Dong-A ST submitted an appeal against patent dispute

over Forxiga

Attempts to overcome material patents with a prodrug strategy and mixed judgments in the first and second trials

AstraZeneca SGLT-2 inhibitor-based diabetes treatment Forxiga

The battle over material patent of Forxiga (Dapagliflozin Propanediol Hydrate), an SGLT-2 inhibitor-based diabetes treatment, will head to the third round.

 

The opportunity for Dong-A ST's generic for Forxiga to release is also expected to vary depending on when and how the Supreme Court decides.

 

◆ Dong-A ST, a letter of appeal was submitted According to the pharmaceutical industry on the 7th, Dong-A ST objected to the patent court's ruling on material patent of Forxiga and filed an appeal on the 4th.

 

Battle over the patent is now finalized by the Supreme Court.

 

The key is whether the Supreme Court ruling will be made before April next year, the expiration date of this material patent.

 

From Dong-A ST's point of view, the generic for Forxiga can only be released a day earlier than other generic companies only if it is ruled in favor of the Supreme Court before April next year.

 

If the Supreme Court loses or a ruling is made after April next year, the opportunity for Dong-A ST's exclusive early launch of the generic product will disappear.

 

At this time, the remaining 14 companies that succeeded in overcoming another material patent and received general for excellence will have an opportunity to release the generic early.

 

◆ According to the Supreme Court's ruling, 14 generic companies may dominate the market The reason why the number of cases is so complicated is that AstraZeneca has double-registered Forxiga material patents.

 

AstraZeneca has registered two material patents: "C-aryl glucoside SGLT2 inhibitor (expired on April 7, 2023)" and "C-aryl glucoside SGLT2 inhibitor and inhibition method (expired on January 8, 2024).

 

Generics first challenged patents that expire in January 2024, which are relatively easy to overcome.

 

14 companies, including Kyungdong Pharmaceutical, Kukje Pharmaceutical, Daewon Pharmaceutical, Donghwa Pharmaceutical, Boryung Pharmaceutical, Samjin Pharmaceutical, Shinil Pharmaceutical, Alvogen Korea, Youngjin Pharmaceutical, Ildong, Jeil, Jong Kun Dang, and Hanwha Pharmaceutical, won all the first and won the generic for exclusivity.

 

This patent awaits the Supreme Court ruling with AstraZeneca's appeal.

 

Unless a reversal ruling is made by the Supreme Court, they can sell generic products when their first substance patent expires in April 2023.

 

◆ Dong-A ST which brought up the prodrug strategy, mixed judgment in the first and second trials In April 2018, Dong-A ST filed a passive trial against AstraZeneca to confirm the scope of rights in Forxiga's first material patent.

 

Dong-A ST is the first in Korea to try to overcome Forxiga's material patent using the "Prodrug" strategy.

 

Prodrug is evaluated as a different drug, such as an original drug.

 

The original drug and chemical structure differ in some parts of the substituent until immediately before taking it after the drug is produced.

 

However, when a patient enters the body after taking it, it has the same effect as the original drug.

 

The salt can be converted into a simple ionic bond.

 

The chemical structure of the substance itself does not change.

 

Prodrug has to change the substituent in a more demanding way called covalent bonds.

 

The chemical structure is different from the original drug.

 

There were mixed judgments in the first and second trials on whether prodrucg could be viewed as a completely new substance.

 

Dong-A ST won the first trial and AstraZeneca won the second trial, respectively.