U.S Trade Rep Cites China, India Over Weak IP Protections

The U.S. Trade Representative flagged China and India on its latest priority watch list of countries with lax intellectual property protections for drugs.

Ninety percent of counterfeit pharmaceuticals seized at the U.S. border in fiscal 2016 were shipped through China, Hong Kong, India, or Singapore — and counterfeit drugs and APIs are a growing problem, the USTR said in its 2017 Special 301 report, which identifies trade barriers involving copyrights, patents and trademarks.

For example, the USTR pointed to China’s unique definitions of “new chemical entity” and “new drug” as unfair to foreign competitors. In March 2016, China limited the definitions to products for which sponsors sought initial approval in China before seeking approval in any other country.

Meanwhile, India’s approval process for generic drugs and follow-on products lack an effective system for notifying the interested parties of marketing approvals for follow-on drugs, which would allow early resolution of potential patent disputes, USTR said.