If Republicans in Congress move past their disappointment with biologics exclusivity provisions and ratify the Trans-Pacific Partnership trade treaty, the stage will be set for a significant strengthening of global IP protections for pharmaceuticals.
The agreement extends key U.S. pharmaceutical IP practices to countries that account for 40% of world trade and sets precedents that could be applied in future trade treaties around the world. It is likely to be expanded by the addition of Indonesia and other Asia-Pacific countries. Korea, the Philippines and Taiwan are considering joining TPP, and China and India would have to take it into consideration when negotiating treaties with other Pacific countries.
Apart from a shorter biologics exclusivity period than PhRMA wanted, the TPP's IP provisions read like a wish list from the trade group's Special 301 annual letter to the Office of the U.S. Trade Representative (USTR). The letter outlines steps the industry believes should be taken to level the international playing field for trade in new drugs.
Protections that innovator pharmaceutical companies have been demanding for decades and that TPP countries have agreed to include criteria for patentability of medicines, extension of drug patents for regulatory and patenting delays and data protection principles (see "Biopharma-Friendly TPP Provisions").
While conservative free-trade supporters are concerned that TPP provides insufficient protection to biologics, the deal is being attacked by progressive Democrats as a giveaway to big pharma.
Hillary Clinton has cited benefits to drug companies as her principal reason for opposing the treaty, and industry critics including Médecins Sans Frontières (MSF), Knowledge Ecology International and Public Citizen are urging Congress to block the deal because