19 Korean companies partially win Forxiga patent dispute

Patent Court rules against AstraZeneca’s appeal to cancel preceding decision

Generic companies with preferential sales rights to release follow-on drugs in January 2024

Product image of Forxiga

A South Korean court ruled in favor of the generic companies in an appeal case for a patent dispute on an antidiabetic sodium-glucose co-transporter-2 (SGLT2) inhibitor Forxiga (dapagliflozin).

 

The original company AstraZeneca lost another patent litigation in a higher court after losing from the Intellectual Property Trial and Appeal Board’s case.

 

On Oct.

 

29, the Patent Court has rejected AstraZeneca’s appeal filed in last May to undo the preceding Intellectual Property Trial and Appeal Board’s decision ruled for 19 pharmaceutical companies with the generics.

 

Regardless, the generic companies again won the five-month-long appeal case.

 

The following companies participated in the case; Kukje Pharma, Intro Biopharma, Han Wha Pharma, Daewon Pharmaceutical, KyungDong Pharmaceutical, Dong-A ST, Samjin Pharm, JW Pharmaceutical, Boryung Pharmaceutical, Jeil Pharmaceutical, Yungjin Pharm, Chong Kun Dang, Ildong Pharmaceutical, Alvogen Korea, Dongwha Pharm, Korea United Pharm, Korea Biochem Pharm, Hanmi Pharmaceutical and Sinil Pharmaceutical.

 

Most of them received the preferential sales rights in last August, as their preceding case allowed them to meet the qualifications of filing and winning the first patent challenge.

 

Accordingly, the companies would be able to release their generics early beginning from Jan 8, 2024.

 

The patent dispute around Forxiga started from 2015.

 

The companies developing the generics first challenged the pharmaceutical formulation patent.

 

They both won the negative patent scope confirmation and the patent nullification cases.

 

The generic companies also challenged the substance patent.

 

Forxiga has two substance patents.

 

One is to expire on Apr.

 

7, 2023, and another one on Jan.

 

8, 2024.

 

The latest decision was made on the patent expiring on Jan.

 

8, 2024.

 

A legal expert commented, “The second patent was on a compound sharing a different number of carbons compared to another original substance.

 

Based on the similarities, the Patent Court has reportedly stated the Forxiga substance lacked novelty and non-obviousness.” However, the generic companies failed to overcome the patent expiring in 2023.

 

Only Dong-A ST with the ‘prodrug’ strategy won the first trial.

 

Refusing to accept the Board’s decision, AstraZeneca has filed an appeal to the Patent Court to revoke the decision.

 

If Dong-A ST also wins the second trial, it would be able to precede the launch of other follow-on drugs with the preferential sales rights by about seven months.