Kwangdong Pharmaceutical has entered the patent race against AstraZeneca’s anticancer drug “Tagrisso” (osimertinib), following Chong Kun Dang’s initial move. The company aims to secure a "first-mover" advantage in the oncology generics sector, with Tagrisso's Post-Marketing Surveillance (PMS) period set to expire in late 2024.

On November 8, Kwangdong filed a passive confirmation trial with the Korean Intellectual Property Trial and Appeal Board to bypass AstraZeneca’s formulation patent for the “pharmaceutical composition containing ZD9291,” valid until January 2035. This patent is one of three listed in the Ministry of Food and Drug Safety's registry, including two others set to expire in late 2033.

Kwangdong’s move is significant for its dual objectives: securing exclusivity rights and reinforcing its reputation as a leader in patent challenges for oncology generics. The company has a strong track record, having successfully contested patents for oncology treatments like Revlimid (multiple myeloma) in 2016 and Afinitor (breast cancer) in 2019, although it later ceded its first-generic position for Afinitor to Boryung. Recently, Kwangdong gained approval for the first capsule-type generic of Pfizer's breast cancer treatment, Ibrance, further cementing its place in the competitive oncology generics market.

The stakes are high for Kwangdong. Anticancer drugs are notoriously challenging to replicate due to stringent regulatory requirements and complex formulations. Nevertheless, a successful launch following the PMS expiration could grant Kwangdong a lucrative foothold in the market.

However, significant hurdles remain. The substance patents for Tagrisso are notoriously difficult to invalidate, and neither Kwangdong nor Chong Kun Dang has yet challenged the remaining patents protecting the drug. These factors suggest a prolonged legal and regulatory battle, likely extending well beyond 2024.

This latest move by Kwangdong underscores its broader strategy: to dominate the oncology generics market through aggressive patent challenges and the pursuit of first-generic status.