Patent Exclusivity for Biologics: Seven or Twelve Years?

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Developing intellectual property standards for biological products is a point of conflict as negotiations on the Trans-Pacific Partnership continue.

Although discussions about the terms of the 12-nation Trans-Pacific Partnership (TPP) free trade agreement are currently underway, there is no consensus yet about how the agreement will deal with the patent period for biologic medicines.

According to Politico, Senator Orrin Hatch (R, Utah) said he would oppose the Trans-Pacific Partnership agreement unless it contains 12 years of data protection for biologic pharmaceutical products. Additionally, U.S. Trade Representative Michael Froman said that the length of data protection for biologics was "one of the most difficult outstanding issues in the negotiation."

The confusion about the data exclusivity period lies with the wording of much of the legislation. Currently, the law provides at least 12 years of regulatory data protection for innovative biological products through the biosimilar pathway, which was created as part of the Biologics Price Competition and Innovation Act. The data exclusivity period for biologic medicines regularly mentioned in the 2015 White House budget, however, refers to a seven-year exclusivity period. In the budget proposal, released in 2014 by United States Department of Health and Human Services, the number of years that a drug company has exclusivity or “monopoly pricing power” for a medication was reduced from 12 to seven years in order to foster biosimilar competition. As a result, there is some talk about whether or not seven years is the timeframe that the TPP will secure for patent protection.

Politico reports that of the 11 other countries involved in the talks, five have zero years for data protection, four have five years of protection and two have eight years of protection. TPP members include the US, Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam.

BIO said in a 2013 brief on TPP that “A strong intellectual property regime will ensure strong incentives throughout the Trans-Pacific region that will stimulate discovery and development of innovative biological products, which in turn will benefit patients throughout this region and elsewhere.”


Meanwhile, groups such as AARP oppose a 12-year exclusivity period, saying this length of a period would keep biosimilars off the market and artificially keep costs high for crucial medications. In a letter to Froman, the organization said that reducing the market exclusivity period for brand-name biologics from 12 years to seven would result in a $3.8 billion savings.

Doctors Without Borders says the 12-year period would extend pharmaceutical monopolies and would restrict access to biosimilars. Rohit Malpani, director of policy and analysis at the MSF Access Campaign, said in a statement that the "US continues to work behind closed doors, without any input from the public, experts, or elected officials, to aggressively push for intellectual property provisions that put the profits of pharmaceutical companies ahead of people’s health.”