GO for patent litigation, NO for suspension of execution

of drug price cuts

Janssen appeals to the Patent Court in the Opsumit patent dispute between Samjin

Janssen Korea has decided not to file a lawsuit for canceling a drug price cut and a request for suspension of execution following the appeal in a patent dispute.

 

It is interpreted as an intention to avoid controversy over the abuse of the suspension system related to the so-called 'Drug Price Reduction and Refund Act' that recently passed the National Assembly.

 

Janssen Korea Opsumit Patent Dispute Appeal Decision.

 

"We will not proceed with the lawsuit to cancel the drug price reduction" According to Janssen Korea on the 19th, the company decided to appeal to the Patent Court in a dispute with Samjin Pharmaceutical over the Opsumit composition patent.

 

This dispute was sparked by Samjin's request for a passive trial to confirm the scope of rights to the Opsumit composition patent in May of last year.

 

In April of this year, Samjin Pharmaceutical won the trial by obtaining a 'claim established' from the Intellectual Property Tribunal (1st trial).

 

Samjin, which won the first trial, released Maciten as the first generic of Opsumit earlier this month.

 

This product was also listed on the list at the same time.

 

Opsumit's price is expected to drop by 30% with the generic drug's insurance coverage.

 

Originally, a price cut was expected this month, but it is said that the drug price cut was delayed by one month of the opinion gathering period, and Janssen Korea has made an objection.

 

Janssen Korea decided not to go through legal procedures to delay the drug price cut in addition to raising objections.

 

It was decided not to file a lawsuit against the government to cancel the drug price cut and to suspend execution accordingly.

 

Many original companies have actively utilized the judiciary's suspension system to delay drug price cuts.

 

Among them, the most common form was prolonged patent disputes.

 

As the final decision has yet to be made, the drug price cut is unfair, so it requested that the drug price cut be suspended until the court makes a ruling.

 

The judiciary cited most of these applications for suspension of execution.

 

Even if it lost in the second trial, the original company prolonged the dispute until the third trial with the same logic, and as a result, the original drug price was maintained for three to five years until the final decision of the Supreme Court.

 

Criticism was raised that the suspension of execution was abused by some.

 

It was criticized for abusing the suspension system, which has a very high quotation rate, to delay drug price cuts even though pharmaceutical companies know they will lose in the main lawsuit.

 

In fact, the Ministry of Health and Welfare has won 100% of the main lawsuits that have been going on so far.

 

When this situation was repeated, the Ministry of Health and Welfare promoted legislation of the so-called Drug Price Reduction and Refund Act.

 

It is a law that contains the basis for recovering health insurance finances that were excessively paid during the suspension of execution after the final judgment.

 

Controversy arose in the course of discussions in the National Assembly, but the government pushed ahead with legislation by adding a provision for refunds in case of opposition, and eventually, this law passed the National Assembly in April.

 

In the case of Opsumit, according to the judgment of Janssen Korea, it was possible to file a lawsuit for canceling a drug price cut and apply for suspension of enforcement.

 

This is because the Drug Price Reduction Refund Act will take effect in November.

 

The law, which passed the National Assembly in April, was promulgated in May, and the effective date is November 20, six months after the date of promulgation.

 

From the perspective of Janssen Korea, it was possible to make the same choice as AstraZeneca Korea recently maintained the drug price of Forxiga through administrative litigation and application for suspension of execution.

 

Janssen Korea decided not to do this.

 

Janssen Korea's decision is to accept the drug price cut for Opsumit, which is expected next month.

 

An official from Janssen Korea said, "After much consideration, we decided against pursuing a separate legal action and accept the financial repercussions, in recognition of the Korean government's drug price system and the potential financial burden on our patients." An official from Janssen Korea explained, "That doesn't mean giving up the Opsumit patent." “We have decided to appeal to the Intellectual Property Trial and Appeal Board, which determined that Samjin Pharmaceutical’s generic products do not fall within the scope of the Opsumit patent, and we filled a lawsuit for revocation of the Patent Court’s decision.” he emphasized.

 

"The application for provisional disposition for patent infringement has not yet been decided."