(Bloomberg) — Drug patent rules are shaping up as one of the thorniest issues standing in the way of a massive Asia-Pacific trade deal as talks get under way in Hawaii.
The dispute pits the administration of U.S. President Barack Obama and the pharmaceutical industry against poorer countries participating in the Trans-Pacific Partnership, such as Chile, Malaysia, Peru and Vietnam. At issue is a class of drugs called biologics. Developing nations are allied with richer countries like Australia, who don’t want to adopt U.S. rules that let drug companies keep confidential clinical data generated to win regulatory approval for such products.
The patent disagreement is one of many that trade ministers from 12 countries are hoping to resolve during talks on Maui to conclude six years of negotiations on the TPP. The pact, which ranges from agriculture to e-commerce, got a boost last month when the U.S. Congress approved Obama’s request for an up-or-down vote on any deal.
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Companies including Pfizer Inc. and Amgen Inc. stand to benefit if more countries adopt U.S.-style patent laws, and industry lobbyists have descended on Maui to make their case.
One issue they’re monitoring is a bid to make sure drug companies can control for 12 years the data generated to win approval for biologics, or biopharmaceuticals. The profitable and relatively new segment of the market involves medicinal preparations made from living organisms, as opposed to chemicals.
The 12-year lock-up, which is already in U.S. law, makes it harder to develop competing products and makes the patents more valuable.