Genentech and Pfizer Reach Settlement Over Biosimilar Trastuzumab

Recently, plaintiff Genentech and defendant Pfizer filed a collective stipulation and proposed order of dismissal of a patent infringement lawsuit over Genentech’s reference trastuzumab product, Herceptin.

In November 2017, Genentech, a subsidiary of Roche, filed a lawsuit against Pfizer claiming that its biosimilar trastuzumab product would infringe on 40 of patents of Genentech’s reference trastuzumab, Herceptin. Herceptin is one of the Genentech’s best-selling products, earning over $7 million globally in 2017 alone.

Genentech’s complaint asked the court to order compensation of lost sales if Pfizer were to launch a biosimilar trastuzumab prior to Herceptin’s US patent expiry, which is coming in 2019.

The stipulation and proposed order of dismissal indicates that a settlement has been reached, though no terms of the agreement have been publicized thus far.

“Plaintiffs and Defendant have entered into a settlement agreement, and mutually agree to voluntarily dismiss all claims and counterclaims asserted in the above-captioned case without prejudice,” read the filing. The judge presiding over the case, Judge Connolly, ordered the dismissal on the same day of the filing.

Under the agreement, all claims and counterclaims were dismissed, and each party is responsible for its own respective attorneys’ fees and costs.

This is not the only lawsuit that Genentech has brought against potential biosimilar trastuzumab competitors. Currently, Genentech has litigation underway with Celltrion and Teva, Amgen, and Samsung Bioepis, all in the District of Delaware, for patent infringement under the Biologics Price Competition and Innovation Act of 2009.

To date, there have been a handful of biosimilar trastuzumab approvals in the European Union (EU) and the United States. In the EU, Ontruzant, Herzuma, and Kanjinti are all competing with the reference product for market share. Conversely, in the United States, there has only been 1 biosimilar trastuzumab thus far, Ogivri, which was approved December 2017. Mylan and Biocon, the co-developers of Ogivri, have yet to announce a marketing launch date.