Kwangdong wins patent lawsuit against Ibrance in reverse

Nine months from the date of notification of application narrowly won the 2nd trial ahead of expiration

Daewoong and Shinpoong who won the first trial and generic for exclusivity

Ibrance

As Kwangdong Pharmaceutical succeeded in reversing the second trial of the patent lawsuit against Ibrance, it boarded the last train for generic exclusivity.

 

As a result, Ibrance's generic for exclusivity is owned by three companies, including Daewoong Pharmaceutical and Shinpoong Pharmaceutical, which won in the first trial, and Kwangdong Pharmaceutical.

 

According to the pharmaceutical industry on the 3rd, the Patent Court ruled in favor of the plaintiff on the 2nd in the patent trial cancellation lawsuit filed by Kwangdong Pharmaceutical against Pfizer.

 

Kwangdong Pharmaceutical, which was defeated in the first trial, succeeded in reversing in the second trial.

 

A total of five companies have challenged the Ibrance patent.

 

These are Kwangdong Pharmaceutical, Shinpoong Pharmaceutical, Daewoong Pharmaceutical, Boryung, and Samyang Holdings.

 

They requested a passive trial to confirm the scope of rights to the Ibrance crystalline patent, which expires in February 2034.

 

Their plan was to avoid crystalline patents and release generics early in time for substance patents to expire in 2027.

 

In the first trial, the decision was mixed.

 

The Intellectual Property Trial and Appeal Board rendered a victory decision for Daewoong Pharmaceutical and Shinpoong Pharmaceutical, and a defeat decision for Kwangdong Pharmaceutical, Boryung, and Samyang Holdings.

 

With the first trial victory, Daewoong Pharmaceutical and Shinpoong Pharmaceutical acquired Ibrance generic for exclusivity.

 

Kwangdong Pharmaceutical, Boryung, and Samyang Holdings, which lost in the first trial, appealed to the Patent Court.

 

Among the three companies, the ruling of Kwangdong Pharmaceutical came out first.

 

Kwangdong Pharmaceutical barely succeeded in obtaining generic exclusivity through a second trial victory.

 

This is because the period for acquiring generic for exclusivity was about to expire.

 

According to the current regulations, there are three requirements to receive generic for exclusivity.

 

A patent trial must be requested for the first time, this trial or subsequent litigation must be won, and a generic license must be applied for the first time.

 

At this time, one proviso clause is attached to the requirement that the judgment and lawsuit be won.

 

The point is that a generic company must apply for generic exclusivity to the Ministry of Food and Drug Safety and obtain a winning trial decision or ruling within nine months from the date the original company is notified of this fact.

 

Kwangdong Pharmaceutical applied for a generic for the exclusivity of Ibrance on August 29 last year.

 

In early September, it is expected that this fact will be notified to Pfizer.

 

In other words, if Kwangdong Pharmaceutical did not win the case by early this month, even generic for exclusivity would be useless.

 

As Kwangdong Pharmaceutical's second trial proceeded quickly, it succeeded in winning the case in early June, and generic exclusivity was eventually made possible.

 

Kwangdong Pharmaceutical is the only company that has even obtained product approval among patent challengers.

 

Kwangdong Pharmaceutical received approval for Alency as a generic version of Ibrance in March of this year.

 

On the other hand, it is analyzed that Boryung and Samyang Holdings, which appealed in the second trial along with Kwangdong Pharm, are highly unlikely to receive generic for exclusivity.

 

The hearing date for Boryung and Samyang Holdings was set for July.

 

Ibrance is a hormone receptor (HR) positive or human epidermal growth factor receptor 2 (HER2) negative treatment for advanced and metastatic breast cancer.

 

According to IQVIA, a pharmaceutical market research institute, Ibrance posted sales of 56.2 billion won in Korea last year.

 

In the first quarter of this year, it was 12.6 billion won, down 13% from the same period last year.