BMS loses the trial to revoke Eliquis’ 30% price cut

Administrative Court dismisses plaintiff’s claim, the reduced price to be applied from next year

BMS hasn’t confirmed filing another appeal

Bristol-Myers Squibb (BMS) filed an administrative litigation to appeal against the government’s decision to lower pricing of new oral anticoagulant (NOAC) Eliquis (apixaban), but lost the case regardless.

 

At a trial to revoke the Maximum Drug Reimbursement Price Adjustment order by the Minister of Health and Welfare on Dec.

 

19, Seoul Administrative Court has decided to dismiss the plaintiff, BMS’ appeal.

 

The court also ordered the plaintiff to pay for the litigation cost.

 

According to the court ruling, the Eliquis price reduction already postponed twice would be enforced soon.

 

However, BMS has not confirmed their intention to file another appeal.

 

The legal dispute between BMS and MOHW over lowering price of Eliquis actually started from a patent dispute.

 

The Eliquis patent dispute began since March of 2015.

 

Huons and other companies challenged Eliquis’ patent to invalidate it.

 

The Patent Court, as a first trial, had decided that the drug patent is invalidated in February, 2018.

 

The Korean companies won preferential sales approval by Ministry of Food and Drug Safety (MFDS) based on the invalidation ruling.

 

Accordingly, apixaban generic was launched this June.

 

With the generic entering the market, MOHW notified it would lower the maximum reimbursement price of the original Eliquis by 30 percent.

 

The administrative measure was made based on the regulation stating the original’s maximum reimbursement price should be lowered, due to commercialization of its generic, by 30 percent in the first year and to 53.55 percent of the initial price from the following year.

 

Therefore, the price of Eliquis was supposed to be lowered by 30 percent from 1,185 won per tablet to 830 won per tablet.

 

However, BMS requested the Administrative Court to suspend the execution urging the ministry’s decision to lower the price was unfair.

 

Simultaneously, the company officially filed for litigation against the administrative action to drop the drug pricing.

 

The Seoul Administrative Court allowed BMS’ request on suspending the execution.

 

The court stated the patent dispute over Eliquis has not been settled, yet, and the litigation to revoke drug price reduction is still ongoing, so the drug pricing reduction should be deferred until the final decision is made.

 

While the BMS’ litigation was in process, price reduction on Eliquis has been postponed twice.

 

MOHW then has decided to maintain the original’s initial pricing until Dec.

 

31 this year.

 

Finally the last decision on the litigation has been made.

 

But the Seoul Administrative Court that previously accepted BMS’ request to suspend the execution made a contrasting decision during the litigation case.

 

Experts see that the Supreme Court invalidating Elquis’ patent in October has played the key role in the decision.

 

The Supreme Court reaffirmed the first and second trial ruling by the Intellectual Property Trial and Appeal Board and the Patent Court, respectively, and ruled for the generic manufacturers.

 

A legal expert elaborated, “The judge made a polarizing decision for the litigation case than for the suspension of execution trial.

 

Whether or not the judge would quote the suspension of execution trial is not to base on the legality of the plaintiff’s claim, but on the predicted loss and the grounds of litigation.”