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.
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.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs
March 29th 2024Despite more biosimilars entering the market and generating significant savings for payers and health care systems, these savings are not resulting in lower out-of-pocket (OOP) costs for patients, according to a recent study.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth
March 14th 2024In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.