On March 8, 2019, Ha Kung Wong was quoted in a Law360 on a new Senate bill to create a patent framework for biosimilars akin to the Hatch-Waxman system for generic drugs that could clarify the biosimilar approval process. According to the article, attorneys say it may conflict with current rules and likely won't curb the patent tactics its sponsors decry.
The Biologic Patent Transparency Act, S.659, was introduced by Sen. Susan Collins, R-Maine, and a bipartisan group of five other senators. They said in a statement that the measure would "encourage competition in the prescription drug marketplace and put an end to the harmful patent strategies that block new drugs from coming to market."
The bill, pitched as a way to reduce drug costs, contains two main provisions. One would require makers of biologic drugs to list their patents with the U.S. Food and Drug Administration — similar to how patents must be listed for small-molecule pharmaceuticals under the Hatch-Waxman Act — and the other would put some restrictions on infringement litigation over those patents.
Those proposed requirements will face opposition from biologics makers, said Wong. While the basic concept of listing patents doesn't present any major issues, he said, the bill's approach "appears overly broad on the front end on what has to be listed and overly harsh on the back end as to what the downside is if you don't list it."
In the Hatch-Waxman Act, branded-drug makers who list their patents secure a 30-month stay of approval of generic competitors. The new bill doesn't include any similar incentive for biologics makers, Wong said, noting that "there's a little bit of give-and-take in Hatch Waxman. There's no clear give-and-take here."