Dispute over Eliquis patent will be closed in six years

Supreme Court announces sentence on the 8th

Price cuts for Eliquis also affect lawsuits

he generic company won the first and second trials. There is increasing interest in whether the decision will change in the Supreme Court.

Eliquis

The six-year-old Eliquis (Apixaban) substance patent lawsuit will be closed next week in the Supreme Court.

 

If the Supreme Court overturns the judgment of the first and second trials and takes the side of the original company, BMS, an all-round lawsuit for damages against related generic companies is expected and attracts attention.

 

The ruling is expected to affect Eliquis prices.

 

It has not yet been lowered even after the generic launch, because BMS has filed a court request to suspend the drug price reduction until the final conclusion of substance patent lawsuit for Eliquis is concluded.

 

According to the pharmaceutical industry on the 2nd, the Supreme Court announced on the 8th the date of the appeal decision on the patent registration invalidation lawsuit filed by BMS against Navipharm, Huons, Intro Bio Pharma, and Alvogen Korea.

 

On March 20, 2015, the dispute over substance patents will be closed after more than six years after Navipharm et al.

 

requested an invalidation trial against a substance patent of BMS.

 

In the preceding 1st and 2nd trials, a generic company has won.

 

In February 2018, the Patent Tribunal ruled that Eliquis' substance patent was invalid.

 

Based on this trial decision, patent challengers tried to release generics for Eliquis early.

 

Prior to this, the patent was also successfully overcome, so it was possible to release it early.

 

However, when BMS applied for a temporary injunction to prohibit patent infringement at the Seoul Central District Court, the release of the generic was put on hold.

 

The Seoul Central District Court accepted the application, and the generics companies had to postpone the release date of September of that year.

 

In March 2019, the Patent Court ruled that substance patents were invalid, similar to the Intellectual Property Trial and Appeal Board.

 

Generics for Eliquis were released one after another.

 

After June 2019 ▲Chong Kun Dang's Liquisia ▲Yuhan's Yuhan Apixaban ▲Samjin's Elxaban ▲Hanmi's Apixban ▲Ajou's Apixaban ▲Yooyoung 's Yupix have been released.

 

It is analyzed that the release of generics has had some effect on the decline in prescription performance of Eliquis.

 

The outpatient prescriptions for the past five years have steadily increased from ₩19.5 billion in 2016 to ₩49 billion in 2019, but fell 3% to ₩47.7 billion last year.

 

The total prescription amount of generics for Eliquis surged from ₩1.2 billion in 2019 to ₩8.3 billion last year.

 

As of last year, Liquisia was ₩2.6 billion, Elxaban was ₩1.7 billion, and Yuhan Apixaban was ₩1.1 billion.

 

Considering the rise in monthly prescription performance, it is expected to exceed ₩10 billion this year.

 

If the Supreme Court approves Eliquis' substance patent, BMS' lawsuit against patent infringement and claims for damages are expected based on this ruling.

 

The generic company is in a situation where it has to return the sales revenue it has earned so far in the event of a discontinuation of generic sales.

 

The ruling is also expected to affect the lawsuit over Eliquis price cut.

 

Earlier, the government announced that it would cut the upper limit by 30% in July 2019 based on the launch of generics.

 

However, BMS applied for suspension of execution to the administrative court because the final result of the substance patent lawsuit did not come out.

 

As a result, Eliquis price remains the same as before.

 

If the Supreme Court takes side with BMS, Eliquis price is likely to remain as they are.

 

If BMS loses, it will be cut from next month.

 

An official in the pharmaceutical industry said, "Like the first and second trials, there is a high possibility of denying the progressiveness of the optional invention." “However, since the Seoul Central District Court has accepted the BMS' provisional injunction application, there is a possibility that a judgment different from the first and second trials may come out.”