Genuone challenges Trajenta’s non-listed patent...Why?

Requests trials on 5 cases that are not listed on the patent register

“To remove uncertainties regarding the release of generic drugs and to additionally attract CMO deals”

Genuone Sciences has challenged the unlisted patents of Trajenta (linagliptin).

 

Industry interpretations are that the move is the company’s strategy to remove uncertainties in releasing generic versions of Trajenta and to additionally attract CMO deals” According to industry sources on the 24th, Genuone Sciences filed a trial to confirm the passive scope of patent rights and invalidation trials for the 5 Trajenta patents, 3 of which are use patents set to expire in May 2027, and one substance and one process patent set to expire in April 2027.

 

One interesting thing to note is that all these patents are not listed on Korea’s patent register.

 

As the patents are not listed on the register, the companies will have no problem obtaining approval for their generic versions even if they do not overcome the patents.

 

However, the situation is different in terms of releasing the products into the market.

 

Administratively, generic drugs can be released when the listed patents expire, but this carries the burden of being involved in a patent infringement lawsuit with the original company.

 

If the original company files an application for an injunction to block the release of the product at the same time it files the patent infringement lawsuit, the release date of generics can be delayed for companies.

 

Also, if generic companies lose the patent infringement lawsuits, this may lead to lawsuits for damages.

 

This is why many generic companies have been challenging unlisted patents to remove uncertainties.

 

Genuone Sciences’ challenge of Trajenta’s unlisted patents is also interpreted to be along this line.

 

There is also the interpretation that Genuone Sciences challenged the unlisted patents of Trajenta to attract additional CMO deals.

 

Genuone Sciences succeeded in avoiding and invalidating the existing Trajenta patent but was unable to receive generic exclusivity (first generic marketing exclusivity) for the drug because it wasn’t able to satisfy the ‘initial request for trial’ condition.

 

19 companies including Alvogen Korea own generic exclusivity for Trajenta generics.

 

In this context, other companies will be interested in the CMO manufacture of Trajenta generics if Genuone Sciences succeed in removing uncertainties by avoiding and invalidating the unlisted patents.

 

Genuone Sciences CMO Trajenta generics for White Life Science and Pharmgen Science.

 

The company made agreements to manufacture the 2.5mg/1000mg dose only for White Life Science, and manufactures the 5mg/500mg and 2.5mg/850mg dose for White Life Science and Pharmgen Science.

 

By formulation, this means that the company may take on 1-2 more companies for manufacture.

 

Trajeta is Boehringer Ingelheim’s DPP-4 inhibitor antidiabetic.

 

Its outpatient prescription sales had been KRW 130.7 billion for the single agent (Trajenta) and combination agent (Trajenta Duo) last year.

 

Trajenta raised KRW 94.2 billion in sales until Q3 this year.

 

The patent for the product is set to expire in June 2024.

 

65 companies have overcome Trajenta's patent and received approval to manufacture its generics.

 

The companies are expected to release their products at the time of Trajenta’s patent expiry.