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Drug companies appear to have lost their fight to include longer-term protection against cheaper copies of some of their products in the historic trade pact reached Monday by the United States and 11 other Pacific Rim nations. While all the details weren’t immediately available, initial reports of a compromise struck between US and foreign negotiators said the sweeping Trans-Pacific Partnership won’t provide the 12 years of commercial protection the US-based biopharma industry had sought. (Weisman, 10/5)

Part of the agreement requires the countries to extend data protection for biologic medicines—drugs produced by living matter—for at least five to eight years. The pharmaceutical industry had hoped for a minimum of 12 years, and some consumer groups had hoped for no minimum exclusivity. ... Biologics currently have 12 years of data exclusivity in the U.S. under federal law, and that's unlikely to change regardless of the trade agreement. The biggest impact will be felt by the partnership's other countries; Australia, Brunei, Vietnam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru and Singapore. At least five of the partnership countries now don't have any exclusivity for biologics, meaning the agreement would require them to pass laws granting at least five years of exclusivity. (Schencker, 10/5)

The biotechnology industry, whose ranks include Gilead Sciences and Amgen, criticized the deal struck by negotiators for the Trans-Pacific Partnership agreement to let drugmakers keep data secret for at least five years, saying negotiators should have extended protection for 12 years. "BIO strongly believes that 12 years of data exclusivity is a prerequisite to attract the investment required to continue medical innovation and develop new biological cures and therapies," Jim Greenwood, president and chief executive officer of the lobbying group Biotechnology Industry Organization, said in an emailed statement. (Edney and Bloomfield, 10/5)

Trade officials from 12 countries agreed Monday to shrink the length of time that pharmaceutical companies can receive monopoly rights for certain drugs, a provision that is already threatening to incite a Big Pharma rebellion on Capitol Hill. Brand-name companies would receive up to eight years of monopoly rights for drugs known as biologics — a decrease from the current 12 years provided under U.S. law, according to officials involved. The final language of the deal has not yet been released. (Ferris, 10/5)

Before free trade supporters get too exuberant about the outcome of the Trans-Pacific Partnership talks, they might want to listen to the chairman of the Senate Finance Committee. “Closing a deal is an achievement for our nation only if it works for the American people and can pass Congress by meeting the high-standard objectives laid out in bipartisan Trade Promotion Authority. While the details are still emerging, unfortunately I am afraid this deal appears to fall woefully short,” Chairman Orrin G. Hatch said in a statement. (Lesniewski, 10/5)