US House approves bill to take on biosimilar ‘patent dance’

The bill aims to reduce US drug prices and could limit IP strategies undertaken by reference biologic makers to ward off biosimilar competition.

Having been first introduce to the House in April, H R 2884 was approved by the House Judiciary Committee yesterday as part of four bills aimed at tackling the high prices of drugs in the US.

According to the text, the bill “limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug,” effectively helping to resolve patent infringement claims made by reference biologic makers against their biosimilar maker counterparts.

Image: Stock Photo Secrets

Reference biologic makers have been skillfully navigating the IP landscape to protect their biologics in a strategy commonly referred to as the ‘patent dance.’

Full details regarding the ‘dance’ are in the box below. But as an example of the effectiveness from a business standpoint AbbVie has an extensive maze of around 130 patents surrounding its blockbuster mAb Humira (adalimumab), which is helping to keep biosimilar competition out of the US until at least 2023, though

“The bill’s provisions apply to an existing framework that gives the biosimilar manufacturer an abbreviated path to Food and Drug Administration approval to sell the biosimilar,” the text states.

“Specifically, if the biosimilar manufacturer completes certain actions under the framework, such as sharing certain information about its product with the reference product manufacturer, the bill limits the number of certain patents that the reference product manufacturer may assert in a lawsuit, such as patents that were filed more than four years after the reference product received market approval. The limit shall not apply to patents claiming certain methods for using the biologic drug.”

The three other bills voted for yesterday aim to stop drugmakers raising prices to fend off competition and ban the tactic of paying generic companies to delay bringing cheaper versions of their medicines to market.

All four bills will next be taken up by the full House and Senate.