All bets are off for patent dispute of Galvus

Ahn-gook gave up the appeal. Choosing the KIPO instead of going to the Supreme Court

Patent Court of Korea '55 days' ruling, the key to acceptance by the KIPO

가브스 제품사진.

The patent dispute over the DPP-4 inhibitor-based diabetes treatment'Galvus (Vildagliptin)' turns around and ends at the KIPO.

 

The Patent Court of Korea sided with Novartis, and Ahn-gook, who lost, gave up the Supreme Court appeal, and the KIPO finally took over the case again.

 

According to the pharmaceutical industry on the 17th, Ahn-gook abandoned its appeal to the Supreme Court after losing the second trial in patent dispute of Galvus with Novartis.

 

With Ahn-gook giving up his appeal, the stage of the dispute is expected to shift back to the KIPO.

 

◆Conflicting 1st and 2nd Judgment...

 

Material patent invalidation period 187 days → 55 days Ahn-gook and Novartis have been in dispute for more than three years.

 

The issue is how much of the'extended duration' of Galvus material patent of Galvus is invalid.

 

When Novartis first registered the material patent of Galvus, it requested that the patent duration be extended by the time it took to supplement the data required by the MFDS.

 

The request was accepted by the Patent Court of Korea, and the duration was extended by two years and two months.

 

In short, the material patent expiration has been delayed from January 2020 to March 2022.

 

In July 2017, Ahn-gook argued that some of this extended substance patent duration was invalid.

 

The KIPO sided with Ahn-gook.

 

Out of a total of two years and two months, it was decided that '187 days' was invalid.

 

◆Novartis objected.

 

The KIPO filed a lawsuit in the Patent Court to cancel the trial decision. After the patent court of Korea ruling, Ahn-gook had two options.

 

Through appeal, the Supreme Court had to more actively insist the period of invalidity, or whether to renounce the appeal and return to the Patent Court of Korea to be tried again.

 

Consequently, Ahn-gook chose to abandon the appeal.

 

To choose to go to the Supreme Court, an appeal must be filed within 14 days of the date the decision was reached (October 30), but Ahn-gook did not file an appeal within the deadline.

 

It is said that Ahn-gook was deeply concerned about the decision to abandon the appeal.

 

The reason Ahn-gook struggled was that the second trial ruling was unclear.

 

Ahn-gook benefited from the court's ruling in some of Novartis' prevailing decisions.

 

Although the period of invalidation of Ahn-gook was reduced from 187 days to 55 days, it is still evaluated that it is not practically bad in that some were recognized as invalid.

 

Moreover, considering that there has been no case of overcoming the duration of an original material patent by invalidity even for a single day, it is worth just 55 days.

 

With Ahn-gook's renunciation of appeal, the dispute is expected to continue at the KIPO again.

 

It has a similar shape to the case that the superior judge canceled and returned the lower court in the general court.

 

◆Will the KIPO accept the judgment of “55 days” The key is whether The KIPO will accept the opinion of the Patent Court of Korea's '55 days of validity'.

 

In the usual remand after reversal case, the lower judge mostly cites the opinion of the higher one.

 

However, in this case, Novartis is strongly opposed to acknowledging the period of invalidity, and the dispute is expected to develop fiercely again.

 

If the KIPO accepts the opinion of the Patent Court of Korea, the release date of Ahn-gook's Galvus generic is likely to be delayed by 130 days from mid-August 2021 to early January 2022.

 

A pharmaceutical industry patent official said, "Novatis, who won the second trial as Ahn-gook gave up the appeal, has legally lost its appeal status.

 

Patent dispute of Galvus is automatically resumed at the KIPO." "The dispute between Novartis and Ahn-gook will be fierce again over how much invalidity will be," he said.