June 03, 2021

Law360 Quotes Chris Loh on China’s New Litigation System for Drug Patents

2 min

On June 3, 2021, Chris Loh was quoted in Law360 on China’s new litigation system for drug patnts. According to the article, the framework was created by a law enacted in October and will mean that owners of drug patents can file infringement suits over planned generic drugs without having to wait until those competing products are on sale.

In many ways, the Chinese system will operate similarly to Hatch-Waxman litigation, where during regulatory review of marketing authorization for a generic drug, the patent owner can file suit to ask if the generic version falls within the scope of its patent rights. There is an equivalent in China to the U.S. Orange Book, which lists the patents that cover branded drugs.

"I was actually surprised at the extent to which the Chinese process mirrors the U.S. Hatch-Waxman process," said Loh. "The broad strokes look fairly familiar to the U.S. system."

There are some key differences between the systems in China and the U.S. One that observers will be watching closely is the time frame for litigation. Under Hatch-Waxman, regulatory approval of a generic drug is generally stayed for 30 months after a generic application is filed. In China, however, the law only states that if there is a decision in the infringement case within nine months, regulators can take that into account when deciding whether to approve the generic.

If generics end up launching before a patent case is resolved, "this law might not necessarily accomplish its intended goal of allowing the parties to resolve their disputes before there's actually a commercial launch," Loh said.

Click here to access the article.