Supreme court to finally rule on ‘Galvus’ patent dispute

Final ruling on Galvus dispute to be made next week

Supreme court announced that it will make a ruling on the 28th… mixed rulings at 1st and 2nd trial

Interest rises on whether this would be the first case of overcoming ‘the extended term of a patent’

The 4-year long patent dispute over the patent of the anti-diabetic DPP-4 inhibitor ‘Galvus (vildagliptin)’ will finally come to an end at the Supreme Court on the 28th.

 

Industry officials believe that the Supreme Court’s decision may affect and modify the overall patent strategies of generic companies in the coming future.

 

If the Supreme Court rules in favor of Ahn-Gook Pharmaceuticals, this will greatly increase the number of challenges filed on substance patents of original drugs, which have been considered impregnable.

 

◆Will the first ‘invalidation of substant patent extension’ case be born?

According to industry sources on the 20th, the Supreme Court issued a notice that it will rule on the Galvus patent dispute between Ahn-Gook Pharmaceutical and Novartis on the 28th.

 

The issue, in this case, is how much of the "extended duration" of the drug substance patent will be considered invalid.

 

The industry anticipates that the Supreme Court’s decision may affect and modify the overall patent strategies of generic companies that will be made.

 

Until now, there has never been a case in which a generic company has overcome the extended term of a drug substance patent.” If the supreme court rules in favor of the generic company and renders even one day of the extended patent term invalid, this will may trigger a series of challenges on substance patents of original drugs, an area that has been considered impregnable.

 

On the other hand, if the Supreme Court accepts Novartis’ claim and recognizes the entire extended period as is, generic companies are expected to maintain their current patent strategy.

 

◆Mixed rulings at 1st and 2nd trial… what will the Supreme Court’s ruling be? Patent rights are usually protected for 20 years from the filing date.

 

For pharmaceutical products, the time taken for clinical trials and regulatory approval is added to the term.

 

Depending on the recognized period, patent protection for a drug can last 21 years or even 22 years.

 

The same applied to Novartis when applying for Galvus’s patent in Korea.

 

The company requested the patent term for Galvus to be extended to make up for the time spent on clinical trials and for the regulatory review by the Ministry of Food and Drugs Safety.

 

The Korean Intellectual Property Office accepted the request and extended the term by 2 years, 2 months, and 23 days (1068 days).

 

Pic.

 

of Galvus

Ahn-Gook Pharmaceutical claimed that ‘187 days’ of the extended term for Galvus’s substance patent was invalid.

 

Hanmi Pharmaceutical later joined in the fight.

 

The court ruled in favor of Ahn-Gook Pharmaceutical in the first trial.

 

The Patent Court of Korea accepted Ahn-Gook’s claim and ruled the 187 days invalid.

 

With the ruling, Ahn-Gook Pharmaceutical received the right to release its generic 187 before the expiry of Galvus’s substance patent.

 

Novartis got a partial win in the second trial.

 

The Intellectual Property Trial and Appeal Board had overturned the first instance judgment and ruled that only 55 of the 187 days are invalid.

 

Despite the reduced period, the ruling still rendered a part of the period invalid.

 

As a result, Ahn-Gook did lose the suit but reaped the rewards.

 

Novartis once again appealed, and the case is now being reviewed by the Supreme Court.

 

Novartis is claiming that not a single day should be rendered invalid.

 

The Supreme Court's ruling is expected to be one of the three – recognizing the ‘187 days invalid’ by accepting the ruling of the first trial; recognizing the ’55 days invalid’ by accepting the ruling of the second trial, or accepting Novartis’ claim and not recognizing any part of the term invalid.