Text of Trade Deal Shows That Eight Years of Market Exclusivity Is Not Guaranteed

Manufacturers of new biologics could receive up to eight years of exclusivity in 12 countries under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Barack Obama inked with 11 other countries in October, were publicly released Nov. 6.

Under the deal, which still requires congressional approval, a company that secures marketing approval for a biologic in one of the 12 signatory countries — Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the U.S. and Vietnam — can receive up to eight years of exclusivity in all of those countries.

This is significantly less than the 12 years of exclusivity that U.S. trade officials have been demanding during the trade deal’s protracted negotiations. However, months of leaks already had established the downgraded terms.

Article 18.52 of the document specifies that signatories must provide biologics patent filers with one of two options for exclusivity: eight years of exclusivity and data protection, or else guarantee five years of protection along with existing measures in that country and overall market protections. Because the second track is more nebulous on requirements beyond the five-year guarantee, many signatory countries may simply opt for five years of exclusivity.

According to the text, the clock starts ticking on the first day a new biologic wins marketing approval. Additionally, the text contains a promise to revisit the terms of exclusivity within 10 years, recognizing that the biologics industry “is in a formative stage and that market circumstances may evolve over time.”

Along with the exclusivity terms, the document provides protections for companies entering markets with protracted and onerous marketing approval processes. The text specifies that participating countries shall “make best efforts to process applications for marketing approval of pharmaceutical products in an efficient and timely manner,” and if that product is patent-protected, then its owner will receive “an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term.”

Additionally, the deal includes terms to prevent third parties from profiting off a new drug developer’s work. A marketing provision specifies that if a participating country allows third parties access to safety and efficacy information about a new drug as part of the marketing approval process, then that country also must guarantee the company that owns the drug certain legal protections.

Similarly, the document contains data protection requirements incumbent on signatory countries in line with the World Trade Organization’s trade-related aspects of intellectual property rights.

Read the text of the trade deal here: www.fdanews.com/11-06-15-TPP.pdf. — Cameron Ayers


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