April 25, 2024

• 

[THE INVESTOR] South Korea’s Celltrion has filed a petition for inter partes review of Genentech’s US patent for the breast cancer therapy Herceptin prior to the US launch of its biosimilar product referencing the blockbuster drug, sources said on Feb. 27.

The Korean biopharmaceutical filed an application with the Patent and Trademark Office to challenge some of Roche subsidiary Genentech’s Herceptin patents which had global sales of US$6.5 billion in 2015. 

Celltrion’s biosimilar to Herceptin Herzuma or CT-P6, completed the phase 1 clinical trials for Herzuma in the US in early September last year and is preparing for the next level of studies.

While Herceptin is commercially available in South Korea, the breast cancer treatment is awaiting regulatory approval by the European Medicines.

Herceptin’s initial US patent was set to expire in 2019 but Genentech extended it till 2030 to hold the exclusivity longer and counter increasing competition from biosimilar makers like Mylan and Hospira.

This is not the first time that Celltrion has filed a petition against a global drug maker.

In 2016, a US court ruled in favor of Celltrion in patent ruling on Johnson & Johnson’s blockbuster arthritis drug Remicade, clearing the way for the Korean company to sell its copycat in the country.

By Park Han-na (hnpark@heraldcorp.com)