Court Calls Genentech's Actions In Trastuzumab Case "Contrary to the Spirit" of the BPCIA

July 24, 2019
Kelly Davio

Genentech had asked the court for a temporary restraining order and a preliminary injunction against Amgen in a Biologics Price Competition and Innovation Act (BPCIA) litigation related to patents covering Herceptin. The United States District Court for the District of Delaware denied Genentech’s motion, and the court has now made public a redacted version of the memorandum opinion in the matter.

Last week, biosimilar developer Amgen launched the first 2 anticancer biosimilars in the US market: Mvasi, a biosimilar bevacizumab referencing Avastin, and Kanjinti, a biosimilar trastuzumab referencing Herceptin.

Genentech, developer of both of the reference products, had previously asked the court for a temporary restraining order and a preliminary injunction against Amgen in a Biologics Price Competition and Innovation Act (BPCIA) litigation related to patents covering Herceptin. The United States District Court for the District of Delaware denied Genentech’s motion, and the court has now made public a redacted version of the memorandum opinion in the matter.

According to the document, Amgen gave its notice of commercial marketing related to Kanjinti in May of 2018. Four weeks after the biosimilar was approved by the FDA, Genentech moved for the restraining order and preliminary injunction; on the same day, the court ordered a standstill to consider Amgen’s response to Genentech’s motions.

The decision points out that a preliminary injunction is a drastic, extraordinary remedy, and that obtaining such relief requires that a party show a likelihood of success on the merits, prove that it would suffer irreparable harm if an injunction was not granted, show a balance of hardships in its favor, and demonstrate that an injunction would be in the public interest.

According to the opinion, Genentech, however, failed to show that it would suffer irreparable harm if its motion were denied. Given that the reference drug maker had known that Amgen planned to launch its drug since it served its notice in May 2018, and given that Genentech received other information from Amgen in the discovery process that alerted the company to the planned Kanjinti launch date, Genentech’s actions are “contrary to the spirit and purpose of the BPCIA,” which gives parties time to adjudicate these types of matters without asking the court for immediate relief.

“Genentech’s undue delay in requesting a preliminary injunction, particularly in light of relevant provisions of the BPCIA, should be sufficient by itself to deny the motion,” reads the opinion.

However, the opinion also adds that Genentech has licensed patents to biosimilar developers Mylan, Celltrion, and Pfizer for biologics in the past—allowing for biosimilar launch dates that are redacted in the opinion—which suggests that Genentech would not suffer irreparable harm if biosimilar competitors enter the market.

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