The Supreme Court, on Thursday, dismissed the appeal filed by Novartis against Hanmi Pharmaceutical and Ahngook Pharmaceutical over the patent extension term of Galvus (ingredient: vildagliptin), closing the four-year-long patent dispute.

The recent ruling marks the first case of domestic pharmaceutical companies to win drug patents against the original developer.

As the court sided with Korean pharmaceutical companies, the duration of the patent for Galvus, Novartis’ original DDP-4 inhibitor for diabetes, will be shortened by 55 days from March 4, 2022.

The dispute began when Ahngook filed an appeal in 2017 to nullify the expiration date of Novartis' Galvus. Next year, Hanmi Pharmaceutical also appealed to the court with the same request.

Korean law usually protects patents for 20 years from the filing date. However, the covered period of pharmaceutical companies' products could be extended according to the time taken for receiving regulatory approval for clinical trials and commercialization.

When Novartis applied to secure a patent for Galvus in Korea, the company requested to include time spent conducting clinical trials and receiving approval from the Ministry of Food and Drug Safety, extending the expiration date to 1,068 days. 

Hanmi and Ahngook filed against the initial court ruling, saying that 187 days of the extended period were invalid. The Intellectual Property Trial and Appeal Board accepted the Korean companies’ claims.

In the subsequent second trial, Novartis partially won, and the patent court ruled that only 55 out of 187 days were invalid.

However, Novartis appealed again to the Supreme Court that not a single day was invalid. The Supreme Court recently turned down and dismissed the case.

The dispute between Novartis and domestic drug developers over the patent expiration date of Galvus became the first case for Korean pharmaceutical companies to win the drug patent case against the original developer after four years of legal battle, industry watchers here said.