off on the final terms of the agreement, which are expected to be made public officially in November.

Comments

Debate on the issue of biologics data exclusivity has continued for more than a year, with US pharma and biotech industry groups calling for 12 years of protection, while nonprofits, such as Médecins Sans Frontières (MSF) and Public Citizen, have said such provisions would "limit access to medicines" in some countries.

Both sides also immediately criticized the TPP deal when it was finalized earlier this week.

On Thursday, President Barack Obama looked to assuage the fears of biopharma CEOs by discussing the deal. Industry group PhRMA released a statement on the meeting, saying: "We emphasized that strong intellectual property protection is necessary for the discovery and development of new treatments and therapies for the world's patients and are disappointed that the TPP, which, by failing to secure 12 years of data protection for biologic medicines, will compromise the next wave of innovation and disrupt the development of new, critically-needed medicines."

With the WikiLeaks release Friday, Public Citizen also weighed in again, saying the text "verifies that the pact would harm public health by blocking patient access to lifesaving medicines."

Leaked TPP Chapter on IP Rights

Public Citizen

Share this article:

Categories: Biologics and biotechnology, Drugs, Compliance, Reimbursement, Submission and registration, News, US, Canada, Asia

Tags: TPP, WikiLeaks, Assange, biologics exclusivity, market exclusivity

Regulatory Exchange: Latest Updates From the Community