Why Vemlidy's patent dispute took 3 years to win the 1st tri

Dong-A, Dae-Woong, Chong Kun Dang succeeded in avoiding salt modified patent

PMS expires this September, the expiration of PMS at the time of request for trial remains at least one year

Generics, which challenged the patent of Gilead Science's hepatitis B treatment Vemlidy (Tenofovir Alafenamide HemiFumarate), won the first trial in about three years.

 

According to the pharmaceutical industry on the 21st, Intellectual Property recently made a "claim establishment" trial on the passive scope of the Vemliddy salt patent filed by Dong-A ST, Daewoong Pharmaceutical, and Chong Kun Dang against Gilead.

 

The patent expires in August 2032.

 

Pharmaceutical companies that won the first trial have been qualified to release generic products after September, when Vemlidy's PMS period expires.

 

Attention is drawn to this by the referee.

 

Dong-A ST and others requested a trial in December 2018.

 

It took more than three years for the decision to be reached.

 

Generics usually apply for a "priority trial" at the same time when requesting a trial, so it is unusual for the decision to take three years.

 

◆The conclusion was reached 3 years after the request for trial The pharmaceutical industry explains that Vemlidy's remaining PMS expiration period had a decisive impact on the prolonged dispute.

 

Vemlidy's PMS expires on September 12.

 

As of December 2018, when generics requested a trial, Vemlidy's PMS expiration date was about three years and nine months away.

 

However, Intellectual Property did not immediately look into the incident.

 

This is due to Intellectual Property's regulations on preferential trials.

 

Article 31 of the Administrative Rules of Intellectual Property's "Patent Trial Handling" stipulates that the claimant's application for a priority trial must be judged before other cases.This regulation stipulates that "the trial case for patent rights related to drugs whose expiration date of the retrial period is one year after the date of application for priority trial is excluded." When generics filed a patent trial in 2018, Vemlidy's PMS did not expire within a year, so it was excluded from the priority trial, and only recently, when the PMS expiration date was within a year.

 

An official from the pharmaceutical industry explained, "With the implementation of the patent-approval linkage system, there have been more requests for patent trials by generics to accept generic for exclusivity, and I understand that Intellectual Property has set these regulations to prioritize." He said, "Under this regulation, hearings have not been conducted for a while since the request for a trial, but only recently have the Patent Tribunal begun to look into the case," adding, "The rest of the Vemlidy salt patents that have yet to be concluded are expected to come out soon." Vemliddy is another hepatitis B drug from Gilead, generic for Viread.

 

The active ingredient is Tenofovir Disoproxil Fumarate, but Gilead has newly developed the drug in pro-drug form.

 

This improved drug resistance and kidney toxicity side effects.

 

Vemlidy is rapidly replacing existing Viread in the hepatitis B treatment market.

 

According to IQVIA, pharmaceutical market research firm, Vemlidy's sales surged in four years from 500 million won in 2017 to 28 billion won last year, the first year of its launch.

 

During the same period, Viread's sales fell nearly half from 129.3 billion won to 63.1 billion won.