13 drugs were sold before patent termination

13 items including smoking cessation treatment until 6th

Treatment of hepatitis B and erectile dysfunction treatments in progress

Some companies prepare alternatives for cancellation of permits

Domestic pharmaceutical companies were caught largely on charges of sales before patent termination.

 

These pharmaceutical companies reported to the MFDS that they would sell after the end of the patent at the time of the application, but the sale was made even before the end of the patent through reporting on supply.

 

The industry believes that they have committed illegal acts due to a lack of understanding of patent-linkage system introduced in 2012.

 

However, there are criticisms that pharmaceutical companies have responded too easily because the allegations of selling before the end of the patent are just the reason for canceling the license.

 

The MFDS has recently disclosed the results of disposing of products suspected of being sold prior to the termination of the patent.

 

A total of 13 items were revoked by the 5th.

 

These items are generic (Varenicline) for Pfizer's anti-smoking treatment 'Champix', and generic (Bazedoxifene Acetate) for Pfizer's osteoporosis treatment 'Viviant'.

 

It was discovered that the items for cancellation of license were sold before the patent expired.

 

According to the Pharmaceutical Affairs Act, the drug is withdrawn before the period expires if a person who applied for approval or revised approval of a drug is filed to market the drug after the period of a registered patent expires.

 

This was reflected in the Pharmaceutical Affairs Act at the time of the introduction of the licensed patent linkage system in 2012.

 

In the case of generic drugs with original patent rights, the application for permission is accompanied by a confirmation of the relationship of the patent, which is to be sold before patent termination through patent challenge or after patent termination.

 

This is notified to the patent holder so that the patent holder can prepare in advance.

 

A patent owner may make a request for prohibition of sales for nine months with a lawsuit against an item deemed to be infringement of a patent to the MFDS.

 

Although the item that was caught this time has been applied for permission to be sold after the patent is over, it is suspected of being sold even before the patent expires.

 

It is known that the MFDS caught the items sold before the end of the patent through report on supply history and field investigation.

 

Administrative measures are underway because more items are caught than the 13 items that have been released so far.

 

According to the industry, hepatitis B treatment and erectile dysfunction treatment are also included.

 

It is known that some companies have additionally approved salt-altering items in preparation for cancellation of the license or have obtained the same active ingredients through affiliates.