AstraZeneca filed a suit with the Patent Court to cancel the Intellectual Property Trial and Appeal Board (IPTAB)’s decision that helped Dong-A ST avoid the patent of AstraZeneca’s SGLT-2 inhibitor Forxiga.

Industry officials are paying attention to whether AstraZeneca’s legal action would put brakes on Dong-A ST’s release of Forxiga generic drug scheduled for the second half of 2021.

AstraZeneca appealed to the patent court against Dong-A ST on Friday.

The appeal came after IPTAB ruled in favor of Dong-A ST on June 23 that the local drug company’s investigational generic drug of Forxiga did not infringe upon the original drug.

AstraZeneca’s Forxiga has two substance patents, over the active ingredient dapagliflozin, that expire on April 7, 2023, and January 8, 2024. Dong-A ST was the only pharmaceutical firm in Korea that avoided both of the two patents.

The IPTAB earlier ruled that an agent contained in the Dong-A ST’s investigational medicine as a prodrug of dapagliflozin did not infringe upon the scope of Forxiga’s patent rights.

However, an official at AstraZeneca claimed that the ingredient of the Dong-A ST’s experimental drug showed the same pharmacokinetics in the body as dapagliflozin. As the ingredient is converted like dapagliflozin to exert its effect, it infringes on Forxiga’s substance patent, he added.

“We will reconfirm the scope of Forxiga’s substance patents and protect our intellectual property obtained from the authorities through the legitimate procedure,” the official at AstraZeneca said.

“Substance patents of dapagliflozin are the result of R&D invested with a lot of effort and cost. I hope that such excellent patents could be respected until the expiration date,” said AstraZeneca Korea CEO Kim Sang-pyo. “I also hope that we can maintain a virtuous cycle of reinvesting profits made through the patents in R&D for new drug development and that the authorities could take a strict measure against the improper use of the patient rights,” he added.

AstraZeneca’s appeal could interfere with Dong-A ST’s plan to roll out Forxiga’s generic medicine next year.

Dong-A ST had earlier said it would seek approval for the latecomer drug in the second quarter of 2021. If the company wins the nod, it can sell Forxiga’s generic drug exclusively for nearly a year.

kym@docdocdoc.co.kr

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