Novartis "No more order suspension for Myfortic 3rd trial"

Novartis “To lessen wasteful loss,” pressured by NA

“The Supreme Court to tell if pricing reduction prior to final decision on patent is just”

Although Novatis took an appeal case on the pricing reduction order for Myfortic Enteric Coated Tablet to the Supreme Court, the company has reportedly decided to not request to halt the administration order.

 

Even if the South Korea’s Ministry of Health and Welfare (MOHW) issues an order to bring down the drug pricing according to the second trial, the company means to give up on the request to delay the order execution until the end of the Supreme Court decision.

 

Sources analyze the multinational company has felt the pressure from the National Assembly.

 

According to pharmaceutical industry sources on Oct.

 

23, Novartis has recently made the decision during an internal meeting.

 

◆Requested postponement of pricing reduction order criticized as ‘buying time’ Typically, when a pharmaceutical company files litigation against MOHW’s order to reduce the drug pricing, the company simultaneously request the administrative order to be suspended.

 

Basically, the company is asking the court to postpone the pricing reduction until the final decision is made.

 

Most of the court cases accept such request, which is why the public makes reproachful comment about the pricing reduction litigation naming them ‘time-wasting’ or ‘abuse of the judicial system.’ Regardless of the court rules in favor of MOHW’s administrative order, the pharmaceutical company has opportunity to appeal.

 

And for those appeals in the second and third trials, the companies again request the court to suspend the order.

 

Taking the case until the third trial, the company buys time as much as possible before the pricing reduction.

 

As for the company, it is more profitable to file litigation, while maintaining the original pricing and making sales.

 

So far, MOHW won all eight cases of pricing reduction order litigations.

 

Considering the precedents, the public point a figure at companies routinely filing litigation with a hidden agenda to suspend the administrative order.

 

The office of Democratic Party Lawmaker In Jaekeun claimed the NHI financial loss is projected at 150 billion won from 2018 through last July due to repeatedly delayed drug pricing order.

 

◆The public label litigation ‘time-wasting,’ Novartis says “No more order suspension in third trial”

To this date, total 17 cases resembled such case.

 

And Novartis’ Myfortic is a great example.

 

With generics launching in April 2018, MOHW issued a notice stating the pricing of Myfortic would be reduced by 30 percent.

 

The order has been delayed even until now.

 

The tablet is still priced at 1,382 won (180 mg).

 

In last month, the court for the second trial has ruled the same as the first trial and said the order was just.

 

The company relentlessly filed an appeal to the Supreme Court.

 

The pharmaceutical industry suspects Novartis would request for the third suspension on the administrative order when filing the appeal.

 

But the company confirmed the third request would not be made.

 

Novartis official on the phone with Daily Pharm stated, “The company has decided not to seek for administrative order suspension to lessen wasted resources and unnecessary l confusion.” The industry experts analyze the company felt the heavy pressure from the lawmakers at the National Assembly.

 

During the National Assembly annual audit by the Health and Welfare Committee convened on Oct.

 

13, Lawmaker In Jaekeun criticized “Administrative litigation and request for pricing reduction suspension have ultimately become a formality to solely benefit pharmaceutical companies.” “An indemnity should be demanded or a penalty should be imposed on companies filing money-making litigation that buys time without a clear purpose,” the lawmaker added.

 

◆Is it fair to order pricing reduction before the final decision on patent litigation is made?

 

Besides the request to halt the administrative order, Novartis has submitted a petition for an appeal and plans to clearly confirm if the pricing reduction order was just.

 

The point of the litigation is to see if it was fair for the government to bring down the original’s pricing, due to a generic launched before the patent litigation was fully concluded.

 

The current regulation allows a generic company to release a follow-on drug, when the company wins during the patent dispute.

 

It does not matter either the Intellectual Property Trial or the Appeal Board (first trial) or the Patent Court (second trial).

 

Once a generic challenges and overcomes the original’s patent, it can be released in the market.

 

And when a generic enters the market, MOHW drops the original’s price.

 

But Novartis claims the pricing reduction before the second or third trial is unfair as sometimes the decision from the first trial could be overturned.

 

The company explains the price reduction during the in between time would make a loss for the company.

 

The Novartis official said, “The company calls for the Supreme Court’s decision to judge if the current government statute regarding the pricing reduction is adequate.

 

During the third trial, the company would assertively appeal the unfairness.”