Forxiga by AstraZeneca appeals against Dong-A ST

Dong-a wins at the first trial

The new patent avoidance strategy of the 'prodrug' method is also at a crossroads

Forxiga

AstraZeneca, which failed in the first round of the patent dispute over the SGLT-2 inhibitor-based diabetes treatment, Forxiga (Dapagliflozin), launched a counterattack against Dong-A ST.

 

It disagrees with the trial decision of the Patent Tribunal, who sided with the generic company, and filed a lawsuit to the Patent Court of Korea to cancel the trial.

 

As AstraZeneca led the patent dispute to the second trial, the 'Pro-drug' method of patent avoidance strategy brought up by Dong-A ST was also put to the test.

 

In the pharmaceutical industry, The pharmaceutical industry is paying attention to the patent court's ruling on whether a new patent strategy that came out long ago can continue.

 

According to the pharmaceutical industry on the 31st, AstraZeneca filed a lawsuit against Dong-A ST to cancel the trial decision in the Patent Court of Korea on the 28th.

 

The intention is that the trial decision made by the Intecllectial Property Trial and Appeal Board is unfair.

 

On June 23, the Board sided with Dong-A ST in a trial to confirm the passive scope of rights filed by Forxiga on a material patent.

 

This decision received great attention from the pharmaceutical industry.

 

This is because many pharmaceutical companies have challenged Forxiga’s material patent, but only Dong-A ST has succeeded in avoiding it.

 

It is explained that there was a technology called 'pro drug' behind Dong-A ST's ability to overcome the patent.

 

Chemical structure of Dapagliflozin

Prodrugs are a different strategy, seemingly like salt-modifying drugs.

 

It is a kind of incrementally modified drugs.

 

It is a way to improve a little differently from the original by changing the substituent of the substance.

 

However, the difference between the salt and the substituent is large.

 

The chemical structure of the substance itself does not change.

 

The chemical structure of the prodrug is partially changed.

 

There is also a big difference in technology.

 

it can be changed by simple ionic bonding.

 

In the case of prodrugs, the substituents must be changed in a more tricky way, called a covalent bond.

 

The likelihood of success is also lower.

 

The salt change strategy adopted by many generic companies in the past has become impossible due to the so-called 'Solifenacin ruling' in January of last year.

 

The Intecllectial Property Trial and Appeal Board (1st trial) regarded the prodrug as a new one different from the original ingredient.

 

On the other hand, AstraZeneca believes that the product being developed by Dong-A ST exhibits the same pharmacokinetics in the body as Dapagliflozin, and is converted into Dapagliflozin to exert an effect, so it is believed to be infringing Forxiga's material patent.

 

Accordingly, AstraZeneca said that it will reaffirm the scope of the rights of material patents and protect Forxiga's intellectual property rights.

 

Sang-pyo Kim, CEO of AstraZeneca Korea said, "Material patent for Dapagliflozin is the result of research and development with a lot of effort and cost, and such excellent patent technology is respected until the expiration date." Forxiga has two material patents.

 

One expires on April 7, 2023, and the other expires on January 8, 2024.

 

Among them, the patent invalidation lawsuit that expires in 2024 won the first trial by generics, and the second trial is currently underway.

 

Dong-A ST is the only one that has avoided both patents.

 

Dong-A ST is expected to be released in the second half of next year as soon as it has undergone clinical and approval.

 

If it goes as planned, it means that it will be possible to release the generic nine months ahead of other companies.