Novartis canceled its lawsuit against Ahngook Pharmaceutical’s anti-diabetic treatment, a copy of Novartis’ dipeptidyl peptidase 4 (DPP-4) inhibitor Galvusmet (ingredient: vildagliptin, metformin). The move relieved pressure on Ahngook which has been preparing to release Galvusmet’s generic drug.
|Novartis’ anti-diabetic treatment Galvusmet|
Industry sources said Novartis withdrew last Thursday from the second trial to determine the scope of its rights over the patent for “agents containing metformin and vildagliptin.”
After the Intellectual Property Trial and Appeal Board (IPTAB) recognized Ahngook Pharm and Ahngook Newpharm’s passive scope of rights over the patent of the original drug in June, Novartis sought a second trial to appeal. However, just a day before the ruling of the appeal trial, Novartis gave up the appeal.
On Feb. 28, Ahngook won the suit against Novartis’ substance patent for Galvusmet, as the court ruled that the extension of the patent period was invalid.
The patent was to expire in December this year, but Novartis applied for an extension of the expiration. The period added two years, two months, and 23 days. Ahngook and Hanmi Pharmaceutical sought a trial to claim that the patent extension was invalid because clinical trials and drug approval were not in progress for 187 days. IPTAB ruled in favor of Ahngook and Hanmi, and the second trial is in progress.
If IPTAB recognizes the two local companies’ claim, Ahngook will be able to sell its generic drug from September 2021.
Galvusmet’s outpatient prescriptions reached 35.1 billion won ($29.4 million) last year, according to UBIST data. Together with the sales of the monotherapy Galvus, the drug sold 44.1 billion won.
Ahngook was quickly catching up to release the first generic drugs of Galvus and Galvusmet. If Ahngook successfully avoids the patent, it will be able to record robust sales out of the first generic drugs, observers said.
The news of Novartis’ pulling from the second trial pushed up the stock price of Ahngook Pharm by 16.99 percent to close at 12,050 won on Monday.